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The Copan Venturi Transystem Amies Medium Without Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium Without Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

The Copan Venturi Transystem Amies Medium Without Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium Without Charcoal and are offered in six models. The only difference in the six models is the type of applicator used for the collection of the bacteriological sample. The applicator shafts vary for facilitation of the collection of the specimen from various sites of the patient. The six types of Copan Venturi Transystem Amies Medium Without Charcoal products are:

• Product Code 108C with plastic applicator .
• Product Code 134C with two plastic applicators .
• Product Code 110C with regular aluminum applicator •
• Product Code 124C with soft aluminum applicator .
• Product Code 128C with slim paper applicator .
• . Product Code 190C with flexible twisted wire applicator

The provided text is a 510(k) Summary for a medical device, the Copan Venturi Transystem Amies Medium Without Charcoal. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a report of a study proving the device meets acceptance criteria. As such, the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, and ground truth types for a study is not present in this document.

Here's what the document does state regarding performance:

Performance Testing (Section 7):

• "Studies were conducted to evaluate the performance characteristics of the Copan Venturi Transystem Amies Medium Without Charcoal products."
• "Recovery studies were performed using Copan and comparative products to determine the ability of the products to maintain viability of anaerobic bacteria during storage and use."
• "Additional studies were performed to determine the ability of the packaging to retard oxygen penetration over the shelf life of the Copan products."
• "The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use."

However, the document does not provide the following information that you requested:

• A table of acceptance criteria and the reported device performance: The specific criteria and quantitative results are not detailed.
• Sample size used for the test set and the data provenance: No sample sizes for the recovery studies or packaging studies are mentioned, nor is the origin of the data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is laboratory testing of microbial viability and packaging, not interpretation of clinical data by experts.
• Adjudication method for the test set: Not applicable for this type of laboratory testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance: This is a specimen collection and transport device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
• The type of ground truth used: The studies involved direct measurement of bacterial viability and oxygen penetration, which would be considered direct experimental results rather than 'ground truth' in the context of expert-determined classifications.
• The sample size for the training set: Not applicable, as this is not a machine learning device.
• How the ground truth for the training set was established: Not applicable.

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