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The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The reusable Rezūm Generator is provided with the following reusable components:

• Generator
• One Power Cord
  The Rezūm Delivery Device Kit contains the following disposable components:
• One sterile Delivery Device with cable and tubing
• One sterile Syringe
• One sterile Spike Adaptor
• One 50 ml Sterile Water Vial
  Additional spike adaptor and syringe accessory is provided as an Accessory Pack.

The provided text describes the Rezūm System, a medical device for treating Benign Prostatic Hyperplasia (BPH), and its clinical studies to support substantial equivalence.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds for clinical outcomes. Instead, it reports the "effectiveness" of the device, primarily measured by the International Prostate Symptom Score (IPSS), and its "safety." The approval for substantial equivalence suggests that the reported performance was deemed acceptable by the FDA.

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

The "test set" in this context refers to the clinical study populations.

• Rezūm FIM Optimization Study:

  • Sample Size: 15 subjects (14 with 6 months follow-up data).
  • Data Provenance: Single site, specific country not explicitly stated, but likely prospective.

• Rezūm I Pilot Study:

  • Sample Size: 50 patients (45 enrolled in European sites).
  • Data Provenance: 3 centers (two in Europe, one in Latin America). Open label, single arm, prospective.

• Rezūm II Pivotal Study:

  • Sample Size: 197 subjects (136 randomized to treatment, 61 to control).
  • Data Provenance: Blinded, 2:1 randomized placebo-controlled study. Countries not specified, but this is a multi-center, prospective study.

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

The document does not provide details on the number or qualifications of experts involved in establishing the "ground truth" for the clinical studies. For BPH clinical trials, the "ground truth" often relies on objective measures (like prostate volume, flow rates) and patient-reported outcomes (like IPSS), which are standard clinical assessments rather than expert consensus on imaging interpretation.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the sense of independent review of endpoints or adverse events by a separate committee. However, the Rezūm II Pivotal Study was described as a "blinded" and "randomized placebo control study," which inherently includes methods to minimize bias in data collection and assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of AI on human reader performance in interpreting medical images. The Rezūm System is a therapeutic device, and the studies focused on its direct clinical outcomes compared to a control or baseline, not on enhancing human diagnostic capabilities.

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

Yes, the studies were effectively "standalone" in terms of evaluating the device's performance as a therapeutic intervention. The Rezūm System is a medical device that performs a procedure; its "performance" is its ability to treat BPH and improve patient symptoms, which was assessed directly in the clinical trials without human diagnostic interpretation of an algorithm output being the primary endpoint.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of the Rezūm System was based on:

• Patient-reported outcomes: Primarily the International Prostate Symptom Score (IPSS), which measures symptoms associated with BPH.
• Clinical outcomes: Reduction in prostate tissue (inferred from the mechanism of action and likely measured, though not detailed as a primary endpoint in the summary), and the occurrence of adverse events.
• Clinical assessment: Responders defined by a certain improvement in IPSS.

8. The Sample Size for the Training Set

The document describes clinical studies used to evaluate the device rather than "training" a machine learning algorithm. Therefore, there is no "training set" in the context of AI development. The clinical studies (FIM, Pilot, Pivotal) served as the primary evidence for safety and effectiveness.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The clinical study results were established through direct patient observation, validated questionnaires (IPSS), and medical follow-up as discussed in point 7.

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