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To remove lice eggs from hair.

The product is a system consisting of two components: (a) a glass reinforced nylon fine tooth nit comb; and (b) an enzyme gel cleansing agent intended to be used together with the comb to facilitate the combing out of lice eggs (nits) from the hair. The combing aid gel is a non-toxic water based vegetable derived enzyme composition. The product is substantially equivalent to other nit removal products, including the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574).

The technological characteristics of the nit comb component are the same as other marketed products, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth (0.1 to 0.2 mm). Spacing between the teeth of the comb component is 0.2 mm. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm).

The provided document**K981147** is a 510(k) summary for a medical device called the "Clear™ Lice Egg Remover System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria and performance metrics in the way a PMA submission might.

Therefore, the document does not contain the detailed acceptance criteria and a study proving device performance against those criteria as would be expected for a new technology requiring such validation. Instead, it focuses on comparing the new device's characteristics to existing, approved devices.

Here's a breakdown based on the information available in the document, and where information is missing:

The document describes the device as a system consisting of:

• A glass-reinforced nylon fine tooth nit comb.
• An enzyme gel cleansing agent, which is a non-toxic water-based vegetable-derived enzyme composition.

The intended use is "To remove lice eggs from hair."

The predicate devices identified are the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574).

Information from the document related to your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit/Inferred from Predicate Equivalence): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For this specific device, the key technological characteristic that determines equivalence for the comb component is the spacing between the teeth.

  • Criterion for Comb: Spacing between comb teeth should be within the range of 100 to 200 microns (0.1 to 0.2 mm), which is typical for other marketed products and predicate devices.
  • Criterion for Effectiveness (Assumed): The comb, combined with the gel, should be effective at removing lice eggs (nits) that are larger than the comb's spacing.

• Reported Device Performance:

  Acceptance Criteria (Implicit)	Reported Device Performance
  Spacing between comb teeth: 100 to 200 microns (0.1 to 0.2 mm)	0.2 mm (meets criterion)
  Lice nit minimum width: Approximately 300 microns (0.3 mm)	(Implies that a 0.2 mm comb spacing is effective for removal, as the nit is larger than the gap)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The 510(k) summary does not mention any specific test set, clinical studies, or data provenance to prove performance against quantitative acceptance criteria in the way a clinical trial would. The submission relies on technological equivalence to predicate devices already on the market.

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: As no specific test set or clinical study to establish ground truth is described, this information is not relevant to this submission type.

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

• Not Applicable / Not Provided: No test set described.

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: This device is a physical nit comb and enzyme gel, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

• Not Applicable: This device is a physical product, not an algorithm.

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

• Implicit Ground Truth (Technological Equivalence): The ground truth for this submission type is based on the established performance and safety of equivalent predicate devices and the physical characteristics of the nits being removed. The statement that "The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm)" serves as a foundational piece of information, implying that a comb with 0.2 mm spacing will physically remove nits effectively.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no "training set" in the context of this 510(k) submission for a physical device.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: Refer to point 8.

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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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