(99 days)
The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys® Precision Laser System (also referred to as the Catalys® System) is a femtosecond laser system intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. 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] Interface1). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). 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.
The provided document is a 510(k) summary for the AMO Manufacturing USA, LLC's Catalys® Precision Laser System. This submission is for software revisions to an already cleared device (predicate device K172002). The core of the summary focuses on demonstrating substantial equivalence to the predicate device, especially considering the software changes.
Based on the provided text, we can extract the following information regarding acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the software changes. Instead, it outlines the scope of the software revisions and states that verification and validation testing was performed to ensure the software meets its intended use and introduces no adverse effects.
The "acceptance criteria" for this 510(k) are implicitly focused on demonstrating that the modified device's performance is maintained and that the software changes do not negatively impact its safety or effectiveness compared to the predicate. The performance aspects mentioned relate to maintaining the ability to deliver laser patterns for capsulotomy, phacofragmentation, and corneal incisions with corresponding accuracy and precision.
Here's how we can interpret and present the information given:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Software revisions do not introduce adverse effects and meet intended use. | Software verification and validation testing, in addition to bench testing, was performed. This included subsystem level verification and regression testing, as well as system validation using the latest software, Mobile Patient Bed, and Liquid Optics Interface. The testing aimed to address: |
- Updates to hardware communication timing to reduce false positive alarms.
- Graphical user interface changes to support use of the Mobile Patient Bed in environments with multiple Catalys systems.
- A revision associated with trajectory timing offsets seen most evidently in the alignment verification function of the System.
The modifications are stated to "employ additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
| Continued ability to deliver various laser patterns (capsulotomy, phacofragmentation, corneal incisions) with accuracy and precision. | Bench testing of the predicate device (K172002) regarding the ability to deliver these patterns with accuracy and precision is directly applicable to the subject device because "there are no significant changes to the subject device other than the design changes resident in the software." The modified device reportedly "employs additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
| System remains safe and effective for its intended use and is substantially equivalent to the predicate device. | Bench testing, coupled with software regression testing, verification, and validation, including regression testing, provides "reasonable assurance that the System remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device." The changes in software are stated not to "raise new questions of safety and efficacy." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing, software regression testing, verification, and validation testing. It does not mention a 'test set' in terms of patient data or clinical samples. The testing is hardware and software focused.
- Sample Size: Not applicable in the context of patient data. The "sample" would be the software builds and system configurations tested. No specific number of test cases or test runs is provided, only the types of testing.
- Data Provenance: Not applicable in the context of patient data. The testing appears to be internal engineering and software validation. No country of origin for data is stated as it's not a clinical study on patients.
- Retrospective/Prospective: Not applicable for this type of software/bench testing.
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)
This information is not provided in the document. The "ground truth" for this submission revolves around the correct functioning of the software and hardware according to design specifications, rather than expert interpretation of medical images or patient outcomes. The testing involves engineers and quality assurance personnel validating system performance against requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this submission. Adjudication methods are typically employed in clinical studies involving multiple expert readers assessing medical data. This submission focuses on software and bench testing, where the "ground truth" is defined by the technical specifications and expected system behavior.
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
No MRMC comparative effectiveness study was done or mentioned. This device is a laser system for cataract surgery, not an AI diagnostic or assistance tool for human readers of medical images. The submission pertains to software updates for the laser system's operational functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical laser system with integrated software. Its performance is inherently "standalone" in the sense that the laser performs the surgical actions. However, it's a human-operated device. The software changes are about the internal operation and control of the laser system, not an external algorithm processing data for human interpretation. The testing described is of the full device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the software revisions and the device's continued substantial equivalence is based on design specifications, pre-defined operational parameters, and expected system behavior for the laser's functions (capsulotomy, phacofragmentation, corneal incisions). This is primarily established through engineering validation, verification, and bench testing. There is no mention of expert clinical consensus, pathology, or outcomes data used as ground truth for these software changes. The original predicate device (K172002) would have had its own validation studies to support its initial clearance, but this submission specifically addresses the impact of software revisions.
8. The sample size for the training set
Not applicable. This submission is for software revisions to an existing medical device, not for an AI/machine learning algorithm that requires a "training set" of data. The software updates are described as modifying hardware communication timing, GUI, and trajectory timing offsets, which points to traditional software engineering rather than an AI model that learns from large datasets.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/machine learning in this 510(k) summary.
§ 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.