(275 days)
ELECTROTHERAPY
VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain.
FES is indicated for stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
DC Continuous Mode is indicated for relaxation of muscle spasm.
ULTRASOUND THERAPY
Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic 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 capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring.
LASER THERAPY
Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.
BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy.
Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues.
BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application.
The BTL-4000 consists of the following main components:
- . control unit
- user interface with 7" LCD color touch screen ●
- therapy modules electrotherapy, ultrasound and laser .
- accessories depends on the combination - electrotherapy electrodes
- laser probe/cluster
- । ultrasound head/HandsFree sono handpiece
The provided text is a 510(k) premarket notification for the BTL-4000 device, which is an ultrasound and muscle stimulator. It explicitly states that the substantial equivalence determination for this device is NOT based on clinical performance testing. Instead, it relies on comparison of technical characteristics between the BTL-4000 and predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
The document states:
- "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the BTL-4000 and compared to the predicate device." (Page 7)
This means there is no study described that proves the device meets specific acceptance criteria in a clinical setting as would be the case for an AI/ML medical device. The "acceptance criteria" here implicitly refer to meeting the defined technical specifications that are comparable to previously cleared predicate devices.
However, to address the prompt as best as possible given the available text, I can infer the "acceptance criteria" are the technical specifications and indications for use, and the "proof" is the comparison table demonstrating similarity to predicate devices.
Here's how I can construct a response based on the inference that the "acceptance criteria" are the technical specifications and the "study" is the comparison to predicate devices, while clearly stating the limitations of the provided text:
The provided 510(k) premarket notification for the BTL-4000 device explicitly states that its substantial equivalence determination is not based on clinical performance testing. Instead, the device's safety and efficacy are demonstrated by a comparison of its technical characteristics to legally marketed predicate devices. Therefore, the document does not describe a conventional clinical study with acceptance criteria and performance data as might be found for novel AI/ML medical devices.
Despite this, we can interpret the technical specifications and indications for use as implicit "acceptance criteria" for substantial equivalence. The "study" that proves the device meets these criteria is the detailed "Comparison with the Predicate Device" table provided in the submission.
Here's a breakdown based on this interpretation, noting where information is explicitly not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
In this context, the "Acceptance Criteria" are the technical specifications and indications of the predicate devices which the BTL-4000 aims to be substantially equivalent to. The "Reported Device Performance" is the BTL-4000's own technical specifications. The extensive comparison table serves this purpose.
Table: Comparison of BTL-4000 with Predicate Devices (Selected Parameters)
| Feature/Parameter | Acceptance Criteria (Predicate Device K031077 & K040662) | Reported Device Performance (BTL-4000) |
|---|---|---|
| Intended Use/Indications | Electrotherapy: Relaxation of muscle spasms; prevention/retardation of disuse atrophy; increase of local blood circulation; muscle re-education; maintaining/increasing range of motion; immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Symptomatic relief and management of chronic, intractable, post-traumatic acute, and post-surgical acute pain (for specific modes). FES for leg/ankle muscle stimulation to improve gait. DC Continuous Mode for relaxation of muscle spasm. | Exactly matches predicate indications as described. (See full list on page 8) |
| Ultrasound: Therapeutic deep heat for sub-chronic/chronic medical conditions; relief of pain, muscle spasms, joint contractures (associated with specific conditions like adhesive capsulitis, bursitis, myositis, soft tissue injuries, shortened tendons, scar tissues); relief of sub-chronic/chronic pain and joint contractures from capsular tightness/scarring. | Exactly matches predicate indications as described. (See full list on page 8) | |
| Laser: Topical heating for temporary increase of local blood circulation; temporary relief of minor muscle/joint aches, pains, stiffness; relaxation of muscles; temporary relief of muscle spasms; temporary relief of minor pain/stiffness associated with arthritis. | Exactly matches predicate indications as described. (See full list on page 8) | |
| Electrical Protection | Predicate K031077: Class I, BF. Predicate K040662: Class I, B. | BTL-4000: Class II, BF (for Electrotherapy Module: BF; for Ultrasound Module: Class II, BF; for Laser Module: BF) – Note: BTL-4000 claims substantial equivalence despite slight difference in class by meeting "BF" which is generally more stringent than "B" and Class II means double insulation, reducing reliance on protective earth compared to Class I. |
| Power Voltage & Frequency | ~100 V to 240 V AC, 50-60 Hz | ~100 V to 240 V AC, 50-60 Hz |
| Electrotherapy Channels | 2; 4 | 2; 4 |
| Electrotherapy Output Intensity | 0-500 V, 0-200 mA | 0-500 V, 0-200 mA |
| TENS-Asymmetrical Biphasic Intensity (CC Mode) | 0-110 mA | 0-110 mA |
| TENS-Asymmetrical Biphasic Frequency Range | 0-250 Hz | 1–250 Hz |
| Ultrasound Intensity (Continuous Mode) | 0 – 2.5 W/cm² | 0.1 – 2 W/cm² (±30%) – Note: Within comparable range, slight difference in upper limit but also has different modes. |
| Ultrasound Frequency | 1 MHz (±5%), 3.3 MHz (±5%) | 1 MHz (±5%), 3.1 MHz (±5%) – Note: Very slight difference in 3 MHz range, claimed to be equivalent. |
| Laser Wavelength | 670 - 950 nm | 685 - 830 nm (±20%) – Note: BTL-4000's range is within the broader predicate range, supporting equivalence for stated indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set data is provided. The "proof" is based on technical specifications comparison, not experimental data from a specific number of cases.
- Data Provenance: Not applicable. No clinical data is referenced. The technical specifications of the BTL-4000 are presumably derived from internal engineering and testing, and the predicate device data is from their original 510(k) submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided and is not relevant to this type of 510(k) submission which relies on technical comparison rather than clinical performance data requiring ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC study was not done. The document explicitly states: "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing." This type of study would be part of clinical performance testing.
- Effect Size: Not applicable as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical therapy machine, not a software algorithm. Its "performance" is its ability to deliver the specified electrical, ultrasound, or laser therapy, which is verified through conformity to safety and performance standards (Non-clinical Testing section).
7. The Type of Ground Truth Used
- Not applicable in the clinical sense. For the technical comparison, the "ground truth" for the predicate devices' performance are the parameters laid out in their cleared 510(k) submissions and compliance with relevant medical device safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device; therefore, no training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
In summary, the BTL-4000 510(k) submission relies entirely on a demonstration of substantial equivalence through technical and functional comparisons to previously cleared predicate devices, rather than new clinical performance data. Therefore, the detailed questions about clinical study design, sample sizes, ground truth, and expert adjudication are not applicable to the evidence presented in this document.
§ 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.