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Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination

The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.

The provided document describes the Pre-Market Notification for the STPTM System - PVA with Zinc, a fixative-preservative for intestinal parasite examination. The study described focuses on the functional performance of the device.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides qualitative acceptance criteria and a statement of successful performance against those criteria. It does not provide quantitative metrics such as sensitivity, specificity, accuracy, or a numerical "reported device performance" value.

Study Details:

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: Not explicitly stated. The document mentions "Specimens were evaluated at independent clinical laboratories," but does not specify the number of specimens or the number of product units tested.
   • Data Provenance: Not explicitly stated. The evaluation was done at "independent clinical laboratories," but the geographic location is not specified. It is likely prospective, as it describes a "performance evaluation" of the product.

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)

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document states "microscopic evaluation," implying trained laboratory personnel, but no specific professional titles or experience levels are provided.

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

   • Adjudication Method: Not specified. The evaluation involved subjective assessment of "satisfactory" or "unsatisfactory" functional performance, but the process for reaching this determination (e.g., single reader, consensus, majority vote) 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

   • MRMC Study: No. This study is a functional performance evaluation of a medical device (specimen collection and preservation system), not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable.

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

   • Standalone Performance: Not applicable. This device is a manual specimen collection and preservation system, not an algorithm. Its performance is entirely dependent on human-in-the-loop procedures for preparation and microscopy.

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

   • Type of Ground Truth: The ground truth for functional performance was established by observing ideal characteristics of microscopy slides. Specifically, it was determined by observing:
     • Adherence of the smear to glass slides.
     • Well-fixed cells with typical morphology and color, examined under a microscope.
   • The "presence of parasites" (mentioned in the conclusion) is the ultimate diagnostic goal, but the study focused on the functional performance of the fixative to allow for that examination, using white blood cells as a proxy for parasites in the testing methodology.

8. The sample size for the training set

   • Sample Size for Training Set: Not applicable. This pre-market notification describes a performance evaluation of a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

   • Ground Truth for Training Set: Not applicable, as there is no training set in this context.

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