Search Results
Found 1 results
510(k) Data Aggregation
(88 days)
The device is intended for the symptomatic relief of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
The Mantra TENS Model NT3 is a Dual Channel Transcutaneous Nerve Stimulator (TENS).
The provided text describes a 510(k) premarket notification for the Mantra TENS Model NT3, a Transcutaneous Nerve Stimulator. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a de novo study with acceptance criteria and performance data in the format typically used for novel AI/ML medical devices. Therefore, much of the requested information regarding acceptance criteria, study design, and AI-specific metrics is not available in the provided document.
However, based on the principle of substantial equivalence, the "acceptance criteria" for the Mantra TENS Model NT3 are implicitly met by demonstrating that it is as safe and effective as the predicate device.
Key Findings from the Document:
- Predicate Device: Classic TENS™ manufactured by Care Rehab, McLean, Virginia (K020437).
- Basis for Substantial Equivalence:
- Same indications for use.
- Equivalent technological characteristics and instructions for use.
- Meets mandatory performance standards.
- Biocompatibility of electrodes established.
Table of Acceptance Criteria and Reported Device Performance (as inferred from substantial equivalence):
| Acceptance Criteria Category | Acceptance Criteria (based on predicate) | Reported Device Performance (Mantra TENS Model NT3) |
|---|---|---|
| Indications for Use | Symptomatic relief of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. | Same as predicate device. |
| Technological Characteristics (TENS modes) | Conventional TENS mode: Rate 2 Hz - 200 Hz, Pulse Width 50 - 300 microseconds (common: 80 Hz, 200 us). Burst mode: short BURST of 9 pulses [200 microseconds] at 150 Hz. Modulation mode: continuously cycling pulse width and rate. | Identical to predicate device (implied by "equivalent technological characteristics"). |
| Safety (Biocompatibility) | Electrodes are biocompatible. | Biocompatibility of electrodes has been established. |
| Mandatory Performance Standards | Meets applicable mandatory performance standards for TENS devices. | Meets mandatory performance standards. |
Missing Information (Not Applicable or Not Provided in this 510(k) Summary):
- Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) based on substantial equivalence, not a de novo performance study with a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was described.
- Adjudication method for the test set: Not applicable.
- 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/ML diagnostic tool and does not involve human readers interpreting AI output.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Performance is based on equivalence to the predicate, not a new ground truth study for efficacy.
- The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1