(84 days)
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:
- . Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy .
- Choroidal neovascularization .
- Branch retinal vein occlusion .
- . Retinal tears and detachments
- Retinopathy of prematurity .
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma
The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.
The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.
Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.
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):
- Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be answered from the provided text. There is no information about a test set or adjudication methods.
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:
- Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.
8. The sample size for the training set:
- Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.
9. How the ground truth for the training set was established:
- Cannot be answered from the provided text. Not applicable for this type of device.
In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.
§ 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.