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mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay.

The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.

The mecA XpressFISH assay is a qualitative fluorescence in situ hybridization (FISH) assay which utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) on smears from blood cultures containing Staphylococcus aureus (SA). After the positive blood culture bottle is confirmed to have SA by Staphylococcus QuickFISH BC, an aliquot of the blood culture is incubated with media containing cefoxitin to induce mecA mRNA expression prior to mecA XpressFISH testing.

The assay consists of mecA mRNA inducing cefoxitin reagents, a fixation reagent, a hybridization reagent, a wash solution concentrate, coverslip mounting media and a microscope slide which has a sample well, and positive and negative control wells. Results are visualized and interpreted using fluorescence microscopy.

Here's an analysis of the provided text, extracting the acceptance criteria and study details for the mecA XpressFISH device:

The document describes the mecA XpressFISH assay, a qualitative nucleic acid fluorescence in situ hybridization assay for the detection of mecA mRNA in Staphylococcus aureus (SA) positive blood cultures. The goal is to identify methicillin-resistant S. aureus (MRSA).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through the comparability with the predicate device (BinaxNOW PBP2a) and the detailed validation studies demonstrating high agreement, sensitivity, and specificity. Explicit, numerical acceptance criteria for each bench test are not always stated, but the results consistently show 100% agreement or very high percentages, indicating successful performance against internal or industry-standard benchmarks.

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

• Clinical Study Test Set Sample Size: 339 routine blood culture bottles that were positive for Staphylococcus aureus by Staphylococcus QuickFISH BC.
• Data Provenance: The clinical study was conducted at seven clinical sites (6 in the US and 1 ex-US). This indicates a multi-center, prospective clinical study collecting real-world samples.

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

The ground truth for the clinical study was established using cefoxitin disk diffusion, which is a widely accepted laboratory method for determining methicillin resistance in clinical microbiology. The document does not specify the number or qualifications of experts who performed or interpreted the cefoxitin disk diffusion tests. It is assumed these were performed by trained laboratory personnel following standard clinical microbiology guidelines.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the clinical study beyond stating the comparison was made against cefoxitin disk diffusion. Discrepant results are noted and briefly analyzed (e.g., "False Positive mecA (weak Green Positive); Negative upon repeat testing. Cefoxitin disk=28 mm."), suggesting individual review of such cases, but a formal adjudication process (e.g., 2+1, 3+1 consensus) is not detailed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not performed or described in this document.
• The device is a diagnostic assay interpreted visually by a single operator, not an AI-assisted diagnostic.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The mecA XpressFISH assay is a standalone diagnostic assay in the context that its results are interpreted by an operator viewing fluorescence microscopy images. It is not an "algorithm only" device in the AI sense.
• The "standalone" performance here refers to the direct output of the assay itself, interpreted by a human, without further AI algorithms altering or assisting that interpretation. The clinical study precisely evaluates this standalone performance.

7. Type of Ground Truth Used

• Clinical Study Ground Truth: Cefoxitin Disk Diffusion for identification of methicillin-resistant S. aureus (MRSA). This is a well-established phenotypic method used in clinical microbiology as a standard of care for resistance testing.
• Bench Testing Ground Truth: Laboratory-characterized strains (e.g., ATCC strains, well-characterized clinical isolates) with known mecA gene status or methicillin resistance phenotypes were used for inclusivity, exclusivity, LOD, and reproducibility studies.

8. Sample Size for the Training Set

• The document does not specify a distinct "training set" in the context of machine learning.
• This device is a traditional in vitro diagnostic (IVD) assay, not an AI/ML-based device that would typically have a separate training set. Development and internal bench testing used various characterized strains, but these do not constitute a "training set" in the AI sense.

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

• As there isn't a "training set" in the AI sense, this question isn't directly applicable.
• For the development and bench marking activities, ground truth was established through:
  • Using reference strains (e.g., ATCC strains with known characteristics).
  • Characterization of clinical isolates using standard microbiological methods to determine their mecA status or methicillin resistance profile.

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The Alere™ PBP2a SA Culture Colony Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus as an aid in identifying methicillin-resistant Staphylococcus aureus (MRSA).

The Alere™ PBP2a SA Culture Colony Test is a rapid immunochromatographic membrane assay intended for the detection of penicillin-binding protein 2a (PBP2a) in isolates identifies as Staphylococcus aureus as an aid in identification of MRSA. The test uses highly sensitive recombinant monoclonal antibody fragments (rFabs) to detect the PBP2a protein directly from bacterial isolates. The rFab and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a pink/purple 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 test strip is placed in the assay tube. Results are read visually at 5 minutes.

Here's a breakdown of the acceptance criteria and study information for the Alere PBP2a SA Culture Colony Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance metrics. The study aims to demonstrate substantial equivalence to the predicate device, which itself reports similar performance ranges. The key performance indicators are Sensitivity and Specificity, stratified by plate type.

Note: The acceptance criteria in the table are inferred from the reported performance of the predicate device. The document does not explicitly state pre-defined acceptance criteria for the Alere™ PBP2a SA Culture Colony Test.

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

• Test Set Sample Size: A total of 454 S. aureus isolates were evaluated in the multi-center clinical study.
• Data Provenance: The study was conducted in three (3) geographically-diverse laboratories in 2013, indicating a multi-site prospective clinical study. The country of origin is not explicitly stated but implies the US given the FDA submission. It is a prospective study as isolates were "evaluated" in the test, suggesting real-time testing.

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

The document does not explicitly state the number of experts used or their specific qualifications.
The ground truth was established by 30 µg cefoxitin disk diffusion interpreted according to Clinical and Laboratory Standards Institute (CLSI) standards. This method is a standardized laboratory procedure, not typically requiring individual expert adjudication in the same way imaging studies might. The interpretation of the disk diffusion results would follow established CLSI guidelines, likely by trained laboratory personnel.

4. Adjudication Method for the Test Set

The ground truth was established by 30 µg cefoxitin disk diffusion interpreted according to CLSI standards. This is a laboratory-based gold standard, not a subjective interpretation requiring an adjudication method like 2+1 or 3+1. Therefore, no multi-reader adjudication method was used for the ground truth.

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 for laboratory use, not an imaging or clinical decision support AI tool designed to assist human readers. Therefore, there is no "human readers improve with AI vs without AI assistance" component.

6. Standalone Performance Study

Yes, the clinical study directly measured the standalone performance of the Alere™ PBP2a SA Culture Colony Test against the ground truth (cefoxitin disk diffusion). The reported sensitivity and specificity values are for the algorithm (device) only, without human-in-the-loop performance.

7. Type of Ground Truth Used

The ground truth used was established by phenotypic susceptibility testing: 30 µg cefoxitin disk diffusion interpreted according to CLSI standards. This is a widely accepted laboratory gold standard for identifying Methicillin-Resistant Staphylococcus aureus (MRSA) and detecting PBP2a expression.

8. Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The studies described are performance validation studies. For IVD devices, a "training set" in the context of machine learning (AI) is not typically described in 510(k) summaries unless the device incorporates AI. This device relies on immunochromatographic assay principles.

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

As no training set is mentioned in the provided text, there is no information on how its ground truth might have been established. Any internal development and optimization of the assay would have likely used characterized isolates with known PBP2a status, similar to what's described in the analytical studies (e.g., using ATCC strains or strains from repositories like NARSA).

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The Alere™ 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 Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

The Alere™ 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 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.

Acceptance Criteria and Study Details for Alere™ PBP2a Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "Sensitivity must be >= 95%"). However, the clinical performance study aims to demonstrate substantial equivalence, implying that the observed performance (Sensitivity and Specificity compared to the reference method) was deemed acceptable for market clearance. Based on the "Clinical Performance" section, the performance of the device was evaluated against cefoxitin (30 ug) disk diffusion.

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

• Sample Size for Test Set: A total of 457 S. aureus samples were evaluated in the clinical performance study.
• Data Provenance:
  • Country of Origin: The clinical performance study was conducted at "three geographically-diverse laboratories." The document explicitly mentions "a collection of strains from Department of Infectious Disease Epidemiology of the Imperial College in London, England" for the analytical performance (analytical reactivity and specificity), which suggests that at least some data or strains originated from outside the US. The main clinical study likely included US sites given the FDA submission, but this is not explicitly stated.
  • Retrospective or Prospective: Not explicitly stated. The wording "A total of 457 S. aureus samples were evaluated" does not indicate whether these were prospectively collected or retrospectively analyzed isolates.

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

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

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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. The study compares the device's performance directly to a reference method (cefoxitin disk diffusion), not the performance of human readers with or without AI assistance.

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

Yes, the study describes the standalone (algorithm only) performance of the device. The Alere™ PBP2a Test is a rapid immunochromatographic membrane assay where results are "read visually at 5 minutes." The performance metrics (Sensitivity and Specificity) are for the device's ability to detect PBP2a compared to the reference method. While a human visually reads the result, the performance assessed is of the diagnostic test itself, not a human interpreting images/data that the device produces.

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

The document does not explicitly state a dedicated "training set" size. The "Analytical Reactivity and Specificity" section mentions testing 162 strains of MRSA and 112 strains of MSSA with expected results to demonstrate analytical performance. While these strains might have informed the development of the device, they are presented as part of an analytical validation rather than a distinct "training set" in the context of machine learning model development. The device described (immunochromatographic assay) is not a machine learning algorithm that requires a traditional training set.

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

As mentioned above, there isn't a "training set" in the machine learning sense. For the strains used in analytical testing (162 MRSA and 112 MSSA), the ground truth (whether they were MRSA or MSSA) was established based on their classification from their source (NARSA, ATCC, and Imperial College collection). These are well-characterized strains with established resistance profiles.

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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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A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.

Rapid slide latex kit for confirmation of Methicillin-resistant Staphylococcus aureus (MRSA).

The kit tests for the mecA gene coding for methicillin resistance, by detecting its product, PBP2' (penicillin binding protein 2'). Organisms grown on suitable culture medium and believed to be Staphylococcus aureus, are emulsified in an extraction reagent, boiled for a set period of time under alkaline conditions, neutralised and centrifuged. A specified volume of supernatant liquid is mixed with a drop of test latex sensitised with a monoclonal antibody directed against PBP2' and control (unsensitised) latex on a test card. The cards are rotated for a defined length of time and examined for agglutination. A positive reaction observed with the test latex only indicates that the organism contains PBP2' and should be reported as a presumptive methicillin-resistant Staphylococcus aureus (MRSA).

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets them. Instead, it describes a 510(k) summary for the MASTALEX MRSA rapid slide latex kit, stating its equivalence to a predicate device and noting that no new performance data was submitted because the device's reagents are identical to the predicate.

Therefore, most of the requested information cannot be extracted from this document. However, based on the principle of substantial equivalence described, we can infer some details.

Here's a summary of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document explicitly states: "The determination of substantial equivalence is not based on performance data. No comparisons are necessary because the device reagents are identical to the predicate device." This means no new performance data for MASTALEX MRSA is reported, nor are specific acceptance criteria for a new study. The device is deemed substantially equivalent based on its identical nature to an already approved predicate device (MRSA-SCREEN, K011400).

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

• Cannot be provided. No new test set data was generated or submitted for this 510(k) application. The substantial equivalence relies on the predicate device's performance data.

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

• Cannot be provided. No new test set data was generated or submitted.

4. Adjudication method for the test set

• Cannot be provided. No new test set data was generated or submitted.

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

• Cannot be provided. This device is a rapid slide latex test for pathogen identification, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

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

• Cannot be provided. This device is a manual rapid slide latex test, not an algorithm.

7. The type of ground truth used

• Cannot be provided for MASTALEX MRSA directly. However, for the predicate device (MRSA-SCREEN), the ground truth for confirming MRSA would typically be established through molecular methods (e.g., PCR for mecA gene) or possibly conventional culture and methicillin susceptibility testing if the mecA gene detection was not the primary confirmation method for that predicate.

8. The sample size for the training set

• Cannot be provided. No new training set data was generated or submitted as it's not an AI/machine learning device.

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

• Cannot be provided. Not applicable as it's not an AI/machine learning device.

In summary, the provided document focuses on substantiating equivalence to a predicate device (MRSA-SCREEN), rather than presenting new performance data for the MASTALEX MRSA kit itself. This approach means that details about specific acceptance criteria and detailed study parameters for the MASTALEX MRSA are not included in this 510(k) summary. The performance of the predicate device is implicitly accepted as meeting the required criteria.

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This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

PBP21 Latex Agglutination Test

The provided text is a 510(k) premarket notification approval letter for the Oxoid PBP2' Latex Agglutination Test. It includes a general description of the device and its intended use, but it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks the actual study design, acceptance criteria, reported performance, and ground truth establishment methods.

Based on the information available, here's what can be extracted:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance values such as sensitivity, specificity, or accuracy. It only states the device's indications for use.

Study Information

The document is a regulatory approval letter and does not include the details of the study that underpinned the 510(k) submission. Therefore, much of the requested information regarding the study is not available in this text.

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

• Sample size for the test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text.

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 available in the provided text, as the method for establishing ground truth is not described.

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

• This information is not available in the provided text, as the study design is not 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

• This device is a latex agglutination test, which is a laboratory diagnostic assay, not an AI-assisted imaging device or system that would typically involve human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable to this type of device and is not mentioned.

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

• This device is a standalone diagnostic test kit that provides a direct result for the presence of PBP2'. Its performance is inherently "standalone" in that it produces a result without human interpretation of complex images or data that an algorithm might process. However, the document does not describe the specific performance study that would detail whether "standalone" performance in a clinical laboratory setting was evaluated and how.

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

• The document does not specify the type of ground truth used. For an antimicrobial susceptibility test, ground truth would typically be established by a reference method for detecting PBP2' or by phenotypic susceptibility testing interpreted against clinical breakpoints (e.g., oxacillin or cefoxitin disk diffusion, broth microdilution).

8. The sample size for the training set

• This information is not available in the provided text. As this is a latex agglutination test, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. However, similar to an algorithm, the test would have been developed and optimized using a set of isolates, but the document does not detail this.

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

• This information is not available in the provided text for the reasons mentioned above.

In summary, the provided document is a regulatory letter of approval and not the detailed technical submission or study report itself. Therefore, much of the specific study design and performance data you requested is absent.

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The ID Biomedical Velogene™ Rapid MRSA Identification Assay is intended as a qualitative assay for the definitive identification of methicillin resistance in presumptively identified cultures of Staphylococcus aureus by detecting the presence of the mecA gene. The presence of the mecA gene confers resistance to methicillin.

The Velogene™ Rapid MRSA Identification Assay is a DNA probe based diagnostic device that is based on Cycling Probe™ Technology (CPT) to generate spectrophotometric or visual results. The assay consists of two reagent kits, MRSA Lysis/Cycle Kit and MRSA Microwell Detection Kit.

Here's a breakdown of the acceptance criteria and study details for the Velogene™ Rapid MRSA Identification Assay, based on the provided text:

Acceptance Criteria and Device Performance

The primary acceptance criterion is substantial equivalence to the predicate device, the Oxacillin Screen Agar (NCCLS approved test for MRSA detection). This substantial equivalence is demonstrated through high agreement in identifying methicillin resistance in S. aureus samples.

7. The type of ground truth used:

• Primary Ground Truth for Clinical Comparison: The Oxacillin Screen Agar (a NCCLS approved test for MRSA detection) served as the primary comparative ground truth.
• Definitive Ground Truth for Discrepancy Resolution: nuc/mecA PCR was used as the definitive ground truth for the 3 discrepant isolates, confirming the presence or absence of the mecA gene. This is a molecular/pathology-based ground truth.
• Analytical Sensitivity/Specificity/Reproducibility: Used defined control strains (S. aureus ATCC 29213 - mecA negative, S. aureus ATCC 33592 - mecA positive) and specific isolates for analytical specificity testing. These are laboratory-defined ground truths.

8. The sample size for the training set:

The document describes performance evaluation studies and does not explicitly mention a dedicated training set or its sample size. This is common for traditional diagnostic assays where performance is validated against established methods and/or molecular gold standards, rather than "trained" like machine learning models. The study focuses on validation of the assay.

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

As no explicit training set is described, this question is not applicable. The assay's principles are based on known molecular biology (detection of the mecA gene).

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