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• 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

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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.

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.

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• 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 chart patient progress during the course of treatment

Not Found

I am unable to provide a description of the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA letter granting substantial equivalence for the "Insight Millennium" device (K990778).

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Study Details: The letter approves the device for marketing and mentions its intended uses, but it does not contain any performance data, acceptance criteria, study design, or results. It's a regulatory approval document, not a scientific study report.
• Focus on Substantial Equivalence: The core of this document is the FDA's determination that the Insight Millennium is "substantially equivalent" to predicate devices marketed before May 28, 1976. This process primarily involves comparing the device's technological characteristics and proposed indications for use to an already legally marketed device, not necessarily requiring a new, comprehensive clinical study with specific performance metrics to be detailed in the approval letter itself.
• Missing Information: All aspects of your request (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, ground truth establishment for training set) are completely absent from the provided text. These details would typically be found in the 510(k) submission itself or in published studies about the device, which are not part of this document.

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