Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

Relieving pain;
Reducing muscle spasm;
Increasing range of motion of contracted joints using heat and stretch techniques; and
Increasing blood flow to tissues in the treatment area.

Device Description

The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz. It provides traditional shortwave diathermy therapy using condenser and electromagnetic coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and the medical practice.

The ME 395 has four wheels for easy transportation between treatment rooms. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 395.

The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting the cables for the condenser and coll applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.

AI/ML Overview

The provided text is a 510(k) Summary for the AUTO*THERM ® 395, Model ME 395. This document focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the format of a typical clinical trial.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving device performance against acceptance criteria cannot be extracted directly from this document.

This 510(k) summary primarily provides:

Device Description: What the AUTO*THERM ® 395 is and how it functions.
Intended Use Statement/Indications for Use: The medical conditions the device is intended to treat.
Comparison to a Predicate Device: A table comparing the technological characteristics of the new device with a legally marketed predicate device (Curapuls 419). This comparison is the primary "study" that proves the device meets the regulatory acceptance criteria for substantial equivalence, not a clinical performance study.
FDA Clearance Letter: Confirming the device's substantial equivalence to the predicate.

Based on the provided text, here is why a direct answer to your request is not possible in the format you've outlined:

Acceptance Criteria & Reported Device Performance: These are not presented in terms of specific clinical metrics (e.g., pain reduction percentage, range of motion improvement with statistical significance). Instead, the "acceptance criteria" for this submission would be demonstrating that its technological characteristics and intended use are substantially equivalent to the predicate device. The "reported device performance" is implicitly that it operates similarly to the predicate and can achieve the stated indications for use.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: These are all elements of a clinical study designed to test the performance or effectiveness of a device. A 510(k) submission, especially for a device like a shortwave diathermy which operates on well-understood physical principles and has a predicate, often relies on demonstrating engineering and functional equivalence rather than new clinical efficacy trials. The document does not describe such a clinical study.
Training Set Information: No machine learning or AI components are mentioned, so there is no training set.

In summary, the provided document is a regulatory submission focused on substantial equivalence rather than a clinical study report. It does not contain the detailed clinical performance data, acceptance criteria, or study methodologies you've requested.

Summary

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AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

K022458

Submitter's Name:	Mettler Electronics Corp.
Address:	1333 South Claudina StreetAnaheim, CA 92805

SEP 2 6 2002

Telephone: 714-533-2221

Contact: Robert E. Fleming Director, QA/RA

Date Prepared: July 26, 2002

Device Name:

a. TRADE NAME:
b. CLASSIFICATION NAME:
c. COMMON NAME:

Auto*Therm® 395, Model ME 395 Shortwave diathermy Shortwave diathermy

Predicate Device:

a. TRADE NAME: Curapuls 419
b. 510(k) Number: K861248

Description of Device:

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AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

Device Intended Use Statement:

510(k) Number: TBD

Device Name: Auto*Therm® 395, Model ME 395

Indications for use:

1. Pain relief
1. Reduction of muscle spasm
1. Localized increase in blood flow
1. Increase range of motion of contracted joints.

Comparison of Technological Characteristics Between Auto*Therm® 395, Model ME 395 and Predicate Devices: (see following page)

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AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

Comparison of Technological Characteristics Between Auto*Therm® 395, Model ME 395 and Predicate Devices:

FEATURE	AUTO*THERM 395	CURAPULS 419
Mains Supply	115 VAC, ±10%, 50/60 Hz230 VAC, ±10%, 50/60 Hz	110, 127, 220 or 240 VAC50/60 Hz
FDA Class	II	II
SafetyClassification	1 Type BF	1 Type BF
Frequency	27.12 MHz, ±0.6%	27.12 MHz, ±0.6%
Pulse RepetitionFrequency (PRF)	70 Hz/350 Hz	15-200 Hz in 10 steps
Pulse Duration(PD)	2 mSec/0.4 mSec	± 400 µSec
HF out continuous	200 W (rms) @ 50 Ω	450 W (rms) @ 70 Ω
HF out pulsed	30 W (rms)400 W (peak) @ 50 Ω	1000 W (peak) @ 70 Ω
Modes	Inductive & Capacitive	Inductive & Capacitive
Timer	Membrane switch padsDigital Indication (min)	Rocker switchDigital indication (min)
Maximum Time	30 minutes	30 minutes
Output Control	Intensity potentiometer	Intensity potentiometer
Output Display	LED bar graph reflects %contact + 3-digit, 7-segmentdisplay of watts	Bar display intensity meter withsilk-screened numerals (1-10)around intensity control
Inductive coilelectrodes	Yes	Yes
Flexible Inductionelectrode	Yes	Yes
Capacitive plateelectrodes	Yes	Yes
Soft rubberelectrodes	Yes	Yes
Configuration	Cabinet-mounted with wheels	Cabinet-mounted with wheels

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Image /page/3/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2002

Mettler Electronics Corp. Robert E. Fleming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805

Re: K022458

Trade/Device Name: Auto*Therm 395, Model ME 395 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Device Regulatory Class: Class II Product Code: IMJ Dated: July 26, 2002 Received: July 26, 2002

Dear Mr. Fleming:

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 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.

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Page 2 - Mr. Robert E. Fleming

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mack n Mellever

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT AUTO*THERM® 395, ME 395

Indications for use -

1. Relieving pain;
1. Reducing muscle spasm;

Increasing range of motion of contracted joints using heat and stretch techniques; and
Increasing blood flow to tissues in the treatment area.

Mark H. Millikan

vision of General, Restorative and Neurological Devices 510(k) Number

Regulation Number and Section

§ 890.5290 Shortwave diathermy.

(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.