Stimulator Mode: The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf.

Interferrential Mode: The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms.

Heating Mode: The Stellar Model HS-04 heating mode is indicated for heating of a body region for the relief of minor muscular or joint pain.

Device Description

The Stellar Model HS-04 is a device that combines the functionality of two devices that have been classified by FDA, the powered muscle stimulator and the powered heating pad. Heat and muscle stimulation are often used at the same time by physical therapists and others to treat patients, and the HS-04 provides both therapies with a single combination device for convenience. The heating elements are contained in the same applicators that hold the stimulation electrodes.

AI/ML Overview

The provided document is a 510(k) summary for the Stellar Model HS-04, a combined powered electrical stimulator and heating pad. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI/ML device would. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristics and safety testing.

Here's a breakdown of the requested information based on the provided text, and where gaps exist because the document is a 510(k) summary for a physical medical device, not an AI/ML algorithm:

Acceptance Criteria and Device Performance

The document does not explicitly define acceptance criteria in the typical numerical performance metric sense (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, acceptance for the Stellar Model HS-04 is based on substantial equivalence to predicate physical devices and compliance with safety standards.

Acceptance Criteria Category	Specific Criteria (Implicit from 510(k))	Reported Device Performance
Safety	Compliance with UL-2601 electrical safety standards.	"Being tested for electrical safety by an independent laboratory." "Will not market device until electrical safety certifications have been successfully completed."
Technological Characteristics	Matching or improved characteristics compared to predicate devices (RS Medical Model RS-4M and Staodyn EMS + 2 for stimulation; PT-PAC Portable Heating Pad for heating).	"The HS-04 has the same technological characteristics as the predicate devices and these characteristics are precise enough to ensure equivalence." (Details on pulse rate, intensity, width, heating elements provided).
Intended Use/Indications	The device performs the functions outlined in its intended use statement, which are combined from the predicate devices.	The device is described as "combin[ing] the functionality of two devices" with indications for muscle reeducation, range of motion, muscle spasms, disuse atrophy, venous thrombosis prevention (stimulator mode), and pain/inflammation relief (interferential and heating modes).

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- N/A. The document does not describe a "test set" in the context of evaluating an AI/ML algorithm's performance on a dataset of patient cases. The evaluation is focused on the physical device itself.
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):
- N/A. This type of expert review for establishing ground truth on a dataset is not relevant to a 510(k) submission for a physical medical device like the Stellar Model HS-04.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as there is no "test set" in the AI/ML sense.
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. An MRMC study is not mentioned. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not applicable to a physical stimulator/heating pad.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. The device is a physical, user-operated therapeutic device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. "Ground truth" in the context of a dataset for an AI/ML algorithm is not applicable here. The "truth" for this device's efficacy and safety is implicitly assumed by its substantial equivalence to previously cleared devices for similar indications and by compliance with electrical safety standards.
The sample size for the training set:
- N/A. The concept of a "training set" is not relevant for this type of device submission.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set mentioned.

Summary of the "Study" (or Testing) that Proves the Device Meets Criteria:

The "study" or testing described in the K973223 submission is primarily focused on electrical safety testing and comparison of technological characteristics to predicate devices to establish substantial equivalence.

Testing Information (Section F):
- The Stellar Model HS-04 is undergoing electrical safety testing by an independent laboratory to assure compliance with UL-2601.
- The manufacturer (KMC Systems) committed to not marketing the device until these electrical safety certifications are successfully completed.
Substantial Equivalence (Section D & E):
- The core of the submission is a detailed comparison of the HS-04's technological characteristics (power, stimulation waveforms, heating elements, pulse rate, intensity, pulse width, applicator pad design) with those of the predicate devices (RS Medical Model RS-4M, Staodyn EMS + 2, and PT-PAC Portable Heating Pad).
- The argument is that these characteristics are "the same as those of the predicate devices" or "precise enough to ensure equivalence," thus demonstrating that the new device is as safe and effective as the legally marketed predicate devices.

Conclusion:

This 510(k) submission relies on a combination of demonstrating substantial equivalence to previously cleared devices based on technological characteristics and committing to successful completion of electrical safety testing (UL-2601) rather than a formal performance study with acceptance criteria and ground truth in the manner of an AI/ML device.

Summary

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K973223

510(k) Summary

FEB 1 8 1998

Stellar Model HS-04

Common/Classification Name: Powered Electrical Stimulator/ Powered Heating Pad, 21 CFR 890.5850 and 890.5740

Stellar Medical Corporation 1800 Second Street, Suite 705 Sarasota, FL 34236

Contact: B. C. James, M.D., Prepared: August 26, 1997

LEGALLY MARKETED PREDICATE DEVICES A.

The Stellar Model HS-04 is substantially equivalent to the RS Medical Model RS-4M (K953136) and the Staodyn EMS + 2 (K926510) electrical stimulators with respect to its stimulation functions and is substantially equivalent to the PT-PAC Portable Heating Pad (K963887)with respect to its heating functions.

B. DEVICE DESCRIPTION

C. INTENDED USE

The Stellar Model HS-04 is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, and prevention of venous thrombosis.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The HS-04 is a medical device, and it combines the indications for use

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of the legally marketed predicate devices. The HS-04 has the same technological characteristics as the predicate devices and these characteristics are precise enough to ensure equivalence. This premarket notification describes the characteristics of the HS-04 in sufficient detail to assure substantial equivalence.

TECHNOLOGICAL CHARACTERISTICS ய்

The system is powered through an AC power adaptor which can accept voltages in the range 90-132 VAC and 46-63 Hz and it draws a maximum of 0.7 Amperes. The stimulator section only (no heat) can be powered temporarily with an alkaline battery.

The HS-04 uses solid state electronics to generate the stimulation waveforms and resistive DC-powered heating elements to produce the heating effect. These characteristics are the same as those of the predicate devices.

The pulse rate and intensity are settable on the controller. In the muscle stimulator mode, the pulse rate may be varied between 1 and 150 pulses per second. The stimulator pulses for five seconds and then is off for five seconds.

The pulse width of the biphasic pulses may range from 1 to 415 microseconds according to the "intensity" setting. The second of the biphasic pair of pulses follows the first by 1 millisecond. The number of pulses per second may be adjusted from 1 to 150 by adjusting a potentiometer on the back of the controller box.

Each applicator pad is rectangular in shape (3 x 3.5 inches) with a thin profile. The heating component forms the back of the pad and the stimulation electrode forms the front surface. The stimulation electrodes have a conductive solid gel which sticks to the pad and the electrical contacts on one side and to the treatment area of the patient on the other.

ட் TESTING

ﻨﺔ

The Stellar Model HS-04 is being tested for electrical safety by an independent laboratory. Tests are being carried out to assure compliance with UL-2601. KMC Systems will not market the device until the electrical safety certifications have been successfully completed.

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G. CONCLUSIONS

This pre-market submission demonstrates Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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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 stylized eagle with three stripes forming its wing and tail. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

T. Whit Athey, Ph.D. ·Senior Consultant C.L. McIntosh Associates, Inc. Representing Stellar Medical Corporation 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K973223 Re : Stellar Model HS-04 Requlatory Class: II IPF, IRT, and LIH Product Codes: December 9, 1997 Dated: December 9, 1997 Received:

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act __ _ 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 (Premarket Approval), 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 895. - A------------------------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Stellar Model HS-04

Indications For Use:

Stimulator Mode

The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf.

Interferrential Mode

The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms.

Heating Mode

The Stellar Model HS-04 heating mode is indicated for heating of a body region for the relief of minor muscular or joint pain.

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

Concurrence of CDRH, Office of Device Evaluatio

(Division Sign-Off)
Division of General Restorative Devices

Prescription Use
(Per 21 CFR 801.109)

OR ..

. Over-The-Counter Use . . . . . . . . . . . . . . . .

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).