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The purpose of the Symphony Device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counter-stimulation.

The Symphony Device is a non-sterile, reusable, cloth-covered foam pad that contains six embedded electric motors that swing eccentric weights to produce vibration throughout the pad. The device is designed to be placed under the user's legs while sleeping. When the device is activated, an electronic controller runs a 35 minute preset vibration cycle. The controller allows the patient to control the intensity level of the vibration for the first 30 minutes of the cycle. In the last five minutes, the controller slowly ramps down the vibration intensity of the device and then automatically shuts the device off at the end of the timed cycle. One repeat cycle can be initiated by the patient. The controller contains the on/off function and has variable mechanical counter-stimulation intensity settings (1 to 9). The motor amplitude and frequency (vibration) can be set to different levels of intensity by means of a knob. The polyurethane foam pad is covered by an inner lycra cover and an outer cover. The outer cover on the Symphony™ Device is made of cotton. The device will be offered in three sizes: Small, Medium, and Large.

Here's a summary of the acceptance criteria and the study details for the Symphony Device, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the clinical effectiveness of the device. Instead, it describes clinical study results and a benefit/risk determination. The non-clinical acceptance criteria are implied by compliance with standards and successful completion of tests.

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

• SMI-001 (Test Set 1):
  • Sample Size: 77 subjects (39 Symphony, 38 sham).
  • Data Provenance: Prospective, multicenter trial (5 sites). The country of origin is not specified but is implied to be the US given the FDA regulatory context.
• SMI-002 (Test Set 2):
  • Sample Size: 81 subjects (52 Symphony, 29 sham).
  • Data Provenance: Prospective, multicenter trial (4 sites). The country of origin is not specified but is implied to be the US given the FDA regulatory context.

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

The study design described is a clinical trial involving patient-reported outcomes for RLS and sleep quality. The "ground truth" for RLS severity (IRLS) and sleep quality (MOS Sleep Scale) is established directly by the patients' subjective responses to the validated questionnaires. There is no mention of experts establishing a separate ground truth for these endpoints. Physicians/investigators at the study sites would have been involved in participant diagnosis and monitoring, but not in creating a "ground truth" for the device's performance in the way an imaging study would use expert radiologists.

4. Adjudication Method for the Test Set

The clinical trials used patient-reported outcome measures (IRLS, MOS Sleep Scale, RLSQOL). These measures are self-administered questionnaires, so an adjudication method in the sense of multiple expert reviews of data to establish a single ground truth is not applicable. The outcomes are the direct responses of the participants. Adverse events were collected and monitored by the clinical sites, and their device-relatedness was assessed, but a formal adjudication committee process is not detailed.

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, an MRMC comparative effectiveness study was not done. This device is a therapeutic device for RLS, not an imaging diagnostic device that would typically involve human readers (like radiologists) or AI assistance in interpretation.

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

This question is not applicable to the Symphony Device. The Symphony Device is a physical, therapeutic vibratory counter-stimulation device. It does not involve an algorithm or AI that operates in a standalone diagnostic or interpretive capacity. Its software controls the vibration cycle, which is a functional control, not an analytical or diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth used in the clinical studies was patient-reported outcomes (PROs):

• International Restless Legs Scale (IRLS) score: A validated scale for RLS symptom severity.
• Medical Outcomes Study (MOS) Sleep Scale scores: Patient-reported assessment of sleep disturbance and quality.
• Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire (RLSQOL): Patient-reported quality of life related to RLS.

8. The Sample Size for the Training Set

The provided text describes two prospective clinical trials (SMI-001 and SMI-002) which serve as the primary effectiveness and safety studies presented for regulatory review. There is no mention of a separate "training set" for an algorithm, as this device does not utilize a machine learning algorithm in the way a diagnostic AI would. The clinical trials themselves provide the data upon which the device's performance is assessed.

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

Since there is no "training set" in the context of an algorithm for this device (see point 8), this question is not applicable. The data from the clinical trials (SMI-001 and SMI-002) were used to demonstrate the device's safety and effectiveness, with "ground truth" established via patient-reported outcomes (IRLS, MOS Sleep Scale, RLSQOL) as described in point 7.

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