(86 days)
The TUNA System Product Family, including Precision Plus TUNA Office System, Precision TUNA Office System, and PROVu TUNA 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.
Each system of the TUNA system product family consists of an RF generator, sterile single-use cartridge, reusable handle, reusable telescope, sterile single-use tubing set, single-use return electrode, and other accessories.
This 510(k) summary (K021804) describes a premarket notification for adding a contraindication to the labeling of the TUNA System product family. As such, the submission does not contain a study demonstrating device performance against specific acceptance criteria. The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices given a labeling change, not to introduce a new or modified device with new performance claims requiring clinical validation.
Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or addressed in this type of submission.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) is to add a contraindication to the labeling of an existing device family, demonstrating substantial equivalence to the same devices without the added contraindication. There are no new performance claims or associated acceptance criteria being evaluated in this submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission does not involve a test set for evaluating device performance against acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission does not involve a test set requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This submission does not involve adjudication of a test set.
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
Not applicable. This device is an electrosurgical generator and accessories, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This submission does not involve ground truth for performance evaluation.
8. The sample size for the training set
Not applicable. This submission does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This submission does not involve a training set for an algorithm.
§ 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.