(29 days)
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.
| Acceptance Criteria (Implied for design modifications) | Reported Performance (for design modifications) |
|---|---|
| Compliance to initial device specifications | "The modifications made to the subject Rezūm System have been tested to ensure compliance to the initial device specifications." |
| Equivalent function to the predicate device | "The conclusion of the performance assessments demonstrate that the device continues to function as intended in a manner equivalent to the predicate device, and that there are no new issues of safety or effectiveness with the implementation of the above listed modifications." |
| Met listed design verification tests | All listed tests (Dimensional, Tensile/bond strength, Full Functional, Fluid resistance, Calorimetry, Corrosion resistance, Packaging and distribution, Sterility validation, Shelf-life aging, Software V&V, Hardware, Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2)) were repeated on the C2 Delivery Device using the same methods as 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)
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).