The Theravant Acleara/TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).

Device Description

The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment. A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study details as requested. It's important to note that the provided text is a 510(k) Summary of Safety and Effectiveness, which is a summary document and often does not contain the granular detail of a full study report.

Based on the document, the device in question is a modification to an existing handpiece for the Theravant Acleara/TheraClear System. The modification involves adding a fine gauge needle to facilitate sebum release during acne treatment, complementing the existing vacuum technology. The primary claim is substantial equivalence to the predicate device (TheraClear System, K101415), arguing that the modification does not alter the fundamental principles of operation or introduce new risks and that the indications for use remain the same.

Therefore, the "acceptance criteria" and "study" are not presented in the typical format of a clinical trial proving specific performance metrics against a threshold for a new, de novo device. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device, particularly that the modification does not introduce new or different risks and that device operation and overall technical capabilities remain the same.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance (Summary of Findings)
No new or different risks introduced by the modification.	"The Handpiece Modification to the Theravant Acleara System does not present new or different risks." (Section VIII. Conclusion)
Device operation remains the same as the predicate.	"The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece." (Section IV. Product Description) and "The indications for use, device operation, overall technical capabilities remain the same..." (Section VIII. Conclusion)
Overall technical capabilities remain the same.	"The indications for use, device operation, overall technical capabilities remain the same..." (Section VIII. Conclusion)
Indications for Use remain the same.	"The device modification does not affect the indications for use..." (Section V. Indications for Use) and "The indications for use... remain the same..." (Section VIII. Conclusion)
Safety and effectiveness supported by performance testing.	"Performance testing, including validation and verification testing, and risk analysis support the safety and effectiveness of the modification." (Section VII. Safety and Effectiveness Information). Specific test details and results are not provided in this summary document.
Substantially equivalent to the predicate device.	"The review of the indications for use and technical characteristics demonstrates that the Acleara System is substantially equivalent to the predicate device." (Section VII. Safety and Effectiveness Information) and "therefore is substantially equivalent to the predicate device." (Section VIII. Conclusion)

Study Information Based on the Provided Document

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the 510(k) summary. The document mentions "Performance testing, including validation and verification testing, and risk analysis" but does not detail a clinical test set size or methodology.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not describe the establishment of a ground truth for a clinical test set in the conventional sense, as it focuses on substantial equivalence based on technical characteristics and risk analysis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/not specified. No clinical 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

No MRMC study was performed or described. The device is a physical modification to a light therapy system for acne; it is not an AI-assisted diagnostic or therapeutic device evaluated with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not a software algorithm, so the concept of standalone performance for an algorithm does not apply directly. The "device performance" relies on its mechanical and energy delivery characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly described in terms of a clinical ground truth for a specific study. The "ground truth" for the current submission is effectively the established safety and effectiveness profile of the predicate device (TheraClear System K101415). The submission argues that the modified device's performance aligns with the predicate, based on technical and risk assessments rather than a new clinical ground truth for efficacy.

8. The sample size for the training set

Not applicable/not specified. The device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI/machine learning model. The "ground truth" for ensuring the modification's safety and effectiveness relies on established engineering principles, risk analysis, and performance testing data (as mentioned in Section VII, but not detailed).

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness KT23889

MAR 4 2013

General Information I.

Submitter:

Theravant Corporation 455 North Canyon Parkway, Suite B Livermore, CA 94551 USA

Contact Person:

Marcy Moore Regulatory Consultant for Theravant Corporation 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-651-1001 fax marcy@marcymoore.com

December 17, 2012 Summary Preparation Date:

II. Names

Acleara System; TheraClear System Trade Names:

Laser Powered Surgical Instruments Primary Classification Name:

K123889

K Number:

III. Predicate Device(s)

TheraClear System (K101415); .

IV. Product Description

The Theravant System is comprised of the following main components:

Main console ●
Treatment Handpiece(s) ●

The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light

{1}------------------------------------------------

is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.

A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.

V. Indications for Use

The device modification does not affect the indications for use, although the modified handpiece is recommended for use in conjunction with the treatment of acne lesions only.

The Theravant Acleara System is intended for:

The treatment of benign vascular and pigmented lesions; ●
. Permanent hair reduction;
The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).

The TheraClear System is intended for use on all skin types (Firzpatrick types I-VI).

VI. Rationale for Substantial Equivalence

The Acleara modified handpiece insert is substantially equivalent to the Acleara Original handpiece inserts. The basis for the insert modification is a simple means to facilitate the release of sebum from the pilosebaceous unit. To a large extent, this is currently achieved during the vacuum process employed by the Acleara system. Using the same principal as traditional lancing or manual extraction of sebum, the modified insert employs a fine gauge needle to ease the release of sebum during the vacuum process. The use of the modified insert is intended as a complimentary procedure to the current recommended Acleara treatment for acne.

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics demonstrates that the Acleara System is substantially equivalent to the predicate device. Performance testing, including validation and verification testing, and risk analysis support the safety and effectiveness of the modification.

VIII. Conclusion

The Handpiece Modification to the Theravant Acleara System does not present new or different risks. The indications for use, device operation, overall technical capabilities remain the same and therefore is substantially equivalent to the predicate device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: March 4, 2013

Theravant, Corporation % Ms. Marcy Moore Regulatory Consultant 131 Kelekent Lane Cary, North Carolina 27518

Re: K123889

Trade/Device Name: Acleara/Theraclear Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: January 22, 2013 Received: February 04, 2013

Dear Ms. Moore:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not-misleading.

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.

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

{3}------------------------------------------------

Page 2 - Ms. Marcy Moore

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/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/MedicalDevices/Safety/ReportalProblem/default.htm 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) 638-204) or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):	K123889
---------------------------	---------

Acleara/TheraClear Device Name:

Indications for Use:

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogdens 2013.02.28 15:06:29 -05'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123889

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.