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The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The OrthoCor General Use Device (marketed as the OrthoCor Active Device) is a portable (battery operated) non-invasive shortwave diathermy medical device. Through the use of resonators and two applicator coils, the device applies electromagnetic energy at a radio frequency (RF) of 27.12MHz 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 General Use Device delivers the pulsed RF signal of 6.5±0.5µWs/cm³ to the tissue target via inductive coupling using two applicator coils. It is a general use device and can be positioned on the body with a wrap designed to hold the device in place at the location that requires treatment.

The provided document is a 510(k) summary for the OrthoCor Active Device, a nonthermal shortwave therapy (SWT) device. It reclassifies the device from Class III to Class II and details the substantial equivalence to a predicate device, the OrthoCor Active Knee System (K091996).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, the focus is on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical specifications and intended use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states "Clinical data submitted: No" for both the OrthoCor General Use Device and the predicate device (K091996). This indicates that no clinical test set (human subjects) was used for this 510(k) submission.
• Data Provenance: Not applicable, as no clinical data was submitted. The data primarily consists of bench testing results and technical specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable, as no clinical test set requiring expert ground truth was used for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data submitted: No."
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device and not an AI-assisted diagnostic tool, and no clinical studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable, as this is a medical device (nonthermal shortwave therapy) and not an algorithm or AI system. Its performance is evaluated based on its physical and electrical properties.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering specifications and bench testing measurements that demonstrate the device's adherence to its design parameters and its equivalence in those parameters to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable, as this submission is not for an AI/machine learning device. There is no concept of a "training set" in the context of this 510(k).

9. How the Ground Truth for the Training Set was Established

• Not applicable, as this submission is not for an AI/machine learning device.

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