(99 days)
Therapeutic Ultrasound:
- 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 pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular tightening
4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms:
- Symptomatic relief of chronic intractable pain
- Post-traumatic pain
- Post-surgical pain
EMS, TENS, Hi Volt and Russian waveforms:
- Relaxation of muscle spasms
- Increase local blood circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
DC (Direct Current):
Relaxation of muscle spasms
The Sonicator® Plus 940 , Model ME 940 is a four-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 940 provides premodulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 940 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The four-channel Sonicator Plus 940 allows the clinician to utilize up to two different waveforms using four channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and premodulated modes offer frequency modulation as well as a static frequency option.
The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. A large LCD output display allows the clinician to monitor four channels simultaneously for four channel combination treatment protocols. It also allows the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms
The provided document is a 510(k) summary for the SONICATOR® PLUS 940, Model ME 940, an ultrasound and muscle stimulator device. The purpose of this summary is to demonstrate substantial equivalence to predicate devices, not to perform a clinical effectiveness study. As such, the document does not contain acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.
Instead, the document focuses on comparing the technological characteristics and intended uses of the proposed device to two predicate devices: Sonicator® Plus 994, Model ME 994 (K984142) and Chattanooga Vectra Genesis (K031077). The underlying assumption for 510(k) clearance is that if the new device is substantially equivalent in terms of technology, safety, and intended use to a legally marketed device, it does not require new clinical performance data to enter the market.
Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable or present in this type of regulatory submission.
However, I can extract the comparative information presented in the document, which serves as the basis for demonstrating equivalence in a 510(k) submission.
Comparative Information between Proposed and Predicate Devices
The "acceptance criteria" in this context are effectively the demonstrated characteristics and performance parameters that are comparable to the predicate devices, thereby establishing substantial equivalence. The "study" proving this is the detailed comparison provided in the 510(k) submission.
1. Table of "Acceptance Criteria" (Predicate Device Performance) and Reported Device Performance (Proposed Device)
The document provides extensive tables comparing the technical specifications of the Sonicator® Plus 940 (Proposed Device) with the Chattanooga Vectra Genesis (Predicate Device K031077) for Neuromuscular Stimulation, Pain Management, Muscle Spasm, and Therapeutic Ultrasound. The "acceptance criteria" here are essentially the specifications of the predicate device. If the proposed device meets or is comparable to these specifications, it is deemed acceptable for marketing.
Example Excerpts from Comparison Tables:
| Characteristic (Acceptance Criteria - Predicate K031077) | Sonicator® Plus 940 (Proposed Device Performance) |
|---|---|
| NEUROMUSCULAR STIMULATION | |
| Waveform | |
| EMS (Premod, Vectra): Biphasic | Biphasic |
| TENS (VMS, Vectra): Biphasic | Biphasic |
| Hi Volt: Pulsed Monophasic | Pulsed Monophasic and Biphasic |
| Russian: Biphasic | Biphasic |
| Shape | |
| EMS (Premod, Vectra): Sinusoidal | Sinusoidal |
| TENS (VMS, Vectra): Square | Square |
| Hi Volt: Twin spike | Twin spike |
| Russian: Gated Sinusoidal | Gated Sinusoidal |
| Max Output Voltage (V) ±20% @ 500 Ω | |
| EMS (Premod, Vectra): 55 | 49 |
| Hi Volt: 544 | 146 |
| PAIN MANAGEMENT | |
| Waveform | |
| Interferential, 4-pole: Biphasic | Biphasic |
| TENS: Biphasic | Biphasic |
| Max Output Current (mA) ±20% @ 500 Ω | |
| Interferential, 4-pole: 114 | 96 |
| Microcurrent: 0.960 | 0.760 |
| THERAPEUTIC ULTRASOUND | |
| Frequency: 1 MHz and 3.3 MHz, ± 5% | 1 MHz and 3 MHz, ± 5% |
| Modes: Continuous and Pulsed | Continuous and Pulsed |
| Maximum Output Power: 20 W for 10 cm² at 1 Mhz only | N/A (12 W for ME 9401, 1.8 W for ME 9402) |
| Maximum Intensity: 2.5 W/cm² for continuous mode | 2 W/cm² for continuous mode |
| Effective Radiating Area: 5 cm² appl. ERA of 4 cm² | 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) |
Note: The tables clearly show differences in some parameters (e.g., maximum output voltage/current, maximum power/intensity for ultrasound). The 510(k) process accepts such differences as long as they do not raise new questions of safety and effectiveness and the device remains substantially equivalent for its intended use. The submission implicitly argues that these differences are not significant enough to warrant new clinical trials.
2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable as this is a 510(k) premarket notification demonstrating substantial equivalence based on technical and performance comparisons to predicate devices, not a clinical study involving test sets of patients or data. The "data" here refers to the device's measured technical specifications. The provenance is internal testing performed by Mettler Electronics Corp. to establish these specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. No ground truth based on expert consensus for clinical outcomes was established as part of this 510(k) submission. The "ground truth" for the technical specifications is the output measured by the manufacturer against industry standards and the predicate device's published specifications.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process for clinical outcomes was part of this regulatory submission.
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:
Not applicable. This device is an ultrasound and muscle stimulator, not an AI-powered diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for therapeutic purposes; it is not an algorithm, and the concept of "standalone performance" in this context is not relevant for a 510(k) based on substantial equivalence. Its performance is measured by its physical output (e.g., electrical stimulation parameters, ultrasound intensity).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to the technical specifications and performance characteristics of the device itself (e.g., voltage, current, frequency, power output, accuracy of timing). This "ground truth" is established through engineering and electrical testing, adhering to recognized standards (e.g., ISO, UL, CSA, IEC/EN, 21 CFR) and measurements against the predicate device's reported specifications.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.