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510(k) Data Aggregation
(177 days)
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) proliferative and non-proliferative diabetic retinopathy, macular-edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. (577nm) proliferative and non-proliferative diabetic retinopathy, macular edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) iridotomy, trabeculoplasty.
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit.
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System, submitted under K123542, is a medical device designed for ophthalmic laser treatments. The acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for novel AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for a laser system, the "acceptance criteria" are primarily related to safety, technical specifications aligning with predicate devices, and demonstrating equivalent performance in a preclinical setting. The document doesn't explicitly state numerical acceptance criteria in terms of accuracy or clinical outcomes for a diagnostic AI. Instead, it relies on the established safety and efficacy of predicate devices and a comparative preclinical study.
| Acceptance Criteria Category | Specific Criteria/Goal | Reported Device Performance (PASCAL® Synthesis™) |
|---|---|---|
| Safety | Compliance with relevant national and international standards (e.g., IEC 60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09 for hardware, IEC 60601-1-2, -4, -6 for electromagnetic, EN 60601-1-4, 62304 for software). | All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate. Conclusion: It is as safe as the predicate device. |
| Technical Equivalence | Substantial equivalence in technical characteristics (e.g., Type of Laser, Output Wavelength, Power output, Duty cycle, Exposure time, Repetition Rate, Pulse Counter, CDRH/European MDD Classification, Electrical Requirements) to predicate devices (K092621, K111108, K121475/K071687). | The technological characteristics of the PASCAL® Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate devices. The tables in Section VII list the specifications, and they are largely identical or within acceptable ranges for equivalence. For example, Output Wavelength (532 nm or 577 nm), Power output (0, 30 mW - 2000 mW), Duty cycle (100%), Exposure time (2 ms - 1000 ms), and Repetition Rate are all highly similar or identical to one or more predicate devices. |
| Clinical Performance Equivalence | Appearance and diameter of retinal laser lesions comparable to predicate device in a preclinical setting. | An animal study compared lesions produced by the PASCAL® Synthesis system with the predicate PASCAL Streamline system. When comparing lesions of the same clinical grades, the appearance was similar. The diameter of the lesions was <20% in mean diameter. Within lesions of the same clinical grade, the variability was approximately 10%. No systematic trend in lesion diameter was observed. Conclusion: The Streamline device and the Synthesis device were comparable in a preclinical setting. |
| Indications for Use | Same indications for use as predicate devices. | The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use as the predicate devices for both posterior and anterior segments (e.g., proliferative and non-proliferative diabetic retinopathy, macular edema, choroidal neovascularization, lattice degeneration, retinal tears and detachments, iridotomy, trabeculoplasty). |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" in this context refers to the animal model used for the preclinical comparison.
- Sample Size: The study included two animals.
- Data Provenance: The study was a prospective comparative study conducted in an animal model. The document does not specify the country of origin but states it was performed "in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: The ground truth (clinical grade of the lesions) was assigned by "the laser operator." The document mentions "laser operator" in the singular.
- Qualifications of Experts: The specific qualifications of the "laser operator" are not detailed in the summary.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. Since a single "laser operator" assigned clinical grades, there was no multi-reader adjudication process described.
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 Done?: No. The provided summary is for a laser system, not an AI-powered diagnostic device designed to assist human readers. The preclinical study was a direct comparison of lesion characteristics between two laser systems.
- Effect size of human reader improvement with AI: Not applicable, as no AI assistance or human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Done?: No. This device is a laser system, not an algorithm. Its performance is evaluated through its physical output and biological effects, not as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for the animal study was the clinical grade assigned by the laser operator(s) (which the document states as "the laser operator" suggesting a single operator) on a 5-point scale. This is a form of expert assessment or grading.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical laser system, not an AI model that requires a training set. The "design specifications" and performance were established indirectly through reference to predicate devices and an animal study.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set described.
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