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The RESTIFFICTM Restless Leg Relaxer Foot Wrap is a prescription device intended to reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults and used during periods of rest or relaxation, when symptoms of RLS occur.

The RESTIFFIC™ Restless Leg Relaxer Foot Wrap device is a foot wrap designed to apply continuous, adjustable squeezing pressure on specific muscles in the feet. The device is to be applied before bedtime or while the person is seated or supine.

A more complete description of the device includes the following:

• An outer cloth wrap to support and hold the pressure pad in place. (The wrap has an . open end so the pad can be removed and replaced, if needed. Only the cloth comes in contact with the skin);
• . VELCRO straps and plastic buckles to hold the cloth wrap in place and allow for adjusting the pressure; and
• Pressure pads of high density foam to put pressure on the medial and bottom part of ● the foot. The RESTIFFIC™ achieves its targeted pressure with a T- shaped pad that presses into the medial and bottom part of the foot.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the regulatory classification of the RESTIFFIC™ Restless Leg Relaxer Foot Wrap, rather than explicitly stating acceptance criteria in the typical performance metric sense (e.g., sensitivity, specificity, accuracy). However, we can infer the primary "acceptance criterion" as demonstrating a statistically significant reduction in symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults, particularly as measured by the International Restless Legs Scale (IRLS) score, with an acceptable safety profile. The "device performance" then refers to the study's findings regarding this symptom reduction and safety.

Study Details

The provided text describes a single-arm, historically-controlled, open-label study.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: n=30 adult subjects.
   • Data Provenance: Not explicitly stated, but implies a prospective clinical study conducted specifically for the device's evaluation. No country of origin is mentioned.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • "Ground Truth" Methodology: The primary outcome (IRLS score) was a patient-reported outcome measure. Secondary outcomes (CGI-I, CGI-S, CGI-EI) were investigator-assessed measures of the subject's illness.
   • Number & Qualifications of Experts: The text does not specify the number or qualifications of the "investigators" who assessed the CGI metrics. It simply refers to them as "investigators."

3. Adjudication Method for the Test Set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the patient-reported outcomes or the investigator-assessed outcomes. The CGI scores appear to be direct assessments by the investigators.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done.
   • The study was a single-arm trial comparing the device's results to "historical drug studies using meta-analyses," rather than a direct comparison with human readers or human readers with/without AI assistance. Therefore, there is no effect size related to human reader improvement with AI.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • This question is not applicable as the RESTIFFICTM device is a physical, non-powered medical wrap and not an algorithm or AI system. Its performance inherently involves human interaction (wearing the device).

6. Type of Ground Truth Used:

   • Primary Ground Truth: Patient-reported outcome (IRLS score).
   • Secondary Ground Truth: Investigator assessment (CGI-I, CGI-S, CGI-EI), which represents a clinical judgment of the subject's status.
   • No pathology or direct objective outcomes data (beyond symptom self-reporting and clinical impression) are mentioned.

7. Sample Size for the Training Set:

   • Not applicable. The RESTIFFICTM device is a physical, non-powered medical device, not an AI or machine learning model that requires a "training set." The study described is a clinical trial evaluating its efficacy in a patient population.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the reasons stated in point 7.

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