(255 days)
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis.
The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
The Indicard™ test is an enzyme activity test.
This document is a 510(k) clearance letter from the FDA for the "INDICARD Test." It primarily focuses on the regulatory approval and indications for use, rather than detailed study results. Therefore, much of the requested information about acceptance criteria and study particulars cannot be fully extracted from this document.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device, meaning it performs similarly, but the actual performance values are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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 available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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 is not an AI device. The INDICARD Test is described as an "enzyme activity test" for detecting bacterial vaginosis. Therefore, an MRMC study and AI-related performance improvements are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device is a "test" and is indicated for "professional use," implying human involvement in performing and interpreting the test.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document states the device is for "detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis." The ground truth for such a device would typically involve a definitive diagnostic method for Gardnerella vaginalis or bacterial vaginosis, such as Gram stain (Nugent score), culture, or PCR, but this is not specified in the document.
8. The sample size for the training set
This information is not available in the provided document.
9. How the ground truth for the training set was established
This information is not available in the provided document.
In summary, this FDA clearance letter is a regulatory document confirming that the INDICARD Test is substantially equivalent to a pre-existing device and outlining its indications for use. It does not contain the detailed technical or clinical study data that would address most of your questions. To obtain such information, one would typically need to review the full 510(k) submission or supporting technical documentation for K964015.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.