(698 days)
The Resultz® Lice & Egg Removal Kit is intended to be used to remove head lice and their eggs from hair. The kit contains a fine-toothed nit comb and cosmetic based combing aid.
The kit contains a fine-toothed nit comb and cosmetic based combing aid.
The provided text is a 510(k) premarket notification letter from the FDA regarding a lice and egg removal kit. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The document is purely administrative, confirming the substantial equivalence of the "Resultz® Lice & Egg Removal Kit" to a legally marketed predicate device. It specifies the product's intended use and regulatory classification.
Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., sample size for test set, number of experts, MRMC study, ground truth) are standard for AI/ML device evaluations, which are not discussed in this document.
§ 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.