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The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lamellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

The LenSx 550 Laser is an ophthalmic surgical laser indicated for use in the creation of a penetrating cut/incision for penetrating and lamellar keratoplasty. Consistent with commercially available femtosecond lasers (Product Code GEX, 878.4810 and OOE, 886.4390) the LenSx 550 Laser creates incisions using focused femtosecond laser pulses. Individual photodisruption locations are controlled by repositioning the laser focus in the cornea. 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 incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired 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 an off-the-shelf, disposable contact lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx 550 Laser System is an ophthalmic surgical laser. The provided text outlines a 510(k) summary for this device, focusing on its substantial equivalence to predicate devices for creating penetrating and lamellar keratoplasty incisions. However, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a detailed performance evaluation of a device like an AI algorithm.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It lists general performance areas evaluated but not specific quantitative criteria or results.

2. Sample size used for the test set and the data provenance

This information is not provided as a test set in the context of an AI algorithm evaluation. The document refers to "nonclinical tests and results" but provides no details on sample sizes or data provenance.

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. As no "test set" in the context of AI evaluation is described, there's no mention of ground truth experts.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an ophthalmic surgical laser, not an AI-assisted diagnostic or interpretative tool.

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

This information is not applicable/provided. The device is a surgical laser, not a standalone algorithm.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, there is no "training set."

9. How the ground truth for the training set was established

This information is not provided.

Summary of what is stated regarding performance and evaluation from the document:

The document states that nonclinical tests were performed to support the safety and substantial equivalence of the LenSx 550 femtosecond laser system to predicate devices. These tests demonstrated the following:

• Accuracy and reproducibility of the depth and geometry of penetrating cuts/incisions: This is a key performance aspect for a surgical laser, implying that the device consistently creates cuts with the intended dimensions.
• Ability to create penetrating corneal incisions in opacified corneas: This highlights the device's efficacy across different corneal conditions.
• Limited collateral tissue effects and retained endothelial cell viability adjacent to penetrating laser corneal incisions as compared to manual trephination: This points back to safety and potentially improved outcomes compared to the traditional manual method.

In conclusion, while the document confirms that performance data was generated to support the 510(k) clearance, it does not detail specific acceptance criteria, quantitative performance metrics, or the methodologies (sample sizes, expert involvement, ground truth establishment) typically associated with evaluating AI-driven diagnostic or interpretative devices. The evaluation here is for a surgical instrument, focusing on its physical capabilities and safety profile in comparison to existing technologies.

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