(302 days)
Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, 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 sub-chronic, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: 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 muscles to prevent venous thrombosis.
Not Found
This is a 510(k) premarket notification for a medical device (CT 1000 SonicStimu Combo) and not a study proving the device meets specific acceptance criteria based on performance data.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document is a 510(k) clearance letter, not a performance study. It does not contain acceptance criteria for specific performance metrics or reported device performance data in that context. The clearance is based on substantial equivalence to a predicate device, implying similar safety and effectiveness without necessarily requiring new, detailed performance studies against defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is not part of a 510(k) clearance letter for this type of device. There's no "test set" of patient data described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No such clinical study or expert-adjudicated test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable as no test set requiring ground truth adjudication is mentioned.
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
- Cannot be provided. This device is an Ultrasound and Muscle Stimulator, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Not applicable as this is a physical therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth definition is relevant for this type of 510(k) clearance.
8. The sample size for the training set
- Cannot be provided. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
What is provided in the document:
- Device Name: CT 1000 SonicStimu Combo
- Regulation Number: 21 CFR 890.5860
- Regulation Name: Ultrasound and muscle stimulator
- Regulatory Class: Class II
- Product Code: IMG, GZJ, LIH
- Manufacturer: Shenzhen Dongdixin Technology Company, Limited
- Indications for Use:
- Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as pain relief, muscle spasms, joint contractures, adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons, capsular tightness, and capsular scarring.
- For TENS, Interferential, premodulated (IFC), NMS, and Microcurrent: Symptomatic relief of chronic intractable pain, post-traumatic acute pain, post-surgical acute pain.
- Additionally for EMS, NMS, Hi-Volt, and Russian: 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 muscles to prevent venous thrombosis.
- Regulatory Basis: Substantial equivalence to legally marketed predicate devices, implying that the device has the same intended use as legally marketed predicate devices, and the same or similar technological characteristics. The safety and effectiveness are considered to be equivalent to that of the predicate 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.