(34 days)
The Supra Ophthalmic Laser Photocoagulator is intended to be used 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 for the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitroretinopathy, 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.
The Quantel Supra is a modification of the Quantel Vitra, (K043236). The SUPRA 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 or intraocular endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at a wavelength of 532 nm. Its basic improvement is the increase of laser power. Controls, indications, and methods of use are basically the same. The two lasers have the same screens and functions, and differ only in that the Supra has two output ports and more output power.
The Quantel Supra Ophthalmic Laser is a modification of the Quantel Vitra and lacks specific acceptance criteria and performance data from clinical studies within the provided text.
Here's a breakdown of why this information is missing based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, laser spot accuracy) are provided for the Supra device.
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable. No clinical tests were conducted for the Supra device.
- Data Provenance: Not applicable.
3. Number of Experts for Ground Truth and Qualifications:
- Number of Experts: Not applicable. No ground truth was established from clinical experts for the Supra device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method:
- Adjudication Method: Not applicable. No adjudication process was described as no clinical data was presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No MRMC comparative effectiveness study was performed or referenced.
6. Standalone Performance (Algorithm Only):
- Standalone Performance: Not applicable. The Supra is a physical medical device (laser), not a diagnostic algorithm, so "standalone performance" in the context of AI algorithms is not relevant.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. No ground truth was established by clinical studies for the Supra device.
8. Sample Size for Training Set:
- Sample Size: Not applicable. As a physical device, there isn't a "training set" in the sense of machine learning algorithms.
9. How Ground Truth for Training Set Was Established:
- How Ground Truth Was Established: Not applicable.
Summary of Device Acceptance and Study Information from the Text:
The FDA 510(k) summary for the Quantel Supra Ophthalmic Laser (K070776) explicitly states:
- (6) Performance Data
- (a) Non-clinical tests: "Supra has been extensively validated, both the laser itself and the software." (However, no specific data from these validations is provided.)
- (b) Clinical tests: "Clinical tests are not necessary, since Supra uses the same technology as the predicate device."
- (c) Conclusions: "Supra is equivalent in safety and efficacy to the legally-marketed predicate devices."
This means that the device's acceptance was based on its substantial equivalence to a predicate device (Quantel VITRA, K043236), rather than through new clinical performance studies demonstrating specific acceptance criteria. The manufacturer argued that because the Supra is a modification of an already cleared device, sharing the same technology but with increased power and two output ports, new clinical trials were not required to establish its safety and efficacy.
Therefore, the document does not contain the detailed clinical study information and performance data typically associated with new medical devices undergoing rigorous clinical validation for specific acceptance criteria.
§ 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.