(365 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.
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 provided 510(k) summary for the Medtronic Prostiva RF Therapy System does not include acceptance criteria or a study that proves the device meets specific performance criteria through clinical or comparative effectiveness studies involving human-in-the-loop AI assistance or standalone algorithm performance.
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through design verification/validation and technical assessments of manufacturing process changes. It explicitly states:
- "No applicable mandatory performance standards or special controls exist for this device."
- "The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indications, or sterilization process. None required clinical evidence to evaluate impact to safety and effectiveness."
- "The changes were considered to be routine changes...and the information generated as part of design verification and validation activities or technical assessments confirmed these change did not adversely affect the device's safety or effectiveness."
Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.
However, based on the information provided, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Rationale: The submission explicitly states that "No applicable mandatory performance standards or special controls exist for this device," and thus no specific acceptance criteria for performance are outlined. The submission relies on demonstrating that modifications did not adversely affect safety or effectiveness compared to predicate devices, rather than meeting new, quantifiable performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical or comparative effectiveness test set was used for performance evaluation of a new AI/algorithm.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No ground truth establishment by experts for a test set was performed as part of this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No test set requiring expert adjudication was used.
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:
- MRMC Study: No. This submission does not describe an AI-assisted device, nor any MRMC comparative effectiveness study.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This submission does not describe an algorithm-based device that would undergo standalone performance evaluation.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable. The submission does not describe a performance study requiring a specific type of ground truth (e.g., pathology, outcomes data). The evaluation was based on design verification/validation of device changes.
8. The sample size for the training set:
- Sample Size: Not applicable. This submission does not describe a machine learning or AI-based device requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. This submission does not describe a machine learning or AI-based device requiring a training set with established ground truth.
Summary of the Study (as presented in the 510(k) Summary):
The submission describes a "Summary of Testing" that includes:
- "The device design and labeling changes discussed in this document have been verified and/or validated through proper Design Verification/Validation and/or Design Assurance Testing where deemed necessary and applicable."
- "For the proposed change to the manufacturing process of a potentially patient contacting material, an evaluation of supplier testing information confirms that the proposed change does not impact the safety or effectiveness of the device."
This indicates that the "study" conducted was primarily focused on design verification and validation testing, along with technical assessments of manufacturing process changes, to confirm that the modifications did not negatively impact the safety or effectiveness of the device compared to its legally marketed predicate devices. It was not a clinical performance study involving patient data or expert interpretation for new performance claims.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.