(90 days)
Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. 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. 3. Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness, Capsular tightening.
4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain.
EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
DC (Direct Current): 1. Relaxation of muscle spasms.
The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available. The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option. The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols. The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.
The provided 510(k) summary for the SONICATOR® PLUS 920, Model ME 920, focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 940, Model ME 940) rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.
Therefore, much of the requested information regarding clinical study design, sample size, expert involvement, and ground truth establishment is not present in the provided document, as it is typical for a 510(k) submission based on substantial equivalence for this type of device. The acceptance criteria generally relate to meeting performance specifications similar to the predicate device and relevant industry standards.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the functional and physical specifications of the predicate device (Sonicator® Plus 940) and compliance with various international standards, as the proposed device claims substantial equivalence to it with minor differences. The reported device performance is presented as a direct comparison to the predicate device.
| Acceptance Criteria (Implicitly based on Predicate and Standards) | Reported Device Performance (Sonicator® Plus 920) | Source of Criteria |
|---|---|---|
| General Characteristics: |
- Power Source: AC line | AC line | Predicate device, IEC/EN 60601-1
- Isolation: Reinforced insulation | Reinforced insulation | Predicate device, IEC/EN 60601-1
- Chassis Max Leakage Current: >50 µA under SFC | >50 µA under SFC | Predicate device, IEC/EN 60601-1
- Electrodes Max Leakage Current: >50 µA under SFC (Predicate: >50 µA) | >100 µA under SFC | Predicate device, IEC/EN 60601-1 (Note: This is a deviation to consider)
- Number of Output Modes: 8 | 8 | Predicate device
- Channel(s): 4 (Predicate) | 2 | Predicate device (A primary difference)
- Constant Current: Yes | Yes | Predicate device
- Automatic Overload Trip: Yes | Yes | Predicate device
- Automatic Over Current Trip: Yes | Yes | Predicate device
- Automatic No Load Trip: Yes | Yes | Predicate device
- Automatic Shut Off: Yes | Yes | Predicate device
- Timer Display: 0 - 60 minutes | 0 - 60 minutes | Predicate device
- Timer Accuracy: ± 3 % | ± 3 % | Predicate device
- Maximum Treatment Time: 30 minutes | 30 minutes | Predicate device
- Software/Firmware/Microprocessor Control: Yes | Yes | Predicate device
Electrical Stimulation Waveform Characteristics (Selected Examples): | | - EMS Max Output Voltage (500 Ω): 49 V (Predicate) | 50 V | Predicate device (Similar range)
- TENS Max Output Current (500 Ω): 90 mA (Predicate) | 100 mA | Predicate device (Similar range)
- Hi Volt Max Phase Charge (500 Ω): 48 µC | 48 µC | Predicate device
- Microcurrent Max Output Current (10 kΩ): 0.750 mA | 0.74 mA | Predicate device (Similar range)
Therapeutic Ultrasound Specifications: | | - Frequency: 1 MHz and 3 MHz, ± 5 % | 1 MHz and 3 MHz, ± 5 % | Predicate device, FDA 21 CFR 1050.10
- Modes: Continuous and Pulsed | Continuous and Pulsed | Predicate device
- Pulse Repetition Rate: 100 Hz ± 10 % | 100 Hz ± 10 % | Predicate device
- Pulse Duration: 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | Predicate device
- Maximum Output Power (ME 9201/9401): 12 W | 12 W for ME 9201 | Predicate device
- Maximum Output Power (ME 9202/9402): 1.8 W | 1.8 W for ME 9202 | Predicate device
- Maximum Intensity: 2 W/cm² (continuous), 3 W/cm² (pulsed) | 2 W/cm² (continuous), 3 W/cm² (pulsed) | Predicate device
- Effective Radiating Area (5.5 cm² applicator): 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | Predicate device
- Effective Radiating Area (0.9 cm² applicator): 0.9 cm² (1 MHz) / 0.9 cm² (3 MHz) (Predicate) | 0.9 cm² (1 MHz) / 0.8 cm² (3 MHz) | Predicate device (Slight difference for 3MHz)
- Maximum Beam Non-Uniformity Ratio (5.5 cm² applicable): 4.55:1 maximum (Predicate) | 4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum | Predicate device (Slight differences, but within acceptable range for equivalence according to submission)
Standards Compliance: | | - ISO 14971 : 2000 | Yes | Predicate device
- UL 2601-1 | Yes | Predicate device
- CSA C22.2 NO 601.1-M90 | Yes | Predicate device
- IEC/EN 60601-1 | Yes | Predicate device
- IEC/EN 60601-1-2 | Yes | Predicate device
- IEC/EN 60601-2-10 (For stimulators) | Yes | Predicate device
- IEC/EN 60601-2-5 (For ultrasonic therapy equipment) | Yes | Predicate device
- MDD 93/42/EEC, Annex II | Yes | Predicate device
- 21 CFR 898 (for sunlamp products, potentially a typo or reference to 21 CFR 1050.10 for ultrasonics) | Yes | Predicate device (Acknowledged for ultrasonic standards 21 CFR 1050.10)
2. Sample Size Used for the Test Set and Data Provenance
This is a premarket notification (510(k)) for substantial equivalence for a medical device (an electrotherapy and ultrasound combination unit), not a clinical trial of a diagnostic or AI-driven device. Therefore, there is no "test set" in the sense of a patient cohort evaluated for diagnostic or AI performance.
The "testing" mentioned typically involves internal engineering verification and validation (V&V) to ensure the device meets its design specifications and complies with relevant safety and performance standards. This V&V data is generally proprietary and summarized in the 510(k) submission, not provided in detail here.
- Sample size for test set: Not applicable in the context of a clinical test set for diagnostic performance. Performance is evaluated against engineering specifications and comparison to the predicate device.
- Data provenance: Not applicable. The data is internal engineering test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for this type of 510(k) submission. There is no "ground truth" derived from expert review of cases, as this is not a diagnostic device or an AI application with human-in-the-loop performance evaluation. The "truth" is established by adherence to design specifications and compliance with standards.
4. Adjudication Method for the Test Set
This is not applicable for this type of device. Adjudication methods like "2+1" are used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome for a test case.
5. 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
This is not applicable. This is not an AI-driven device or a diagnostic imaging system that would involve human readers and AI assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical therapy unit, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This is not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance evaluation would be its conformance to specified electrical and ultrasonic output parameters as measured by calibrated equipment, and verification against design requirements and safety standards. The primary "ground truth" supporting its marketing is its substantial equivalence to the predicate device which has a history of safe and effective use.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable. As it's not an AI/ML model, there is no training set or associated ground truth.
In Summary:
The provided 510(k) summary demonstrates compliance by comparing the proposed device's technical specifications and intended uses to those of a legally marketed predicate device (Sonicator® Plus 940). The acceptance criteria are largely implicit in demonstrating that the Sonicator® Plus 920 performs as intended and is as safe and effective as the predicate device by meeting similar engineering specifications and conforming to recognized electrical and medical device safety standards (e.g., IEC/EN 60601 series, ISO 14971, FDA 21 CFR 1050.10).
The study that "proves" the device meets acceptance criteria, in this context, is the technical comparison report (the "Comparison of Technological Characteristics" tables in the document) and documentation of compliance with various international standards. This type of submission relies on the established safety and effectiveness of the predicate device. Differences are highlighted (e.g., 2 channels vs. 4 channels, minor variations in output parameters or applicator ERAs), and the manufacturer's responsibility is to demonstrate that these differences do not raise new questions of safety or 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.