(379 days)
- To measure bilateral differences in surface EMG along the spine
- To measure surface EMG along the spine during functional tasks
- To measure bilateral differences in skin temperature along the spine
- To measure Range of Motion of the three spinal regions
- To measure patient self-reported pressure sensitivity in joints and muscles
- To measure Heart Rate
- To chart patient progress during the course of treatment
The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.
The provided text describes the Insight Millennium III, a non-invasive, multi-modality physiologic monitoring device. However, it does not include information about specific acceptance criteria for its performance (beyond general accuracy specifications) or the studies conducted to prove the device meets these criteria in the context of clinical efficacy or diagnostic accuracy.
The document is a 510(k) Summary, which focuses on establishing substantial equivalence to predicate devices rather than proving new clinical efficacy or diagnostic performance through specific studies with acceptance criteria.
Therefore, the following information is not present in the provided document:
- A table of acceptance criteria and reported device performance related to a clinical study (only general performance specifications are given).
- Sample size used for a test set or data provenance in a study for performance validation.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone performance study.
- Type of ground truth used (beyond implying the device measures physiological parameters).
- Sample size for training set.
- How ground truth for the training set was established.
What is available in the document regarding "performance" are the device's technical specifications:
1. Table of Acceptance Criteria (Technical Specifications) and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Implied by specification) |
|---|---|---|
| EMG | ||
| Calibrated Range | 0.1 - 999 uV | Meets 0.1 - 999 uV |
| Input Bias Current | Less than 2.0 Picoamperes | Meets 1,000,000 Megaohms |
| Common Mode Rejection | 150 dB | Meets 150 dB |
| Bandwidth | 20-500 Hz (50/60 Hz notch) | Meets 20-500 Hz (50/60 Hz notch) |
| Noise | Less than 0.1 uV (inputs shorted) | Meets |
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).