(89 days)
The LensAR-fs Laser System 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 predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared for use in anterior capsulotomy in cataract surgery (K090633) and anterior capsulotomy and laser phaco fragmentation performed individually or consecutively during the same surgery (K102727). In new laser device with modification to the pulse width of the laser (LensAR-fs Laser System) is intended for use in the same indication as cleared in K102727. The system employs a mode-locked Yb:YAG laser which generates a high frequency series of ultrashort (1500 femtosecond), low energy pulses at a wavelength of 1030, my The system is technologically the same as defined for the predicate device, 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 itssue at the beam focus. The precision capsulotomy and lens fragmentation is generated by computercontrolled 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, patient interface device that consists of two separately packaged parts: a commercially wailable Suction Ring with Spring Loaded Syringe to fixate the eye and an Index Matching Eye Docking (IMED) device designed to match the refractive index of the comea to optimize beam targeting accuracy.
The LensAR-fs Laser System is an ophthalmic surgical laser indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy and Reproducibility of Capsulotomy Incisions (ex vivo) | The device produces anterior capsulotomy incision patterns that are accurate and predictable in size and shape. |
| Equivalence of Geographical Cutting Patterns (human donor ocular globes for phaco fragmentation) | Equivalence of the geographical cutting patterns to those established for the predicate LensAR Laser was established. The fs laser causes the lens to be divided, employing linear cuts, into a number of radial sections, similar in shape to those created by the conventional manual "phaco chop" surgical technique, and then further divided by applying a set of concentric cylindrical cuts through the radial sections. |
| Ocular Safety Equivalence | An optical radiation hazard analysis by Dr. Sliney confirms the continuing ocular safety equivalence to the predicate device detailed in 510(k) K102727. |
| Technological Characteristics Comparability (with predicate devices) | The pulse width, minor software and hardware changes are incorporated while remaining consistent with the technological characteristics of the predicate device LensAR Laser. The technical characteristics of the LensAR-fs Laser fall between those of the LensAR Laser and the LenSx Laser... and raise no new issues with respect to the safety and effectiveness of the device. The technology and mechanism of laser-tissue interaction are similar to other ultrashort pulse lasers identified in the table above. The differences are insignificant and do not affect safety or effectiveness. |
| Indication for Use Statement Consistency (with predicate devices) | The indication for use statement for anterior capsulotomy and laser phaco fragmentation for the LLS-fs is the same as that of the predicate devices. |
| Absence of New Issues of Safety or Effectiveness (compared to predicate devices) | The activities and information provided do not identify any new issues of safety or effectiveness. |
The study aimed to demonstrate substantial equivalence to predicate devices (LensAR Laser System K090633 and K102727, and LenSx 550 Laser System K094052 and K082947) by showing similar performance characteristics and no new safety or effectiveness concerns despite changes in pulse width and minor hardware/software modifications.
2. Sample Size and Data Provenance for the Test Set
- Ex vivo porcine eyes: The exact number is not specified, but the testing was done on "ex vivo porcine eyes."
- Human donor ocular globes: The exact number is not specified, but evaluations were done in "human donor ocular globes."
- Data Provenance: The studies were preclinical and conducted on ex vivo biological material (porcine eyes, human donor globes). The country of origin is not specified, nor is whether the data was retrospective or prospective, though preclinical studies of this nature are typically prospective in design.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of clinical studies with expert image interpretation. The evaluation was primarily based on objective measurements and observations of the laser's physical effects.
- For Ocular Safety: An optical radiation hazard analysis was performed by Dr. Sliney. His specific qualifications are not detailed beyond "Dry Sliney confirms."
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the studies were preclinical and focused on physical and technical performance rather than subjective interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this device. The submission explicitly states that "thus no new clinical evaluations were required," relying instead on pre-clinical data and comparison to predicate devices. Therefore, no effect size for human readers improving with AI vs. without AI assistance is provided or relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The device is a laser system, not an AI algorithm. Its performance is inherent to its physical operation, and it is designed for use by a human surgeon. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance was evaluated based on the physical outcomes of its laser application.
7. Type of Ground Truth Used
The ground truth was established through:
- Objective Measurements/Observations: For capsulotomy incisions (e.g., accuracy, predictability in size and shape) and phaco fragmentation patterns (e.g., division into radial and concentric sections).
- Technical Comparability: Comparison of the device's technical characteristics (e.g., pulse width, laser-tissue interaction) with established predicate devices.
- Optical Radiation Hazard Analysis: Expert assessment of ocular safety.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical laser system, not an artificial intelligence or machine learning model that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 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.