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510(k) Data Aggregation
(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 < 2.0 Picoamperes |
| Differential Input Impedance | Greater than 1,000,000 Megaohms | 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 < 0.1 uV |
| Detector | Log power detector, 250 mS averaging filter. | Meets log power detector, 250 mS avg. filter. |
| Range of Motion | ||
| Range | 360 degrees | Meets 360 degrees |
| Accuracy | +/- 1 degree nominal | Meets +/- 1 degree nominal |
| Temperature | ||
| Calibrated Range | 55°F - 120°F | Meets 55°F - 120°F |
| Accuracy | +/- 0.2°F nominal | Meets +/- 0.2°F nominal |
| Algometer | ||
| Calibrated Range | 0-100 lbs. | Meets 0-100 lbs. |
| Accuracy | +/- 3% nominal | Meets +/- 3% nominal |
| Heart Rate Sensor | ||
| Output Voltage | 5 - 50 mV, typical at rest | Meets 5 - 50 mV, typical at rest |
| Output Impedance | 1 kΩ, nominal | Meets 1 kΩ, nominal |
The study that proves the device meets the acceptance criteria:
The document is a 510(k) submission, which primarily establishes substantial equivalence to a previously legally marketed device (the Insight Millennium Plus and Medac System/3) rather than demonstrating de novo clinical effectiveness or diagnostic accuracy through new performance studies against specific acceptance criteria.
The "study" cited for regulatory clearance is the comparison of technical specifications and features of the Insight Millennium III to its predicate devices. The submission asserts that the physical and electrical characteristics (performance characteristics) of the Insight Millennium III are equivalent to the Insight Millennium Plus, with the key difference being the addition of a heart rate sensor whose characteristics are equivalent to the Medac System/3 heart rate sensor.
The closest thing to "proving it meets acceptance criteria" for the new heart rate sensor is the assertion that its physical and electrical characteristics are equivalent to the already cleared Medac System/3 heart rate sensor. This implies that the performance parameters of the Medac System/3 heart rate sensor serve as the "acceptance criteria" for the Insight Millennium III's heart rate sensor. However, the document does not elaborate on specific performance studies for this equivalence beyond the comparison of specifications.
In summary, the provided text describes a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against predefined acceptance criteria for diagnostic accuracy or clinical efficacy.
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