(87 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 chart patient progress during the course of treatment
The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four 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, and (4) algometer used to measure patient self-reported pressure sensitivity.
The provided 510(k) summary for the Fasstech Insight Millennium Plus describes a premarket notification for a medical device and its substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance, diagnostic accuracy, or a multi-reader, multi-case study.
The document primarily focuses on establishing substantial equivalence based on device features, technical specifications, and safety design, compared to existing predicate devices.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size, ground truth, expert qualifications, MRMC studies, or standalone performance) are not present in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance specifications for the individual sensors, which can be interpreted as acceptance criteria for the technical performance of the device components. However, these are not clinical acceptance criteria for overall device efficacy or diagnostic accuracy.
| Performance Characteristic | Acceptance Criteria (Specified in 510(k)) | Reported Device Performance (Specified in 510(k)) |
|---|---|---|
| EMG | ||
| Input Bias Current | N/A | Less than 2.0 Picoamperes |
| Differential Input Impedance | N/A | Greater than 1,000,000 Megaohms |
| Common Mode Rejection | N/A | 150 dB |
| Bandwidth | N/A | 20-500 Hz (50/60 Hz notch) |
| Noise | N/A | Less than 0.1 uV (inputs shorted) |
| Range of Motion | ||
| Accuracy | N/A | +/- 1 degree nominal |
| Temperature | ||
| Accuracy | N/A | +0.2ºF nominal |
| Algometer | ||
| Calibrated Range | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but predicated on JTECH's range and own stated range for Insight Millennium Plus. | 0-100 lbs |
| Accuracy | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but compared to JTECH's "Not Published" accuracy. Fasstech states its own accuracy. | +/- 3% nominal |
| Contact Area | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but compared against JTECH's options. | 1.0 cm² |
| Instrument Console | ||
| A/D Converter (bits) | N/A | 12 bit, 8 channel |
Important Note: The "acceptance criteria" in this context are the specified technical performance parameters the manufacturer states the device achieves. The 510(k) process primarily evaluates substantial equivalence to legally marketed predicate devices, not necessarily independent proof of meeting clinical acceptance criteria through a formal study with defined endpoints.
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe a clinical test set or data from a study. It focuses on device specifications and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is described.
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/Not provided. The Insight Millennium Plus is a biofeedback device with sensors, not an AI-assisted diagnostic imaging device requiring an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is an instrument with sensors; it does not present as an "algorithm only" device in the context of typical standalone performance studies for AI. The section on the "Algometer" explicitly states it is not stand-alone (referring to the Insight Millennium Plus system, not the Algometer component itself being stand-alone).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. As no performance study with a test set is described, no ground truth types are mentioned. The "ground truth" for the device's technical specifications would be the physical measurements taken by the manufacturer during its own testing and calibration.
8. The sample size for the training set:
- Not applicable/Not provided. The document describes a hardware and software system for data acquisition and display, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set is described.
§ 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.