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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:

1. Relaxation of muscle spasms
2. Prevention of retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. 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.

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The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.

The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.

The provided document is a 510(k) summary for the Mantra Electrode, which is a cutaneous electrode. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, expert involvement, or MRMC studies.

Therefore, most of the requested information cannot be extracted from this document based on the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document states "The device meets the mandatory performance standards" but does not define what those standards are or present any specific performance data from a study.

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

• Cannot be provided. No study or test set details are mentioned in the document.

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)

• Cannot be provided. No ground truth establishment or expert involvement for a test set is mentioned.

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

• Cannot be provided. No test set or adjudication method is mentioned.

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

• Cannot be provided. This document describes a simple medical device (an electrode), not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance are not applicable and are not mentioned.

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

• Cannot be provided. As above, this is not an AI or algorithm-driven device.

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

• Cannot be provided. No ground truth is mentioned. The substantial equivalence is based on "indications for use," "technological characteristics," and "biocompatibility."

8. The sample size for the training set

• Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.

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

• Cannot be provided. No training set or ground truth for it is mentioned.

Summary of available information:

The document focuses on demonstrating substantial equivalence to a predicate device (Uni-Patch Electrode Model Re-Ply®, K983097) rather than providing detailed performance study data against specific acceptance criteria. This is common for 510(k) submissions of certain classes of devices.

The basis for substantial equivalence is listed as:

• Same indications for use.
• Equivalent technological characteristics and instructions for use.
• Meets mandatory performance standards (though these are not detailed).
• Biocompatibility established (details not provided).

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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):

Missing Information (Not Applicable or Not Provided in this 510(k) Summary):

1. 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.
2. 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.
3. Adjudication method for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. 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.
7. The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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