Search Results

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 cc.

This premarket notification is being submitted for additional components of the Medtronic TUNA System to create two configurations of the TUNA System, branded Precision Plus and PROSTIVA. These new components include:

• Medtronic TUNA Therapy Model 8930 RF Generator ●
• Medtronic TUNA Therapy Model 8929 Hand Piece .
• Medtronic TUNA Therapy Model 8909 Hand Piece .
• Medtronic TUNA Therapy Model 8934 Return Electrode .

The provided text describes a 510(k) premarket notification for the Medtronic TUNA System. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or analytical studies with defined performance metrics. Therefore, many of the requested details are not explicitly present in the document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report device performance against such criteria. Instead, it states: "In-vitro testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the additional components of the Medtronic TUNA System meet all of the design and performance requirements."

Since no specific metrics are given, this table cannot be populated as requested.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "in-vitro testing" was performed. This typically refers to laboratory or bench testing, not human subject testing. No sample sizes for devices or test conditions are specified, nor is there any information about data provenance (e.g., country of origin, retrospective or prospective data collection) as it relates to clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The "ground truth" concept usually applies to clinical or diagnostic studies where expert consensus or a gold standard is used to evaluate device accuracy. For this 510(k) submission, the evaluation was primarily based on "in-vitro testing" to demonstrate substantial equivalence, which typically involves engineering or technical performance assessments rather than expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no human-reviewed test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document makes no mention of an MRMC study or any comparative effectiveness study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device described is an electrosurgical generator and accessories (TUNA System), which is an intervention device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not relevant here. The "performance" refers to its physical and functional operation.

7. The Type of Ground Truth Used:

For "in-vitro testing," the ground truth would typically be established by validated engineering specifications, physical measurements, and established electrosurgical performance standards rather than expert consensus, pathology, or outcomes data in a clinical context. The document implies that the device's performance was compared against the "design and performance requirements" of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The "training set" concept is irrelevant for an electrosurgical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device