(204 days)
The neoV810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist 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.
The neoV980 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist 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.
The neoV1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist 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.
The neoV1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist 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.
The neo V Diode Laser Family are medical grade, solid-state, infrared diode lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10 and LSV1064-20), and neoV1470, and are designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and 1470mm respectively, at power levels ranging from 8Watts up to 20Watts. 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 fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.
The provided text is a 510(k) Summary for the neoV Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on technical specifications and comparisons, not on a clinical study demonstrating the device's performance against specific acceptance criteria for an AI algorithm.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, are not applicable and not present in this document.
The "acceptance criteria" discussed in this document relate to compliance with regulatory standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics of an AI model against a specific medical task.
Here's a breakdown of what can be extracted from the provided text based on your request, with the understanding that it pertains to the device as a laser surgical instrument, not an AI system:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of numerical thresholds for an AI's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with international standards and substantial equivalence to predicate devices as its basis for acceptance. The "reported device performance" is essentially that it meets these standards and is comparable to existing devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-22: 2007 (Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment) | The neoV Diode Laser family has been tested for compliance to IEC 60601-2-22: 2007 (Third Edition). |
| Compliance with IEC 60601-1: 2005 (Third Edition) (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | The neoV Diode Laser family has been tested for compliance with all functional requirements of IEC 60601-1: 2005 (Third Edition). |
| Compliance with IEC 60825-1:2007 (Safety of Laser Products - Part 1: Equipment classification, requirements and user's guide) | The neoV Diode Laser family has been tested for compliance with all functional requirements of IEC 60825-1:2007. |
| Compliance with EN 60601-1-2: 2007 (Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests) | The neoV Diode Laser family has been tested for compliance with EN 60601-1-2: 2007. |
| Substantial Equivalence to Predicate Devices (Quanta Diode Laser Family K100558 and Sheaumann Laser PL-1064 K120938) regarding technical and performance characteristics and intended use. | The neoV Diode Laser Family shares the same technical and performance characteristics and the same intended use as the predicate devices. This is supported by the comparison table of specifications (wavelength, max power, laser media, output mode, etc.). |
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. This document describes a medical device (a laser), not an AI algorithm evaluated on a data set. The "testing" refers to compliance with safety and performance standards for the hardware, not an evaluation of an AI model's performance on a dataset of patient information. No patient data or test sets, in the context of AI, are mentioned.
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 sense established for this device, as it is not an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set for an AI algorithm is present.
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. No MRMC study was done, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a standalone medical device (a laser), not a standalone AI algorithm. It operates independently of an AI, though it is used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the context of AI evaluation is used. The "ground truth" for this device's acceptance is its adherence to established electrical and laser safety standards, and its technical specifications matching those of already-cleared predicate devices.
8. The sample size for the training set
- Not Applicable. This device does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a training set for an AI algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.