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Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types.

Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.

Here's a breakdown of the acceptance criteria and study information for the Puritan Amies Medium Collection and Transport System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: The document states "known inoculum of ATCC type culture and clinically significant microorganisms" were used. It does not provide a specific number for the sample size (i.e., number of bacterial strains or replicates).
   • Data Provenance: Not explicitly stated, but the use of ATCC type cultures suggests a lab-based study rather than patient-derived retrospective or prospective data. The clinical significance of some microorganisms suggests they might be strains commonly isolated in clinical settings, but their exact provenance (e.g., country, specific source) is not detailed.

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

   • This information is not provided in the document. The study's ground truth for microbial recovery would typically be established by laboratory methods (e.g., colony counting) rather than expert interpretation in the way, for example, a radiology study would use expert readers.

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

   • This concept is not applicable to this type of microbiology recovery study. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where human readers interpret results and consensus is needed. For microbial recovery studies, quantitative measures (e.g., colony-forming units) are the primary endpoint.

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 type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Puritan Amies Medium is a specimen collection and transport device, not an AI diagnostic tool.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical device (collection and transport medium), not an algorithm or AI system.

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

   • The ground truth for the recovery testing was established by quantitative microbiological methods, specifically by comparing the recovery (viability) of known inoculums of ATCC type cultures and clinically significant microorganisms in the Puritan Amies Medium versus a predicate device. This would involve standard laboratory techniques like plating and colony counting to quantify viable organisms.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical device, not an AI model or algorithm, so there is no "training set."

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

   • Not applicable. As there is no training set for this type of device, this question is not relevant.

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