Search Results

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.

Ask a specific question about this device