(52 days)
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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1998
Mr. Hans Schwartz ·Research Associate National Pediculosis Association, Incorporated 50 Kearney Road Needham, Massachusetts 02194
Re : K981250 LiceMeister™ Comb Trade Name: Regulatory Class: Unclassified Product Code: LJL Dated: March 30, 1998 Received: April 6, 1998
Dear Mr. Schwartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. র substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Schwartz
through 542 of the Act for devices under the Electronic enrough sadiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene rogalación Shoreiou) : Bianalig bj - Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluațion Center for Devices and Radiological Health
Enclosure
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Re. K981250
Indications For Use
| Labels | Values |
|---|---|
| 510(k) Number (if known) | K981250 |
| Device Name: | LICE MEISTER COMB |
Indications For Us =:
cleening DETECTION THEIR E of LICE
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescripcion Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Paticia Cuenca
(Division Sign-Off) Division of Demal. Infection Control, and General Hospital Devices 510(k) Number.
§ 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.