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Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

The OrthoCor 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/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power

Here's an analysis of the provided text regarding the OrthoCor Knee System and its acceptance criteria, focusing on the requested information:

This submission (K091996) is for a medical device (OrthoCor Knee System), not an AI/ML device. Therefore, many of the questions related to AI/ML specific criteria (such as training sets, ground truth methodology for AI, MRMC studies, and stand-alone algorithm performance) are not applicable to this document. The submission focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical parameters rather than performance against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OrthoCor Knee System are based on its physical and electrical characteristics matching those of its predicate device, the Ivivi Torino II (K070541). The "reported device performance" here refers to the OrthoCor Knee System meeting these specified parameters during bench testing.

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

• Test Set Sample Size: This type of submission relies on bench testing of the device's physical and electrical properties, not on a clinical "test set" in the sense of patient data. The sample size would refer to the number of devices or components tested to ensure consistent output. This specific number is not provided in the document.
• Data Provenance: The data comes from bench testing performed by ORTHOCOR MEDICAL, Inc. It is not patient data from a specific country, nor is it described as retrospective or prospective clinical data.

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

• This question is not applicable as the evaluation is based on objective physical/electrical measurements against established standards and predicate device specifications, not on expert-adjudicated ground truth from a clinical standpoint. Product conformity to standards like IEC 60601-1 would typically be verified by qualified engineers or testing facilities.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "adjudication method" in the traditional sense for this type of bench testing. The device's output parameters are measured and compared directly to the specified criteria and the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a non-AI therapeutic device based on demonstrating substantial equivalence through technical specifications, not a clinical effectiveness study involving human readers or AI assistance.

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

• No, this is not applicable. The OrthoCor Knee System is a physical medical device that delivers energy, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the specified technical parameters and performance characteristics of the predicate device (Ivivi Torino II K070541), along with conformity to international electrical and electromagnetic safety standards (IEC 60601-1, IEC 60601-1-2). The device is deemed acceptable if its measured outputs and characteristics meet or fall within the acceptable range of these established benchmarks.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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