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Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

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This is an FDA 510(k) clearance letter for a medical device (a specimen collection and transport system), not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment is not typically found in this type of document.

A 510(k) clearance indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device is as safe and effective as a predicate device, often through comparison of technical characteristics and performance data that align with generally accepted methods for that device type. It does not typically involve the detailed study protocols, acceptance criteria tables, expert reviews, or MRMC studies that would be present in a comprehensive clinical study report for a novel or higher-risk device.

Here's an attempt to answer the questions based on the provided document, with the understanding that much of the requested detail is not available here:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance metrics in the format requested. The FDA has reviewed the "premarket notification of intent to market" and determined the device is "substantially equivalent" to predicate devices. This implies that the performance characteristics presented by the manufacturer (though not detailed here) met the FDA's criteria for equivalence for this type of device.

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

This information is not provided in the FDA clearance letter. The document mentions a "premarket notification," which usually includes data, but the specifics of the sample size, data provenance, and study design are not detailed in this public clearance letter.

3. 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)

This information is not provided.

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

This information is not provided.

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

This type of study is not relevant to this device. The device is a "Microbiological specimen collection and transport device," not an AI-powered diagnostic or imaging tool that would involve human readers or AI assistance in interpretation.

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

This question is not applicable. The device is a physical specimen collection and transport system, not an algorithm.

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

For a microbiological specimen collection and transport device, the "ground truth" would typically involve demonstrating:

• Maintenance of viability and infectivity of various microorganisms over specified timeframes and temperatures.
• Comparability of recovery rates to predicate devices.
• Absence of inhibitory substances.

However, the specific "type of ground truth" used in the manufacturer's submission to the FDA is not detailed in this clearance letter. It would likely have involved laboratory-based challenge studies with known microbial cultures.

8. The sample size for the training set

This information is not provided and is generally not applicable to the evaluation of this type of device in the way it would be for an AI/ML diagnostic. Training sets are relevant for machine learning models, which this device is not.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device requiring a training set.

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Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.

Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad.

Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen.

The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.

To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Wire Virocult® Virus Collection and Transport System:

Based on the provided 510(k) summary, the device is a virus collection and transport system, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs associated with AI medical devices (like those involving expert adjudication, multi-reader multi-case studies, or AI standalone performance) are not applicable to this submission.

The "acceptance criteria" for a device like this would primarily revolve around its ability to preserve viral viability and infectivity, its stability over time, and its pH, recovery, and toxicity characteristics as a transport medium. The study done proves its performance against these criteria.

Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) for a physical medical device (transport medium), the study details differ significantly from those for AI/Software as a Medical Device (SaMD).

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

   • The document does not specify exact sample sizes (e.g., number of swabs, number of viral strains, number of tests conducted) for the performance testing. It generally states that "Tests were done to simulate transport" and "Stability studies were performed."
   • Data Provenance: The studies were conducted by the manufacturer, Medical Wire & Equipment Company (Bath) Ltd., as part of their 510(k) submission. The country of origin for the testing would presumably be the UK, where the company is based. The studies appear to be laboratory-based performance evaluations rather than clinical trials with patient data, so they are prospective in the sense of being planned experiments.

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

   • Not Applicable. This is a physical device used to collect and transport biological samples, not an AI system making diagnostic interpretations. "Ground truth" in this context would be defined by the known initial viral concentration in the samples used for testing, and the known conditions (temperature, time) that the samples were subjected to. These would be laboratory-controlled parameters, not expert-adjudicated diagnoses.

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

   • Not Applicable. No human adjudication of diagnostic outcomes is involved. The evaluation relies on laboratory measurements of viral viability/recovery.

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 a physical collection and transport device, not an AI system or an AI-assisted diagnostic tool. There are no "human readers" (e.g., radiologists, pathologists) whose performance would be improved by this device in a diagnostic context, nor is there any AI involved.

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

   • Not Applicable. This is a physical medical device, not an algorithm or AI.

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

   • For the performance testing (viral recovery, stability), the ground truth is primarily established through laboratory standards and controls. This would involve:
     • Known initial concentrations of specific viruses (reference strains).
     • Standardized methods for viral culture and quantification (e.g., plaque assays, PCR measurement of viral load) to determine recovery rates after transport.
     • Measurement against established benchmarks for acceptable viral viability post-transport (likely derived from CLSI guidelines or internal validation against predicate devices).

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

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

   • Not Applicable. As there is no AI or machine learning model, there is no "training set" or ground truth for it. The product's formulation and specifications are based on scientific principles of viral preservation and chemical stability, not trained data.

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