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The Reza Band® UES Assist Device is indicated for patients 18 years and older to reduce the symptoms of larvngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The device is worn by the patient when sleeping.

The Reza Band® UES Assist Device (Reza Band) (Figure 1) is a non-invasive, non-sterile device worn by the patient and is designed to provide a set pressure (20-30 mm Hg) on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES). The patient wears the Reza Band after being fit by the physician (Figure 2).

The Reza Band has 5 main components:

• Frame
• Cushion
• Comfort Band
• Clasp
• Comfort Dial

The Reza Band® External Manometer (External Manometer) is a hand-held device and is connected to the Reza Band® Pressure Sensor (Pressure Sensor). It is used by the treating physician, is powered by a AAA battery and displays the pressure being applied to the cricoid cartilage region by the Reza Band in millimeters of Mercury (mm Hg) as the Reza Band® is being fitted (Figure 3).

The Pressure Sensor connected to the External Manometer is regulated as a miniature pressure transducer (21 CFR Part 890.1615) which is Class I exempt. The Pressure Sensor and the External Manometer were assessed to ensure that the Reza Band® was accurately applying the specified pressure.

The Reza Band® Upper Esophageal Sphincter (UES) Assist Device did not undergo a study that assessed its performance against specific, pre-defined acceptance criteria with a quantifiable metric (e.g., accuracy, sensitivity, specificity). Instead, the studies focused on demonstrating the safety and effectiveness of the device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a direct table of "acceptance criteria" where a specific quantitative metric (like accuracy or AUC) is listed alongside a target value and then the device's performance against that target for a classification task. The studies provided focus on demonstrating safety and symptomatic improvement.

Bench Test Acceptance Criteria and Results (from Table 2):

Clinical Study Effectiveness Endpoint (from Study #1):

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

• Study #1 (Clinical Effectiveness Study):

  • Sample Size:
    • Enrolled: 95 patients
    • Analyzed for Effectiveness: 89 patients (who wore the device for at least 2 weeks and provided one post-baseline RSI assessment). 6 subjects discontinued and were excluded from this specific effectiveness analysis, but a worst-case sensitivity analysis confirmed no impact on treatment effect.
  • Data Provenance: Prospective, multi-center (5 investigational sites). Country of origin is not explicitly stated, but implicitly US given the FDA submission context.

• Study #2 (Safety of Intentionally Displaced Device):

  • Sample Size: 20 subjects
  • Data Provenance: Prospective. Country of origin not explicitly stated, but implicitly US given the FDA submission context.

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

This information is not explicitly provided in the document for either study.

• Study #1: The primary effectiveness endpoint, Reflux Symptom Index (RSI), is a "validated nine-item, patient-administered outcome questionnaire." This suggests the ground truth for effectiveness is based on patient-reported outcomes, rather than expert assessment of the RSI score itself. Clinical diagnosis of LPR was made by healthcare professionals, but the evaluation of effectiveness relied on the patient-completed RSI.
• Study #2: Ground truth for safety was established by direct physiological measurements (heart rate, blood pressure, cardiac rhythm, IOP). These are objective measurements, not requiring expert consensus for ground truth establishment in the dataset.

4. Adjudication Method for the Test Set

Not applicable to these studies as the primary endpoints are either patient-reported (RSI) or direct physiological measurements, not requiring expert adjudication of a "test set" in the context of diagnostic performance.

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 not an AI/diagnostic imaging device, so this type of study is not relevant.

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

Not applicable. The Reza Band is a physical medical device, not an algorithm. Its performance is tied to its physical application and effect on the patient.

7. The Type of Ground Truth Used

• Study #1 (Effectiveness): Patient-reported outcomes (Reflux Symptom Index - RSI). The RSI is a validated questionnaire.
• Study #2 (Safety in Displaced Position): Objective physiological measurements (heart rate, blood pressure, cardiac rhythm, intraocular pressure).

8. The Sample Size for the Training Set

Not applicable. The Reza Band is a physical medical device. It does not utilize machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device itself refers to its design, testing, and refinement, not an algorithmic training process.

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

Not applicable, as there is no "training set" for an AI algorithm.

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