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Lice egg detection and removal.

The product is a nit comb intended for use in detecting and removing lice eggs from the hair. It is constructed of closely spaced stainless steel teeth imbedded in a high density polyethylene handle. The points and edges of the teeth are rounded so as not to cut or damage hair or scalp. The comb can be cleaned with soap and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (K822574).

The technological characteristics of the Clear Special Nit Comb are the same as other marketed nit combs, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm). The spacing between the teeth of the Clear Special Nit Comb is 200 microns (0.2mm).

This 510(k) submission (K981037) for the Clear™ Special Nit Comb does not contain a study that proves the device meets specific acceptance criteria in the manner typically expected for medical devices involving algorithmic performance or diagnostic accuracy.

Instead, this submission is based on substantial equivalence to predicate devices (Innocomb Lice Comb and Innomed PD-1 Kit). The "acceptance criteria" are implicitly met by demonstrating that the device has the same technological characteristics and intended use as legally marketed predicate devices, particularly regarding the spacing of its teeth.

Therefore, many of the requested categories (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission relies on substantial equivalence based on product design and published biological information (e.g., nit size), not a performance study with a test set of data.

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

• Not applicable. There was no "test set" in the context of an algorithmic or diagnostic performance study that required ground truth established by experts.

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

• Not applicable. No test set or expert adjudication was performed for this submission.

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:

• No. This is a physical device (a comb), not an AI-powered diagnostic or assistive tool.

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

• No. This is a physical device, not an algorithm.

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

• Not applicable. The "ground truth" implicitly relied upon is the biological size of lice nits (approximately 300 microns) and the known effectiveness of predicate nit combs with similar tooth spacing. This is more akin to established scientific understanding rather than a specifically generated "ground truth" for a performance study.

7. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device, not an AI model.

Summary Explanation:

The K981037 submission for the Clear™ Special Nit Comb sought 510(k) clearance based on substantial equivalence. This means the manufacturer demonstrated that their device is as safe and effective as legally marketed predicate devices without requiring new clinical trials or extensive performance studies typically associated with novel or high-risk devices, or those involving AI/diagnostic algorithms.

The key "evidence" presented was:

• Comparison of Technical Specifications: The tooth spacing (200 microns) was shown to be within the range of predicate devices and smaller than the minimum width of a lice nit.
• Description of Materials and Design: The construction (stainless steel teeth, polyethylene handle, rounded edges, cleanable) was presented as being similar to predicate devices and suitable for its intended use without causing harm.
• Intended Use Alignment: The stated intended use for lice egg detection and removal was identical to that of predicate devices.

The FDA's review concluded that the device was substantially equivalent, allowing it to be marketed. No performance studies with human subjects or data sets were required or cited in the provided documents for this type of submission.

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