Search Results

The LenSx Laser 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.

The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness corneal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens and cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incisions or tissue separation.

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx Laser is an ophthalmic surgical laser that has previously been cleared for use in:

• • Anterior capsulotomy (K082947), performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule.
• · Phacofragmentation (K090452), performed by delivering series of laser pulses to form two intersecting ellipsoidal planes that divides the lens into quadrants.
• . Cuts/incisions for keratoplasty (K092647) which are performed by delivering a pattern of circles and arcs with programmable incision length and depth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the acceptance criteria for the modified LenSx Laser System were the "same parameter acceptance criteria as established for single plane cuts/incisions" for the predicate LenSx 550 Laser and modified LenSx Laser. However, the document does not provide the specific numerical values or ranges for these acceptance criteria. It only mentions what was evaluated against them.

2. Sample Size and Data Provenance for the Test Set:

• Test Set Sample Size: The document mentions "Evaluation of stepped cuts/incisions in human cadaver eyes for lamellar keratoplasty, penetrating keratoplasty and cataract surgery." However, the exact number of human cadaver eyes used for this evaluation, or any other test set, is not specified.
• Data Provenance: The only explicit mention of data provenance for testing is "human cadaver eyes." No country of origin is specified. The study is retrospective in the sense that cadaver eyes are used, not living patients.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

The document does not provide any information regarding the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This device is a surgical laser system, not an AI diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

The document describes the performance testing of the device itself, which is a surgical laser system. In this context, "standalone algorithm performance" is not directly applicable in the same way it would be for an AI diagnostic algorithm. The performance tests evaluate the physical capabilities of the laser system (accuracy and reproducibility of cuts), not an algorithm's diagnostic output.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations appears to be based on physical measurements and observations of the cuts and incisions created by the laser system. This would infer measurement of depth, geometry, and potentially histological examination in cadaver eyes, but the document does not explicitly state "pathology" or "outcomes data." It implies objective physical assessment.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is consistent with the nature of the device; it's a physical surgical tool, not an AI algorithm that undergoes a distinct "training phase" on labeled data in the traditional sense. Its development and refinement would involve engineering and testing, rather than algorithmic training.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of an AI algorithm, the document does not describe how ground truth for a training set was established. The development of the device would rely on engineering principles, iterative design, and performance testing, rather than labeled data for algorithm training.

Ask a specific question about this device