Zeno is a portable hand-held device that produces accurately controlled low level sustained heat for use in treating dermatological disorders, specifically, mild to moderate acne. Individual acne blemishes are treated for a preset time of 2 ½ minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish. The device is powered by rechargeable AAA nickel-metal hydride batteries.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Zeno™ Acne Device. It details the device's indications for use, summary of substantial equivalence, and some performance data. However, it does not explicitly state acceptance criteria or provide a detailed study report that proves the device meets specific performance criteria.

Here's an analysis of the information that can be extracted, and what is missing based on your request:

Information Extracted from the Document:

Acceptance Criteria and Reported Device Performance:

The document states: "Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that Zeno is as safe and effective as the predicate device."
It also mentions: "Preclinical testing demonstrated significant sensitivity of p. acnes bacterial cells to the effects of sustained low-level heat."
However, specific quantitative acceptance criteria (e.g., a certain percentage reduction in acne lesions, a specific lesion resolution time) and the reported device performance against those criteria are not provided in this document. The document concludes that "the proposed device has been shown to be safe and effective for its intended use" based on testing, but the numerical results of that testing are absent.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric/Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document	Not explicitly defined in the document
Safety and Effectiveness	"as safe and effective as the predicate device"
P. acnes sensitivity to heat	"significant sensitivity... to the effects of sustained low-level heat"

Sample Size Used for the Test Set and Data Provenance:
- The document states that "Clinical testing was conducted," but it does not specify the sample size for the test set (number of participants, number of lesions treated, etc.).
- Data Provenance: It indicates the study was "conducted in both a controlled practitioner office environment and a consumer home-use environment." The country of origin of the data is not specified, but given the US FDA submission, it's likely primarily US-based. It was likely a prospective clinical study.
Number of Experts Used to Establish Ground Truth and Their Qualifications:
- The document makes no mention of experts used to establish a "ground truth" for the test set. Clinical studies for acne treatment often rely on dermatologists or trained clinicians for assessment, but their number and specific qualifications are not detailed.
Adjudication Method for the Test Set:
- The document states that the controlled clinical study design was a "randomized, double-blinded study." This implies a methodical approach to blinding participants and assessors, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is mentioned. The study referenced is a clinical trial to demonstrate safety and effectiveness compared to a predicate device, but not one involving multiple human readers assessing cases with and without AI assistance. The device itself is an acne treatment device, not an AI diagnostic tool that would typically involve an MRMC study.
Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- The device is a physical treatment device (a "portable hand-held device that produces accurately controlled low level sustained heat"). It is not an AI algorithm in the context of diagnostic or interpretive tasks. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in the way it would be for AI software. Its performance is inherent in its use by a human.
Type of Ground Truth Used:
- For the clinical study, the "ground truth" would likely be the clinical assessment of acne lesions by trained clinicians or dermatologists (e.g., reduction in lesion count, improvement in severity scores). However, the specific methodology for establishing this clinical ground truth (e.g., specific grading scales, independent review) is not detailed. For preclinical p. acnes sensitivity, the ground truth would be lab results (e.g., bacterial colony counts).
Sample Size for the Training Set:
- The document describes a clinical study and preclinical testing, but it does not mention a "training set" in the context of machine learning or AI, as the Zeno device itself is not presented as an AI/ML product. The clinical and preclinical data serve as evidence for its safety and effectiveness.
How Ground Truth for the Training Set Was Established:
- As there is no mention of a "training set" for an AI/ML model, this question is not applicable.

In summary, while the document confirms clinical and preclinical testing were conducted to support the device's safety and effectiveness compared to predicate devices, it lacks the specific quantitative details regarding acceptance criteria, study sample sizes, expert involvement, and detailed outcome measures that would fully answer your request. This level of detail is often found in the full 510(k) submission, not typically in the summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S." is arranged in a circular pattern around the eagle.

JUL 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tyrell, Inc. c/o Ms. Darla J. Elkin Director, Regulatory Affairs, Quality Systems Synergos, Incorporated 2202 Timberloch Place, Suite 230 The Woodlands, Texas 77380

Re: K043377 Trade/Device Name: Zeno Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 2,2005 Received: March 3,2005

Dear Ms. Elkin:

This letter corrects our substantially equivalent letter of June 1,2005.

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 (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 - Ms. Darla J. Elkin

Please be advised that FDA's issuance of a substantial equivalencedeterminationdoes 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); 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.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam Provost, Ph..
Miriam Provost. Ph.D
Acting Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Premarket Notification Tyrell, Incorporated - Zeno™ Acne Device

Indications for Use

510(k) Number: K043377

Device Name: Zeno

Indications For Use: Zeao is indicated for the treatment of individual actic pimples in persons with mild to moderate inflammatory acne.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE F NEEDED |

Concurrence of CDRH, Office of Device Evaluation(ODE)

Z. Chin

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List of General, Restorative
Neurological Devices

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JUN 1 - 2005

510(k) Premarket Notification Tyrell, Incorporated Zeno™ Acne Device

510(k) SUMMARY TYRELL, INCORPORATED - Zeno Acne Device

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Sponsor's Name and Address:	Tyrell, Inc.515 West Greens Road, Suite 725Houston, TX 77067
	Telephone: (281) 880 - 6541Facsimile No. (281) 880 - 6702
Submittor Information:	Darla J. ElkinDirector, Regulatory Affairs, Quality SystemsSYNERGOS, Inc.2202 Timberloch Place, Suite 230The Woodlands, TX 77380-1109
	Telephone No.: (281) 367-6655Facsimile No.: (281) 367-9679
Device Trade Name:	Zeno™
Common Name:	Acne Treatment Device
Classification:	Class II
Predicate Devices:	National Biological CorporationDerma-WandK982082
	CureLight Ltd.ClearLight Phototherapy System, Model CI 420K013623
	Radiancy (Israel) Ltd.Radiancy Acne System With ClearTouch Light Unit AK032205

Description of the Device

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510(k) Premarket Notification Tyrell, Incorporated Zeno™ Acne Device

Indications for Use

Zeno is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Performance Data

Preclinical and clinical testing performance testing was conducted with Zeno.

Preclinical Testing

In vitro testing demonstrated significant sensitivity of p. acnes bacterial colls to the effects of sustained low-level heat.

Biocompatibility testing of the tip material was conducted in accordance with the ISO 10993 Biological Testing of Medical and Dental Materials and Devices and the tip material is considered biocompatible.

Zeno was tested for EMI in accordance with the IEC 60601-1 standard. Zeno operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601-1 standard.

Clinical Testing

Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that Zeno is as safe and effective as the predicate device. The controlled clinical study design was a randomized, doubled-blinded study.

Substantial Equivalence

The Zeno and its predicate devices are all devices that use either light or heat to treat the dermatological condition of mild to moderate acne by exposing the surface of the skin to the light at precise wavelengths and temperatures or heat at precise temperatures. Although there are differences in the technological characteristics of the Zeno and its predicate devices, those differences do not raise new questions of safety or efficacy. Another difference is Zeno will be available over the counter (OTC) versus the predicate device which is prescription use only however there are no new safety or efficacy concerns regarding this use as evidenced by the clinical testing that was conducted on Thus, Zeno is substantially equivalent to the predicate device for treatment of Zeno. mild to moderate acne.

Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.