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.

AI/ML Overview

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."

Summary

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K093144

Larada Sciences,Inc.	Premarket NotificationLouseBuster™	Oct. 02, 2009Page 18 of 40
--------------------------	----------------------------------------	--------------------------------

5. 510((k) Summary

5.1 Preparation Date 02 October 2009

Submitted By
Randall Block President, COO Larada Sciences, Inc. 825 North 300 West Suite 500 Salt Lake City, UT 84103-1459 Phone (801) 533 5423 / Fax 801 355 5423 randall@laradasciences.com

Contact Person/ Prepared By

Phil Triolo PhD RAC Principal Phil Triolo and Associates LC 148 S. 1200 E. Salt Lake City, UT 84102 Phone (801) 699 9846 / Fax 801 328 2399 philt@philt.com

5.2 Device Identification

LouseBuster™ Trade Name Louse Eradication System Common Name Classification Name Lice Removal Kit §880.5960

5.3 Predicate Device(s)

LouseBuster (K083206)

5.5 Device Description

.. .. .....

,·· ·

ﻪ ﻧ

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 singleuse applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to

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Larada Sciences,	Premarket Notification	Oct. 02, 2009
Inc.	LouseBuster™	Page 19 of 40

systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.

5.6 Intended Use

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.

Comparisons and Conformance with Standards 5.7

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.

5.8 Conclusion

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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 6 2009

Larada Sciences, Incorporated C/o Phil Triolo, PhD, RAC Principal Phil Triolo And Associates LC 148 South 1200 East Salt Lake City, Utah 84102

Re: K093144

Trade/Device Name: Larada Sciences LouseBuster™ Lice Eradication System Regulation Number: 21 CFR 880.5960 Regulation Name: Lice Removal Kit Regulatory Class: I Product Code: LJL Dated: October 2, 2009 Received: October 5, 2009

Dear Dr. Triolo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Dr. Triolo

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Susan Runes

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: -

Larada Sciences LouseBuster™ Lice Eradication System
The LouseBuster

Indications For Use: The LouseBuster™ is intended for use to kill or remove lice and

lice and
made for use to kill or remove lice and

lice eggs in the head hair of adults and children 4 years of age and

older.

Prescription Use AND/OR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Over-The-Counter Use _ X ___ (Part 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles E
(Divisio

(Division Sign-Off) (Pression Off)
Division of Anesthesiology, General Hospital The Store of Anesthesiology, General Devices

510(k) Number: K093160

Page 1 of _1

Regulation Number and Section

§ 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.