Search Results

The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation, and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

neoV980 & neoV1470, members of the neoV Diode Lasers family, cleared under K133006, are medical grade, solid-state, infrared Diode lasers, designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively, with power level ranging from 10 to 20 Watts respectively. The lasers are controlled via a high-resolution color touch screen. The touch screen display includes a user interface allowing selection of continuous, repeat pulse, or single pulse modes of operation as well as repetition rates, aiming beam settings, password key protection, and standby/ready mode selection. The units have an emergency shut off button on the front of the unit.

The Laser System: The laser system consists of an optical block which contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and electronics which include the color touch screen control panel. The unit utilizes an external low voltage power supply, as well as an external wired foot switch for laser activation.

The Delivery System: The delivery system consists of either sterile fibers (not provided with the system) or non-sterile fibers and hand pieces. Safety goggles, non sterile fibers, handpieces and a safety sign are provided with the unit.

The provided document is a 510(k) summary for the neoV980 & neoV1470 Diode Lasers. This document describes a traditional medical device (laser surgical instrument), not an AI/ML-powered device. Therefore, the specific questions regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance assessment are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The "acceptance criteria" and "study" in this context refer to the testing and analysis performed to support this claim of substantial equivalence for a physical medical device.

Here's an interpretation of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device, performance is demonstrated by compliance with recognized standards and comparison to predicate devices, rather than a specific set of accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for this type of device submission. Performance is assessed through engineering tests and comparison to predicates, not a clinical test set with data provenance.

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. There is no "ground truth" in the AI/ML sense. The evaluation relies on standardized engineering tests and regulatory review by the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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, as this is not an AI-assisted device.

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

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The "truth" for this device is its compliance with international safety and performance standards for medical lasers and its similarity to predicate devices.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

In summary, the provided document details the substantial equivalence of a diode laser system to pre-existing predicate devices, primarily through compliance with established electrical and laser safety standards and by demonstrating similar functional and technical characteristics. It does not involve AI/ML technology, and therefore, the requested information regarding AI/ML specific performance metrics, ground truth, and study designs is not present.

Ask a specific question about this device