(52 days)
cleaning DETECTION THEIR E of LICE
Not Found
The provided documents are a 510(k) clearance letter from the FDA for a device called "LiceMeister™ Comb". This type of document is for regulatory clearance based on substantial equivalence to a predicate device, not for reporting on a specific study with acceptance criteria and a detailed performance evaluation in the way you've outlined for an AI/software device.
A 510(k) submission typically requires demonstrating that a new device is as safe and effective as a legally marketed predicate device. For mechanical devices like combs, this usually involves a comparison of design, materials, and intended use, and sometimes bench testing, rather than clinical trials with statistical endpoints and ground truth as would be associated with a diagnostic AI product.
Therefore, most of the information requested in your prompt (e.g., acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance) is not applicable to the clearance of the LiceMeister Comb as described in these documents.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Not applicable/Not provided in the document. The document states the device is "substantially equivalent" to legally marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) submission of this nature. There are no performance metrics like sensitivity, specificity, accuracy, etc., for the comb itself in this document. The "performance" is implicitly to effectively detect and remove lice, similar to other combs on the market.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This type of information would be relevant for a clinical study, which is not described here.
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):
- Not applicable/Not provided. Ground truth is not established in the context of this 510(k) for a comb.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/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:
- Not applicable/Not provided. MRMC studies are for diagnostic interpretation, typically by human readers, often with AI assistance. This device is a physical comb, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The LiceMeister Comb is a manual device operated by a human.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
8. The sample size for the training set:
- Not applicable/Not provided. (Relevant for AI model development)
9. How the ground truth for the training set was established:
- Not applicable/Not provided. (Relevant for AI model development)
In summary: The provided FDA clearance letter for the LiceMeister Comb is a regulatory document confirming substantial equivalence to other legally marketed combs for "DETECTION AND REMOVAL of LICE". It does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth methodologies that would be associated with the clearance of a diagnostic AI device.
§ 880.5960 Lice removal kit.
(a)
Identification. The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.(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 the limitations in § 880.9.