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The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.

The provided text is a 510(k) summary for the ComboCare 2000 device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The document explicitly states that no clinical testing was performed. Instead, the submission relies on non-clinical testing to validate the design against specified requirements and assure conformance with voluntary design standards (EN 60601-1, EN 60601-1-2, EN 60601-2-10). The basis for substantial equivalence is primarily the technological characteristics similar to predicate devices (K081141 Xanacare Technologies LLC ComboCare 2000 and K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS).

Given this information, it is not possible to provide the requested details regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies, as these typically relate to clinical evaluations that were not conducted for this device's 510(k) submission.

Therefore, the response will reflect the absence of such information from the provided document.

1. Table of acceptance criteria and the reported device performance:

Since no clinical testing was performed and the submission relies on non-clinical testing for design validation and conformance to voluntary standards, there are no reported acceptance criteria or device performance metrics related to clinical efficacy. The device performance was assessed against design requirements and safety standards, but specific quantitative acceptance criteria or clinical performance data are not provided in this document.

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

Not applicable. No clinical test set was used for an effectiveness study. Non-clinical testing was performed, but details on sample sizes or data provenance for these non-clinical tests are not provided in the summary.

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

Not applicable. No clinical test set requiring expert-established ground truth was reported.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring adjudication was reported.

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 device is a TENS unit for pain relief, not an AI-assisted diagnostic tool involving human readers. No MRMC study was conducted or referenced.

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

Not applicable. This device is a medical device for physical therapy, not an algorithm or AI system.

7. The type of ground truth used:

Not applicable. No clinical data requiring "ground truth" (e.g., from pathology, expert consensus, or outcomes data) was used for this 510(k) submission. Non-clinical testing focused on design validation against company specifications and compliance with safety and performance standards.

8. The sample size for the training set:

Not applicable. This device did not involve machine learning algorithms requiring a training set.

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

Not applicable. This device did not involve machine learning algorithms requiring a training set with established ground truth.

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