(94 days)
a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pair.
b. NMS: The device in recommended for use for the following conditions:
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining and increasing range of motion.
The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.
This document is a 510(k) Summary for a medical device called "Mantra Combo." It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting novel performance studies with specific acceptance criteria and results.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully provided from the given document, as it does not contain such a study design or results.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document states "Performance testing was conducted on the 'Mantra Combo' combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device." However, it does not detail specific acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or quantitative performance metrics against those criteria. Instead, it relies on demonstrating equivalence to predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size: This information is not available within the document. Since the submission focuses on substantial equivalence based on identical design and circuitry, it's highly probable that no new clinical test set of patients was used for a performance study.
- Data Provenance: This information is not available. Given the likely absence of a new clinical test set, questions of data provenance (country of origin, retrospective/prospective) are not applicable in this substantial equivalence argument.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. Since there is no described clinical test set or study involving patient data endpoints, the concept of establishing ground truth by experts for a test set is not applicable here.
4. Adjudication method for the test set:
This information is not available. As no new clinical test set is described, there's no mention of an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Therefore, no effect size for human readers' improvement with AI assistance is reported. This device is a transcutaneous electrical nerve stimulator and a neuromuscular stimulator, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study for an algorithm was not done. The device described is a physical TENS/NMS unit, not an algorithm.
7. The type of ground truth used:
This information is not applicable/available. Given the nature of the device and the submission's focus on substantial equivalence through design and circuitry, the concept of "ground truth" as it applies to diagnostic accuracy or clinical outcomes is not addressed in relation to a new study.
8. The sample size for the training set:
This information is not applicable/available. The device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable/available. As there is no training set mentioned, there is no ground truth established for it.
Summary of Device and Evidence Presented:
The "Mantra Combo" device is a transcutaneous nerve stimulator (TENS) combined with a neuromuscular stimulator (NMS). The basis for its 510(k) clearance is substantial equivalence to two previously cleared predicate devices:
- Mantra TENS Model NT3 (K041520) for TENS functionality.
- Classic NMS™ manufactured by Care Rehab Inc (K021905) for NMS functionality.
The document explicitly states that the Mantra Combo is "physically identical to both the Manta TENS NT3 and Classic NMS™ consisting of exactly the same cabinet, PCB and circuity." It also asserts that the TENS functionality (modes and programs) and the NMS functionality (modes and programs) are "identical" to their respective predicate devices.
Therefore, the "performance studies" referenced are likely non-clinical (e.g., electrical safety, electromagnetic compatibility, perhaps output parameter verification) to confirm that the new device indeed replicates the performance characteristics of the predicates. The clinical effectiveness and safety are implicitly accepted based on the established safety and effectiveness of the equivalent predicate devices.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).