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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.

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Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet.

Nix® Ultra Lice Killing Solution is a formulated device containing dimethicone and isoparaffin. The product kills lice and their eggs by physically coating the lice and clogging the spiracles through which they breathe and conduct water exchange; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb. The Nix® Ultra Lice Treatment Kit is intended for over-the-counter use.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nix® Ultra Lice Treatment Kit:

Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission for the Nix® Ultra Lice Treatment Kit does not explicitly state pre-defined quantitative acceptance criteria in the typical sense (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Clear™ Lice Egg Remover System (K981147).

The closest equivalent to "acceptance criteria" and "reported device performance" in this document is the demonstration of effectiveness against lice and nits and safety through in-vitro studies and a clinical study. The primary endpoints in the clinical study focused on "cure rates" (no infestation) at different time points.

Here's a table summarizing the relevant performance metrics from the studies:

Study Details

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

   • In-vitro studies: The document details the subjects as "adult lice, nits, and lice genetically confirmed to be permethrin- and DDT-resistant (BR-HL strain)". The exact numerical sample size (e.g., number of lice or nits per test) is not provided, only the resulting mortality rates.
   • Clinical Study (Ref# NUHL001-10/15): The tables show results for 25-26 subjects for "Reference" and 25-26 subjects for "Test" in the "All baseline infestations" category. For "Mild and Moderate Baseline Infestation," it's 19 subjects for "Reference" and 17-18 subjects for "Test". The specific country of origin is not explicitly stated, but the mention of a European marketer for post-marketing data suggests the clinical trial could have been conducted in Europe. The study is described as a "randomized, controlled, investigator- and assessor-blinded study," indicating it was a prospective clinical trial.
   • Post-marketing adverse event data: This involved 518,095 units sold in Europe from June 2007 to December 2015, making it retrospective observational data.

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

   • In-vitro studies: Not explicitly stated. The ground truth (live vs. dead lice/nits) would typically be assessed by laboratory technicians trained in entomology, potentially under the supervision of experts in parasitology. Specific qualification details are not provided.
   • Clinical Study: The study involved an "investigator" to assess the baseline infestation and presumably monitor for cure or presence of lice. The document does not specify the number of investigators or their qualifications beyond the term "investigator." For Head Lice studies, these are often medical professionals or trained personnel experienced in examining scalps for lice and nits.

3. Adjudication method for the test set:

   • In-vitro studies: Not specified, but generally, clear criteria for "mortality" in entomological studies are pre-defined and applied consistently by trained observers.
   • Clinical Study: Not explicitly described. Given it was an "investigator- and assessor-blinded study," it implies that at least two independent parties were involved in assessments, one of whom was blinded. However, the specific adjudication process (e.g., if there were discrepancies between assessors) is not detailed.

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:

   This is not an AI/imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The clinical study was a comparison of the Nix® Ultra product against a "Reference" product in terms of cure rates.

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

   This is not an AI/algorithm-driven device. Therefore, a standalone algorithm-only performance study is not applicable. The "device" in this context is a physical lice treatment kit.

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

   • In-vitro studies: Biological endpoint (mortality/viability of lice and nits) observed directly by trained personnel. This could be considered a form of direct biological observation, which is highly objective.
   • Clinical Study: Clinical outcome (presence or absence of head lice infestation), assessed by an "investigator" based on visual examination, likely aided by comb-out procedures. This would implicitly involve a form of expert assessment or consensus if multiple investigators were involved, but the document doesn't detail this.
   • Post-marketing adverse event data: Self-reported adverse events from users and classified by the marketer. This is outcomes data based on user experience.

7. The sample size for the training set:

   This device is a chemical and mechanical treatment for lice, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable.

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

   As this is not a machine learning device, the concept of a "training set" and its associated ground truth establishment is not applicable.

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The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.

The LouseBuster (LB) is a portable, electrically powered, reusable, device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.

The provided document is a 510(k) Premarket Notification for the LouseBuster™ Lice Eradication System. It focuses on establishing substantial equivalence to a predicate device and does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for diagnostic devices (e.g., sensitivity, specificity for an AI algorithm).

Here's a breakdown of why the requested information cannot be fully provided based on this document:

• Device Type: The LouseBuster is a physical device that uses heated airflow to kill lice, not a diagnostic AI algorithm. Therefore, the concept of a "test set," "training set," "ground truth," "expert consensus," "MRMC study," or "standalone performance" for an AI model is not applicable to this submission.
• 510(k) Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria from a de novo study.

However, I can extract the relevant information from the document that loosely aligns with your request, focusing on the device's intended use and effectivity.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/diagnostic context:

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

Since this is a physical device with a 510(k) submission, "acceptance criteria" for performance are generally tied to its intended use and demonstrated effectivity. The document does not provide a table of performance metrics like sensitivity/specificity. Instead, its "performance" is implicitly tied to its ability to "kill or remove lice and lice eggs."

Note: The document implicitly assumes that the device, being substantially equivalent to its predicate, is effective for its stated purpose. It does not provide quantitative data on efficacy (e.g., what percentage of lice are killed).

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. This is a physical device submission demonstrating substantial equivalence, not a clinical trial for a diagnostic or AI device with "test sets." The submission states "No design changes have been made to the device. From design and manufacturing standpoints, the subject LouseBuster device is identical to the cleared LouseBuster device." This implies reliance on previous data for the predicate device, but no new clinical "test set" data for this specific submission is detailed.

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. There is no mention of "experts" establishing "ground truth" for a test set in this 510(k) submission.

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

Not applicable. No test set requiring adjudication is 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 is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable in the context of AI/diagnostic "ground truth." For a physical device like this, the "ground truth" of its effectiveness would typically be established through clinical studies demonstrating actual reduction or eradication of lice infestations, but such specific data is not part of this 510(k) summary (which focuses on equivalence).

8. The sample size for the training set

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

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

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

Summary of what the document does provide:

• Device: LouseBuster™ Lice Eradication System, a portable, electrically powered device using controlled, heated airflow to kill lice and lice eggs.
• Intended Use: To kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
• Predicate Device: LouseBuster (K083206).
• Substantial Equivalence: The submission claims "The LouseBuster intended for non-prescription use is substantially equivalent to the predicate LouseBuster intended for prescription use, and is safe and effective for its intended use." It explicitly states that "No design changes have been made to the device. From design and manufacturing standpoints, the subject LouseBuster device is identical to the cleared LouseBuster device." This is the basis for its perceived "acceptance."

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The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.

The LouseBuster (LB) is a portable, electrically powered, reusable, prescription-use device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.

The provided text is related to the K083206 510(k) submission for the Larada Sciences LouseBuster™ device. However, it does not contain the detailed acceptance criteria or the specific results of the study proving the device meets those criteria, nor the information about sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document refers to a clinical trial that "demonstrated that the safety and efficacy of the LouseBuster device was equivalent to that of the predicate device." It also states that "Results of additional design verification studies demonstrated that the device met pre-defined acceptance criteria for electrical and mechanical mace. Biological safety risks were found to be acceptable in accordance with ISO 10993-1 and FDA Memo G95-1."

Since this document predates the widespread use of AI/ML in medical devices, the detailed information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, ground truth establishment methods for AI, MRMC studies) is not present. The device described, the LouseBuster™, is a physical device that uses heated airflow to kill lice, not an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details for an AI/ML device based on the provided text. The information required for such a description is simply not available in this 510(k) summary.

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the removal of head lice and their eggs (nits) from hair

The kit consists of two components, the combing pretreatment shampoo. The comb is stainless steel with the teeth set to 0.3 mm (300 micron) spacing and capable of removing nits which are greater than 0.3 mm when attached to the hair. The second element is a shampoo that contains no pesticides but does facilitate lice removal and allows for rinsing and combing the nits out of the hair.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KIEL LABORATORIES, INC. KLOUT™ LICE COMB and PRETREATMENT SHAMPOO:

Summary of Device and Intended Use:

The KLOUT™ kit consists of a stainless steel comb with 0.3 mm tooth spacing and a pesticide-free shampoo. Its intended use is the removal of head lice and their eggs (nits) from hair.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a controlled study with statistically reported device performance metrics (e.g., sensitivity, specificity, accuracy, removal rates, etc.) for the KLOUT™ kit itself.

Instead, the submission relies on a "Basis for Comparison" to predicate devices (CLEAR™ LICE EGG REMOVER SYSTEM - K981147 and LICEMEISTER™ COMB - K981250) to demonstrate substantial equivalence. The acceptance for this device is based on showing that its features and intended use are similar to those of legally marketed predicate devices, implying that if the predicates are safe and effective, then the KLOUT™ kit, with similar characteristics, also should be.

The table below reflects the comparison points used to establish substantial equivalence, which implicitly act as the "acceptance criteria" by aligning with the established performance/features of predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

No specific test set or clinical study data is provided in this submission. The approach is based on demonstrating substantial equivalence to predicate devices, not on a new performance study with a distinct test set. Therefore, there is no sample size for a test set or data provenance to report.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no specific performance study with a test set was conducted for the KLOUT™ kit, there were no experts required to establish ground truth for such a study. The "ground truth" here is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set or associated adjudication method is described in the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document does not describe an MRMC comparative effectiveness study involving human readers or AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No. This device is a physical product (comb and shampoo), not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (CLEAR™ LICE EGG REMOVER SYSTEM - K981147 and LICEMEISTER™ COMB - K981250) as accepted by the FDA. The submission demonstrates that the KLOUT™ kit is substantially equivalent to these devices based on its components, intended use, and functional characteristics.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used for this device.

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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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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.

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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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