The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems (and the delivery accessories that are used with them) are indicated for use in the medical specialties of physical medicine, general and plastic surgery and neurology for medical purposes/applications requiring:

Electrical Stimulation for Muscle & Soft Tissue Stimulation/Pain Management:

TENS, Russian, High Voltage Therapy Modes

Treatment and relaxation of muscle spasms .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation .
Muscle re-education .
Maintaining or increasing range of motion .
Immediate postoperative/post-surgical stimulation of calf muscles to prevent venous . thrombosis

TENS, Microcurrent, Interferential and Premodulated Modes

Symptomatic relief of chronic and/or intractable pain .
Management of acute pain associated with post-traumatic or post-operative conditions .

The Reliant BTL 5000 Sono Ultrasound System and the BTL 5000 Combi Combination Electrical Stimulation & Ultrasound System (and the delivery accessories that are used with them) are indicated for use in the medical specialty of physical medicine for medical purposes/applications requiring:

Ultrasound for Deep Heat/Pain Management:

· Application of therapeutic deep heat for the treatment of selected chronic and subchronic medical conditions such as:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with: >
  - Adhesive capsulitis .
  - Bursitis with slight calcification .
  - . Myositis
  - Soft tissue injuries .
  - Shortened tendons due to past injuries and scar tissues .
- Relief of chronic and subchronic pain and joint contractures resulting from: >
  - Cansular tightness ●
  - Capsular scarring .

The combination ultrasound and electrotherapy modes deliver deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Only one electrotherapy mode (TENS, High Voltage. Interferential or Premodulated) can be utilized at a time in conjunction with the ultrasound mode.

Device Description

Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems are comprised of the following main components:

A system console (including software and control electronics); .
A control and display panel; ●
. Delivery device accessories (patient cables and electrodes and/or ultrasound cables and sound heads.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reliant BTL 5000 devices:

Upon reviewing the provided text, it's clear that this is a 510(k) Premarket Notification submission to the FDA. The primary method of demonstrating safety and effectiveness for these types of devices (electrical stimulators and ultrasound systems) is through Substantial Equivalence to legally marketed predicate devices, rather than through extensive clinical trials with strict acceptance criteria and performance metrics typically associated with novel or high-risk devices.

Therefore, the structure of the acceptance criteria and study information will reflect this regulatory pathway.

Revised Acceptance Criteria and Device Performance Table:

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance
Indications for Use	Must have the same or similar indications for use as the predicate devices.	The Reliant BTL 5000 Puls, Sono, and Combi systems share the same general indications for use in physical medicine, general and plastic surgery, and neurology applications. Specific indications for electrical stimulation (muscle relaxation, atrophy prevention, circulation increase, muscle re-education, ROM maintenance, post-surgical calf stimulation, chronic/post-traumatic/post-operative pain management) and for ultrasound (therapeutic deep heat for pain, muscle spasms, joint contractures in conditions like adhesive capsulitis, bursitis, myositis, soft tissue injuries, shortened tendons, scar tissues, capsular tightness/scarring) are listed and are consistent with predicate devices.
Technological Characteristics & Features	Must possess the same or similar basic characteristics and features as the predicate devices.	The Reliant BTL 5000 devices have the same or similar basic characteristics and features as the predicate devices (Chattanooga Group Vectra 2C/4C, Vectra Pro 2/4; Dynatronics Dynatron 150 Plus; Excel Tech XL Tek Ultra VM; Empi 300 PV). These include a system console, control/display panel, and delivery device accessories (patient cables, electrodes, ultrasound cables, sound heads).
Safety and Effectiveness	Must be demonstrated to be safe and effective when used as indicated, comparable to predicate devices.	Validation documentation and a comparison of technical characteristics and features were provided to demonstrate that the devices are safe and effective. The FDA concluded that the devices are "substantially equivalent" to the predicate devices, implying they meet the safety and effectiveness standards established by those legally marketed devices.

Study Information (Based on Substantial Equivalence Pathway):

Given that this is a 510(k) for devices demonstrated to be substantially equivalent to predicates, the concept of a "study" with traditional elements like "test set," "ground truth," "MRMC trial," or "standalone performance" does not apply in the conventional sense of a clinical trial proving new performance benchmarks. Instead, the "study" is a comparison and validation demonstrating equivalence.

Here's how to address your numbered points in the context of this 510(k) submission:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable in the traditional sense. There isn't a "test set" of patients or data for performance evaluation in the way one would for a diagnostic AI or imaging device. The "test" is the comparison of the device's technical specifications and indications for use against the predicate devices. The data provenance would be the technical specifications and indications for use of the Reliant BTL 5000 devices themselves, compared against the public information (K-numbers) of the predicate devices.
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. "Ground truth" for an electrical stimulator or ultrasound system being deemed substantially equivalent doesn't involve expert consensus on patient outcomes or image interpretation. The "truth" is established by regulatory bodies (FDA) based on the well-understood mechanisms of action and established safety/effectiveness of similar marketed devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This isn't a diagnostic or interpretive device requiring adjudication of results.
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. This type of study is entirely irrelevant for an electrical stimulator or ultrasound therapy device. These are physical therapy devices, not AI-assisted diagnostic tools.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. There is no "algorithm only" component in the sense of AI performance. The devices perform their intended physical therapy functions (electrical stimulation and/or ultrasound) directly on the patient, with human operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Regulatory "ground truth" through predicate comparison. The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices as determined by the FDA. The submission's "validation documentation and a comparison of the technical characteristics and features" serve as the evidence for this equivalence.
The sample size for the training set:
- Not applicable. These devices are not AI or machine learning systems that require training data.
How the ground truth for the training set was established:
- Not applicable. (See above point).

In Summary:

The provided text details a 510(k) premarket notification where the Reliant BTL 5000 devices demonstrate Substantial Equivalence to existing predicate devices. The "study" referenced is the submission of "validation documentation and a comparison of the technical characteristics and features" to the FDA, which then reviewed this information against the established profile of the predicate devices. This regulatory pathway does not involve the types of performance studies, test sets, or ground truth methodologies that would be used for novel diagnostic algorithms or AI-driven medical devices. The "acceptance criteria" are effectively the requirements to prove substantial equivalence: same/similar indications for use, and same/similar technological characteristics and features, leading to comparable safety and effectiveness.

Summary

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Attachment 15 510(k) Summary Statement for the Reliant BTL 5000 Puls Electrical Stimulation, BTL 5000 Sono Ultrasound, & BTL 5000 Combi Combination Electrical Stimulation & Ultrasound Systems

I. General Information

Submitter:	Reliant Technologies, Inc.260 Sheridan AvenueSuite 208Palo Alto, CA 94306
Contact Person:	Anne C WordenPrincipal Regulatory ConsultantAL Voss AssociatesP.O. Box 405Angels Camp, CA 95221
Summary Preparation Date:	September 11, 2002

II. Names

Device Names:	Reliant BTL 5000 Puls Electrical Stimulation SystemReliant BTL 5000 Sono Ultrasound SystemReliant BTL 5000 Combi Combination ElectricalStimulation & Ultrasound System
Primary Classification Name:	Ultrasound and Muscle Stimulator (and Accessories)

III. Predicate Devices

· Chattanooga Group, Inc. Vectra 2C and Vectra 4C (K982317);
· Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324);
· Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728);
· Excel Tech XL Tek Ultra VM Ultrasound (K001166); and
· Empi 300 PV Complete Electrotherapy System (K021100).

IV. Product Description

A system console (including software and control electronics); .
A control and display panel; ●
. Delivery device accessories (patient cables and electrodes and/or ultrasound cables and sound heads.

Premarket Notification, 510(k) Submission for:

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Indications for Use V.

The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems (and the delivery accessories that are used with them) are indicated for use in the stimulating, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms, and joint contractures in the medical specialty of physical medicine. The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems are indicated for the treatment and relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, symptomatic relief of chronic, intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected medical conditions such as relief of pain, muscle spasms and joint contractures, relief of pain, muscle spasms and joint contractures that may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of chronic and subchronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound. The combination ultrasound and electrotherapy modes deliver deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Only one electrotherapy mode (TENS, High Voltage, Interferential or Premodulated) can be utilized at a time in conjunction with the ultrasound mode.

VI. Rationale for Substantial Equivalence

The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems share the same general indications for use in physical medicine, general and plastic surgery and neurology applications and share the same or similar basic characteristics and features and, therefore, are substantially equivalent to the Chattanooga Group, Inc. Vectra 2C and Vectra 4C (K982317), the Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324), the Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728) , the Excel Tech XL Tek Ultra VM Ultrasound (K001166), and the Empi 300 PV Complete Electrotherapy (K021100) systems.

VII. Safety and Effectiveness Information

Validation documentation and a comparison of the technical characteristics and features were provided to demonstrate that the Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems are safe and effective, when indicated in specific applications in the medical specialties of physical medicine, general and plastic surgery and neurology.

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VIII. Conclusion

The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combination Electrical Stimulation & Ultrasound systems were found to be substantially equivalent to the predicate Chattanooga Group, Inc. Vectra 2C and Vectra 4C (K982317), the Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324), the Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728), the Excel Tech XL Tek Ultra VM Ultrasound (K001166), and the Empi 300 PV Complete Electrotherapy (K021100) systems. The Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound systems share similar indications for use and characteristics and functional features, and thus are substantially equivalent to, the currently marketed predicate devices.

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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 or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Reliant Technologies, Inc. C/O: Ms. Anne Worden AL Voss Associates P.O. Box 405 Angels Camp, CA 95221

Re: K023050 Dated: January 3, 2003 Received: January 6, 2003

Trade/Device Name: BTL 5000 Combi Electrical Stimulation & Ultrasound System with rubber electrodes and sponge covers Regulation Numbers: 21 CFR 890.5860, 21 CFR 882.5890, 21 CFR 882.1320 Regulation Names: Ultrasound and muscle simulator, transcutaneous electrical nerve stimulator for pain relief, cutaneous electrodes Regulatory Class: Class II Product Codes: IMG, GZJ, GXY, LIH

Trade/Device Name: BTL 5000 Puls Electrical Stimulation System with rubber electrodes and sponge covers Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890, 21 CFR 882.1320 Regulation Names: Powered muscle stimulator, transcutaneous electrical nerve stimulator for pain relief, cutaneous electrodes Regulatory Class: Class II Product Codes: IPF, GZJ, GXY, LIH

Trade/Device Name: BTL 5000 Sono Ultrasound System Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasound diathermy Regulatory Class: Class II Product Code: IMI

Dear Ms. Worden:

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.

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Page 2 - Ms. Worden

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. 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-. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milkuson

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

Enclosures

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Attachment 2 Indications For Use Statement as Requested by FDA

510(k) Number (if Known): K023050

Device Name: Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combination Electrical Stimulation & Ultrasound System

Indications For Use:

The Reliant BTL 5000 Puls Electrical Stimulation System and the BTL 5000 Combi Combination Electrical Stimulation & Ultrasound System (and the delivery accessories that are used with them) are indicated for use in the medical specialties of physical medicine, general and plastic surgery and neurology for medical purposes/applications requiring:

Electrical Stimulation for Muscle & Soft Tissue Stimulation/Pain Management:

TENS, Russian, High Voltage Therapy Modes

Treatment and relaxation of muscle spasms .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation .
Muscle re-education .
Maintaining or increasing range of motion .
Immediate postoperative/post-surgical stimulation of calf muscles to prevent venous . thrombosis

TENS, Microcurrent, Interferential and Premodulated Modes

Symptomatic relief of chronic and/or intractable pain .
Management of acute pain associated with post-traumatic or post-operative conditions .

* Continued on Following Page (page 1 of 2)*

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for

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

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
510(k) Number K023050
(Optional Format 1-2-96)

Attachment 2 - Page 1 Page Revised 02/05/2003

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Attachment 2 Indications For Use Statement as Requested by FDA

K023050 510(k) Number (if Known):

Device Name: Reliant BTL 5000 Puls Electrical Stimulation System, BTL 5000 Sono Ultrasound System, and BTL 5000 Combi Combination Electrical Stimulation & Ultrasound System

Indications For Use:

Continued from Previous Page (page 2 of 2)

Ultrasound for Deep Heat/Pain Management:

· Application of therapeutic deep heat for the treatment of selected chronic and subchronic medical conditions such as:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with: >
  - Adhesive capsulitis .
  - Bursitis with slight calcification .
  - . Myositis
  - Soft tissue injuries .
  - Shortened tendons due to past injuries and scar tissues .
- Relief of chronic and subchronic pain and joint contractures resulting from: >
  - Cansular tightness ●
  - Capsular scarring .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Premarket Notification, 510(k) Submission for: Reliant BTL 5000 Puls Electrical Stimulation, BTL 5000 Sono Ultrasound & BTL 5000 Combi Electrical Stimulation & Ultrasound Systems

Attachment 2 - Page 2 Page Revised 02/05/2003

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Attachment 15 510(k) Summary Statement for the Reliant BTL 5000 Puls Electrical Stimulation, BTL 5000 Sono Ultrasound, & BTL 5000 Combi Combination Electrical Stimulation & Ultrasound Systems

I. General Information

II. Names

III. Predicate Devices

IV. Product Description

Indications for Use V.

VI. Rationale for Substantial Equivalence

VII. Safety and Effectiveness Information

VIII. Conclusion

Page 2 - Ms. Worden

Attachment 2 Indications For Use Statement as Requested by FDA

*** Continued on Following Page (page 1 of 2)***

Attachment 2 Indications For Use Statement as Requested by FDA

Continued from Previous Page (page 2 of 2)

§ 890.5860 Ultrasound and muscle stimulator.

* Continued on Following Page (page 1 of 2)*