(79 days)
The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
The Cobra Hand Piece delivers the energy from the VidaMed TUNA System RF Generator. The Cobra Hand Piece contains two needle electrodes which are deployed at an angle of 90°. The needles can be deployed at 4 preset lengths which vary between 10-22mm. The needles are insulated at the base to protect the urethra during ablation of the prostatic tissue. The disposable Cobra Cartridge is attached to a reusable handle, containing the mechanism for the needle deployment and retraction. The Cobra Hand Piece only works with the VidaMed TUNA System RF Generator.
The provided text describes a 510(k) submission for the VidaMed Cobra Hand Piece, which is a modification to an existing electrosurgical device for treating benign prostatic hyperplasia (BPH).
Based on the provided text, a formal study proving the device meets specific acceptance criteria is not explicitly detailed. The submission focuses on demonstrating "Substantial Equivalence" to previously cleared devices. This means that instead of new clinical trials with acceptance criteria, the regulatory approval is based on the new device (Cobra Hand Piece) being similar enough in intended use, technological characteristics, safety, and effectiveness to a predicate device (VidaMed's TUNA System and RF Generator) that has already been approved.
Therefore, the information you requested about acceptance criteria, study details, sample sizes, ground truth, and expert adjudication for a prospective study is largely not applicable (N/A) in this specific context, as the approval route is substantial equivalence rather than a new clinical efficacy study.
However, I can extract the relevant information regarding the device's intended use, which would implicitly define its performance domain.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria for this new device and reported performance for this specific device from a standalone clinical trial are not presented. The "performance" is implicitly tied to the predicate device's established performance, assuming the modifications do not negatively impact it.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Implied by Substantial Equivalence to Predicate) |
|---|---|
| Effective treatment of symptoms due to urinary outflow obstruction secondary to BPH. | Capable of treating symptoms due to urinary outflow obstruction secondary to BPH. |
| Safe use in men over the age of 50 with prostate sizes between 20 and 50 cc. | Safe for use in men over the age of 50 with prostate sizes between 20 and 50 cc. |
| Delivers RF energy from the VidaMed TUNA System RF Generator as intended. | Delivers RF energy from the VidaMed TUNA System RF Generator as intended. |
| Needles deploy at 90° for ablation. | Needles deploy at 90° for ablation at 4 preset lengths (10-22mm). |
| Needles insulated at the base to protect the urethra. | Needles are insulated at the base to protect the urethra. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: N/A (No specific test set for efficacy or performance described in this 510(k) summary for the Cobra Hand Piece itself; relies on substantial equivalence to predicate device's prior approvals).
- Data provenance: N/A (Not specified for a new clinical study. The existing TUNA System would have had data from its prior approvals, but not detailed here for the Cobra Hand Piece).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: N/A
- Qualifications of experts: N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: N/A
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 done: No. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant to its approval.
- Effect size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: N/A. This is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: N/A (Relies on the established safety and effectiveness of the predicate device).
8. The sample size for the training set
- Sample size for training set: N/A (No algorithm or machine learning training set mentioned).
9. How the ground truth for the training set was established
- Ground truth for training set established: N/A (No algorithm or machine learning training set mentioned).
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The provided document describes a 510(k) submission based on "Substantial Equivalence." This regulatory pathway does not typically involve a new clinical study with explicit acceptance criteria for the new device itself. Instead, the submission argues that the Cobra Hand Piece is a modification to an already legally marketed device (VidaMed's TUNA System and RF Generator) and shares similar features and functions.
The "proof" that the Cobra Hand Piece meets acceptance criteria stems from the fact that its predicate device, the TUNA System, has already been cleared for the treatment of symptomatic BPH in several prior 510(k)s. The current submission for the Cobra Hand Piece asserts that the modifications do not raise different questions of safety and effectiveness compared to the predicate device. Therefore, the device meets its intended use and is deemed substantially equivalent, implying it will perform similarly to the previously approved predicate. No new clinical trials, expert consensus, or specific dataset analyses (as would be typical for AI/diagnostic devices) are detailed in this summary for the Cobra Hand Piece itself.
§ 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).