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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 Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The Rezum System consists of a reusable Generator and a sterile Delivery Device Kit consisting of one Delivery Device with cable and tubing, one syringe, one spike adaptor, and one 50mL sterile water vial. The Delivery Device is EtO sterilized.

The Rezūm System converts water into vapor outside of the body with the vapor delivered to the prostate tissue via a needle within the sterile Delivery Device. The vapor ablates the targeted tissue within the prostate via thermal ablation as energy is transferred from the vapor to the prostate tissue. The amount of vapor delivered is controlled by a Radiofrequency (RF) Generator which also control the amount of saline flush used to cool the urethra during the treatment.

The provided text is a 510(k) summary for the Rezūm System, a medical device used to treat Benign Prostatic Hyperplasia (BPH). It describes design modifications to a previously cleared device (K160417) and argues for substantial equivalence to this predicate.

The document does not contain acceptance criteria or a study proving that the device meets specific performance criteria related to clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating that the modified device performs equivalently to the predicate device regarding its physical performance and safety following design changes.

Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document in the typical sense of a diagnostic or predictive AI device.

However, I can extract information regarding the performance data provided to ensure substantial equivalence of the modified device to its predicate.

Here's the information based on what is available in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific quantitative acceptance criteria or detailed reported device performance in a table format for clinical efficacy. Instead, it states that the modifications were tested to ensure compliance with initial device specifications and equivalent function to the predicate device.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified for any of the listed performance assessments.
• Data provenance: Not specified. This typically refers to the testing of the physical device or components, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/not specified. The "ground truth" for these engineering and performance tests would be established through defined measurement standards and engineering principles, not expert clinical consensus.

4. Adjudication method for the test set:

• Not applicable/not specified.

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:

• Not applicable. This is a medical device for treatment, not an AI diagnostic or assistive imaging device.

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

• Not applicable. This is a medical device for treatment. Software verification and validation were performed, but this is related to the device's operational software, not a standalone AI algorithm for interpretation.

7. The type of ground truth used:

• For the physical and electrical performance tests listed (e.g., Dimensional, Tensile, Electrical safety, EMC), the "ground truth" would be established by validated test methods, reference standards, and compliance with relevant industry standards (e.g., IEC 60601-1).

8. The sample size for the training set:

• Not applicable. The document describes modifications to a physical device, not an AI/ML algorithm that requires a training set of data in the typical sense. Software verification and validation would have been performed on the device's operational software.

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

• Not applicable. (See #8)

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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 ≤ 80cm². 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.

Here's a breakdown of the acceptance criteria and study information for the NxThera Rezūm System, based on the provided FDA 510(k) summary:

Important Note: This document is a 510(k) summary for a modified device, seeking substantial equivalence to a prior predicate device (K150786). Therefore, the performance data presented primarily focuses on demonstrating that the modifications do not negatively impact safety and effectiveness, rather than establishing de novo safety and effectiveness for the original device. The original clinical studies cited were for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by repeated tests on modified device,
as the specific acceptance thresholds are not explicitly stated, but are assumed to be met if "compliance to initial specifications" is achieved)

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

• For the Modified Device (K160417):

  • Test Set Sample Size: Not applicable in terms of human subjects. The testing described for the modified device was primarily benchtop testing (e.g., tensile/bond strength, tubing tests, functional tests, biocompatibility). The number of individual units or samples used for these bench tests is not specified, but the focus was on validating engineering changes.
  • Data Provenance: Not applicable as no new human clinical data was generated for this specific 510(k) for the modified device. The bench testing data would be from the manufacturer's internal labs.

• For the Predicate Device (K150786) clinical studies (referenced):

  • Test Set Sample Size:
    • Feasibility and pilot open-label studies: 65 patients
    • Randomized placebo-controlled study: 197 patients
  • Data Provenance: Not explicitly stated, but generally, clinical trials for FDA submissions are often multi-center and could involve various countries, but the specific origins are not in this summary. These were prospective clinical studies.

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

• For the Modified Device (K160417): Not applicable, as detailed human subject ground truth establishment (e.g., by experts for diagnostic accuracy) was not the focus of this 510(k) for device modifications. Bench testing does not typically involve expert ground truth in this way.
• For the Predicate Device (K150786) clinical studies: The document does not provide details on the number or qualifications of experts for establishing ground truth for the clinical outcomes in the referenced studies. Clinical trial outcomes (e.g., symptom relief, prostate volume reduction) are typically measured objectively or reported by patients using validated questionnaires, with physician assessment of adverse events.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• For the Modified Device (K160417): Not applicable, as no human subject adjudication is mentioned for the bench tests.
• For the Predicate Device (K150786) clinical studies: The document does not specify any adjudication methods for clinical outcomes or adverse events in the referenced studies. In multi-center clinical trials, independent data monitoring committees or clinical events committees often perform adjudication, but this is not mentioned here.

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

• Not applicable. The Rezūm System is an endoscopic electrosurgical unit for BPH treatment, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this device type.

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

• Not applicable. The Rezūm System is a medical device for direct treatment, not an algorithm. Its performance is evaluated by its function in ablating prostate tissue and the clinical outcomes achieved when used by a physician.

7. The Type of Ground Truth Used

• For the Modified Device (K160417): For the bench testing, the "ground truth" was the initial specifications of the predicate device and engineering standards.
• For the Predicate Device (K150786) clinical studies:
  • Clinical Outcomes/Symptoms: Likely patient-reported outcomes (e.g., IPSS scores for BPH symptoms), objective measurements (e.g., prostate volume reduction via imaging, uroflowmetry for obstruction), and adverse event monitoring.
  • Effectiveness: Reduction in symptoms, improvement in quality of life, reduction in prostate tissue, and relief of obstruction.
  • Safety: Incidence and severity of adverse events.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering development and testing to meet specifications.

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

• Not applicable. As stated above, this is not an AI/machine learning algorithm. The "ground truth" for its development would be based on engineering principles, scientific understanding of thermal ablation, and clinical requirements for BPH treatment.

Ask a specific question about this device

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.

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