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The LenSx Laser System is indicated for use:

• · In the creation of corneal cuts/incisions (single-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.
• · In the creation of corneal pockets for placement/insertion of a corneal inlay device and for creation of corneal tunnels for the placement of corneal rings.

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 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 provided text describes a 510(k) premarket notification for the LenSx Laser System, which is an ophthalmic surgical laser. The submission aims to seek clearance for additional indications for use: the creation of corneal tunnels and corneal pockets. The document states that the LenSx Laser System is "essentially the same device as the predicate LenSx Laser System" and that "All modifications were tested to show substantial equivalence to the predicate device as safe and as effective as the predicate device."

However, the provided text does not contain specific acceptance criteria, reported device performance metrics, or details about the study design elements such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The "Performance Data" section discusses that the accuracy and reproducibility of depths and geometry of treatment patterns were evaluated, but it does not provide the quantitative results or the acceptance criteria used for these evaluations.

Therefore, based solely on the provided text, I cannot complete the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document mentions "acceptance criteria established for the predicate LenSx Laser" but does not state what those criteria are or the quantitative results achieved by the modified device against them.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser, not an AI algorithm. Its performance is intrinsic to its mechanical and optical capabilities in creating cuts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it mentions evaluating "accuracy and reproducibility of the depths and geometry," it doesn't specify how these were measured to establish ground truth (e.g., using imaging, physical measurements, etc.).
8. The sample size for the training set: Not applicable. This is a hardware device with software controls, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of what is present:

• Device Name: LenSx Laser System
• Purpose of Submission: Seek clearance for additional indications for use:
  • Creation of corneal pockets for placement/insertion of a corneal inlay device.
  • Creation of corneal tunnels for the placement of corneal rings.
• Comparison to Predicate: The modified system is stated to be "substantially equivalent" to the primary predicate device (K163551) and additional predicate devices (K141852, K141476) in terms of indications for use, technological characteristics, and fundamental scientific technology.
• Performance Data Mentioned (but no specifics): Evaluation of accuracy and reproducibility of depths and geometry of previously cleared and new treatment patterns.
• Safety Standards Compliance: The device underwent medical electrical equipment testing and was found compliant with several IEC and ANSI AAMI standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366).
• Software Verification and Validation: Conducted according to FDA guidance for "major" level of concern software, demonstrating fulfillment of functional and safety critical requirements.

Conclusion: The provided document is a 510(k) summary focusing on substantial equivalence for a surgical laser, and while it mentions performance data were collected, it does not disclose the quantitative acceptance criteria or the specific results of those performance tests. It does not describe a study that would typically involve a test set with ground truth established by experts, as is common for diagnostic imaging AI devices, but rather focuses on engineering and functional performance of the laser itself.

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