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

The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position. A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifinge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tube containing the sample.

The provided text describes a pre-market notification for the STP™ System - SAF, a fixative-preservative for intestinal parasite examination. The goal is to demonstrate substantial equivalence to Meridian's Para-Pak® SAF Fixative.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state quantitative acceptance criteria in terms of specific percentages or thresholds (e.g., "sensitivity of X%"). Instead, the acceptance is based on a qualitative functional evaluation that aims to ensure the device performs comparably to established methods for preparing stool specimens for parasite examination.

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

• Sample Size: Not explicitly stated. The text mentions "Specimens were evaluated at independent clinical laboratories," but does not provide the number of specimens or the number of units of the device tested.
• Data Provenance: Not explicitly stated. It mentions "independent clinical laboratories," but the country of origin is not specified. The study appears to be prospective in nature as it describes a specific testing procedure for evaluating the functional performance of the device.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The evaluation involved "microscopic evaluation of permanent slides and wet mounts," implying trained laboratory personnel or medical professionals, but their specific qualifications (e.g., medical technologists, parasitologists) are not detailed.

4. Adjudication Method

• Adjudication Method: Not described. The evaluation concluded with a binary outcome ("satisfactory or unsatisfactory"), but the process by which this determination was made, especially if multiple evaluators were involved, is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the functional performance of the device itself rather than comparing human reader performance with and without AI assistance. The context is a device for specimen preparation, not an AI diagnostic tool.

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

• Standalone Study: Yes, in a sense, a standalone device performance study was done. The evaluation assessed the device's ability to fix and preserve specimens, leading to well-prepared slides suitable for microscopic examination, without human variability being the primary focus of the performance measure. The "algorithm" here is the physical and chemical mechanism of the fixative and filter, not a computational AI algorithm. The performance was assessed based on the quality of the prepared slides directly attributed to the device's function.

7. The Type of Ground Truth Used

• Ground Truth: The ground truth for evaluating the device's performance was based on artificially spiked samples and expert interpretation of the quality of the prepared slides. White blood cells (buffy coat from uncoagulated human blood) were used "in lieu of parasites" and added to human stool specimens. The "ground truth" for the device's function was that these added cells should be well-fixed, display typical morphology and color, and allow for thorough microscopic examination. This is an objective assessment of the device's preservation and preparation capabilities.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. This device is a physical product (fixative-preservative system), not a machine learning model that requires a training set. The "training" in this context refers to standard laboratory procedures and established chemical principles.

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

• Training Set Ground Truth: Not applicable. As mentioned above, this is not an AI/ML device requiring a training set with established ground truth. The "ground truth" for its development would be the known efficacy of SAF solution and the physical design for specimen collection and preparation.

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