(29 days)
The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Medtronic Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Prostiva® RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue. The Prostiva RF Therapy Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.
The provided text describes a 510(k) premarket notification for a medical device, the Prostiva RF Therapy Model 8929 Hand Piece. This notification is for a material change in an already marketed device and therefore the study performed focuses on biocompatibility and functionality after the material change, rather than proving the overall effectiveness of the therapy.
Here's an analysis of the provided text in relation to your questions:
Acceptance Criteria and Device Performance Study for Prostiva RF Therapy Model 8929 Hand Piece
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance acceptance criteria are mentioned in the document. The focus is on demonstrating that a material change does not affect functionality or biocompatibility compared to the predicate device. | - A material change assessment was conducted. |
| - Biocompatibility testing was performed. | |
| - The conclusion was that the change to the insulation of the thermocouple wires does not affect the functionality or biocompatibility of the device. | |
| - The modified device is substantially equivalent to the currently marketed PROSTIVA RF Therapy Model 8929 Hand Piece based on the material change assessment and biocompatibility test results. |
Note: The document explicitly states: "No applicable mandatory performance standards or special controls exist for this device." The purpose of this 510(k) is to demonstrate substantial equivalence following a material change, not to establish initial clinical performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the testing. It mentions a "material change assessment" and "biocompatibility testing." The nature of these tests (e.g., in-vitro, in-vivo) and their specific sample sizes are not detailed.
The data provenance (country of origin, retrospective/prospective) is not mentioned as the testing performed appears to be laboratory-based (biocompatibility) and an assessment of a material change, rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The study is not an AI/diagnostic imaging study that would require expert consensus for ground truth. It focuses on engineering and biological testing related to a material change.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is mentioned or required for this type of testing (material change assessment and biocompatibility).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is not an AI algorithm for diagnostic interpretation that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (hand piece for RF therapy), not a software algorithm.
7. The Type of Ground Truth Used
For the biocompatibility testing, the ground truth would be established by standardized biological assays and tests designed to assess material safety and compatibility with biological systems (e.g., cytotoxicity, sensitization, irritation). These tests have predefined endpoints and acceptance criteria from regulatory standards.
For the material change assessment, the ground truth involves engineering analysis and comparison to the original device's specifications and performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device and study.
§ 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).