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The TUNA 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.

The Medtronic TUNA (Transurethral Needle Ablation) Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Medtronic is commercializing the branded product as the PROSTIVA® RF Therapy System which 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 special change being effected in Medtronic's Prostiva RF Therapy Model 8929 Hand Piece. It seeks to demonstrate substantial equivalence to a legally marketed predicate device.

However, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical report for a novel medical device.

The document explicitly states: "No applicable mandatory performance standards or special controls exist for this device." and "The results of the design verification testing indicate that the modified PROSTIVA RF Therapy Model 8929 Hand Piece with handle modifications is substantially equivalent to the currently marketed device. There are no changes in specifications or indications for use." It further mentions "Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device and the device met all design and performance requirements."

This indicates that the submission focuses on demonstrating that the modified device is still equivalent to the original predicate device, rather than proving the efficacy or performance of a new device against specific clinical acceptance criteria in a comprehensive study. The "design verification testing" likely refers to engineering tests to ensure the new handle design doesn't negatively impact the device's functionality or safety, not clinical performance metrics.

Therefore, many of your requested items cannot be extracted from this specific 510(k) summary.

Here's what can be gathered or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated within this document. The document refers to "design and performance requirements" that the device met during design verification testing, but it does not detail these requirements or provide specific quantitative acceptance thresholds for clinical performance or accuracy. Since this is a 510(k) for a modification and not a new device, the primary acceptance criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance: Not explicitly stated in terms of clinical outcomes or performance metrics. The document concludes that "the modified device...met all design and performance requirements" and is "substantially equivalent" to the predicate. This implies that its performance is presumed to be the same as the predicate, but no new quantitative performance data is presented.

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

• Sample Size (Test Set): Not applicable/Not provided. This document describes "design verification testing" for a device modification, which typically involves engineering bench testing rather than clinical testing with a human test set. No patient sample size is mentioned.
• Data Provenance: Not applicable.

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

• Not applicable/Not provided. No clinical ground truth establishment is described for a test set.

4. Adjudication method for the test set

• Not applicable/Not provided.

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

• No. This device is a radiofrequency therapy hand piece for BPH treatment and is not an imaging or diagnostic device that would involve "human readers" or AI assistance in interpretation.

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

• No. This is a medical device (a hand piece for RF ablation), not an algorithm.

7. The type of ground truth used

• Not applicable/Not provided. The "ground truth" for this submission is implicitly the performance and safety characteristics of the predicate device, to which the modified device is compared to establish substantial equivalence.

8. The sample size for the training set

• Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable/Not provided.

In summary:

This 510(k) focuses on demonstrating that a modified version of an existing device remains substantially equivalent to its predicate. The "study" referenced is "design verification testing," which typically involves engineering and bench testing to ensure the device modification doesn't compromise its safety or performance, rather than clinical trials with detailed performance metrics against specific acceptance criteria. The document does not provide the kind of performance data, study design, or ground-truth establishment details you would find for a novel device or AI/ML product.

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