(231 days)
The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.
The UINCARE HOME software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
The UINCARE HOME software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients.
UINCARE HOME software provides medical professionals the tools to record and track movements in threedimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the patient performance metrics can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise. The UINCARE HOME is a software tool that helps extend that expertise.
The UINCARE HOME software has three separate applications.
- (1) UINCARE Client: Patient Application. This application prompts and monitors patients in the performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
- (2) UINCARE Manager: Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
- (3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.
The provided text is a 510(k) Summary for the UINCARE HOME device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No specific acceptance criteria are listed with numerical targets. The document mentions "Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation." However, these "design specifications" and "allowable deviation" are not quantified or detailed.
- No specific study is described with performance results against acceptance criteria. The "Performance Test Range of Motion Assessment Test" is mentioned, but its methodology, results, and specific metrics are absent.
Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract what is available.
Here's the information that can be gleaned about the performance testing for the UINCARE HOME:
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A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The document states that "Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation." However, the specific design specifications, acceptance criteria (e.g., in terms of accuracy, precision, or other performance metrics), and the reported numerical performance data are not included. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. The document mentions "Performance Test Range of Motion Assessment Test" but does not specify the sample size, type of data (e.g., patient data, simulated data), or its provenance. -
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):
This information is not provided. The nature of the "Range of Motion Assessment Test" suggests a comparison to a known standard or expert assessment, but no details on ground truth establishment or experts are given. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. -
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:
No MRMC study was conducted. The device is a software system for physical rehabilitation, not an AI for image interpretation or diagnosis. It assists patients with exercises and provides performance metrics to medical professionals. The document states: "No clinical studies were considered necessary and performed." Therefore, there is no discussion of human readers improving with or without AI assistance. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The "Performance Test Range of Motion Assessment Test" would likely be a standalone assessment of the software's ability to track motion and assess range of motion. However, no specific performance metrics or results are detailed. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The type of ground truth for the "Range of Motion Assessment Test" is not specified. It can be inferred that it involved comparing the device's measurements to a known or established standard for range of motion, but the exact method (e.g., expert measurement, gold standard sensor) is not described. -
The sample size for the training set:
This information is not provided. The document mentions "Software Validation" and that it "was designed and developed according to a software development process and was verified and validated," but it does not detail any training sets, as the device is described as a software system using an off-the-shelf camera, not necessarily a machine learning system that requires a distinct training set in the typical sense. -
How the ground truth for the training set was established:
This information is not provided, as details about a training set are absent.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.