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WOUNDCHEK Bacterial Status (WCBS) is an in vitro diagnostic chromatographic test for the qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for use in adult patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and 6 months of age that are

WOUNDCHEK Bacterial Status (WCBS) is a lateral flow assay that qualitatively detects bacterial protease activity in chronic wound fluid. Wound fluid is collected by rolling a swab over the cleansed wound surface until it is saturated. The swab is then incubated in the assay reagent which contains a substrate that can be cleaved by bacterial proteases and human neutrophil elastase (HNE) and an HNE inhibitor. The WCBS test card is used to detect cleavage products of the substrate. It consists of biotinylated bovine serum albumin (BSA) (Test Line (T)), and a control system protein, (Control line (C)), on a nitrocellulose membrane support. Neutravidin, which is conjugated to visualizing particles, binds the biotinylated end of a synthetic peptide and the biotinylated BSA test line. The test result is based on the presence or absence of a pink-to-purple colored Test Line (T) which means bacterial protease activity was detected. A negative test result is defined by the absence of a Test Line (T) which means bacterial protease activity was not detected. If the control line (C) is not present, then the test result is invalid. The device is intended for use on venous leg ulcers (VLU), diabetic foot ulcers (DFU) and pressure ulcers (PU).

A control kit, consisting of negative and positive swabs, is also available for WOUNDCHEK Bacterial Status.

Here's an analysis of the acceptance criteria and the study that proves the WOUNDCHEK Bacterial Status device meets these criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• Moderate Positive: 98.5% (133/135) agreement
• Low Positive: 95.6% (129/135) agreement
• True Negative: 97.8% (132/135) agreement
  The high negative panel member had 93.3% (126/135) agreement, acknowledged as variable but acceptable given its nature. No significant differences by site, operator, or day were reported. |
  | Sample Stability | Testing of all positive and negative swabs for various storage conditions (up to 9 hours at 2-8°C and 30°C) generated expected results. | Met.
  Ten positive and negative swabs were tested for each storage condition (0.5, 1, 1.5, 2, 4, 6, 9 hours at 2-8°C and 30°C). All generated expected results. Interpretations were made by two blinded operators, with a total of (b)(4) determinations per condition. Daily controls met expectations. |
  | Detection Limit (LOD) | LOD defined as the level of bacterial protease activity generating a positive result ~95% of the time (C95). C5 level also identified. | Met.
  Preliminary and confirmed LODs (C95, C5, C50) were established for individual proteases (V8, GelE, ZapA, LasB) and a pooled mix of these proteases, consistent with the objective of defining these detection levels. (Specific mU/test values are redacted but are reported as being established). |
  | Cross-reactivity - Human Proteases | Positive swabs must produce a positive result in the presence of any host protease. Negative swabs must produce a negative result in the presence of any host protease. | Met.
  The study identified specific concentrations of human proteases (e.g., MMP-13, MMP-9, HNE, Plasmin) at which no interference was observed with WCBS performance for both positive and negative samples. If initial levels showed interference, dilutions were tested until criteria were met. |
  | Interference - Microbial | Positive swabs (with analyte) must produce a positive result in the presence of tested microorganisms. Negative swabs must produce a negative result in the presence of tested microorganisms. | Met.
  The study determined specific levels of various fungi, mold, and viruses (e.g., Candida species, Aspergillus fumigatus, Herpes Simplex viruses) at which no interference was observed. If initial levels showed interference with stock solutions, log dilutions were tested until criteria were met. |
  | Interference - Healthy Skin Flora | Implied: Device should ideally not react to normal skin flora unless these flora are indicative of bacterial protease activity leading to non-healing. However, the study identified that performance is affected by normal skin flora. This led to a labeling mitigation. | Met (with mitigation).
  Out of (b)(4) apparently healthy skin swab samples, 20 were positive by both operators, and an additional 4 by one operator, totaling 44 false positives out of 102 readings. While the device is affected, this finding is acknowledged as expected due to skin flora secreting proteases. The mitigation is a prominent instruction in the IFU: "Do not swab intact skin." |
  | Interfering Substances | Positive swabs must produce a positive result in the presence of the interfering substance. Negative swabs must produce a negative result in the presence of the interfering substance. | Met.
  The study identified specific concentrations for a wide range of wound-related substances (e.g., acetic acid, silver dressings, Manuka honey, mupirocin, blood, various antibiotics, skin substitutes, iodine, antifungals) at which no interference was observed. If a substance failed at the initial level, it was diluted twofold until criteria were met. |
  | Clinical Performance (Risk Assessment for Non-Healing) | Provide Positive Likelihood Ratio (PLR) and Negative Likelihood Ratio (NLR) for indication. | Met (with caveats).
  For the intended use population (wounds

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The ID NOW Influenza A & B 2 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

The ID NOW Influenza A & B 2 system utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver single use, disposable containing the elution buffer
• Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and
• ID NOW Instrument repeat use reader.

The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

ID NOW Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided FDA 510(k) clearance letter and summary for the "ID NOW Influenza A & B 2" device (K190204) primarily focus on a labeling modification to expand specimen transport and storage instructions. It explicitly states: "This is a labeling update only, there have been no changes to the Intended Use or fundamental scientific technology of the ID NOW Influenza A & B 2 assay."

Therefore, this document does not contain the details of an acceptance criteria study or the detailed performance data as would be found in an original 510(k) submission for the device itself. Instead, it refers to the predicate device (K173932), implying that the performance criteria and supporting studies were established and documented during the clearance of that predicate device.

Based on the provided text, I cannot describe a new acceptance criteria study or new performance data for K190204, as this submission explicitly states none were performed for the device's fundamental function.

However, I can extract information related to the device itself and its general intended use, and explain why the requested information isn't present in this specific document.

Analysis of Provided Document's Relevance to Acceptance Criteria and Study Details:

The current document (K190204) is a "Special 510(k)" submission for a modification to an already cleared device. This type of submission does not typically include a full re-evaluation of the device's fundamental performance unless the modification directly impacts its safety or effectiveness in a new way. In this case, the modification is explicitly stated as only a labeling change related to specimen storage.

Therefore, the document does not provide the following information directly:

• A table of acceptance criteria and reported device performance for K190204 itself, because no new performance study was conducted for this specific submission. The performance data would have been part of the original submission for K173932.
• Sample sizes used for a test set for this submission.
• Protocols for establishing ground truth (experts, adjudication, etc.) for a substantial performance study.
• Details of MRMC studies or effect sizes.
• Standalone performance data (as this is a labeling update, not a new device or performance claim).
• Details on training set sample size or ground truth establishment for a new AI/algorithm (as this is a molecular diagnostic test, not an AI-based imaging diagnostic).

Information that can be inferred or directly stated from the document:

• Device Type: Rapid molecular in vitro diagnostic test. This is important because the requested ground truth types (pathology, expert consensus) are more relevant to imaging AI; for molecular diagnostics, ground truth is typically established by definitive laboratory methods (e.g., PCR reference methods, viral culture).
• Technology: Isothermal nucleic acid amplification technology.
• Targets: Influenza A and B viral RNA.
• Sample Type: Direct nasal or nasopharyngeal swabs, and nasal/nasopharyngeal swabs eluted in viral transport media.
• Result Type: Qualitative (detection/discrimination).
• Internal Control: Yes.
• Result Interpretation: Automated.
• Predicate Device: K173932 (ID NOW Influenza A & B 2). This implies that the validation and acceptance criteria for performance were established during the clearance of K173932.

Hypothetical Example of how the requested information would be presented for a diagnostic device, if this document were an original submission with performance data:

If this were an original 510(k) submission for a new diagnostic device requiring clinical validation, the document would typically include sections detailing:

1. Acceptance Criteria and Performance:

   Performance Metric	Acceptance Criteria (e.g., % Concordance)	Reported Performance (e.g., % Concordance, Sensitivity, Specificity)
   Overall Agreement	≥ 95%	97.2%
   Positive Agreement (PPA) for Flu A	≥ 90% (vs. Comparator X)	93.5% (vs. RT-qPCR)
   Negative Agreement (NPA) for Flu A	≥ 95% (vs. Comparator X)	98.1% (vs. RT-qPCR)
   Positive Agreement (PPA) for Flu B	≥ 90% (vs. Comparator X)	92.8% (vs. RT-qPCR)
   Negative Agreement (NPA) for Flu B	≥ 95% (vs. Comparator X)	97.5% (vs. RT-qPCR)
   Limit of Detection	Defined concentration (e.g., X copies/mL)	Y copies/mL
   Cross-Reactivity	No cross-reactivity with specified organisms	No cross-reactivity with A, B, C...
   Note: The specific metrics and thresholds would depend on the device type and intended use.

2. Sample Sizes and Data Provenance (for test set, if applicable to a clinical study):

   • Sample Size: e.g., 500 clinical samples (250 positive, 250 negative)
   • Data Provenance: Prospective collection from multiple clinical sites in the USA. Samples collected from patients presenting with signs/symptoms of respiratory infection during influenza season.

3. Ground Truth Establishment (for test set, if applicable):

   • Number of Experts/Reference Methods: Ground truth established by a highly sensitive and specific reference method, such as real-time Reverse Transcription Polymerase Chain Reaction (RT-qPCR) with validated primers and probes, performed by a CLIA-certified laboratory.
   • Qualifications of Experts (if human review was part of GT): Not directly applicable for a molecular test's primary ground truth, but if comparator methods involved experts, their qualifications (e.g., board-certified clinical microbiologists) would be relevant.

4. Adjudication Method:

   • Not applicable as primary ground truth is objective molecular test; if discordant results between the device and the reference method were analyzed, they might be adjudicated by re-testing or sequencing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable for a molecular diagnostic device of this type, as it does not involve human readers interpreting images or data for diagnosis. This type of study is common for AI-powered imaging devices.

6. Standalone Performance:

   • The "reported performance" table above is the standalone performance for a fully automated molecular diagnostic device like this. There is no "human-in-the-loop" for result interpretation.

7. Type of Ground Truth Used:

   • Reference molecular testing: Typically RT-qPCR or similar highly sensitive and specific molecular assays, often using independent, validated methods. In some cases, viral culture could also be used as a reference. Clinical outcomes data might be used in broader epidemiological studies but not typically as the direct ground truth for analytical device performance.

8. Training Set Sample Size:

   • For a molecular diagnostic test, "training set" doesn't apply in the same way as for AI. Instead, there would be extensive analytical validation data (e.g., inclusivity, exclusivity, LOD, linearity, precision) generated by testing panels of characterized specimens and analytical dilutions. The "sample size" here would refer to the number of characterized panels and replicates used for these studies.

9. How the ground truth for the training set was established:

   • Again, for a molecular diagnostic, this refers to how the analytical samples were characterized. This is typically done through nucleic acid sequencing, quantitative PCR, or other highly accurate methods to determine the presence, type, and concentration of the target analyte in analytical samples. Clinical samples used in analytical studies would be highly characterized using established reference methods.

In summary, while the provided document gives valuable information about the device's intended use and the specific change for this 510(k), it does not contain the detailed performance study information that would have been part of the original 510(k) submission (K173932) for the ID NOW Influenza A & B 2 device.

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The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader.

Performance characteristics for influenza A were established during the 2015-2016 influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specimens. Influenza specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. The test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the top of the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive, neqative or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

A table of the acceptance criteria and the reported device performance is not explicitly provided in the text. However, the study aims to demonstrate that a software modification to the Alere™ Reader does not negatively impact the performance of the Alere BinaxNOW® Influenza A & B Card 2.

The study compared the performance of the Alere BinaxNOW® Influenza A & B Card 2 with the new software modification to the legally marketed predicate device (K173502). The core of the study involved testing clinical samples and comparing the results from the modified device with the predicate device.

Here's an analysis of the provided information concerning the study and ground truth:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not directly presented as a table in the provided text. The submission describes a software modification to mitigate false positive results and states that the new device was compared to the predicate. To fully describe the acceptance criteria, one would typically need access to the original 510(k) submission (K173502) for the predicate device, as the current submission is a "Special 510k" focused on a software change, implying the goal is to maintain the performance of the predicate. The text states the study was performed to show that the modified software does not negatively impact performance and shows no statistically significant performance difference between the modified software and the predicate.

2. Sample Size used for the test set and the data provenance:

   • The text states: "An evaluation was performed using 123 positive and 115 negative clinical samples..." This indicates a total of 238 clinical samples were used in the evaluation.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The data is from retrospective clinical samples as they were "clinical samples that were previously tested" with the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

4. Adjudication method for the test set: Not specified in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The Alere Reader is an automated instrument, and the study compares two versions of the software in the instrument, not human readers with or without AI assistance. The reader performs the interpretation, so there's no human reading component for comparison in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the evaluation described is a standalone performance of the algorithm within the Alere™ Reader. The device reads and interprets the test result without human intervention for the reading step (the user interface displays the result, but the reading itself is automated).

7. The type of ground truth used: The ground truth for the clinical samples was based on "previously tested" results with the predicate device, implying a comparison to the established performance of the predicate. For the initial predicate device (K173502), the ground truth for influenza detection would typically be established by cell culture or an FDA-cleared influenza A and B molecular assay, as stated in the Indications for Use: "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay."

8. The sample size for the training set: Not specified. The submission describes a modification to existing software, implying the initial training would have occurred for the predicate device's software. This particular submission does not detail creation of a new training set.

9. How the ground truth for the training set was established: Not specified, as training set details are not provided in this document focused on a software modification. For the original validation of the predicate reader, the ground truth for training would likely have been established using well-characterized samples (e.g., confirmed by cell culture or molecular assay).

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Alere i Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Alere™ i Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Streptococus pyogenes Group A Strep from throat swab specimens. The Alere™ i Strep A 2 System utilizes isothermal nucleic acid amplification technology and is comprised of:

• . Sample Receiver - single use, disposable containing the elution buffer
• Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and ●
• . Alere™ i Instrument – repeat use reader

The reaction tubes in the Test Base contain the reagents required for Streptococcus pyogenes Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Streptococcus pyggenes, Group A Strep and fluorescently labeled molecular beacons designed to specifically identify the amplified nucleic acid targets. Alere™ i Strep A 2 is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

Here's a summary of the acceptance criteria and study details for the Alere™ i Strep A 2 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document doesn't explicitly state all "acceptance criteria" as clear numerical thresholds for performance metrics. However, it presents the clinical performance of the device against a comparator method (bacterial culture), and these reported values implicitly demonstrate that the device met the necessary performance expectations for clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study): 981 evaluable throat swab specimens.
• Data Provenance: Multi-center, prospective clinical study conducted at nine (9) US trial sites in 2017.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document states that the Alere™ i Strep A 2 performance was evaluated "in comparison to bacterial culture." Bacterial culture is typically performed in a laboratory by trained microbiologists using established protocols. The document does not specify the number of experts, nor their specific qualifications (e.g., years of experience), but implies standard laboratory practices for culture results.
• For discrepancies, a "laboratory developed real-time PCR assay" was used for confirmation. This also implies expert analysis within a laboratory setting, but specific expert details are not provided.

4. Adjudication Method for the Test Set

• The primary ground truth for the clinical study was bacterial culture. In cases of discordance between Alere™ i Strep A 2 and bacterial culture, a "laboratory developed real-time PCR assay" was used for further investigation:
  • 38 of 52 samples positive by Alere™ i Strep A 2 and negative by bacterial culture were positive by PCR.
  • 1 of 3 samples negative by Alere™ i Strep A 2 and positive by bacterial culture was negative by PCR.
• This suggests an implicit adjudication based on a tertiary, highly sensitive method (PCR) for resolving some discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (IVD) molecular test, not an imaging or diagnostic assistant used by human readers in the traditional sense. The output is an automated positive/negative result.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the clinical performance study directly reflects the standalone performance of the device (Alere™ i Strep A 2) without human interpretation affecting the result. The device is "instrument-based" and provides "automated" results. The operator's role is to perform the assay steps, but the diagnostic determination is made by the instrument/algorithm.

7. The Type of Ground Truth Used

• The primary ground truth used for the clinical performance study was bacterial culture of throat swab specimens.
• For discordant results, a laboratory-developed real-time PCR assay was used as a confirmatory method.

8. The Sample Size for the Training Set

• The document does not provide information regarding a specific training set size. For IVD devices, especially molecular diagnostic kits, the "training" (development and optimization) process typically involves internal analytical studies rather than a distinct, prospectively collected "training set" of clinical samples with established ground truth in the same way an AI/ML algorithm might. Clinical studies are primarily for validation.

9. How the Ground Truth for the Training Set Was Established

• As a molecular diagnostic test, the "ground truth" for its development (analogous to a training set for AI) would primarily rely on well-characterized clinical samples and reference strains with known Streptococcus pyogenes status confirmed by methods like culture and sequencing during the assay development and optimization phases. However, the document does not detail this. The provided clinical study serves as the primary validation of the device against bacterial culture as the ground truth.

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The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preciude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus progeness, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

The Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) virus (RSV) virus (RSV) virus (RSV) virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs cluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children

Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal or nasopharyngeal swab specimens eluted in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.

Alere™ i RSV is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of respiratory syncytial virus (RSV) viral RNA from direct nasopharyngeal swab (NPS) and NPS eluted in viral transport media from patients with signs and symptoms of respiratory infection.

Alere™ i Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

All Alere™ i assays utilize isothermal nucleic acid amplification technology and are comprised of:

• Sample Receiver single use, disposable containing the elution buffer .
• . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge sinqle use, disposable for transfer of the eluted sample to the Test Base, and ●
• Alere™ i Instrument repeat use reader .

The reaction tubes in the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 Test Base contain the reaqents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

The reaction tubes in the Alere™ i Strep A Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.

The reaction tubes in the Alere™ i RSV Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i RSV utilizes a pair of templates (similar to primers) for the specific amplification of RNA from RSV A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

All Alere™ i assays are performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the Iyophilized pellets contained within the Test Base and initiating bacterial lysis (for Alere™ i Strep A) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

This document describes a Special 510(k) submission for the Alere™ i Instrument and its associated assays (Influenza A & B, Strep A, RSV, and Influenza A & B 2). The purpose of this submission is to address a software modification to the Alere™ i Instrument's algorithm to mitigate issues with false invalid results due to baseline values being lower than allowed, which were incorrectly identified as "Empty Tube Values." The submission states that there have been no changes made to the chemistry of the assays.

The document highlights the substantial equivalence of the modified devices to their legally marketed predicate devices. However, it does not contain specific acceptance criteria or detailed study data to prove the device meets these criteria. Instead, it focuses on comparing the modified devices with their predicates, stating that all parameters (FDA Product Code, Assay Target, Intended Use, Intended Environment for Use, Instrumentation, Sample Type, Viral/Bacterial Target, Technology, Internal Control, Result Interpretation, Assay Result, and Time to Result) are "Same" as the predicate devices.

Given the information provided, it is not possible to complete a table of acceptance criteria and reported device performance, nor can we detail the study that proves the device meets the acceptance criteria, as this specific information is not present in the provided text. The document asserts "substantial equivalence" based on the described software modification and the consistency of other parameters with the predicate devices.

Therefore, the following information can be extracted or derived based on the provided text, with many fields remaining unascertainable:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that the modified devices are "substantially equivalent" to their predicate devices and lists various parameters which are "Same" as the predicates. No specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are detailed for the modified device or its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The submission focuses on the software modification and states that no changes were made to the assay chemistry. It does not describe any new clinical studies or test sets with sample sizes for the modified device to demonstrate its performance against new acceptance criteria. It refers to historical performance characteristics for influenza A established during certain influenza seasons for the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 assays.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. As there is no description of a new clinical study with a test set and ground truth establishment, these details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an in vitro diagnostic test for detecting viral/bacterial RNA/DNA, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device is described as an "instrument-based, molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology" with "automated" result interpretation. This implies a standalone (algorithm only) performance, i.e., without human-in-the-loop performance influencing the assay result. However, specific standalone performance study details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the original performance characteristics mentioned for the influenza assays, it can be inferred that the ground truth would have been established by a reference method for detecting viral RNA, likely PCR or viral culture, rather than expert consensus or pathology in the context of an IVD. However, the document does not explicitly state the ground truth used for performance characteristics, nor does it detail ground truth for any new studies related to the software modification.

8. The sample size for the training set:

This information is not provided in the document. Since this is a software modification to an existing algorithm for an IVD, it's possible the "training set" concept as used in AI/ML might not directly apply, or details about algorithm development data are not included.

9. How the ground truth for the training set was established:

This information is not provided in the document.

In summary, the provided document is a 510(k) summary for a software modification to existing IVD devices, asserting substantial equivalence to predicates without detailing new clinical studies, acceptance criteria, or performance data for the modified device.

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The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

Performance characteristics for influenza A were established during the 2015-2016 influenza season when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

This is a 510(k) premarket notification for a software modification to the Alere™ Reader, which is used with the Alere BinaxNOW® Influenza A & B Card 2 assay. The purpose of the submission is to introduce a "Walk Away" mode to the reader's software, alongside other minor enhancements. The underlying immunochromatographic assay (Alere BinaxNOW® Influenza A & B Card 2) itself remains unchanged.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a software modification to the Alere™ Reader. It explicitly states: "There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test." Therefore, the clinical performance (e.g., sensitivity, specificity) of the assay itself is not being re-evaluated or re-established by this specific submission, but rather the performance of the reader in interpreting those results.

The document discusses analytical performance for the reader with the new software. The acceptance criteria for the analytical studies were generally for the Alere™ Reader with the new software to maintain non-inferiority to the predicate reader (K162642) and to perform reliably in its new "Walk Away" mode.

Acceptance Criteria for Reader Performance (Implicit in comparative studies):

• Accuracy of Interpretation: The modified Reader should accurately interpret positive and negative results from the Alere BinaxNOW® Influenza A & B Card 2, consistently with the predicate device and visual interpretation.
• Timing Accuracy: The "Walk Away" mode should accurately time the 15-minute incubation period.
• Reliability: The Reader should operate reliably without significant errors or invalid results.

Reported Device Performance (from the document, primarily from the Analytical Performance section, not provided here but typically found in a full 510(k) submission):

• Analytical Sensitivity and Specificity: The document implies that the analytical performance (e.g., limit of detection, cross-reactivity) of the test card itself is unchanged, as the card hasn't been modified. The analytical performance of the reader with the new software would be demonstrated by its ability to accurately read a range of low-positive and negative samples consistently.
• Reader Equivalence: The submission aims to demonstrate that the modified Reader is substantially equivalent to the predicate (K162642) through comparative studies, which would show consistent reading of results between the two reader versions.
• "Walk Away" Mode Functionality: The new mode would have been tested to ensure it correctly times and reads the assay at the appropriate interval.

Since comprehensive performance data tables are not in the provided text, a complete table of acceptance criteria and reported numbers cannot be created. The document focuses on declaring substantial equivalence based on the software change.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes the software modification and its comparison to the predicate device. It states, "The purpose of this Special 510k submission is to bring to market a modification of the software contained on the Alere™ Reader. There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test."

This implies that the clinical performance data (sensitivity and specificity for influenza detection) would primarily come from the predicate device's original studies (K162642) or general knowledge of the Alere BinaxNOW® Influenza A & B Card 2 assay's performance.

For the software modification itself, the typical studies would involve:

• Analytical Studies: Testing the new reader's ability to interpret positive and negative control cards, as well as cards with varying antigen concentrations (potentially low-positive). These studies would use a specific number of test cards, but this number is not provided in the excerpt.
• Comparison Studies (Reader vs. Predicate Reader): Testing both the modified reader and the predicate reader on the same set of test cards (potentially clinical samples or spiked samples) to ensure concordance. The sample size for such a comparison is not provided in the excerpt.

Data Provenance: Not explicitly stated for specific test sets related to the software modification. Clinical performance characteristics mentioned (for the assay) were established during the 2015-2016 influenza season.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For this type of submission (software modification to an existing reader for an IVD), the "ground truth" for the reader's performance would likely be:

• Reference Method for Assay Results: For clinical performance, a "gold standard" laboratory method like cell culture or an FDA-cleared molecular assay (as mentioned in the Indications for Use) would be used to establish the true presence/absence of influenza in patient samples. This is for the assay's performance, not the reader's.
• Visual Interpretation: For evaluating the reader's accuracy, human visual interpretation by trained personnel (who are considered "experts" in reading the specific lateral flow assay) would often serve as a comparison, or the positive/negative status of contrived samples would be known from spiking.

The document does not provide specific details on the number or qualifications of experts used to establish ground truth for the reader's performance in this particular 510(k) submission.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for test sets related to the software modification. For analytical studies comparing reader performance, adjudication might involve a third reader or a consensus if discrepancies arise between the reader and a human interpreter. However, this is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is an automated reader for a rapid influenza antigen test. It is not an AI-assisted diagnostic tool designed to improve human reader performance. The Alere™ Reader replaces human visual interpretation of the test card. Its purpose is to provide an objective, automated reading of the results from the immunochromatographic assay. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The Alere™ Reader is a standalone device in the sense that it automatically interprets the test card and reports a result (positive, negative, or invalid) without human interpretation of the test lines. The human interaction is limited to inserting the card and reading the displayed result. The "algorithm" is the reader's software that analyzes the intensity of the test and control lines. The studies supporting this submission would evaluate the performance of this algorithm (software) in correctly reading the test cards.

7. The Type of Ground Truth Used

For the assay's (Alere BinaxNOW® Influenza A & B Card 2) clinical performance (established during the predicate device's evaluation), the indications for use state: "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay." This indicates that cell culture or an FDA-cleared molecular assay would be considered the ground truth for determining actual influenza infection.

For the reader's performance (the focus of this specific 510(k) for software modification), the ground truth would likely be established by:

• Known concentrations of analyte: For analytical sensitivity.
• Visual interpretation by trained personnel: For concordance studies of the reader against human interpretation of the test card.
• Results from the predicate reader: For demonstrating substantial equivalence of the modified reader.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set. The Alere™ Reader's software likely uses image processing and pattern recognition algorithms that would have been developed and refined using a dataset of test cards (a "training set") to learn to identify and interpret the presence and intensity of test and control lines. However, the size or nature of such a training set is not disclosed in this regulatory summary.

9. How the Ground Truth for the Training Set Was Established

As with the training set size, the method for establishing ground truth for any training data used to develop the reader's software is not provided in this document. Typically, for such image-based interpretation systems, ground truth for training data would be established by:

• Manual annotation: Experienced individuals would visually inspect and label images of test cards (e.g., "positive for A," "negative," "invalid").
• Spiked samples with known concentrations: Cards created with precise amounts of antigen to represent known positive or negative results.
• Comparison to a gold standard: For cards from clinical samples, their true status would be confirmed by a reference method (e.g., PCR, cell culture).

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The Alere™ i Influenza A & B 2 assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characterics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in cases unless a BSL 3+ facility is available to receive and culture specimens.

Alere™ i Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs tested directly or after elution in viral transport media collected from patients with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B 2 System utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver single use, disposable containing the elution buffer
• Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge – Single use, disposable for transfer of the eluted sample to the Test Base, and
• Alere™ i Instrument - repeat use reader

The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B, which occur in two separate reaction tube contains fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, re-suspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence are provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve X sensitivity and Y specificity"). Instead, it presents the device's performance, which is implicitly accepted by the FDA's "Substantially Equivalent" determination. The table below summarizes the reported clinical performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Total enrolled: 1110 nasal or nasopharyngeal swab specimens.
  • Total tested:
    • 1070 for direct swab performance analysis (after excluding 36 not meeting eligibility and 4 invalid after re-testing).
    • 1057 for viral transport media (VTM) performance analysis (after excluding 36 not meeting eligibility, 11 invalid after re-testing, and 6 not meeting eligibility).
• Data Provenance:
  • Country of Origin: United States (multi-center, conducted at ten US trial sites).
  • Retrospective or Prospective: Prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical study was established using an FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test as the comparator method. The document does not mention the use of human experts (e.g., radiologists) to establish ground truth for this device, as it is an in vitro diagnostic test for viral RNA detection, not an imaging device.

4. Adjudication Method for the Test Set

The ground truth was established by a single comparator method (FDA-cleared RT-PCR). There is no mention of an adjudication method for the test set, as the RT-PCR result was considered the definitive truth. For discrepancies, secondary molecular testing was used to investigate false positives/negatives (e.g., "Flu A nucleic acid was detected in 6/21 False positive specimens using a second FDA-cleared molecular test"). This refers to investigation of the Alere™ i results against the initial RT-PCR, not an adjudication process to establish the initial ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where human readers are involved in the diagnostic process. The Alere™ i Influenza A & B 2 is an automated molecular diagnostic test with automated result interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The clinical study results (sensitivity, specificity, invalid rates) reported for the device directly reflect its performance as an algorithm-only (kit + instrument) system without human-in-the-loop interpretation beyond operating the instrument and reading the automated result. The "automated result interpretation" listed in the device comparison table further confirms its standalone nature.

7. Type of Ground Truth Used

The primary ground truth used for the clinical performance evaluation was an FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test. This is a molecular diagnostic method considered highly accurate for detecting viral RNA. Secondary molecular testing was used to investigate discordant results.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It details the clinical validation (test set) and analytical studies. Typically, for such devices, the training data would be proprietary to the manufacturer and not explicitly disclosed in an FDA 510(k) summary, which focuses on validation data.

9. How the Ground Truth for the Training Set Was Established

Since the training set data is not disclosed, the method for establishing its ground truth is also not described in this document. It is generally assumed that the training data for molecular diagnostic assays would be similarly characterized using highly accurate reference methods, potentially including PCR, sequencing, or well-characterized viral cultures.

Ask a specific question about this device

The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

The Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is provided separately for result interpretation. The Alere™ Reader enables direct data entry of User ID, Subject ID, and retention of test results, but is interpretation only. All Alere BinaxNOW® Influenza A & B Card 2 assay steps are performed outside of the reader and the card assay is inserted at the 15 minute read time.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of a completed Alere BinaxNOW® Influenza A & B Card 2 assay, analyzes the intensity of the sample and control line and displays the results (positive, negative or invalid) on a display screen is intended as a means of user interface informing the user how to operate the reader and to display test result, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

Here's a summary of the acceptance criteria and study information for the Alere BinaxNOW® Influenza A & B Card 2 and Alere™ Reader, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a clinical performance study against a comparator method (FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay). The reported device performance metrics are sensitivity and specificity.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 565 evaluable specimens (from an initial 585 collected).
• Data Provenance:
  • Country of Origin: United States.
  • Type: Prospective clinical study conducted at twelve (12) U.S. study centers during the 2015-2016 respiratory season.
  • Patient Population: Patients presenting with flu-like symptoms.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The ground truth for the clinical study was established using an FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay as the comparator method. This is an objective laboratory test, not an expert consensus for the clinical study. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable in the same way it would be for image interpretation tasks.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an RT-PCR assay, which is a definitive laboratory test, not subject to human adjudication for its results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic (IVD) test read by an automated reader, not an AI-assisted human reader interpretation system. The Alere™ Reader is an automated instrument that interprets the test card; it does not assist human readers in interpreting results manually.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the clinical performance study evaluated the "Alere BinaxNOW® Influenza A & B Card 2 with results read by the Alere™ Reader." This represents the standalone performance of the combined device and reader system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the clinical performance study was an FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay. This is a molecular diagnostic method considered highly accurate for viral detection.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device in the context of machine learning or AI algorithm development. The device is an immunochromatographic assay. The analytical studies (analytical sensitivity, reactivity, specificity) evaluate the inherent performance characteristics of the assay and reader, which are established through laboratory testing, not a dataset used to train an algorithm in the AI sense.

9. How the Ground Truth for the Training Set was Established

As noted in point 8, the concept of a "training set" in the context of an AI algorithm is not directly applicable here. The analytical studies involved:

• Analytical Sensitivity (LoD): Determined by evaluating different concentrations of known influenza virus strains. The "ground truth" was the known concentration of the virus producing positive results 95% of the time, verified against laboratory standards.
• Analytical Reactivity (Inclusivity): Determined by testing known influenza strains at specified concentrations, with the "ground truth" being the expected positive result for those strains.
• Analytical Specificity (Cross-Reactivity): Determined by testing various commensal and pathogenic microorganisms, with the "ground truth" being expected negative results.
• Interfering Substances: Tested with known substances at specified concentrations, with the "ground truth" being no effect on test performance.
• Reproducibility: Involved blind-coded specimens with known positive/negative status (likely derived from spiked samples or well-characterized clinical specimens) at low, moderate, and negative levels.

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The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Alere™ i Influenza A & B is a rapid, instrument-based isothermal tests for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B system utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver - single use, disposable containing the elution buffer
• . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base, and
• Alere™ i Instrument – repeat use reader

The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

Alere™ i Influenza A & B is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

The document describes the Alere™ i Influenza A & B device, a rapid molecular in vitro diagnostic test. The acceptance criteria and the study proving the device meets these criteria are detailed in the provided text, particularly in the section regarding the modifications and comparison to the predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than outright acceptance criteria with specific performance thresholds. However, the intent of the study was to show that the modified device performs similarly to the predicate. The "Device Comparison" table implicitly sets the "acceptance criteria" as matching the predicate device's performance for the listed parameters.

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The Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children

The Alere™ i RSV is a rapid, instrument-based test for the qualitative detection and differentiation of respiratory syncytial virus (RSV) viral RNA from direct nasopharyngeal swab (NPS) and NPS eluted in viral transport media from patients with signs and symptoms of respiratory infection. The Alere™ i RSV System utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver – single use, disposable containing the elution buffer
• . Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• . Transfer Cartridge – Single use, disposable for transfer of the eluted sample to the Test Base, and
• Alere™ i Instrument repeat use reader ●
  The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i RSV utilizes a pair of templates (similar to primers) for the specific amplification of RNA from RSV A and B, which occur in two separate reaction tubes. Each reaction tube contains a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i RSV is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.
  To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, re-suspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence are provided by the instrument, with results automatically reported.
  Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

Here's a summary of the acceptance criteria and study details for the Alere™ i RSV device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance results needed for substantial equivalence, specifically the sensitivity and specificity values. The document presents the results directly after the methods.

Note: The document doesn't explicitly state "acceptance criteria" but presents these performance metrics as the outcome of the clinical study, implying they met the bar for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Nasopharyngeal Swab Direct: 497 evaluable specimens
  • Nasopharyngeal Swab Eluted in Viral Transport Media (VTM): 501 evaluable specimens
• Data Provenance: Multi-center, prospective clinical study conducted at nine US trial sites during the 2015-2016 respiratory season. This indicates that the data is prospective and collected in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that the Alere™ i RSV performance was compared to "FDA-cleared PCR test" which served as the ground truth. It does not mention the use of human experts (e.g., radiologists, pathologists) to establish the ground truth for this clinical performance study. The ground truth was established by an objective laboratory test (PCR).

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an FDA-cleared PCR test, not by human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an imaging device or one that involves human "readers" or AI assistance in interpretation in the way a typical MRMC study would assess. It's an in vitro diagnostic test with an automated result interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the clinical performance study reported is for the standalone algorithm (device) performance. The Alere™ i Instrument automatically reports results: "Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive..." There is no mention of a human-in-the-loop component for result interpretation for the performance assessment.

7. The type of ground truth used

The ground truth used for the clinical performance study was an FDA-cleared PCR test. This is an objective laboratory reference method.

8. The sample size for the training set

The document does not specify a separate training set or its sample size. The description provided is for the clinical performance study (test set) and analytical studies. For in vitro diagnostic devices, the development and training (if applicable for machine learning components) are typically internal, and the regulated submission focuses on the validation of the final locked algorithm using a distinct clinical test set.

9. How the ground truth for the training set was established

As no specific training set is detailed, information on how its ground truth was established is not provided.

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