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OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.

The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. Treatment may occur directly through dressings, clothing, casts, compression garments or supports.

The provided text describes a 510(k) submission for the OrthoCor Active Knee System, a medical device for pain and edema. The submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and adherence to safety standards, rather than conducting a detailed clinical study with acceptance criteria for device performance in a clinical context.

Therefore, many of the requested categories related to clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable or not provided in this document.

Here's the information that can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The document states that "Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below." This implies a bench testing study was conducted to compare the technical specifications and outputs of the OrthoCor Active Knee System against its predicate device (Ivivi Torino II K070541).

2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on bench testing for technical equivalence, not clinical data sets with "test sets" in the context of AI/diagnostic device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical studies, not technical equivalence bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the technical specifications and measured outputs of the predicate device (Ivivi Torino II K070541), which the OrthoCor Active Knee System aimed to match. The assessment was based on objective physical measurements during bench testing.

8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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