(136 days)
The LensAR Laser System - fs 3D (LLS-fs 3D) is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.
The LensAR Laser System - fs 3D (LLS-fs 3D) employs a mode-locked Yb:YAG laser which generates a high frequency series of femtosecond, low energy pulses at a wavelength of 1030 nm. The system is technologically the same as the predicate device defined in K112098, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy and lens fragmentation incision patterns are generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, proprietary patient interface device (PID) that consists of a Suction Ring which is affixed to the eye, and a precision fused silica window, which when mounted onto a PID Arm, fixates the eye and allows the laser light to be coupled into the eye through a refractive index matching cell. The index matched light coupling allows the focused laser pulses to be accurately delivered to target locations within the patient's crystalline lens.
The provided text describes a 510(k) summary for the LensAR Laser System - fs 3D (LLS-fs 3D). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics, ground truth establishment, or expert consensus.
Therefore, much of the requested information, such as a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types for a performance study, is not explicitly detailed in this 510(k) summary.
However, based on the provided text, I can extract the following relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data presented focuses on verifying that the new device performs similarly or equivalently to the predicate devices and that any changes do not adversely affect safety or effectiveness. Specific quantitative acceptance criteria with reported performance values, as would be found in a clinical trial report, are not present.
| Acceptance Criterion (Inferred from 510(k) Summary) | Reported Device Performance |
|---|---|
| Accuracy and precision of biometric and beam delivery systems | Testing performed using ex vivo porcine and human donor eyes and custom artificial eyes. Further testing in acrylic plastic confirmed shot placement accuracy (individual shots, lines, rings) was the same as the predicate device. |
| Fit and function of enhanced Patient Interface Device (PID) and 3D-CSI system imaging | Demonstrated in an evaluation that confirmed performance as substantially equivalent to predicate devices. |
| Optical radiation hazard to non-target tissue | Analysis demonstrated that LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (LEDs) are eye safe under all normal operating and known fault conditions. |
| Sterility and packaging of disposable PID | Sterilization and packaging testing using gamma radiation ensured a sterility assurance level of 10-6. Functional testing after gamma irradiation was demonstrated. Method of cleaning and autoclaving reusable PID Arm was validated. |
| Biocompatibility of disposable PID components | Testing on all parts of disposable Patient Interface Device (direct/indirect fluid contact with eye tissue) performed for: cytotoxicity, irritation, sensitization, and chemical/physical characteristics. No biocompatibility issues found. |
| Thermal and Acoustic effects | Unchanged from K102727 and K112098. |
| Laser tissue interaction characteristics and capsular tensile strength | LLS-fs 3D laser tissue interaction characteristics and capsular tensile strength remain unchanged from LLS-fs Laser (K112098). Tensile strength characteristics of anterior capsule button cut with LLS-fs are consistent with K090633. |
| Hazard analysis | Analysis performed for all potential hazards to patient, surgeon, and operators, considering changes between LLS-fs 3D and predicate LLS-fs. Demonstrates all potential hazards have acceptable levels of probability/severity characteristics. |
| Adjunctive use of ultrasound in cataract surgery | Adjunctive use of ultrasound for LLS-fs 3D was not significantly different from the LensAR Laser cohort (K112098) across cataract grades. Significant reduction in CDE required for Grade 2-4 nuclear cataracts compared to K102727 Control cohort (conventional procedures). Grade 5+ cataracts approximated K102727 Control for Grade 4. |
| Capsule complications | In cases with capsule complications, the event was documented to be associated with irrigation aspiration, ultrasound fragmentation, or IOL placement procedures, not with the laser procedures. |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "testing" referenced in the summary seems to involve various engineering and preclinical assessments rather than a single clinical "test set" in the traditional sense of a diagnostic device.
- Sample Size:
- Ex vivo eyes & artificial eyes: No specific number provided, only "ex vivo porcine and human donor eyes and custom built artificial eyes."
- Clinical observation for adjunctive ultrasound use: The study "Consistent with the predicate devices Indication for Use (K102727 and K112098), the LensAR Laser System - fs 3D was studied for the indication of anterior capsulotomy and laser phaco fragmentation during cataract surgery." refers to a patient cohort. However, the exact sample size for the LLS-fs 3D laser cohort is not specified. It is compared to "the LensAR Laser cohort" (from K112098) and the "Control Cohort in K102727" (conventional procedures), which implies patient data.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The mention of "ex vivo porcine and human donor eyes" suggests laboratory/pre-clinical setting. The clinical observation on adjunctive ultrasound implies prospective patient data, likely conducted as part of the predicate device studies or a limited follow-up for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the summary. The studies described are primarily engineering validations and comparisons to existing predicate device performance, not assessments against expert-established ground truth for diagnostic accuracy. Clinical observations on adjunctive ultrasound use would implicitly rely on surgical outcomes and clinician assessment, but no formal ground truth establishment by a panel of experts is mentioned.
4. Adjudication method for the test set:
This information is not provided in the summary.
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:
This is not applicable to this device. The LensAR Laser System - fs 3D is a surgical laser system for cataract surgery, not an AI-assisted diagnostic or imaging system for human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone surgical instrument that performs specific laser procedures (anterior capsulotomy and laser phaco fragmentation). Its performance is evaluated on its ability to execute these procedures precisely and safely. The summary details tests on the system's accuracy, precision, safety, and physical characteristics. Therefore, in a sense, the device's technical performance without human intervention (beyond initiating the procedure) is what's being assessed by the engineering and preclinical tests.
7. The type of ground truth used:
- Engineering/Physical Ground Truth: For tests on accuracy and precision, the ground truth would be precise measurements of shot placement in artificial materials (acrylic plastic) or ex vivo tissues. For biometric system accuracy, the ground truth would be known dimensions or established imaging standards.
- Clinical/Surgical Outcome Ground Truth: For the observation related to adjunctive ultrasound use and capsule complications, the "ground truth" would be the observed surgical metrics (e.g., CDE – Cumulative Dissipated Energy, which is a common metric in phacoemulsification, and documentation of complication causes). This is an outcomes-based assessment rather than an expert consensus on an image.
8. The sample size for the training set:
This information is not provided. The device uses "computer-controlled scanning of the position of the laser beam focus" and "software used to generate the custom incision patterns." It also has a "biometric system to measure and construct a three dimensional model of the optical surfaces within the eye." These systems would likely involve algorithms and models that were developed and validated, but the summary does not detail a specific "training set" of data as would be described for a machine learning algorithm.
9. How the ground truth for the training set was established:
This information is not provided. As above, the summary doesn't detail a specific "training set" or its ground truth establishment. The biometric system's ability to measure optical surfaces and the software's pattern generation are likely based on known physics, ophthalmological principles, and engineering validation rather than a distinct labeled "training set" as understood in modern AI/ML contexts.
§ 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.