The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. This document is a 510(k) premarket notification for a therapeutic massager, the TherMassager.

Instead, the document details the device's substantial equivalence to a predicate device (UPC Therapeutic Massager, K990445) based on a comparison of device characteristics and intended use. The core of this submission is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present novel performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because this type of data is not present in the provided 510(k) summary.

The closest information available related to "acceptance criteria" is the comparison of device characteristics to the predicate device to establish substantial equivalence.

Here's a breakdown of what can be extracted or inferred based on the document's content, acknowledging the limitations for your specific request:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in a format of "acceptance criteria" versus "reported performance." Instead, the document presents a side-by-side comparison of features between the TherMassager and the predicate device (LPG). Substantial equivalence is the "acceptance criteria" here, meaning the device's characteristics and performance are similar enough to the predicate to be considered safe and effective for the same indications.

Feature	TherMassager (Reported Device)	LPG (Predicate Device)	Substantially Equivalent? (SF?)
Indications for Use	Relief of minor muscle aches and painsRelief of muscle spasmTemporary improvement of local circulationTemporary improvement in the appearance of cellulite	SAME	YES
Power Requirements	AC/DC AdaptorInput = 120 VDC - 60 HzOutput = 9 VDC	120 VAC -- 60 Hz	YES
Weight: MassagerAC/DC Adapter	1.8 Kg.5 Kg	2 Kg - Handpiece only	YES
Leakage Current	≤50 µamp	<50 µamp	YES
Vacuum (Torr)	Variable, 760-400 Torr	Variable, 50-500 mBar (720 - 385 Torr equivalent)	YES
Materials	Housing: medical grade plastic - 2401 MT SGRollers silicone - ISO 10993 compliant	Medical grade materials, unspecified	YES
Massage Unit	Variable speed - User controlled	Variable according to vacuum freq. and cycle rate	YES
Vacuum frequency & cycle rate	Constant - force variable	Variable - pulsates	YES
Rollers	Powered	Powered	YES

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. This is a 510(k) submission based on substantial equivalence to an existing device, not a performance study with a test set of data points. There is no mention of a clinical or analytical study with a test set of samples.

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. No ground truth establishment by experts is described as part of this 510(k) submission.

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

Not applicable. There is no test set or adjudication process 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 device is a therapeutic massager, not an AI or imaging diagnostic device.

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

Not applicable. This device is a physical therapeutic massager, not an algorithm.

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

Not applicable. The basis for equivalence relies on comparing technical specifications and intended use to an already legally marketed device, not on clinical ground truth or outcomes data for the new device.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm or model.

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

Not applicable. There is no mention of a training set or ground truth establishment.

Summary

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K061001

Summary of 510(k) InformationPremarket Notification, Section 510(k)			THERMAGE, INC.OCTOBER 6, 2006
	Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
1.	Device Name:
	Trade Name:	TherMassager	OCT 12 2006
	CommonName(s):	Therapeutic massager
	ClassificationName(s):	Therapeutic massager
2.	Establishment Name & Registration Number:
	Name:	Thermage, Inc.
	Number:	2954746
3.	Classification(s):
	Sec. § 890.5660(a) Identification. A therapeutic massager is an electrically powered device intended for medicalpurposes, such as to relieve minor muscle aches and pains.
	Device Class:	Class I for all requested indications
	Classification Panel:	Physical Medicine
	Product Code(s):	ISA

Equivalent Predicate Device: 4.

Thermage believes that the TherMassager is substantially equivalent to the massage system identified below:

I. UPC Therapeutic Massager, K990445, LPG, USA, Inc.

Device Description: 5.

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Table of device characteristics.

Feature	TherMassager	LPG	SF?
Indications for Use	Relief of minor musele aches and painsRelief of musele spasmTemporary improvement of local circulation(i.e., blood circulation)Temporary improvement in the uppearunce ofcellulite	SAME	y ES
Power Requirements	AC/DC AduptorInput = 120 VDC - 60 HzOutput = 9 VDC	120 VAC -- 60 ILz	YES
Weight:MassagerAC/DC Adapter	1.8 Kg.5 Kg	2 Kg - Handpiece only	yes
Leakage Current	=50 micump	<50 micamp	YES
Vacuum (Torr)760 Torr =I atmosphere)	Variable, 760-400 Tim	Variable, 50-500 mBar720 - 385 Torr equivlacut	પ્રદેશ
Materials	Housing: medical grade plastic - 2401 MT SGRollers siliconc - ISO 10993 compliant	Medical grade materialsunspecified	YES
Massage Unit	Variable speed - User controlled	Variable according to vacuum freq.and cycle rate	YES
Vacuum frequency &evele rate	Constant - force variable	Variable - pulsatos	YES
Rollers	Powered	Powered	ਮ ਜੋੜ

Summary basis for equivalence.

Based on a direct comparison of the information and attributes summarized in the table above, Thermage believes that the TherMassager is substantially equivalent to the referenced massage system. Equivalence can be seen in the design, material composition, mode of action and intended use.

Indications for Use.

Relief of minor muscle aches and pains .
- Relief of muscle spasm
Temporary improvement of local circulation (i.e., blood circulation) .
. Temporary improvement in the appearance of cellulite

Applicant Name & Address: રું.

Thermage, Inc. 25881 Industrial Blvd Hayward, CA 94545-2991 510.782.2286 fax 510.782.2287

7. Company Contact:

Ms. Pamela M. Buckman, RN, MS Thermage, Inc. 25881 Industrial Blvd Hayward, CA 94545-2991 510.782.2286 fax 510.782.2287

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

NOV 18 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thermage, Inc. % Ms. Sharon Thompson, VP RA/QA 25881 Industrial Boulevard Hayward, California 94545-2991

Re: K061001

Trade/Device Name: Thermage TherMassager Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 08, 2006 Received: September 11, 2006

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of October 12, 2006.

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 such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Sharon Thompson

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 begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Neil RP Ogden

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of I

510(k) Number:

Device Name(s): TherMassager

kobioci

Indications for Use:

The TherMassager is indicated for use in:

Relief of minor muscle aches and pains 비
요 Relief of muscle spasm
Temporary improvement of local circulation "(i.e., "blood" circulation)" 이
Temporary improvement in the appearance of cellulite 트

Prescription Use	X
OR	Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Goldman

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number K061001

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.