(154 days)
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:
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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 .
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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.
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.
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:
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. These devices are not AI or machine learning systems that require training data.
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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.
§ 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.