(82 days)
The PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation.
When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy
- Macular edema
- Choroidal neovascularization
- Branch and central retinal vein occlusion
- Age-related macular degeneration
- Lattice degeneration
- Retinal tears and detachments
- Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.
The PASCAL Synthesis Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology of the PASCAL multi-spot photocoagulator (a predicate device) with other commercially available laser platforms. This offers existing commercially available laser platforms the ability to deliver a full spectrum of pattern scanning options. The PASCAL Synthesis Delivery System is intended for use by trained ophthalmologists for diagnosis and treatment of ocular pathology.
The PASCAL Synthesis Delivery System consists of the following system components:
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- Scanning laser delivery system integrated into an Optimedica slit lamp with LCD/Touchscreen GUI that can be positioned by the user for optimal access and viewing.
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- Scanner control module with scanner controls, power supply, electronics, optical fiber & electrical connections integrated into a slit lamp table.
The PASCAL Synthesis Delivery System is compatible with the following commercially available laser systems:
- Alcon Ophthalas 532 Eyelite Laser Photocoagulator
- Zeiss Visulas 532s
The provided text describes a medical device, the PASCAL Synthesis™ Delivery System, and its clearance process through a 510(k) submission. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy against specific acceptance criteria in the way a new drug or novel medical device might through a large-scale clinical trial.
Therefore, the study design and acceptance criteria outlined in the input request are not directly applicable to this type of regulatory submission. There isn't a traditional "study" in the sense of a clinical trial with human subjects, a defined test set with ground truth established by experts, or MRMC comparative effectiveness.
However, I can extract information related to performance verification and equivalence that serve a similar purpose within the context of a 510(k) submission.
Here's an interpretation based on the provided text:
Description of Acceptance Criteria and Device Performance:
The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices in terms of intended use and technological characteristics, and that its performance is equivalent to its predicate.
This is verified by demonstrating that the PASCAL Synthesis Delivery System performs functionally identically to the PASCAL Photocoagulator (its predicate device that incorporates the same delivery system) and that it allows for multi-spot photocoagulation similar to another predicate device (Infinitech Multi-Spot Slit Lamp Laser Adapter) when connected to compatible laser systems.
1. Table of "Acceptance Criteria" (Substantial Equivalence Metrics) and Reported Device Performance:
| "Acceptance Criterion" (Equivalence Metric) | Reported Device Performance |
|---|---|
| Intended Use (Treatment of ocular pathology in posterior/anterior segments, retinal photocoagulation, etc.) | Same as predicate device: "The indications for use for the PASCAL Synthesis Delivery System are the same as those cleared for the predicate device, the PASCAL Photocoagulator (K043486)." (Section 2.7) |
| Technological Characteristics (Scanning laser delivery system, single spot & pattern mode, multi-spot photocoagulation) | Same as predicate device: "All user parameters and technological characteristics of the PASCAL Synthesis Delivery System are consistent with those of the predicate device, the OptiMedica PASCAL Photocoagulator. Specifically, the PASCAL Synthesis Delivery System is the same delivery system as the delivery system in the cleared PASCAL Photocoagulator (K043486)." (Section 2.5) |
| Material Equivalence | Same as predicate device: "The materials used for the manufacture of the PASCAL Synthesis Delivery System and the delivery system of the predicate device, the PASCAL Photocoagulator, are also the same." (Section 2.7) |
| Functional Equivalence (Measured system performance: power delivered, pulse widths, scan patterns, spot size & beam uniformity) | Equivalent to predicate device: "All test results demonstrated that performance of the PASCAL Synthesis Delivery System, when connected to these two commercially-available laser systems, was equivalent to the performance of the PASCAL Photocoagulator that incorporates the same delivery system." (Section 2.6) |
| "Verification testing conducted on the PASCAL Synthesis Delivery System also demonstrated compliance with system performance requirements and specifications: this testing further confirmed that this device consistently and accurately produces laser outputs that are equivalent to those produced by the PASCAL Photocoagulator predicate device." (Section 2.6) | |
| Compatibility with External Laser Systems | Successfully tested and found compatible with Zeiss Visulas 532s and Alcon Ophthalas 532 Eyelite Laser Photocoagulator. (Section 2.5, 2.6) |
Detailed Information on the "Study" (Performance Verification Testing):
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or medical images, but rather involves testing the physical device's performance parameters. The testing involved connecting the PASCAL Synthesis Delivery System to two compatible commercially available laser systems: the Zeiss Visulas 532s and the Alcon Ophthalas 532 Eyelite Laser Photocoagulator.
- Data Provenance: The testing was performed at OptiMedica's facility in Santa Clara, CA, and at outside test facilities as required. This indicates prospective, in-house technical testing rather than retrospective patient data analysis.
- Nature of the "Test Set": The "test set" here refers to the device's operational parameters and functionalities (e.g., power delivered, pulse widths, scan patterns, spot size, beam uniformity) as measured under various conditions when integrated with the two specified laser systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of expert-driven ground truth establishment is not applicable to a 510(k) performance verification. The "ground truth" for the device's technical specifications and performance metrics would be based on engineering specifications, industry standards, and the known performance of the predicate device. The "experts" would be the engineers and technicians conducting the verification tests, qualified in device design, testing, and metrology.
4. Adjudication Method for the Test Set:
- Not applicable in the context of this technical performance verification. Adjudication methods (like 2+1 or 3+1) are typically used for clinical endpoints or image interpretation where human judgment is being consolidated. Device performance parameters are measured objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This submission is for substantial equivalence of a delivery system which enables a laser, not a diagnostic AI device or a decision support system for human readers. The focus is on the technical performance of the laser delivery.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a form of standalone performance was assessed, though it's not an "algorithm" in the typical AI sense. The PASCAL Synthesis Delivery System itself (the "algorithm") was rigorously tested for its technical performance parameters (power, pulse widths, scan patterns, spot size, beam uniformity) "standalone" in the sense that its intrinsic, objective output was measured. The phrase "algorithm only" isn't quite fitting, as it's a hardware delivery system, but its performance was evaluated independent of clinical outcomes, focusing solely on its output capabilities.
7. Type of Ground Truth Used:
- The "ground truth" was based on defined engineering specifications, compliance with performance requirements, and objective measurements of physical parameters (e.g., laser power, spot size, pulse duration, pattern accuracy). The ultimate "ground truth" for substantial equivalence was the established performance and indications of the predicate device (OptiMedica PASCAL Photocoagulator).
8. Sample Size for the Training Set:
- Not applicable. This is a hardware device where "training" refers to engineering design and optimization processes, not a dataset used to train a machine learning model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as explained above. The design and development of the PASCAL Synthesis Delivery System would have been guided by engineering principles, optical physics, safety standards, and lessons learned from previous iterations and existing devices (including the predicate).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.