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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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Alere™ i Influenza A & B:

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 nasal swabs 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 2012-2013 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 Strep A:

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 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.

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

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 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. Both Alere™ i Influenza A & B and Alere™ i Strep A Systems 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 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 Alere™ i Influenza A & B 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.

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.

Both 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 lyophilized 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.

The provided document describes the Alere™ i Instrument, Alere™ i Influenza A & B, and Alere™ i Strep A devices. This submission focuses on a software modification to the Alere™ i Instrument to allow it to run both the Influenza A & B and Strep A assays, rather than changes to the assays themselves. Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the software modification does not negatively impact the performance of the previously cleared assays.

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

Rationale for the Study: The primary goal of this 510(k) submission (K151690) is to demonstrate that a software modification to the Alere™ i Instrument, which enables it to run both the Alere™ i Influenza A & B and Alere™ i Strep A assays, does not alter the established safety and effectiveness of these assays. The previous versions of these tests (Alere™ i Influenza A & B, K141520 and Alere™ i Strep A, K141757) were already cleared. Therefore, the study focuses on validating the software modification.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical "acceptance criteria" for clinical performance that needed to be met by a de novo study of the device. Instead, the acceptance criterion for this submission is implicitly that the software modification does not change the performance of the previously cleared assays. The reported "performance" for the modified device is that its functionality remains unchanged compared to the predicate devices.

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

The document explicitly states: "Software verification and validation studies performed demonstrated that Alere™ i Influenza A & B and Alere™ i Strep A assay functionality remains unchanged due to this change."

However, no specific sample sizes for a "test set" (e.g., number of patient samples, artificial samples) used in these software validation studies are provided in the excerpt. The data provenance (country of origin, retrospective/prospective) is also not detailed for these specific software validation studies. Given that the submission asserts "no changes to the Alere™ i Influenza A & B or Alere™ i Strep A tests," it's highly probable that the software validation primarily involved testing with internal samples or simulated data to ensure proper functionality and integration, rather than a new full-scale clinical study with patient samples. The information indicates the tests themselves had established performance characteristics from previous submissions.

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

Since the study described here is focused on software validation and demonstrating unchanged functionality of existing assays, rather than determining the initial clinical accuracy of the assays against a clinical ground truth, there is no mention of experts establishing a ground truth for a test set in this context.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set requiring expert ground truth, no adjudication method is described.

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

No MRMC comparative effectiveness study was mentioned. The device is an in vitro diagnostic test, not an AI software intended to assist human readers in image interpretation or a similar task. It is a standalone instrument that provides qualitative diagnostic results.

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

Yes, the performance of the Alere™ i Instrument is inherently standalone. The device processes the sample and provides an automated qualitative result ("Influenza A Detect", "Influenza B Detect", "Strep A Detect", or "Not Detected"). The "Software verification and validation studies" described would have assessed this standalone performance with the modified software.

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

For the original clinical performance studies of the Alere™ i Influenza A & B (K141520) and Alere™ i Strep A (K141757) assays, the ground truth would typically involve:

• For Influenza A & B: Viral culture as the gold standard, or potentially a highly multiplexed PCR reference method, on patient nasal swab samples.
• For Strep A: Bacterial culture as the gold standard on patient throat swab samples.

However, for this specific submission (K151690), the "software validation" would likely use pre-characterized samples (e.g., positive and negative control samples, spiked samples with known concentrations of nucleic acid targets) or previously run clinical samples with known results from predicate studies, to verify that the software processes them identically and yields the same results. The document does not specify the ground truth for these software validation studies, but it would not be a new clinical ground truth establishment.

8. The Sample Size for the Training Set

No training set is mentioned in the context of this software modification. The assays themselves are isothermal nucleic acid amplification tests, not machine learning algorithms that require a training set in the typical sense. Any "training" would have been part of the initial development and optimization of the assays prior to the K141520 and K141757 submissions.

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

Not applicable, as no training set for a machine learning model is described.

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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 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.

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

Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. The Alere™ i Strep A 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 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. Alere™ i Strep A 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 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 an analysis of the acceptance criteria and the study that proves the device (Alere™ i Strep A) meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" are not explicitly stated in a quantitative manner (e.g., "Sensitivity must be >90%"). However, the clinical study's performance metrics act as the de facto demonstration of acceptable performance for regulatory purposes. The reported performance is what was considered sufficient for substantial equivalence.

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

• Sample Size (Clinical): 481 evaluable throat swab specimens.
• Data Provenance: Multi-center, prospective clinical study conducted at 8 US trial sites in 2014.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the device performance was "compared to bacterial culture," implying independent laboratory analysis, but details about the personnel involved in interpreting these cultures are not provided.

4. Adjudication Method for the Test Set

The document doesn't explicitly describe an "adjudication method" in the typical sense (e.g., 2+1 reader adjudication for imaging studies). For samples with discordant results between the Alere™ i Strep A and the initial bacterial culture, a "laboratory developed real-time PCR assay" was used for further investigation:

• Of 18 samples positive by Alere™ i Strep A and negative by bacterial culture, 13 were positive by RT-PCR.
• Of 6 samples negative by Alere™ i Strep A and positive by bacterial culture, 4 were negative by RT-PCR.

This suggests that the PCR assay acted as a secondary confirmation method for discordant results, but it's not a formal "adjudication method" agreed upon by multiple human readers in the context of interpretation.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, where performance is typically evaluated against a gold standard (like bacterial culture or PCR), not by comparing human reader performance with and without AI assistance, as would be common for imaging AI.

6. Standalone (Algorithm Only) Performance Study

Yes, the clinical study (and analytical studies) assess the standalone performance of the Alere™ i Strep A device. It's an automated, instrument-based test, meaning its performance is inherently "algorithm only" in the sense that the instrument provides the result without human interpretation of the primary signal. The comparator (bacterial culture) serves as the ground truth.

7. Type of Ground Truth Used

• Clinical Study: Bacterial culture was the primary ground truth. For discordant results, a laboratory developed real-time PCR (RT-PCR) assay was used as a secondary method.
• Analytical Sensitivity: Defined by the concentration of Group A Strep bacteria producing positive results 95% of the time, determined by testing known bacterial concentrations.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" for the Alere™ i Strep A. This is typical for IVD devices where the "training" (development and optimization) of the assay is conducted internally by the manufacturer, rather than through publicly documented machine learning training datasets. The presented clinical and analytical studies are validation studies, not training studies.

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

As no separate training set details are provided, the method for establishing its ground truth is also not elaborated. The development of such assays involves extensive internal research, optimization, and verification using characterized bacterial strains and clinical samples, but these are not typically documented as a "training set" in the same way an AI model's training data would be.

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