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A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

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This FDA 510(k) clearance letter for the Vera device does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of the study that proves the device meets those criteria. The letter primarily confirms the device's substantial equivalence to predicate devices and outlines regulatory obligations.

However, based on the provided text, I can infer some information and highlight what is explicitly missing.

Information that CAN be extracted or inferred:

• Device Name: Vera
• Intended Use: A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults (upper extremity, trunk, and lower extremity) in the clinic and at home, with audiovisual feedback, graphic movement representations for patients, and remote access to patient exercise videos for clinicians. Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.
• Regulatory Status: Cleared as a Class II medical device (Product Code LXJ), Regulation Number 21 CFR 890.5360 (Measuring Exercise Equipment).
• Use Type: Prescription Use.

Information that is NOT present in the provided text and is crucial for your request:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically found in the 510(k) summary or the full submission, not in this clearance letter.
2. Sample sizes used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not mentioned, and generally less common for this type of device (measuring exercise equipment).
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned, though the device has a standalone component (the software system itself). The performance metrics for this standalone component are what's missing.
7. The type of ground truth used: Not mentioned. For a rehabilitation device, this could involve motion capture systems, clinical assessments, or expert observation.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain the specific information you are looking for (acceptance criteria, study details, performance metrics, ground truth methods, sample sizes), you would need to access the full 510(k) submission for K192474, which may be available through the FDA's website or by filing a Freedom of Information Act (FOIA) request. The public 510(k) summary, if available, would be the most likely place to find a high-level overview of the performance data.

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The provided text is an FDA 510(k) clearance letter for the device "Vera" by Reflexion Health, Inc. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance data, study design parameters (sample size, data provenance, expert qualifications, adjudication methods), or details about training sets or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The document is essentially a regulatory clearance notice, not a clinical study report or a technical performance specification document.

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A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

The Vera™ 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. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional 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 recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise. The Vera™ software has three separate applications: Patient Application, Clinician Application, and Server Application.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Vera device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 230 observations (10 Physical Therapists (PTs) x 23 Exercises/PT).
• Data Provenance: The study involved "healthy volunteers performing rehabilitation movements." The location of these volunteers or the study is not explicitly stated in the provided text. It is a prospective study as clinicians reviewed videos of performances.

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

• Number of Experts: 10 Physical Therapists (PTs).
• Qualifications of Experts: The document explicitly states "Clinicians reviewed a series of video recordings." In a later section, it mentions "10 PTs," confirming the experts were Physical Therapists. No further details regarding their years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (such as 2+1 or 3+1). It describes that "Clinicians reviewed a series of video recordings... to verify that the movement seen in the video is recognized as physical therapy exercise and determine if they would recommend the movement to their patients." It appears each therapist made individual assessments, and the results were aggregated to report percentages of agreement. There is no mention of a process to resolve disagreements among the 10 therapists if they occurred.

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?

No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with or without AI assistance was not performed. The study described focuses on clinician recognition and acceptance of exercises delivered by the Vera system, not on improving human reader performance.

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

The study described evaluates the "clinical relevance of exercises delivered by the Vera System" and whether movements "executed by an individual interacting with the system" are recognized as exercises by clinicians. This is not a standalone algorithm performance study. While the Vera system tracks movements and provides data, the core of this particular study is about clinician perception of the exercises facilitated by the system, rather than the raw algorithmic accuracy in isolation. The document states a "hazard analysis of the Vera™ software also indicates low risk to the end user" and that "Vera™ has been validated for accuracy / performance effectiveness both clinically and through software testing with appropriate change management and design controls," which may allude to some standalone testing, but the details of such are not provided for the clinical study section.

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

The ground truth for this specific study was expert consensus / expert opinion from the 10 Physical Therapists. They evaluated whether the movements performed by healthy volunteers via the Vera system were indeed recognized as physical rehabilitation exercises and if they would recommend them.

8. The sample size for the training set

The document does not provide any information regarding a training set size. This study appears to be a clinical validation of the exercises, not an evaluation of a machine learning model's training data. The Vera device itself is a "software system utilizing optical recording for rehabilitation exercises" and includes "motion sensing camera" technology (Kinect v2). While such a system internally would have trained algorithms for skeletal tracking and movement analysis, the details of that training are not part of the provided clinical performance data summary.

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

As no training set is discussed in the context of this document's clinical performance section, the method for establishing its ground truth is not provided.

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