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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.

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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.

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