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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 Discovery is a non-invasive, multi-modality physiologic monitoring device. The Insight Discovery contains the following six sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) algometer used to measure patient self-reported pressure sensitivity, and (4) heart rate sensor to measure heart rate, (5) an inclinometer used to measure end-point range of motion, and (6) a wireless version of the inclinometer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Insight Discovery device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Insight Discovery device are directly derived from its specifications, which are stated to be identical to its predicate device, the Insight Millennium III, with the exception of the added wireless inclinometer. Since this is a 510(k) submission primarily focused on substantial equivalence rather than de novo approval, the "acceptance criteria" are essentially the documented performance specifications that demonstrate it functions as intended and is comparable to a legally marketed device.

The Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical study with specific acceptance criteria beyond direct comparison to the predicate's established performance.

The "study" proving the device meets acceptance criteria is fundamentally a comparative analysis of specifications and functional equivalence to the predicate device (Insight Millennium III, K023209).

• Evidence of Equivalence: The document explicitly states: "The Insight Discovery is equivalent to this legally marketed device in the following ways: The physical characteristics and electrical characteristics (performance characteristics) of the Insight Discovery are identical as to the Insight Millennium III, as cleared by FDA. The only difference is the addition of an optional wireless dual inclinometer in the place of the standard wired inclinometer."
• Performance Specification Section: Section 5, "Performance Specification," lists the detailed technical specifications for all components (EMG, Temperature, Algometer, Heart Rate Sensor, Single Inclinometer, Dual Inclinometer, Instrument Console). These specifications are presented as the device's inherent performance. The implication is that these specifications are the acceptance criteria, and by design and manufacturing, the device embodies these specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not describe a "test set" in the context of human subject trials or a specific dataset for algorithm evaluation. This is a medical device hardware and software combination that measures physiological parameters. The "testing" likely involved engineering verification and validation against the stated specifications, and possibly bench testing or limited in-house user testing to confirm functionality. No patient sample size for performance evaluation is mentioned.
• Data Provenance: Not applicable, as there's no mention of a clinical data set or patient data used for evaluation of the device's performance within this submission beyond its technical specifications. The focus is on the device's hardware and software capabilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. This submission does not involve a diagnostic algorithm or AI where "ground truth" is established by experts on a test set. The device itself is a measurement tool. Its accuracy is determined by its technical specifications (e.g., Temperature Accuracy: ±0.2°F nominal, Inclinometer Accuracy: ±1 degree nominal) rather than an expert consensus on a subjective interpretation.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a test set requiring adjudication in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms that assist human readers in interpretation. The Insight Discovery is a physiological monitoring device that provides objective measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable in the typical sense of an AI algorithm. The device itself performs measurements; its "standalone performance" is its ability to accurately measure the specified physiological parameters according to the listed specifications, which is assumed by its design and substantial equivalence to the predicate. There is no distinct "algorithm" performance test described separate from the device's overall functionality.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance is its engineering specifications and metrology. For instance, the accuracy of the temperature sensor (±0.2°F nominal) would be validated against a calibrated temperature reference. The inclinometer's accuracy (±1 degree nominal) would be validated against a known angle. This is standard for measurement devices. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. The Insight Discovery is a measurement device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its functionality is based on established engineering principles and sensor technology.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

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The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.

The CWAS 100 measures the following physiologic signals:

• Bilateral differences in surface EMG along the spine
• Heart Rate
• Skin temperature
• Galvanic Skin Resistance
• Body fat percentage in subjects eighteen years and older

The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The CWAS 100 contains the following five sensor types: (1) surface EMG, (2) IR Plethsmograph, (3), Skin temperature, (4) Galvanic Skin Resistance and (5) IR Body Composition Analyzer.

Hardware: The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.

Software: The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.

This document describes the CWAS 100 electromyograph, a multi-modality physiologic monitoring device. The provided text outlines the device's indications for use, description, and a comparison to predicate devices, but does not contain information about a specific study or acceptance criteria demonstration for the CWAS 100 itself.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications listed are for the CWAS 100's components and are largely presented as equivalent to or derived from the predicate devices. There is no section detailing a study to prove these specifications are met for the CWAS 100.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text for the CWAS 100. The provided information is limited to the device's stated specifications and equivalence claims based on predicate devices.

Based on the provided text, the following information can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The "Reported Device Performance" for the CWAS 100 in this table is based on its stated specifications and the claim of substantial equivalence to predicate devices, rather than results from an independent performance study specifically for the CWAS 100 that is detailed in the provided text. The submission focuses on demonstrating equivalence to predicate devices which have presumably already met their performance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document describes device specifications and predicate comparisons but does not detail a study with a test set of data.

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)

Not provided. No study with a test set and associated ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. No study with a test set 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 done / Not applicable. The CWAS 100 is a physiologic monitoring device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. The document does not describe any AI component or any study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not done / Not applicable. The CWAS 100 is a hardware-based physiologic monitoring device with software to display and report data. It does not rely on an "algorithm only" performance in the sense of an AI diagnostic tool. Its performance is linked to the accuracy and range of its sensors, which are claimed to be substantially equivalent to predicate devices. No standalone performance study details are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided / Not applicable. No study requiring external ground truth for performance evaluation is described for the CWAS 100. The device's performance relies on its physical measurements and their accuracy, which are presented as specifications rather than being evaluated against a "ground truth" derived from patient data. For the IR Body Composition Analyzer, the predicate device Futrex 6100/XL likely established its accuracy against a gold standard for body fat measurement, but this specific detail for this submission is not provided.

8. The sample size for the training set

Not provided. No training set for an algorithm is mentioned as the device is not described as an AI/ML-based system.

9. How the ground truth for the training set was established

Not provided. No training set for an algorithm is mentioned.

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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 chart patient progress during the course of treatment

The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The Insight Genesis contains two surface EMG sensors used to measure muscle activity.

Hardware: The Insight Genesis hardware consists of an instrument console and two surface EMG sensors. The Insight Genesis will plug directly into the UL-2601 listed wall mounted power supply. The Instrument Console is powered by a computer (IBM compatible) via an isolated serial port connection.

Software: The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that readings are stable prior to data collection. The Insight Genesis software allows the user to: (1) collect and store surface EMG, (2) view and analyze surface EMG, and (3) print out reports.

The provided document is a 510(k) summary for the Insight Genesis device. It's a premarket notification for a medical device and describes its equivalence to a predicate device, technical specifications, and intended use. However, it does not include performance criteria, a study proving acceptance criteria, or details regarding ground truth establishment, sample sizes for training/test sets, or expert involvement as requested in the prompt. This information is typically found in detailed device validation studies, which are usually separate from the 510(k) summary provided here.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study details or effect size.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (Insight Millennium) based on design, indications for use, and technological characteristics, rather than presenting a performance study with acceptance criteria.

The information that can be extracted from the document is related to the device description and its comparison to the predicate device, which is not what was requested.

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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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Ask a specific question about this device