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The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser is a solid state femtosecond laser used in ophthalmology. It is used for producing cuts in ocular tissue and can be used in corneal and cataract surgery.

The Z8 produces femtosecond laser energy that is absorbed by the tissue, resulting in plasma formation. This plasma rapidly expands, creating a cavitation bubble separating the tissue. This process is known as photodisruption. Because of its very short pulse duration, femtosecond laser technology deploys low pulse energy that virtually eliminates damage peripheral to the incision site and can therefore be used to dissect tissue on a microscopic scale. Femtosecond laser systems may use closer spot spacing to overlap these cavitation regions, producing less tissue bridges.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser system consists of the following functional units:

• Base Station (BS), integrating the Laser Cavity, Fixed Mirror Articulated Arm (FMAA), Power -Supply, Computer, Touchscreen Monitor, Suction Unit, OCT Box, and Safety System
• Handpiece (HP) integrating the Cutting Lens and Topview Camera
• Disposable accessories

The provided document is a 510(k) Summary for the FEMTO LDV™ Z8 Femtosecond Surgical Laser, which is a medical device. This document does not describe a study involving an AI/Machine Learning component, nor does it provide acceptance criteria and performance metrics typically associated with such studies.

Specifically, the document focuses on demonstrating substantial equivalence of a modified version of an existing ophthalmic laser device to its predicate device. The changes are primarily hardware and minor software updates (bug fixes, not new algorithms with performance metrics).

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, etc.) because the document does not contain this type of data related to an AI/ML device study.

The document states: "The changes described in section IV did not require clinical performance data to demonstrate substantial equivalence to the predicate device." This indicates that no new clinical studies were performed to assess the performance of the modified device in terms of efficacy or diagnostic accuracy, which would be the typical context for the acceptance criteria and study details you've asked for. The studies mentioned are focused on safety, EMC, biocompatibility, sterilization, and software verification/validation, rather than a performance study of an AI algorithm.

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The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDVIM Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

The design of the FEMTO LDV™ Z8 is based on the FDA cleared FEMTO LDV™ Z Models Femtosecond Surgical Lasers Z2-Z6. The application of femtosecond lasers in the field of cataract surgery was achieved with extended focusing capabilities and improved visualization based on existing technologies. The FEMTO LDV™ Z8 Femtosecond Surgical Laser uses smaller spots with lower pulse energies at higher repetition rates to achieve tissue dissection.

The provided document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter, a 510(k) summary, and an indications for use statement for the FEMTO LDV™ Z8 Femtosecond Surgical Laser.

The sections that would typically contain such information (like "Acceptance Criteria," "Device Performance," or details of a clinical study) are absent. Instead, the document focuses on:

• Substantial equivalence: Comparing the new device to predicate devices (Ziemer LDV™ Z6 and Optimedica® Catalys™ Precision Laser System) based on technological characteristics and safety profiles.
• Nonclinical tests: Mentioning sterilization validation, shelf-life testing, biocompatibility testing, safety tests (IEC 60601-1, IEC 60601-1-2, IEC 60825), design validation (including in-vitro performance testing), and software validation. These are general and do not specify performance metrics or acceptance criteria for the intended use.
• Intended Use/Indications for Use: Describing the surgical applications of the laser.

Therefore, it is not possible to complete the requested table or answer the questions based on the provided text. The document states that "The FEMTO LDV™ Z8 Femtosecond Surgical Laser was found to perform equivalently to the predicate devices to achieve tissue dissection for corneal flap, rings, pockets, keratoplasty, corneal and arcuate incisions, capsulotomy, and lens fragmentation." This is a general statement of equivalence rather than a detailed report of specific performance criteria and a study demonstrating their achievement.

The document emphasizes that no new issues of safety and effectiveness arise compared to the predicate devices due to similar underlying physical processes and comparable performance profiles.

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