(57 days)
Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine.
The indications of the DermaWave 5000 Combi Max System also include the 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 postsurgical stimulation of calf rnuscles to prevent venous thrombosis, symptomatic relief of chronic intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected 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 capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissucs, relief of chronic and sub-chronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound.
The DermaWave 5000 Combi Max System is also indicated for use in providing topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The DermaWave 5000 Combi Max System is comprised of the following main components:
- A system console including software and control electronics. .
- A control and display panel. .
- · Delivery device accessories including patient cables and electrodes, ultrasound cables, soundheads, and infrared heating accessories.
The DermaWave 5000 Combi Max System is a medical device incorporating multiple modalities, including ultrasound, electrical stimulation, and infrared heating. The provided document describes its 510(k) submission, asserting its substantial equivalence to previously cleared predicate devices rather than detailing a specific clinical study with acceptance criteria in the traditional sense for a novel device.
The "study" referenced in the document is a comparative analysis of technical characteristics and features, and, for the infrared component, a heating characteristics test.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| General Indications for Use: Similar to predicate devices in physical medicine, general and plastic surgery, and neurology applications. | The DermaWave 5000 Combi Max System shares the same general indications for use in physical medicine, general and plastic surgery, and neurology applications. |
| Basic Characteristics & Features: Similar to predicate devices. | The DermaWave 5000 Combi Max System shares the same or similar basic characteristics and features as the predicate devices (Chatanooga Group Inc., Dynatronics Corporation, Excel Tech). It utilizes identical accessories as MedX Health products (MedX LCT 100, MedX Duolight 500, MedX 600). |
| Infrared Heating Characteristics: Elevate tissue temperature above 40°C and below 45°C for a minimum 10-minute period. | The DermaWave 100 Accessory has almost identical heating characteristics as the MedX line of infrared lamp accessories and falls within the recommended guidelines for such devices in raising the temperature of tissue to no more than 45°C in continuous operation over a set time period (implying the 10-minute duration is also met). Comparative temperature charts were included in Section 10 of the submission. |
| Safety and Effectiveness: Demonstrate safety and effectiveness for indicated applications. | Validation documentation and a comparison of technical characteristics and features were provided to demonstrate that the DermaWave 5000 Combi Max System is safe and effective when indicated in specific applications. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a traditional clinical test set with human subjects. For the infrared component, the "test set" would be the DermaWave 100 Accessory undergoing heating characteristic measurements. The sample size for this specific test is not detailed (e.g., number of devices tested, number of measurement points).
- Data Provenance: The document does not specify the country of origin for any specific test data. It refers to "widely accepted clinical data" for infrared heating guidelines. The submission itself is from a US company (DermaWave LLC, Loxahatchee, FL). The "Comparative temperature charts" were included in Section 10 of the submission, implying generated data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. The "ground truth" for the infrared heating characteristic was established by "widely accepted clinical data" (i.e., established medical guidelines for therapeutic heating devices) rather than a panel of experts specifically adjudicating measurements for DermaWave's accessory. For substantial equivalence, the "ground truth" essentially is the "predicate device's performance and indications."
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Adjudication method for the test set:
- Not applicable as no expert adjudication process is described for a clinical test set. The evaluation primarily centered on comparing the device's technical specifications and heating characteristics to established guidelines and predicate devices.
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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 is not an AI-assisted diagnostic device. The DermaWave 5000 Combi Max System is a therapeutic physical medicine device. Therefore, no MRMC study, or assessment of human reader improvement with AI assistance, was conducted or applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to a limited extent for specific components. The assessment of the DermaWave 100 Accessory's heating characteristics described in the document is a standalone performance test. It evaluates the device's ability to achieve specific temperature ranges independently of human interaction during the measurement process, adhering to pre-defined clinical guidelines. However, this is not a "standalone algorithm" in the context of an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the infrared heating component, the ground truth was established medical/clinical guidelines for therapeutic heating devices: "above 40°C and below 45°C for a minimum 10 minute period."
- For the overall device, the "ground truth" for substantial equivalence is the performance and indications for use of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set." The closest analogy might be the data used to develop the predicate devices, but this is not discussed.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.