(28 days)
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.
Not Found
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.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.