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The LenSx Laser is indicated for use:
· In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses 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. A computer-controlled scanning system directs the focused laser beam throughout a three-dimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of 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 SoftFit Patient Interface model is offered with three different sizes of soft contact lenses that are positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the performance testing of the new SoftFit Insert sizes. It generally states "Performance testing on the new sizes."

The data provenance is not explicitly stated (e.g., country of origin). The testing described appears to be internal device validation rather than a clinical study with patient data provenance in the context of country of origin. The study is prospective in nature, as it involves testing new versions of a device component.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The performance testing described focuses on objective measurements of device output (accuracy and reproducibility of laser patterns) rather than subjective human assessment requiring expert ground truth in the traditional sense of clinical imaging interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the testing described focuses on objective device performance metrics and does not involve human interpretation or subjective assessment that would require an adjudication method.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or that AI is involved. The changes relate to physical device components (contact lens inserts) and their impact on laser performance during surgery, not an AI-assisted diagnostic or interpretative system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an ophthalmic surgical laser system, and the changes relate to patient interface accessories. There is no mention of algorithms or AI being evaluated in a standalone capacity within this document.

7. The Type of Ground Truth Used

The ground truth used for this performance testing is based on the objective measurements of the physical outcomes of the laser treatment patterns created by the device, such as the depths and geometry of corneal cuts and capsulotomies. This would likely involve metrology and precision instruments to characterize the laser's output when the new inserts are used, compared to established specifications for the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device modification. The device is a physical laser system, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for an AI/ML model for this device.

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