Search Results

The Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis.

The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.

The Motive Knee Wrap device (Motive device) is an over-the-counter (OTC) electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) for relief of knee pain associated with knee arthritis. The Motive device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and knee pain relief. The stimulator is placed over the thigh muscle and just above the knee.

The provided text describes CyMedica Orthopedics, Inc.'s Motive Knee Wrap device and its 510(k) summary (K220738). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. The document primarily details non-clinical bench testing, software validation, usability studies, and a comparison of technological characteristics with predicate devices.

Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not explicitly present as a separate clinical study for the Motive Knee Wrap itself. Instead, the justification for effectiveness relies on the equivalence to a predicate device (CyMedica IntelliHab System, K210604) for which clinical data was previously submitted.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a formal table of "acceptance criteria" for a clinical study with corresponding reported device performance outcomes for the Motive Knee Wrap. The performance information provided is primarily related to non-clinical (bench) testing of electrical and physical characteristics to meet safety and performance standards.

Table: Performance Summary from Non-Clinical Testing

2. Sample size used for the test set and the data provenance

• Test Set for Clinical Performance: Not applicable as a new clinical study was not conducted for the Motive Knee Wrap itself. The document states: "Clinical data submitted in the predicate device application, IntelliHab System, K210604 applies to the subject Motive device." No details of that predicate study's sample size or provenance are provided in this document.
• Test Set for Human Factors/Usability Study: A "self-selection study and human factors study" was conducted to validate usability for OTC and home use. The specific sample size is not provided in this document.
• Data Provenance: Not explicitly stated for any clinical data. For the human factors study, it doesn't specify country of origin or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as a specific clinical study for establishing ground truth for the Motive Knee Wrap was not conducted. The clinical effectiveness is deferred to the predicate device's data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided as a specific clinical study for the Motive Knee Wrap was not conducted directly.

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

• No, an MRMC comparative effectiveness study was not conducted. This device is an electrical muscle stimulator, not an AI-assisted diagnostic imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of typical algorithm performance for diagnostics. The device's "performance" is its ability to deliver the specified electrical stimulation consistently and safely, which was assessed via bench testing (Section 15) and regulated power output/closed-loop feedback (Section 11).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance tests (electrical, EMC, battery), the ground truth is defined by the standards themselves (e.g., IEC 60601-1, FCC CFR47 Part 15).
• For the usability study, the ground truth is derived from the study participants' ability to successfully use the device per instructions and labeling.
• For the clinical effectiveness, the document states that "Clinical data submitted in the predicate device application, IntelliHab System, K210604 applies to the subject Motive device." The type of ground truth for that predicate study is not described in this document.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning model that requires a "training set" in the conventional sense. The "training" for this device involved its design, development, and bench testing to meet engineering specifications and regulatory standards.

9. How the ground truth for the training set was established

• Not applicable for the same reason as point 8.

Ask a specific question about this device