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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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The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the comea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Corneal dissection with the FEMTO LDV Z6 Femtosecond Surgical Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical pulses which are delivered through an applanation window assembly while fixating the eye under a vacuum.

The provided text describes the submission of a 510(k) summary for the FEMTO LDV Z6 Femtosecond Surgical Laser but lacks detailed information regarding specific acceptance criteria, study methodologies, and performance metrics typically found in a comprehensive clinical or non-clinical study report.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states that "Results of the software validation and the in-vitro validation show that the design changes made to the device are substantially equivalent." And specifically, that "An in-vitro validation was performed that demonstrated the accuracy and precision of the new incisions."

However, no specific quantitative acceptance criteria or reported performance values (e.g., specific accuracy percentages, precision ranges, or success rates) are provided within the given text. The document broadly states that the validation "demonstrated the accuracy and precision," but does not detail what those demonstrated values were or against what specific benchmarks they were measured.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document mentions "an in-vitro validation was performed." This implies a test set was used, but the sample size for this test set is not provided.
   • Data provenance is not explicitly stated, but "in-vitro" suggests a laboratory-based study rather than data from human subjects. This would typically mean no specific country of origin, and it is by nature a prospective design for the experimental setup.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. Since the validation was "in-vitro" and focused on "accuracy and precision of the new incisions," the ground truth would likely be established through precise metrological measurements (e.g., using calipers, microscopy, or other optical measurement tools) against pre-defined design specifications, rather than expert human interpretation. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not relevant here.

3. Adjudication method for the test set:

   • Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation where there might be disagreement among readers. For an in-vitro validation of accuracy and precision, the measurements performed would be objective and rely on verified instruments and procedures, not human adjudication.

4. 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:

   • No. The provided text does not describe an MRMC comparative effectiveness study. The device is a surgical laser, and the validation described is an "in-vitro validation" of its physical performance (accuracy and precision of incisions), not a diagnostic AI system requiring evaluation of human reader performance.

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

   • Yes, in spirit. The "in-vitro validation" focusing on the accuracy and precision of incisions produced by the laser itself, without human intervention in the cutting process (beyond initial setup and operation), can be considered analogous to a standalone performance evaluation of the device's cutting capabilities. There is no AI algorithm being evaluated for diagnostic performance, but rather the physical output of the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the "in-vitro validation" of incision accuracy and precision would have been pre-defined engineering specifications or physical measurements from a highly accurate reference system (e.g., specific dimensions, depths, or shapes of the incisions as intended by the device design).

7. The sample size for the training set:

   • Not applicable / Not specified. This device is a surgical laser, and the validation described is for its mechanical/optical performance. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "software changes" mentioned relate to the control software for the laser, which would undergo traditional software validation and verification, not machine learning training.

8. How the ground truth for the training set was established:

   • Not applicable / Not specified. As there is no AI/ML training set in the context of this device and validation, the concept of establishing ground truth for a training set does not apply.

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The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface.

The FEMTO LDV Z4 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea.

The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect the corneal surface that may enclose a volume of the cornea.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to SIE AG for their Femto LDV™ Z-Generation Femtosecond Surgical Lasers (models FEMTO LDV Z2, Z4, and Z6). This document is an approval letter, not a study report or clinical trial summary.

Therefore, it does not contain the detailed information required to answer the request about acceptance criteria, device performance, study methodology, sample sizes, expert qualifications, or ground truth establishment.

The letter merely states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. It outlines regulatory requirements and general information but does not include the specifics of the performance testing.

In summary, the input text does not provide the information needed to fill out the requested table and answer the study-related questions.

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