(184 days)
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- Relaxation Training
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- Muscle Re-education
The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.
The provided text is a 510(k) summary for the MuscleSense™ II EMG device. While it describes the device's intended use and specifications, it does not contain any information about a study that proves the device meets specific acceptance criteria.
The summary states: "The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity." However, this is a general statement and does not provide details about acceptance criteria or the study methods used.
Therefore, I cannot populate the requested table and answer the subsequent questions fully. Here's why and what information would be needed:
Missing Information:
- Specific Acceptance Criteria: The document mentions "an acceptable sensitivity range" but does not define what that range is or any other specific performance metrics (e.g., accuracy against a known standard, precision, correlation with other EMG devices under specific conditions).
- Study Details: There is no mention of a formal study being conducted, its design, methodology, or results.
- Sample Size, Ground Truth, Experts, Adjudication, etc.: All of these details are dependent on a described study, which is absent from the provided text.
Based only on the provided text, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What they would be, if specified) | Reported Device Performance (As stated, without quantified criteria) |
|---|---|
| Device falls within an acceptable sensitivity range to effectively monitor muscle activity (Specific range not provided). | "The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity." (No specific numerical performance given). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information provided. The text only mentions "threshold sensitivity testing" without details on experimental design or sample size.
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):
No information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information provided.
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 an EMG device, not an AI-assisted diagnostic tool for "human readers." No such study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" EMG device used for measurement. The description of "threshold sensitivity testing" implies an evaluation of the device's intrinsic measurement capabilities, which is a form of standalone performance assessment, but no details of such a study are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information provided. For EMG sensitivity, ground truth would typically involve a known electrical signal input or comparison to a gold-standard device, but this is not detailed in the summary.
8. The sample size for the training set:
Not applicable/No information provided. Device testing is described, not an AI training process.
9. How the ground truth for the training set was established:
Not applicable/No information provided. Device testing is described, not an AI training process.
In summary, the provided 510(k) document is very limited in its description of performance testing beyond a general statement of compliance. To answer these questions fully, a detailed study report or test protocol would be required.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.