(28 days)
The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.
The Catalys™ Precision Laser System ("Catalys™ System" or "System") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect phacofragmentation, thus facilitating efficient lens removal. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically coregistered and provide for precise overlap between imaging and treatment beams. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench/Clinical) |
|---|---|---|
| OCT Subsystem Accuracy/Precision | Depth, Surface Profiles, Iris Diameters: | All OCT-measured values met: |
- ±40μm for all thicknesses and diameters
- ±1% for all surface radii |
| Laser Pattern Accuracy/Precision | Intended Cut Dimensions: ±100μm | All measured values met: - ±100μm relative to the intended cut dimensions. (Validated for a variety of capsulotomy and phacofragmentation patterns within specified limits.) |
| Capsulotomy Effectiveness | (Implied non-inferiority to CCC control) | Difference from Intended Diameter (Catalys™ System): - Mean: 29 µm
- Standard Deviation: 26 µm
- Minimum: 1 µm
- Maximum: 132 µm
Difference from Intended Diameter (Control - CCC): - Mean: 339 µm
- Standard Deviation: 248 µm
- Minimum: 23 µm
- Maximum: 1013 µm
Conclusion: Catalys™ System demonstrated significantly higher precision in capsulotomy diameter compared to the manual CCC control. |
| Laser Phacofragmentation (CDE) | (Implied non-inferiority to traditional phacoemulsification) | Cumulative Dissipated Energy (CDE) Values: - Catalys™ System: Mean 10.39, StDev 6.61, Min 0.91, Max 27.65
- Control: Mean 18.54, StDev 12.07, Min 5.23, Max 47.86
Conclusion: Catalys™ System showed a lower mean CDE, indicating less ultrasound energy used, which is generally considered beneficial. |
| Safety | (Implied comparable to control and mild/transitory device-related complications) | Non-device-related complications and adverse events: Comparable between the two cohorts.
Device-related complications: Limited to petechiae (72%) and subconjunctival hemorrhage (5%). All were mild and transitory, resolving in less than 30 days without intervention. |
2. Sample Size Used for the Test Set and Data Provenance
- OCT Subsystem Bench Testing: "Various test article substrates of known dimensions were measured multiple times." (Specific number of samples not provided)
- Laser Pattern Bench Testing: "Multiple samples for a given test pattern were created..." (Specific number of samples not provided)
- Clinical Study (Capsulotomy & Phacofragmentation): The study was a "prospective, randomized non-inferiority trial in which one eye was randomly assigned to receive treatment with the Catalys™ System, including capsulotomy and laser phacofragmentation, followed by standard ultrasound phacoemulsification as necessary. The subject's contralateral eye, serving as the study Control eye, was assigned treatment with the current 'gold standard' surgical technique of continuous curvilinear capsulorrhexis (CCC) and standard ultrasound phacoemulsification." The specific number of subjects/eyes is not provided, but it states "all subjects treated with the Catalys™ System" and "all subjects" for phacofragmentation.
- Data Provenance: The provenance is a prospective clinical study. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the bench or clinical test sets.
- For bench testing, NIST-traceable reticules and known dimensions were used for ground truth.
- For the clinical study, the "gold standard" surgical technique (CCC) in the contralateral eye served as a comparison point for capsulotomy effectiveness, and CDE values were objectively measured. Safety outcomes (complications/adverse events) were observed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method involving experts for any of the test sets. For the bench testing, measurements were performed directly. For the clinical study, outcomes (capsulotomy diameter, CDE, adverse events) were reported as measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical study compares device performance against a "gold standard" surgical technique, not against human readers' performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance of the Catalys™ System for OCT measurements, laser pattern accuracy, capsulotomy, and phacofragmentation effectiveness, as well as safety, is presented as a standalone assessment of the device's capabilities. Human intervention still occurs in the overall surgical procedure, but the reported metrics specifically evaluate the device's physical outputs and their direct clinical outcomes compared to a control, without evaluating a human-in-the-loop diagnostic accuracy task.
7. The Type of Ground Truth Used
- OCT Subsystem Bench Testing: Known dimensions of test article substrates.
- Laser Pattern Bench Testing: NIST-traceable reticule under magnified digital image analysis of cross-sectioned samples from the laser patterns.
- Clinical Study (Capsulotomy): The actual diameter of the capsulotomy (measured) compared to the intended diameter, and compared to the diameter of the continuous curvilinear capsulorrhexis (CCC) performed as the "gold standard" in the control group.
- Clinical Study (Phacofragmentation): Cumulative Dissipated Energy (CDE) values reported at the conclusion of cataract surgery.
- Clinical Study (Safety): Tallying of subject complications and adverse events.
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. The device is a physical laser system with integrated OCT, not an AI/ML algorithm that typically has a distinct "training set" in the traditional sense for diagnostic image analysis. While there would have been internal development and calibration data, it is not described here as a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or applicable in the traditional AI/ML sense for this device, a method for establishing its ground truth is not provided. The "training" for such a system would involve engineering design, calibration, and verification against known physical standards.
§ 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.