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The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, singleuse 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 With Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

The Copan Venturi Transystem Amies Medium With Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium With 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 With Charcoal products are:

• Product Code 114C with plastic applicator .
• Product Code 136C with two plastic applicators .
• Product Code 116C with regular aluminum applicator .
• Product Code 125C with soft aluminum applicator .
• Product Code 129C with slim paper applicator .
• Product Code 192C with flexible twisted wire applicator .

The provided document is a 510(k) summary for the Copan Venturi Transystem Amies Medium With Charcoal, a specimen collection and transport system. It is a premarket notification for a Class I medical device, which generally means it's considered low-risk and doesn't require extensive clinical trials like higher-risk devices.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics. Instead, it refers to "acceptable performance." This is common for Class I devices and 510(k) submissions where the focus is on substantial equivalence to predicate devices rather than proving specific performance against predefined thresholds.

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

• Sample Size: The document does not specify exact sample sizes for the "recovery studies" or "additional studies" performed. It only mentions "Studies were conducted to evaluate the performance characteristics."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission from a US-based company (Copan Diagnostics Inc., Corona, CA), it's highly probable the studies were conducted in the US. The timeframe suggests they would have been prospective studies specifically designed for regulatory submission, rather than retrospective analysis of existing data.

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

This type of information is not applicable to this device and the context of its 510(k) submission. Ground truth established by medical experts (e.g., radiologists) is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging), not for specimen collection and transport systems where a definitive microbiological culture or molecular diagnostic result would serve as the "truth." The studies would have focused on the viability of microbial samples, not on expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks, which is not the nature of the performance testing described for this device.

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

An MRMC comparative effectiveness study is not applicable to this device. These studies are conducted for devices, particularly AI-driven ones, that assist human readers in making diagnoses (e.g., medical imaging interpretation). The Copan Venturi Transystem is a physical device for specimen collection and transport, not an interpretive aid. Therefore, there is no "human reader improvement with AI vs without AI assistance" to measure.

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

This information is not applicable as the device is a physical specimen collection system and not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document implies that the ground truth for performance evaluation would be based on microbiological viability (e.g., culture growth) outcomes. For example, "Recovery studies were performed... to determine the ability of the products to maintain viability of anaerobic bacteria." The "truth" would be whether the bacteria remained viable to allow for subsequent laboratory examination and identification.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical collection and transport system, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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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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