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The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus.

The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

The BinaxNOW® PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from blood cultures which have been identified as being positive for S. aureus. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device.

Specimens are aliquots from blood cultures which have been identified as positive for Staphylococcus aureus. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.

Acceptance Criteria and Study for BinaxNOW® PBP2a Test

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BinaxNOW® PBP2a Test, as derived from the provided document, are presented in the table below, alongside the reported device performance.

Note: The document does not explicitly state numerical acceptance criteria. The "Implied Acceptance Criteria" are inferred from the demonstrated performance and the context of a 510(k) submission, where high agreement with established methods is required for substantial equivalence.

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

• Sample Size for Clinical Performance Test Set: 199 S. aureus samples.
• Data Provenance: Multi-center clinical study conducted in 2008-09 at four geographically diverse hospital laboratories within the United States. The study was prospective in nature, as samples were "evaluated in the BinaxNOW® PBP2a Test and compared to standard methods."

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

The document states that the ground truth for the clinical performance was established by "standard methods used routinely by the laboratories: Cefoxitin (30 µg) disc diffusion, Oxacillin (1 µg) disc diffusion, and automated Minimum Inhibitory Concentration (MIC) Systems." It also mentions "Individual samples were evaluated by multiple laboratory methods, and in all cases there was 100% agreement between the reference methods."

While specific "experts" for establishing ground truth are not explicitly named or quantified, the ground truth was determined by multiple, routinely used laboratory methods performed by qualified laboratory personnel within the four hospital laboratories. The qualifications of these individuals would typically include clinical microbiologists or medical technologists with experience in performing and interpreting these standard susceptibility tests. The document implies that the "experts" were the laboratory staff routinely performing these validated reference methods.

4. Adjudication Method for the Test Set

The document notes that "Individual samples were evaluated by multiple laboratory methods, and in all cases there was 100% agreement between the reference methods." This indicates that if there were any discrepancies between results from the Cefoxitin disc diffusion, Oxacillin disc diffusion, and automated MIC systems, they were resolved or did not occur. The fact that only three clinical samples (1.5%) produced "discrepant results" overall (compared to the BinaxNOW test) suggests that there was an established reference standard, and these three were just discordant with the device, not necessarily with the reference methods themselves. No specific formal adjudication method (e.g., 2+1, 3+1) for resolving conflicts between the reference methods is described, as 100% agreement among them was reported. Discrepancies between the device and the reference methods were simply noted.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the diagnostic accuracy of the device against standard laboratory methods, not on how human readers' performance improved with or without AI assistance. The BinaxNOW® PBP2a Test is a rapid immunochromatographic assay, meaning it is a diagnostic test kit that provides a direct result, not an AI system designed to assist human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The entire clinical performance study section describes the algorithm's (the BinaxNOW® PBP2a Test's) performance "alone" against established reference methods. The results presented in the table are the direct output of the BinaxNOW® PBP2a Test without human-in-the-loop intervention in the interpretation of the enzymatic reaction as positive or negative. While a human reads the test, the test itself provides a direct biochemical result that is interpreted.

7. Type of Ground Truth Used

The type of ground truth used for the clinical performance study was expert consensus (of established laboratory methods). Specifically, it relied on the results from:

• Cefoxitin (30 µg) disc diffusion
• Oxacillin (1 µg) disc diffusion
• Automated Minimum Inhibitory Concentration (MIC) Systems

The document states there was "100% agreement between the reference methods" for individual samples, indicating these methods collectively formed the definitive truth.

8. Sample Size for the Training Set

The document does not specify a sample size for a "training set." The BinaxNOW® PBP2a Test is described as an immunochromatographic assay, which is a chemical reaction-based test, not a machine learning or AI model that typically requires a separate training set. The various analytical studies (reactivity, specificity, sensitivity, interfering substances) might be considered part of the development and "training" (calibration/validation) of the assay itself, but these are based on known reference strains and substances rather than patient data used in a typical machine learning training set.

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

As noted above, there is no explicit "training set" in the context of a machine learning model. However, if we consider the development and validation of the assay, the "ground truth" for analytical studies was established using known, well-characterized bacterial strains from sources like the American Type Culture Collection (ATCC) and the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA). For example, MRSA strains from these collections were expected to test positive, and MSSA, other Staphylococcal, and non-Staphylococcal strains were expected to test negative. These strains have established classifications regarding their methicillin resistance.

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The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip.

Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.

The Clearview® Exact PBP2a Test is a rapid immunochromatographic assay for detecting penicillin-binding protein 2a (PBP2a) in Staphylococcus aureus isolates, aiding in the detection of methicillin-resistant Staphylococcus aureus (MRSA).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria. However, it reports sensitivity and specificity performance values for the device compared to a reference method. We can infer that the reported performance values were considered acceptable for regulatory clearance.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A total of 457 S. aureus samples were evaluated in the clinical performance study.
• Data Provenance: The study was a multicenter clinical study conducted in 2009 at three geographically-diverse laboratories. The analytical performance section also mentions bacterial strains obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA), American Type Culture Collection (ATCC), and a collection from the Department of Infectious Disease Epidemiology of the Imperial College in London, England. This indicates a mix of strains from reference collections and clinical isolates, and at least some data provenance from England in addition to the diverse US laboratories. The study appears to be retrospective in the sense that existing S. aureus samples were evaluated by the new device.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to a standard method (cefoxitin disk diffusion), not to human readers' performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done. The clinical performance study directly evaluated the performance of the Clearview® Exact PBP2a Test against the reference method without human intervention in the interpretation of the device's results, as it is a visual read test that relies on the device's output. The reproducibility study also tested the device in a standalone manner.

7. Type of Ground Truth Used

The ground truth used for the clinical performance study was cefoxitin (30 ug) disk diffusion, interpreted according to CLSI (Clinical and Laboratory Standards Institute) standards. This is a recognized phenotypic method for determining methicillin resistance in S. aureus.

8. Sample Size for the Training Set

The document does not explicitly mention a dedicated "training set" or its size for the development of the Clearview® Exact PBP2a Test. The analytical performance section mentions that 162 MRSA strains and 112 MSSA strains were tested for analytical reactivity and specificity, which might represent samples used during later stages of development or validation, but it's not explicitly labeled as a training set.

9. How Ground Truth for the Training Set Was Established

Since a distinct training set is not explicitly defined, the method for establishing its ground truth is not detailed. However, for the strains used in analytical performance (162 MRSA and 112 MSSA), it is implied that their methicillin-resistant/sensitive status was known, likely established through standard microbiological identification and susceptibility testing methods (e.g., CLSI guidelines, reference lab testing) given their origin from reputable collections (NARSA, ATCC, Imperial College).

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The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device. Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.

Here's a summary of the acceptance criteria and the study details for the BinaxNOW® Staphylococcus aureus Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Performance Study): 325 blood culture samples.
• Data Provenance: Retrospective and/or prospective (not explicitly stated if combined or separate, but clinical performance was "established in a multicenter clinical study conducted in 2008-09"). The data originated from three geographically-diverse hospital laboratories within the US.

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

• The document states that the BinaxNOW® Staphylococcus aureus Test performance was compared "to standard methods used routinely by the testing laboratories." It does not specify the number of experts or their qualifications for establishing the ground truth, but implies it was based on established laboratory protocols and potentially expert interpretation where applicable for "standard methods." The reference method essentially serves as the "ground truth."

4. Adjudication Method for the Test Set

• The document does not describe a specific adjudication method (like 2+1 or 3+1). The comparison was made against "standard methods used routinely by the testing laboratories," suggesting that the results from these standard methods were taken as the truth without further expert adjudication beyond the routine lab procedures.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool for human readers. Its performance is evaluated independently or against a reference method.

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

• Yes, the clinical performance study evaluated the standalone performance of the BinaxNOW® Staphylococcus aureus Test. It's an immunochromatographic assay that provides a direct result, not an aid to a human reader. Its results were compared directly to the reference method without human interpretation as part of the device's output.

7. The Type of Ground Truth Used

• The ground truth for the clinical performance study was established using "standard methods used routinely by the testing laboratories." For an IVD like this, this typically refers to recognized microbiological culture and identification techniques, which are considered the gold standard for bacterial identification.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of device development or clinical trials. This is common for rapid immunochromatographic assays, where development involves analytical studies (reactivity, specificity, sensitivity) and then validation in clinical samples. The "training set" concept is more pertinent to machine learning algorithms.

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

• As a "training set" is not explicitly mentioned for this type of device, the method for establishing its ground truth is not applicable or described in the provided text. The analytical studies (reactivity, specificity) used well-characterized bacterial strains (e.g., ATCC, NARSA strains) for which the identity was already known, serving a similar function to establishing "ground truth" for those specific analytical evaluations.

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The Clearview Advanced™ Strep A test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.

The Clearview Advanced™ Strep A test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test, Reagent 1 (R1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent. The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control coniugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is resuspended with R1 and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample. If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.

Here's a breakdown of the acceptance criteria and study details for the Clearview Advanced™ Strep A Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for sensitivity and specificity. However, regulatory bodies implicitly expect high performance from diagnostic tests for infectious diseases. The provided confidence intervals indicate a robust performance profile. For analytical sensitivity and specificity, the acceptance criteria are described directly in the text (e.g., "produces positive... approximately 95% of the time" for LOD, and "all... were negative" for cross-reactivity).

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

• Sample Size (Clinical Performance Test Set): A total of 297 throat swab specimens.
• Data Provenance:
  • Country of Origin: United States.
  • Retrospective or Prospective: Prospective clinical study.
  • Study Design: Multi-center study conducted in 2008-2009 at five geographically diverse physician offices, clinics, and emergency departments.

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

• The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth ("bacterial culture") is an objective laboratory method rather than an expert interpretation in this context.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method. The comparison is directly between the Clearview Advanced Strep A test results and the bacterial culture results.

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

• No, an MRMC comparative effectiveness study was not done. This study assesses the performance of a device (immunoassay) against a gold standard (bacterial culture), not how human readers improve with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical performance section describes the algorithm's (device's) performance without human intervention in interpreting the test result. The test is a qualitative, lateral flow immunoassay where the visual appearance of a line directly indicates a positive or negative result, and its accuracy is compared to the bacterial culture.

7. Type of Ground Truth Used

• Bacterial Culture. The clinical performance of the Clearview Advanced Strep A test was established by comparing its results to bacterial culture, which is considered the gold standard for diagnosing Group A Streptococcal infection.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. The description of the clinical study refers to the "test set" or "evaluation set" for performance metrics. For traditional immunoassay devices like this, there isn't typically a distinct "training set" in the machine learning sense. The device's design and parameters are developed through analytical studies (e.g., LOD, cross-reactivity) rather than through training on a large dataset of patient samples.

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

• Since there's no explicitly defined "training set" in the context of machine learning for this device, a ground truth establishment method for it is not applicable/not described. The robust design of the immunoassay, informed by analytical studies, serves as its "training" or development process.

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The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.

The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product insert. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f.specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working properly and the operator performed the test procedure correctly.

The provided text describes a 510(k) submission for the BinaxNOW® Malaria Positive Control, a quality control material, not a diagnostic device with performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design parameters for evaluating device performance against ground truth, and human-in-the-loop studies is not applicable to this type of submission.

The "performance summary" section details the stability and shelf life of the control material, which are the relevant performance characteristics for a quality control product.

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary "performance" of this device is its stability and its ability to consistently produce a positive result when run with the BinaxNOW® Malaria Test, which verifies the test's proper function.

2. Sample size used for the test set and the data provenance

Not applicable. This is a quality control material, not a diagnostic device evaluated against a patient test set. The "testing" referred to in the document is internal stability testing of the control material itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for diagnostic devices (e.g., disease presence) is not relevant for a quality control material. The "ground truth" for this control is its consistent positive reactivity.

4. Adjudication method for the test set

Not applicable.

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 AI-assisted diagnostic device, nor is it a multi-reader study.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the BinaxNOW® Malaria Positive Control, the "ground truth" is its designed positive reactivity. When run on the BinaxNOW® Malaria Test, the control is intended to "always generate positive results on both the P.f. specific (HRP II) test line and on the pan-malarial test line." This demonstrates that the control material is functioning as intended, and by extension, that the test reagents and operator procedure are correct.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or diagnostic device for this quality control product.

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

Not applicable.

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The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by cell culture.

The BinaxNOW* Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. These 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 device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's an analysis of the BinaxNOW® Influenza A & B Test, detailing its acceptance criteria and the supporting studies:

Acceptance Criteria and Device Performance for BinaxNOW® Influenza A & B Test

The provided document describes a 510(k) submission to expand the claims of the BinaxNOW® Influenza A & B Test. While explicit "acceptance criteria" in a numerical target format are not directly stated, the document presents detailed performance data from clinical and analytical studies. The implied acceptance criteria are that the device demonstrates adequate sensitivity and specificity for the detection of influenza A and B antigens in various sample types, comparable to the reference standard (cell culture/DFA). The analytical studies further establish the device's limit of detection, reactivity to various strains, and cross-reactivity.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Given the nature of the submission (expansion of claims for an existing device), the "acceptance criteria" are implicitly set by regulatory expectations for diagnostics and comparison to the predicate device and reference methods. The reported performance is directly from the clinical studies presented.

Clinical Performance vs. Cell Culture/DFA (Prospective Study)

Clinical Performance vs. Cell Culture/DFA (Retrospective Study)

Analytical Sensitivity (Limit of Detection - LOD)

Reactivity Testing

Analytical Specificity (Cross Reactivity)

Interfering Substances

Transport Media

Reproducibility

Study Details:

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

• Clinical Studies (Prospective):
  • Sample Size: 846 prospective specimens.
  • Data Provenance: Not explicitly stated, but the mention of "patients presenting with influenza-like symptoms" and demographic breakdown (male/female, pediatric/adult) suggests a general clinical population. No specific country is mentioned, implying it could be multi-site within the US or a general US population. The study is prospective.
• Clinical Studies (Retrospective):
  • Sample Size: 293 retrospective frozen clinical samples.
  • Data Provenance: Clinical samples collected from symptomatic patients at multiple physician offices, clinics, and hospitals located in the Southern, Northeastern, and Midwestern regions of the United States, and from one hospital in Sweden. The study is retrospective.
• Analytical Sensitivity:
  • Sample Size: 24 determinations per concentration level (12 operators x 2 devices).
  • Data Provenance: Not specified, likely internal lab studies.

3. Number of Experts and Qualifications for Ground Truth (Clinical Studies):

• The ground truth for the clinical studies was established by Cell Culture / DFA (Direct Fluorescent Antibody assay). This is a laboratory-based method.
• Number of Experts: The document does not specify the number of human experts involved in interpreting the cell culture or DFA results, nor their specific qualifications. It is assumed that trained laboratory personnel performed these reference tests.

4. Adjudication Method for the Test Set:

• The document implies that the BinaxNOW® test results were directly compared to the Cell Culture/DFA results. There is no mention of a separate adjudication method (e.g., 2+1, 3+1 consensus) for the test set itself, as the Cell Culture/DFA is treated as the definitive ground truth.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human reader performance with and without AI assistance. The device is a rapid diagnostic kit, not an AI-powered image analysis system interpreted by human readers. The clinical studies evaluate the device's performance against a reference standard. The "operators" mentioned in the analytical sensitivity section are performing the device test, not interpreting complex medical images.

6. Standalone Performance:

• Yes, standalone performance was done. The entire clinical and analytical performance sections evaluate the device (algorithm/test kit) in a standalone manner against a reference standard (Cell Culture/DFA) or known concentrations/strains. There is no human-in-the-loop component being evaluated in the reported performance. The "interpretation" of the BinaxNOW test results is based on visible lines, which is a direct reading of the device's output.

7. Type of Ground Truth Used:

• Clinical Studies: The type of ground truth used was Cell Culture / DFA. This is a laboratory-based diagnostic method considered a gold standard for influenza detection at the time of the study.
• Analytical Studies: The ground truth for analytical sensitivity, reactivity, and specificity used known concentrations of inactivated viruses, specific influenza strains, or panels of other microorganisms at known concentrations.

8. Sample Size for the Training Set:

• The document describes a 510(k) for an existing device (BinaxNOW® Influenza A & B Test; K062109). This type of submission typically focuses on validation and verification of the device's performance, not on the explicit "training" of an algorithm in the machine learning sense.
• Therefore, there is no identifiable "training set" sample size in the context of an algorithm or AI. The immunoassay technology relies on pre-designed antibodies, not a trained computational model.

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

• As there is no explicit "training set" in the context of an AI/algorithm, this question is not applicable to this device submission. The immunoassay is developed and validated through laboratory methods (antibody selection, antigen-antibody binding studies) rather than machine learning training.

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The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.

The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.

To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.

Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.

Here's a breakdown of the acceptance criteria and the study details for the BinaxNOW® G6PD Test, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria revolve around the agreement of the BinaxNOW® G6PD Test results with a commercially available quantitative G6PD test, particularly for identifying G6PD deficiency and normal activity.

Study Details:

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

   • Sample Size: 246 subjects (for the initial clinical sample performance study).
   • Data Provenance: Prospective study conducted in 2007-2008 in the U.S.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number or qualifications of experts used to establish the ground truth. The "ground truth" was established by a "commercially available quantitative G6PD test," implying a quantitative laboratory assay rather than human expert interpretation of the BinaxNOW® test results.

3. Adjudication method for the test set:

   • Adjudication method for the test set results is not explicitly mentioned. The BinaxNOW® G6PD Test is a visual screening test. The comparison was made against a "commercially available quantitative G6PD test," implying a direct numerical comparison against the quantitative assay's results.

4. 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, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow, enzyme chromatographic) for G6PD deficiency, read visually, not an AI-powered diagnostic imaging tool. It involves a single visual reading of the color change on the strip.
   • The closest "multi-reader" equivalent mentioned is the Reproducibility Study, which involved "multiple operators" (6 operators) across "3 separate sites." However, this was to assess the consistency of the device's output and interpretation, not to compare human performance with/without AI assistance.

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

   • Yes, in effect, a standalone performance was done for comparing the device's output against the quantitative method. The BinaxNOW® G6PD Test is designed to be a standalone visual screening test. The "performance summary" directly compares its qualitative output (deficient/normal) to the quantitative method's results, indicating its performance as a standalone diagnostic tool. Human readers are involved in the interpretation of the visual result of the BinaxNOW® test, but the device itself is a qualitative biochemical assay, not an AI algorithm.

6. The type of ground truth used:

   • Quantitative Assay Results: The ground truth was established using results from a "commercially available quantitative G6PD test." This serves as the reference standard. A specific cut-off value of 4.2 U/gHb from the comparative method was used to define "deficient" and "normal" for comparison purposes.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" as would be typical for machine learning models. For this type of in-vitro diagnostic device, development and optimization often involve internal studies, but specific details on a "training set" size for a machine learning context are not provided because it's not an AI device. The clinical performance study used 246 subjects.

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

   • As noted above, a distinct "training set" with established ground truth in the context of an AI algorithm is not applicable here. The development and validation of the BinaxNOW® G6PD Test would have involved establishing performance characteristics against known G6PD activity levels, likely using quantitative methods, but this is a product development process rather than an AI model training process.

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The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.

The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in respiratory specimens. These 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 device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline, or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's a breakdown of the acceptance criteria and study details for the BinaxNOW® Influenza A & B Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for sensitivity and specificity are not explicitly stated as pre-defined targets within the provided text. Instead, the document presents the observed performance of the device against the reference method (cell culture/DFA) in various clinical studies. The substantial equivalence is established by comparing this observed performance to the predicate device, the BD Directigen™ Flu A+B Test (though detailed performance for the predicate is not provided in this summary).

For the purpose of this analysis, we will present the reported device performance from the prospective and retrospective clinical studies.

BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Prospective Study)

BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Retrospective Study)

Analytical Sensitivity (Limit of Detection - LOD)

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

• Prospective Study Test Set:

  • Total Specimens: 846
  • Provenance: Multi-center, "central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season." Data is prospective.
  • Patient demographics: 44% male, 54% female, 54% pediatric (<18 years), 46% adult (≥18 years).
  • Sample types: Nasopharyngeal (NP) swabs, nasal swabs.

• Retrospective Study Test Set:

  • Total Specimens: 293
  • Provenance: Collected from symptomatic patients at multiple physician offices, clinics, and hospitals in the Southern, Northeastern, and Midwestern regions of the United States, and from one hospital in Sweden. Data is retrospective (frozen clinical samples).
  • Patient demographics: 53% male, 47% female, 62% pediatric (<18 years), 38% adult (≥18 years).
  • Sample types: Nasal wash/aspirate (61%), NP swabs (39%).

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to "Cell Culture / DFA" as the reference method. In a typical clinical setting, cell culture and Direct Fluorescent Antibody (DFA) testing would be performed and interpreted by trained laboratory professionals, such as medical technologists or microbiologists. Specific expert qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for disagreements or indeterminate results between different readers or between the device and the ground truth. The "ground truth" (Cell Culture/DFA) is treated as the definitive reference.

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 is mentioned, as this device is a rapid diagnostic test (immunochromatographic assay) and not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest mention of human involvement in interpretation is in the analytical sensitivity study, where "Twelve (12) different operators each interpreted 2 devices run at each concentration," which is an operator variability assessment, not an MRMC study for diagnostic improvement.

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

This device is an in vitro diagnostic test, meaning its performance is inherently standalone in the sense that the test itself (reagents, membrane, etc.) produces the result. Human interpretation is required to read the pink-to-purple colored Sample Lines and the blue Control Line. However, there is no "algorithm" in the modern AI sense described. The "standalone" performance here refers to the device's ability to detect antigens in specimens without comparison to human interpretation of the same device output; rather, its output is compared to a gold standard (cell culture). The clinical study data presented (sensitivity and specificity) can be considered the standalone performance of the device as interpreted by an operator.

7. The Type of Ground Truth Used

The type of ground truth used is Cell Culture / DFA (Direct Fluorescent Antibody testing). This is a common and accepted laboratory reference method for influenza virus detection.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. Since this is an immunochromatographic assay and not an AI/ML-based device, there isn't a traditional "training set" as understood in machine learning. The clinical and analytical studies serve to validate the device's performance against established methods.

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

As there is no traditional "training set" for an AI/ML algorithm, this question is not directly applicable. The "ground truth" for the performance evaluation (test sets) was established using Cell Culture/DFA, which are established laboratory techniques performed by trained personnel.

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The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal specimens. These 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, bookshaped hinged test device.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's an analysis of the provided text regarding the BinaxNOW® Influenza A & B Test, focusing on acceptance criteria, study details, and data provenance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BinaxNOW® Influenza A & B Test are implicitly derived from its comparison to a clinical reference method (cell culture/DFA) and to its predicate devices (Binax NOW® Flu A Test and Binax NOW® Flu B Test). The study aimed to demonstrate acceptable sensitivity and specificity.

Note: The document does not explicitly state numerical acceptance criteria in the typical "must achieve X% sensitivity and Y% specificity" format. Instead, the performance is presented to demonstrate substantial equivalence to established methods and predicate devices. The clinical study against culture/DFA has very small numbers of positive cases, leading to wide confidence intervals and potentially lower apparent sensitivity. The studies against the predicate Binax NOW® Flu A and B tests show much stronger performance, suggesting the extended claim focuses on maintaining equivalence to those previously cleared devices.

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

• Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA):
  • Sample Size: 114 specimens (113 NP swab, 1 wash/aspirate).
  • Data Provenance: Prospective study conducted in 2004 outside the US. Specimens collected from children (<18 years) and adults (>=18 years) presenting with influenza-like symptoms.
• Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests):
  • Sample Size: 306 retrospective frozen clinical samples for Flu A comparison; 303 retrospective frozen clinical samples for Flu B comparison.
  • Data Provenance: Retrospective frozen clinical samples. Collected from symptomatic patients at multiple physician offices, clinics, and hospitals in the Southern, Northeastern, and Midwestern regions of the United States, and one hospital in Sweden.
• Clinical Study (Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture - for predicate devices):
  • Sample Size: 373 prospective clinical samples.
  • Data Provenance: Multi-center prospective study conducted during the 2002 Flu season at physician offices and clinics in the Western and mid-Atlantic United States.

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

The document does not specify the number or qualifications of experts used to establish the ground truth.

• For the prospective study comparing the BinaxNOW® combined test to cell culture/DFA, "cell culture and/or DFA" serves as the reference standard (ground truth). It is assumed these reference methods were performed by qualified laboratory personnel, but no specifics are given.
• For the retrospective study comparing the BinaxNOW® combined test to the individual NOW® Flu A and Flu B Tests, those individual tests are treated as the reference standard.
• For the predicate device studies, "cell culture" served as the reference.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set. It mentions that "Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay." This suggests a single interpretation per device, without multi-reader adjudication outlined. For the analytical sensitivity, 12 different operators interpreted devices to determine the LOD.

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 done. This device is an in vitro diagnostic (IVD) rapid immunoassay, not an AI-assisted diagnostic tool for interpretation by human readers. The output is a visual presence or absence of a line on a test strip.

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

Yes, the performance data presented are for the device (the BinaxNOW® Influenza A & B Test) as a standalone diagnostic tool. It is a rapid immunoassay that outputs a visual result, which is then interpreted by a human, but the performance metrics provided (sensitivity, specificity) reflect the device's ability to detect the antigen itself, not the human interpreter's performance. The analytical studies (analytical sensitivity, reactivity testing, analytical specificity) are also standalone performance evaluations of the device.

7. The Type of Ground Truth Used

• Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA): Cell Culture and/or Direct Fluorescent Antibody (DFA). This is a laboratory-based reference standard.
• Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests): The individual Binax NOW® Flu A and Flu B Tests (predicate devices) were used as the reference standard.
• Clinical Study (Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture - for predicate devices): Cell Culture.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development (e.g., machine learning training). As a rapid immunoassay, this device relies on biological interactions (antibody-antigen binding) rather than a trained algorithm. The various analytical and clinical studies serve to validate its performance.

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

Not applicable, as there is no mention of a "training set" in the machine learning sense for this immunochromatographic device. The development and optimization of such assays would involve extensive in-house testing using characterized positive and negative samples, but these are not typically referred to as a "training set" in the regulatory context for IVDs.

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The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal specimens. These 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 device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity and specificity. Instead, it demonstrates performance by comparing the new BinaxNOW® Influenza A & B Test to existing predicate devices (Binax NOW® Flu A Test and Binax NOW® Flu B Test) and viral culture. The key indication of "acceptance" is the determination of "substantial equivalence" to the predicate devices by the FDA.

Based on the performance data presented, here's a summary:

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

• Clinical Sample Comparison (BinaxNOW® A & B vs. individual NOW® A & B tests):

  • Influenza A comparison: 306 retrospective frozen clinical samples.
  • Influenza B comparison: 303 retrospective frozen clinical samples.
  • Data Provenance: Retrospective frozen clinical samples collected from symptomatic patients at multiple physician offices, clinics, and hospitals in the Southern, Northeastern, and Midwestern regions of the United States, and one hospital in Sweden.

• Original Multi-site Prospective Clinical Study (comparing individual NOW® Flu A & B Tests to viral culture, 2002):

  • 191 nasal wash specimens
  • 182 nasopharyngeal (NP) swab specimens
  • Data Provenance: Multi-center prospective study during the 2002 flu season at physician offices and clinics located in the United States.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical comparison directly assessing the BinaxNOW® Influenza A & B Test.

• For the comparison against the predicate devices: The predicate devices (individual NOW® Flu A and NOW® Flu B Tests) were used as the reference standard (ground truth). The ground truth for these predicate devices themselves would have been established historically (likely via viral culture).

• For the historical 2002 multi-site prospective clinical study: The ground truth was viral culture, which is considered an objective laboratory method, not reliant on expert interpretation of the rapid test results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical test sets in terms of resolving discrepancies between readers or between the device and ground truth. The comparisons are presented as direct measures against a reference standard (predicate devices or viral culture).

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, an MRMC comparative effectiveness study was not done as described in the context of assistance from AI.
• This device is a rapid diagnostic test (immunochromatographic assay), not an AI-powered diagnostic imaging or interpretation system. The "readers" for the analytical sensitivity experiment were "operators" interpreting the device results, not expert diagnosticians being assisted by AI.

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

• Yes, standalone performance was assessed in the context of a rapid diagnostic test. The results (sensitivity, specificity) presented for the BinaxNOW® Influenza A & B Test were generated by having operators read the test strip, not by integrating it with human interpretive assistance beyond the basic instruction of how to read the pink-to-purple lines.
• The "Analytical Sensitivity Comparison" section involved 12 different operators interpreting devices for LOD and cutoff levels. This is a form of standalone performance evaluation for the test itself.

7. The Type of Ground Truth Used

• Clinical Sample Comparison (BinaxNOW® A & B vs. individual NOW® A & B tests): The ground truth was the result from the predicate devices (Binax NOW® Flu A Test and Binax NOW® Flu B Test). This implies that the predicate devices were considered the accepted standard for influenza detection in these samples.
• Original Multi-site Prospective Clinical Study (of individual NOW® Flu A & B Tests): The ground truth was viral culture. Viral culture is generally considered a gold standard for influenza diagnosis.

8. The Sample Size for the Training Set

The document does not specify a training set in the context of machine learning or algorithm development. This device is an immunochromatographic assay, which is a chemical and biological test, not typically "trained" in the way an AI algorithm is. The "development" of the test would involve optimization of its biological components and chemical reactions.

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

As there is no mention of a training set for an algorithm, this question is not applicable. The development of the immunochromatographic assay relies on chemical and biological principles and optimization, not on a "training set" with established ground truth in the AI sense.

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