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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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