(62 days)
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
Retinal photocoagulation for the treatment of:
Diabetic retinopathy including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal Tears, Detachments and Holes
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and Branch Retinal Vein Occlusion
Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including:
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the anterior and posterior segments of the eye. The laser is particularly well suited for treating the eye because it has minimal effect on transparent tissues and materials. This means that the laser can be efficiently delivered to opaque structures of the eye through the transparent cornea, aqueous humor, lens, and vitreous humor. This allows many conditions to be treated by non-invasive techniques.
Laser energy is delivered to opaque structures within the eye by means of laser delivery systems including slit lamp, indirect ophthalmoscope, operating microscope, cyclophotocoagulation probe and laser probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. The laser energy is delivered to the delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens may have mirrors so that laser energy can be delivered to areas of the retina behind the iris, or into the angle so that the trabecular meshwork can be treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.
The Quantel Medical Vitra 810 is an ophthalmic laser system intended for photocoagulation of ocular tissues in the treatment of diseases of the eye, specifically retinal diseases and glaucoma.
Here's an analysis of the acceptance criteria and the study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, substantial equivalence is claimed based on comparing the technological characteristics and intended use of the Vitra 810 with two predicate devices. The "Performance Data" section primarily lists compliance with recognized consensus standards related to safety and essential performance, as well as hardware and software validation. These can be considered the implicit acceptance criteria, demonstrating that the device meets established regulatory and technical benchmarks.
| Acceptance Criteria Category | Details / Reported Device Performance |
|---|---|
| Intended Use | Photocoagulation of ocular tissue including the retina and pigmented tissue (Matches predicates). Specific indications for use (retinal photocoagulation for diabetic retinopathy, retinal tears, AMD, etc., and laser trabeculoplasty, iridotomy, transscleral cyclophotocoagulation for glaucoma) are identical to the secondary predicate (Iridex IQ 810). |
| Technological Characteristics (Comparison) | Laser Source: Laser Diode (Matches predicates) |
| Wavelength: 810 nm (Matches predicates) | |
| Treatment Power: 50-3000 mW (depending on delivery device) (Matches predicates) | |
| Laser Safety Class: 4/IV (Matches predicates) | |
| Pulse Duration (Continuous Wave): 10 ms to continuous (up to 60 seconds) (Matches predicates) | |
| Pulse Duration (Subthreshold Mode - Ton): 0.1 ms to 1.0 ms (5% to 35% duty cycle) (Within range of Iridex IQ 810's 0.025 ms to 1.0 ms with 0.5% to 50% duty cycle) | |
| Repeat Interval (Continuous Wave): 50 ms to 1000 ms and one pulse (Similar to Iridex IQ 810's 50 ms to 1000 ms and one pulse; predicate Supra Twin states "Repeat mode: 0.1 - 1 s") | |
| Repeat Interval (Subthreshold Mode - Toff): 0.3 ms to 19 ms (duty cycle: 5% to 35%) (Matches Iridex IQ 810's 1.0 ms to 9.5 ms, 0.5% to 50% duty cycle within acceptable parameters) | |
| Aiming Beam Source: Red Laser Diode, 1 mW maximum (Matches predicates) | |
| Aiming Beam Wavelength: 635 - 650 nm (Matches predicates) | |
| Compliance with Standards | IEC 60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 (General requirements for basic safety and essential performance) |
| IEC 60601-1-2:2014 (Electromagnetic compatibility) | |
| IEC 60601-1-6:2010+A1:2013 (Usability) | |
| IEC 60601-2-22: 2007 (Third Edition) + A1:2012 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | |
| IEC 60825-1 (Safety of Laser Products – Equipment Classification and Requirements) | |
| Software and Hardware Validation | Hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the major level of concern was provided. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical test set with a specific sample size, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The assessment for substantial equivalence is based on a comparison of technical specifications and intended use against legally marketed predicate devices, along with compliance to international safety standards. It does not appear to involve a new clinical study with a patient test set in the traditional sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the documentation does not describe a clinical study with a test set requiring expert-established ground truth. The device is a medical laser, and its substantial equivalence is determined by engineering and regulatory comparisons, not by diagnostic performance against an expert-derived ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, for the same reasons as point 3.
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
This information is not applicable. The Vitra 810 is a surgical laser device (a treatment tool), not a diagnostic device or an AI-assisted diagnostic tool. Therefore, an MRMC study assessing human reader improvement with AI assistance is irrelevant for this type of medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Vitra 810 is a medical laser system operated by trained medical personnel. It is not an algorithm-only or AI-based device, so standalone algorithm performance testing is irrelevant.
7. The Type of Ground Truth Used
This information is not applicable. As discussed, the substantial equivalence decision is based on technical specifications, intended use, and compliance with safety standards, rather than the performance of a diagnostic algorithm against a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a training set as the device is not an AI/ML-based system requiring data for training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, for the same reasons as point 8.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.