(28 days)
The Precision™ Plus TUNA® Office System is indicated for use in 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.
The Precision™ Plus TUNA® Office System consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories. The Precision™ Plus TUNA® Office System delivers low levels of 460 kHz RF energy up to 15 W from each of the 2 needles directly into prostatic tissue to produce a localized necrotic lesion to treat the symptoms associate with BPH. Each lesion takes 3.0 minutes.
The provided text is a 510(k) summary for the Precision™ Plus TUNA® Office System. This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study evaluating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
Here's an analysis of what can be gleaned and what is missing:
Inability to Fully Address Request
The provided 510(k) summary for the Precision™ Plus TUNA® Office System focuses on demonstrating substantial equivalence to a predicate device (PROVu™ TUNA® System) primarily through "lab bench testing" for "lesion equivalence." It does not contain the detailed clinical study design, performance metrics, acceptance criteria, or ground truth establishment typically found in a clinical trial report or a submission designed to prove device performance against predefined criteria.
Available Information (and what's missing)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance |
|---|---|
| Lesion equivalence with predicate device | "Lesion equivalence between the Precision™ Plus TUNA® Office System and the PROVu™ TUNA® System has been established through lab bench testing." |
| Other specific performance metrics (e.g., success rate, symptom improvement, complication rates, % reduction in prostate size, etc.) | Not reported in this document. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not provided. The text refers to "lab bench testing," which implies physical tests rather than patient studies. If it involved simulated tissue or animal models, the sample size of those would not be explicitly stated here.
- Data Provenance: "Lab bench testing." This implies in-vitro or simulated environment testing, not human patient data. No country of origin is specified for this lab testing, nor is it identified as retrospective or prospective patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not applicable / Not provided. Since the "test" mentioned is "lab bench testing" for "lesion equivalence," there's no indication of human experts establishing ground truth in the context of clinical outcomes. The equivalence would likely be determined by physical measurements or similar objective laboratory metrics.
4. Adjudication Method for Test Set
- Not applicable / Not provided. Given the nature of "lab bench testing" for "lesion equivalence," an adjudication method for a test set of patient cases is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe any MRMC study. The device is an electrosurgical generator and accessories, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a medical instrument (electrosurgical unit), not an algorithm or AI. Its performance is intrinsic to its physical and functional operation, not a computational output.
7. Type of Ground Truth Used
- For "lesion equivalence" in lab bench testing: The ground truth would likely be objective physical measurements of the created lesions (e.g., size, depth, necrosis characteristics) using standard laboratory methods, rather than expert consensus, pathology in a clinical setting, or patient outcomes data. The specific methods are not described.
8. Sample Size for Training Set
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
9. How Ground Truth for Training Set was Established
- Not applicable. As above, no training set for an algorithm exists here.
Summary Limitations:
The provided 510(k) summary is a regulatory document focused on demonstrating that the new device is "substantially equivalent" to a previously cleared predicate device. This process often relies on comparisons of technical characteristics and performance data from internal testing (like the "lab bench testing" mentioned) rather than comprehensive clinical trials with detailed acceptance criteria and outcome measures, especially for devices like electrosurgical generators. Therefore, it does not contain the level of detail requested for a deep dive into clinical study design and performance metrics.
§ 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.