(88 days)
The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of:
- Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
- Soft tissue injuries and shortened tendons due to past injuries and scar tissue
- Joint contractures resulting from capsular tightness and scarring.
The XLTek Ultra V is a Therapeutic Ultrasound
The provided text is a 510(k) summary for the XLTek Ultra V Therapeutic Ultrasound device and the FDA's response letter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes.
Crucially, this document does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific elements requested in your prompt.
The 510(k) process for a device like a therapeutic ultrasound often relies on demonstrating that the new device has the same technological characteristics and intended use as a legally marketed predicate device. This typically involves performance testing to ensure the device operates within expected parameters (e.g., ultrasound frequency, intensity, output power accuracy) rather than a clinical study establishing efficacy or comparing it to human readers.
Therefore, I cannot populate the table or answer most of your specific questions based only on the provided text.
Here's a breakdown of what can be extracted and what cannot:
What can be extracted:
- Device Name: Ultra V Therapeutic Ultrasound
- Intended Use/Indications for Use: Provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with chronic and sub-chronic conditions of:
- Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
- Soft tissue injuries and shortened tendons due to past injuries and scar tissue.
- Joint contractures resulting from capsular tightness and scarring.
- Predicate Device: Excel Tech Ultra Max [510(k) K944065, formerly called Ultra SX]. Also refers to Ultra SX [510(k) K923076].
What cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone algorithm-only performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain the information you're seeking, you would typically need to review the full 510(k) submission, which would detail any performance testing, design verification and validation activities, and specific data if they were required and performed for this type of device. Given that this is a therapeutic ultrasound (not an AI-driven diagnostic tool), many of the questions related to AI-specific evaluation (like MRMC studies, ground truth for AI, training sets) are unlikely to be relevant to this particular 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.