(72 days)
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."
| Acceptance Criteria (Implied by Intended Use) | Reported Device Performance (Implied) |
|---|---|
| Effectively kill or remove lice | The device is intended and cleared for "use to kill or remove lice and lice eggs" |
| Effectively kill or remove lice eggs | The device is intended and cleared for "use 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."
§ 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.