(260 days)
532 nm Indications For Use:
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
810 nm Indications For Use:
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810mm is indicated for use for :
Phocoagulation or ablation of pigmented tissue within the eye,
Transcleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),
Limited and pan-retinal photocoagulation,
Transpupillary photocoagulation,
Endophotocoagulation.
Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choroidal neovasculature, and Age related macular degeneration (AMD) treatments.
The Quantel Supra Twin is a modification of the Quantel Supra (K070776) and the Quantel Viridis Twin (K023464). The SUPRA Twin laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery of itraocular endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at wavelengths of 532 nm. and 810 nm. Its basic improvement is the laser. Controls, indications, and methods of use are basically the me,
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy | Equivalent to legally-marketed predicate devices (Quantel Supra K070776 and Quantel Viridis Twin K023464). |
2. Sample Size for Test Set and Data Provenance
The provided document does not include information about a specific clinical test set, as "Clinical tests are not necessary" for the Supra Twin device. The equivalence claim is based on the device using the "same technology as the predicate device." Therefore, there is no explicit test set, sample size, or data provenance mentioned for a clinical study on the Supra Twin itself.
3. Number of Experts and Qualifications for Ground Truth
Not applicable, as no clinical study with a test set requiring expert ground truth establishment for the Supra Twin is described.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study with a test set requiring an adjudication method for the Supra Twin is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission explicitly states that clinical tests were not necessary because the Supra Twin uses the same technology as predicate devices.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device is an ophthalmic laser, not an AI algorithm. Its performance is related to its physical properties and intended medical procedure, not an algorithm's diagnostic or predictive capabilities.
7. Type of Ground Truth Used
Not applicable, as no new clinical study requiring ground truth establishment for the Supra Twin device is described. The basis for safety and efficacy is substantial equivalence to predicate devices.
8. Sample Size for the Training Set
Not applicable, as this device is an ophthalmic laser, not an AI algorithm that requires a training set. The "validation" mentioned (both the laser itself and the software) would typically refer to engineering verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device is an ophthalmic laser, not an AI algorithm that requires a training set.
§ 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.