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The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic 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 aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single swab applicator and the Copan Easy-Swab II is offered with two swab applicators. The Copan Easy-Swab is composed of a sterile peel pouch containing one or two swab applicators inside the transport tube. The swab applicator incorporates a polyurethane foam tip on a plastic shaft secured to a cap. The tube is manufactured from polypropylene.

To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube and used to collect the clinical specimen. During specimen collection, the applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.

Here's an analysis of the provided text regarding the Copan Easy-Swab Collection and Transport System, focusing on the acceptance criteria and the study that proves the device meets them:

Overall Assessment:

The provided document (K993161) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with strict acceptance criteria for novel performance claims. Therefore, many of the requested elements (like specific effect sizes for human readers in MRMC studies, details on ground truth for training sets, etc.) are not applicable or not explicitly provided in this type of regulatory submission. The "study" here refers to performance testing to show viability and stability.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Test Set Sample Size: Not explicitly stated in terms of a specific number of individual swabs or patient samples. The text mentions "a variety of aerobic organisms" were used for recovery studies.
   • Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer (Copan Diagnostics Inc. is based in Corona, CA, USA), but this is not explicitly stated. It is a prospective study as it involves active testing of the device.

2. 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):

   • Not Applicable / Not Provided. For a device like a specimen collection and transport system, "ground truth" would typically be established by standard microbiological culture techniques performed by trained laboratory personnel. The document does not describe the use of "experts" in the sense of clinical specialists establishing a diagnosis. The viability assessment would be based on standard lab protocols.

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

   • Not Applicable / None. Adjudication methods like 2+1 are typically used in studies involving subjective interpretation (e.g., imaging studies). For a device like this, performance is assessed by objective microbiological viability counts, not subjective interpretation.

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:

   • Not Applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting results in the way an MRMC study would measure. It's a collection and transport system.

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

   • Not Applicable. This is a physical device, not an algorithm. Performance is inherent to the device's ability to maintain organism viability.

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

   • Microbiological Culture Viability. The ground truth for the performance claim ("All organisms tested remained viable...") is established by standard microbiological culture methods, where the presence and growth of viable microorganisms are directly observed and quantified after the transport period. This is an objective, laboratory-based measurement.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

   • Not Applicable. As there is no training set for a machine learning model, this element is not relevant.

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