(77 days)
The Vitra Ophthalmic Laser Photocoagulator 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.
The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices.
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
Explanation: This 510(k) submission (K043236) is for a modified indication for use for an existing device, the Quantel Vitra Ophthalmic Laser Photocoagulator, and is based on substantial equivalence to predicate devices. For this type of submission for a laser device, quantitative performance criteria (like accuracy, sensitivity, specificity, etc., typically seen with diagnostic or AI-powered devices) are not required or provided. Instead, the acceptance criteria are implicitly that the modified indications are safe and effective, and that the device operates fundamentally similarly to its predicates for these expanded uses. The "Performance Data: None required" statement explicitly confirms this.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable.
- Data Provenance: Not applicable.
Explanation: No clinical study involving a test set of patient data was conducted or required for this 510(k) submission. The submission relies on a comparison to legally marketed predicate devices to establish substantial equivalence for the expanded indications.
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)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
Explanation: As no test set data was used, no ground truth establishment by experts was necessary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
Explanation: No test set data was used to require adjudication.
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
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This device is an ophthalmic laser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable.
Explanation: This device is a treatment device (laser photocoagulator), not an algorithm. Furthermore, it operates with a human operator (ophthalmologist) in the loop, directly controlling the energy delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable.
Explanation: No clinical data or test sets requiring ground truth were used in this submission. The "ground truth" for proving safety and effectiveness relies on the established safety and effectiveness of the predicate devices for similar applications, demonstrating that the Vitra laser operates within similar parameters and delivers similar therapeutic effects.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: This is a hardware device (laser) and not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: No training set was used.
§ 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.