Search Results

The Scrambler Therapy MC-5A TENS Device is indicated for:

• . Symptomatic relief of chronic, intractable pain, post surgical and posttraumatic acute pain
• Symptomatic relief of acute pain .
• Symptomatic relief of post-operative pain .

The Scrambler Therapy MC-5A TENS Device is a multi-channel TENS device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.

The provided text is a 510(k) Summary for the Scrambler Therapy MC-5A TENS Device. It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, it explicitly states that the device meets "design and performance specifications" but does not contain detailed information about specific acceptance criteria or the results of a clinical study demonstrating performance against those criteria.

Therefore, I cannot fulfill all parts of your request with the provided information.

Here's what I can extract and what is missing:

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

• Acceptance Criteria: Not detailed in the provided text. The document broadly states "design and performance specifications" were met, but doesn't list them.
• Reported Device Performance: Not detailed in the provided text. No specific performance metrics or outcomes are reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is irrelevant as no clinical study with ground truth establishment is described. The device is a TENS device, and the 510(k) focuses on substantial equivalence based on technological characteristics and intended use, not clinical trial performance.

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

• Not applicable, as no clinical study requiring adjudication is described.

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 not an AI-based diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

• Not applicable. This device is a TENS device, not an algorithm.

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

• Not applicable, as no clinical study requiring ground truth is described.

8. The sample size for the training set:

• Not applicable, as no machine learning algorithm with a training set is described.

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

• Not applicable, as no machine learning algorithm with a training set is described.

Summary of available information from the text:

The document states:

• "Competitive Technologies, Inc. claims substantial equivalence of the Scrambler Therapy MC-5A TENS Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics." (Section 6)
• "Testing of the Scrambler Therapy MC-5A TENS Device demonstrates that the device meets design and performance specifications." (Section 7)

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, which is a common pathway for TENS devices. It does not present detailed acceptance criteria or the results of a clinical performance study that would typically involve test sets, ground truth, experts, or the other specific elements you requested. The "Performance Testing" section only broadly states the device meets its design and performance specifications without providing specifics.

Ask a specific question about this device