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The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen

Based on the provided text, the document is a 510(k) clearance letter for the ProSpecT® Campylobacter Microplate Assay. It does not contain the detailed study information required to answer all aspects of your request. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

However, I can extract the following:

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

• Acceptance Criteria: Not explicitly stated in this document. The focus of this letter is substantial equivalence to a predicate device, not a performance report against specific criteria.
• Reported Device Performance: Not detailed in this document. The letter indicates the device is cleared for "qualitative detection of Campylobacter Specific Antigen" but does not provide sensitivity, specificity, or other performance metrics.

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

• This information is not available in the provided document.

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 document.

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

• This information is not available in the provided document.

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

• This type of study is not applicable as the device is an in vitro diagnostic assay, not an AI-powered image analysis tool for human readers. This information is not available in the provided document.

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

• The device is described as a "microplate EIA," which is a lab-based assay, implying it functions in a "standalone" manner (i.e., the device itself performs the detection) rather than requiring continuous human-in-the-loop performance for each test result interpretation beyond standard laboratory procedures. However, the specific details of a "standalone performance study" in the context of your question are not provided.

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

• This information is not available in the provided document. For an in vitro diagnostic for infectious disease, typical ground truth would involve culture methods, PCR, or other established diagnostic tests.

8. The sample size for the training set

• This information is not available in the provided document. For an in-vitro diagnostic assay, the concept of a "training set" in the machine learning sense is generally not applicable in the same way. The development and validation involve different types of sample sets.

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

• This information is not available in the provided document.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the ProSpecT® Campylobacter Microplate Assay for its stated indications for use but does not delve into the detailed performance study data, acceptance criteria, or ground truth establishment methodologies that would be found in a more comprehensive clinical study report.

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ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.

ProSpecT® Cryptosporidium Microplate Assay

The provided document is a 510(k) clearance letter from the FDA for a device called "ProSpecT® Cryptosporidium Microplate Assay." It does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states the FDA's finding of substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information about acceptance criteria and study details from this document. The document confirms the device's classification and allows it to be marketed but does not delve into the specifics of performance studies.

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The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

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This looks like a 510(k) clearance letter from the FDA for a diagnostic device. Unfortunately, clearance letters typically do not contain the detailed study results, acceptance criteria, or performance data that you are requesting. They primarily state that the device has been found substantially equivalent to a legally marketed predicate device.

To get the information you're asking for, one would typically need to refer to the 510(k) summary or the full 510(k) submission document itself, which is often much more detailed. These documents would contain the clinical study design, acceptance criteria, and performance outcomes.

Based solely on the provided text, I cannot provide the requested information. The document only confirms the device's clearance and its intended use.

If you had the 510(k) summary or the full submission document, I would be looking for sections that detail:

• Clinical Performance Studies: This is where the bulk of the requested information would be found.
• Performance Characteristics: Typically a summary of sensitivity, specificity, accuracy, etc.
• Study Design: Details on population, sample size, ground truth, etc.
• Acceptance Criteria: Predetermined thresholds for performance metrics.

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