(105 days)
Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle spasm
- Localized increase of blood flow
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Muscle re-education
- Maintaining or increasing range of motion
The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
· A system console including software and control electronics;
· A control and display panel;
· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.
The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.
The provided document (K052340) is a 510(k) summary for a medical device called "The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System." This type of submission is for substantiating that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a high-risk device or novel technology.
The document explicitly states:
- "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Not applicable"
- "Discussion of Clinical Tests Performed: Not applicable"
This means that the manufacturer did not perform studies with acceptance criteria in the way you're asking, for example, a study to demonstrate a certain level of diagnostic accuracy (like sensitivity, specificity, AUC) or a specific clinical outcome. Instead, substantial equivalence was established by demonstrating that the DU857 has the same intended use and similar technological characteristics to the predicate device (Mettler Electronics Corp., Sonicator Plus 930, Model ME 930, K013192), and that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these types of studies were not performed or reported in this 510(k) submission.
The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device based on comparison of technical specifications and adherence to relevant safety standards, rather than performance metrics from a diagnostic or interventional study.
Here's what can be extracted based on the provided document and the typical nature of a 510(k) submission for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type (for Substantial Equivalence) | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (DU857) |
|---|---|---|
| Intended Use | Same as predicate (Therapeutic Ultrasound and Neuromuscular Stimulation for specific conditions) | Meets: Same intended use as the predicate device (Sonicator Plus 930). |
| Technological Characteristics | Substantially similar, or differences do not raise new questions of safety or effectiveness. (e.g., power source, classification, physical specs, output parameters, safety features, standards compliance) | Meets: Generally similar to the predicate device with some differences in specifications (e.g., maximum output current/voltage, frequency range for interferential mode, maximum treatment time for electrical stimulation, specific standards met). These differences were deemed not to raise new safety/effectiveness questions. |
| Safety Standards Compliance | Compliance with relevant electrical, thermal, and mechanical safety standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-2-10). | Meets: Compliant with IEC 60601-1, IEC 60601-2-5, IEC 60601-2-10, FCC Part 15-B, EN-55011, FDA 21 CFR 1050.10, MDD 93/42EEC Annex II. |
| Biocompatibility | Yes (implicit for patient contact materials, if any) | Meets: Stated "Yes". |
| Sterility | Not used (similar to predicate) | Meets: Stated "Sterilization is not used". |
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical "test set" was used as no clinical study was performed for this 510(k) submission. The equivalence was established through technical comparison to the predicate device and adherence to recognized safety standards.
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 for a test set was established as no clinical study was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method was used as no clinical study was performed.
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 for physiotherapy, not a diagnostic AI device requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical therapy device, not an algorithm-based diagnostic or therapeutic system that would have a "standalone performance" study in the typical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth was established or used for performance evaluation in this 510(k). The "ground truth" for this submission concerned the technical specifications and safety profile of the device being equivalent to a predicate.
8. The sample size for the training set:
- Not applicable. This device is hardware-based with some software for control, not an AI/ML algorithm that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or associated ground truth was relevant for this type of device submission.
§ 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.