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The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia(BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm³ ≤ 150 cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Following thermal therapy for BPH, small pieces of coagulated tissue may slough off and be expelled via urination. This sloughing process may continue for a few months post-procedure depending on the rate of healing.

The Rezūm System consists of the following:
• Rezūm Generator – reusable, non-sterile capital equipment, provided with one power cord
• Rezūm Delivery Device Kit – sterile, single-use kit containing the following disposable components:

• One sterile Delivery Device with cable and tubing
• One sterile syringe
• One sterile spike adaptor
• One sterile water vial

The provided FDA 510(k) clearance letter and summary for the Rezūm System (K250584) focuses on an expanded indication for use, specifically for larger prostate volumes, rather than establishing acceptance criteria for a new device's performance. The information provided describes studies demonstrating the comparable safety and effectiveness of the device for this expanded range, rather than defining specific performance metrics against pre-defined acceptance criteria for a novel device.

Since the document is for an expanded indication and not a de novo clearance, the acceptance criteria are implicitly that the device performs similarly in safety and effectiveness in the expanded patient population as it did in the previously cleared population. The study's goal was to demonstrate this similarity.

Here's an analysis based on the provided text, outlining what can and cannot be extracted regarding acceptance criteria and performance data:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context is less about a numerical threshold for a novel device's performance (e.g., sensitivity > X%, accuracy > Y%) and more about demonstrating that the device's safety and efficacy profile remains acceptable and comparable within the expanded patient population.

Implicit Acceptance Criteria:

• Safety: No new or unexpected adverse events in patients with prostate volumes >80 cm³ and ≤150 cm³. The rates of adverse events, including serious complications, should be generally similar to those observed in patients with prostate volumes ≤80 cm³.
• Effectiveness: Significant and similar improvements in functional and quality of life outcomes in patients with prostate volumes >80 cm³ and ≤150 cm³ compared to patients with prostate volumes ≤80 cm³. No negative impact on sexual function.

Reported Device Performance (as demonstrated by the supporting studies):

• Safety: "Patients with prostate volumes >80 cm³ had generally similar rates of adverse events, including serious complications. No unexpected adverse events were reported, and all adverse events were consistent with those reported in the Rezūm System pivotal clinical study."
• Effectiveness: "Significant and similar improvements in functional and quality of life outcomes were demonstrated in both patient populations, with no negative impact to sexual function."

Table of (Implicit) Acceptance Criteria and Reported Device Performance:

Study Details:

The document describes two types of clinical evidence used to support the expanded indication:

1. Systematic review and meta-analysis of clinical studies: This reviewed existing data on the Rezūm System for patients with prostate volumes >80 cm³ and compared outcomes to patients with prostate volumes ≤80 cm³.
2. Manufacturer-sponsored prospective, non-randomized, single-arm study: This study specifically evaluated the safety and effectiveness of the Rezūm System in patients with prostate volumes >80 cm³ and ≤150 cm³. The results were compared to data from the Rezūm System's original "pivotal clinical study."

Based on the provided text, here's what can be answered for each point:

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

   • Systematic Review/Meta-analysis: The text does not specify the exact sample size. It states it was a "systematic review and meta-analysis of clinical studies," implying a pooling of data from multiple studies. The data provenance (country of origin, retrospective/prospective) is not specified for the individual studies included in the meta-analysis, but they are existing clinical studies.
   • Manufacturer-sponsored study: The text does not specify the exact sample size. It describes the study as "prospective, non-randomized, single-arm." It evaluates patients with prostate volumes >80 cm³ and ≤150 cm³. Data provenance is primarily domestic, as it's a manufacturer-sponsored study submitted to the FDA. It is prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The Rezūm System is a therapeutic device (for relieving symptoms and reducing prostate tissue), not a diagnostic algorithm. Therefore, "ground truth" in the typical sense of expert label annotations for images or diagnostic classifications is not directly applicable here. The outcomes (symptom relief, prostate tissue reduction, adverse events, quality of life, sexual function) are assessed directly from patient reports, objective measurements (e.g., prostate volume changes), and clinical evaluations by treating physicians. The text does not mention a specific "ground truth" panel of experts, nor would it typically be required for a therapeutic device study focused on clinical outcomes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable (N/A). As a therapeutic device focusing on direct clinical outcomes, adjudication methods like those used for diagnostic algorithms (e.g., for image interpretation) are not described or typically relevant in this context. Clinical events and outcomes are recorded based on predefined criteria, and adverse events are typically reported and classified by investigators and reviewed by safety committees.

4. 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 (N/A). This is a therapeutic device, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable (N/A). This is a therapeutic medical device, not an algorithm. The Rezūm System is a physical device used in a procedure performed by a human clinician.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   As explained in point 3, the concept of "ground truth" for a therapeutic device is different. For this submission, the "ground truth" and evidence of effectiveness and safety comes from:

   • Clinical Outcomes Data: Patient-reported symptoms, quality of life scores, measures of sexual function, and potentially objective measures like post-treatment prostate volume.
   • Adverse Event Reporting: Documentation and classification of adverse events.
   • Comparison to a Pivotal Clinical Study: The study for the expanded indication compared its outcomes to those established in the device's original pivotal clinical study.

7. The sample size for the training set:
   Not applicable (N/A). This is a therapeutic medical device; there is no "training set" in the context of machine learning or AI algorithms. The development of the device itself would have involved engineering, preclinical, and early human studies, but these are not referred to as a "training set."

8. How the ground truth for the training set was established:
   Not applicable (N/A), as there is no "training set" in the AI/ML context for this device.

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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 reusable Rezum Generator is provided with the following reusable components:

• Generator
• One Power Cord

The single-use Rezum Delivery Device contains the following disposable components:

• One sterile Delivery Device with integrated cable and tubing
• One sterile Syringe
• One sterile Spike Adaptor
• One 50 ml Sterile Water Vial

This document is a 510(k) summary for a modified medical device, the Rezum System, and does not contain information about the original acceptance criteria or a study proving its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K190093) based on minor modifications (labeling, sterilizer, and sterilization cycle).

Here's a breakdown of why the requested information cannot be found in the provided text:

• No specific acceptance criteria are listed for the device's performance for this submission. The submission is for a modification to an already cleared device, not for the initial clearance of a new device with novel performance claims.
• No clinical study to prove device performance is described. Performance testing is mentioned, but it refers to sterility testing (lethality and sterilant residual testing) repeated due to changes in sterilization, and leveraging of other performance testing from the predicate. This is not a study assessing the clinical efficacy or safety of the device against acceptance criteria.

Therefore, most of the specific questions cannot be answered from the provided text.

However, I can extract information related to the performance testing that was conducted for this specific submission, which primarily focuses on demonstrating that the modifications did not negatively impact safety or function.

Information that can be extracted or inferred about this specific 510(k) submission (K191505) related to performance:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table for acceptance criteria related to clinical performance (e.g., symptom relief, prostate tissue reduction) or a study proving those. For this modification, the acceptance criteria were implicitly that the changes in labeling, sterilizer, and sterilization cycle should not alter the device's intended function or safety.

   • Acceptance Criteria (for this specific modification): The device continues to function as intended, is biocompatible, and maintains a sterility assurance level (SAL) of 10^-6, with no new issues of safety or effectiveness compared to the predicate.
   • Reported Device Performance (for this specific modification): The conclusion of assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device and raises no new issues of safety or effectiveness. Sterility testing (lethality and sterilant residual testing) was repeated and confirmed.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided for this submission. The "test set" for this modification would involve engineering and sterility validation tests.

   • Data Provenance: The device continues to be sterilized by ethylene oxide (EO) to an SAL 10^-6 level.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert-evaluated clinical test set is mentioned.

4. Adjudication method for the test set: Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used: For the sterility performance, the ground truth would be established through standard microbiological and chemical testing methodologies to confirm sterility and residual levels. For overall device function, the ground truth is its equivalence to the predicate device, K190093.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

To obtain the information about the acceptance criteria and supporting studies for the original Rezum System's performance (i.e., its clinical efficacy in relieving BPH symptoms and reducing prostate tissue), one would need to refer to the 510(k) submission for the predicate device, K190093, or any prior PMA/clinical trial data if applicable to that original clearance.

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 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)

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 ≤ 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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