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· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea

· In patients undergoing surgery or other trequiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments

· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

· In lamellar IEK and corneal harvesting

· 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 a lamellar cutresection of the cornea for lamellar IEK and for the creation of a penetrating cutincision for penetrating IEK

· In patients undergoing ophthalmic surgery or other treation of corneal channel for placement/ insertion of a corneal inlay device

The iFS Laser System is an ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use as follows:

• . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
• . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
• . In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal
• In lamellar IEK and corneal harvesting
• 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 a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK
• In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channels for placement/insertion of a corneal inlay device

The iFS Laser System uses focused femtosecond laser pulses to create incisions and separate tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. 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 continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

Here's an analysis of the provided text regarding the iFS Laser System, focusing on acceptance criteria and supporting studies:

The provided documents describe the iFS Laser System and its clearance for creating corneal channels for corneal inlay devices. There is limited detailed information on specific acceptance criteria and a single, comprehensive study as might be found for a diagnostic AI device. Instead, the information points to a validation process that appears to be focused on demonstrating the new functionality and adherence to existing safety and performance standards for a surgical laser.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a surgical laser adding a new pattern), the "acceptance criteria" are implied through compliance with safety standards and a demonstrated ability to perform the new cut pattern effectively and precisely.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of "samples" in a clinical trial sense. The "test set" for the laboratory verification consisted of:
  • Glass microscope slides
  • Agarose gel
  • Porcine eyes
    The number of each material used is not specified.
• Data Provenance: The data is from laboratory verification bench studies. There is no mention of human clinical data or geographical provenance (e.g., country of origin) for these bench studies.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For the safety and electrical performance, compliance with standards would typically involve certified testing labs and engineers.
  • For the software validation, software engineers and quality assurance professionals would be involved.
  • For the new cut pattern performance, the text doesn't mention expert assessment of the "cut quality" in a formal ground-truthing process. It refers to "acceptable performance," implying a comparison against established standards or benchmarks, potentially assessed by the manufacturer's R&D personnel or quality control.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. These were bench studies, not a clinical study involving human assessment that would typically require adjudication. The performance was assessed against predefined metrics (channel widths, depths, and cut quality) and compliance with standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is measured. The iFS Laser System is a surgical instrument.

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

• Yes, in essence, standalone performance was evaluated. The "algorithm" (the laser's software-controlled cutting pattern) was tested independently on non-human biological and artificial substrates (glass, agarose gel, porcine eyes) to demonstrate its ability to create the specified corneal channels with acceptable widths, depths, and cut quality. The performance of the laser system itself was verified without direct human-in-the-loop interaction for the cutting process once the pattern was initiated.

7. The Type of Ground Truth Used

• The "ground truth" for the new cut pattern was predefined physical metrics and expectations of performance (e.g., specific channel widths and depths, and acceptable cut quality) derived from existing, cleared resection patterns and the requirements for corneal inlay device placement. This is a form of physical/benchmarking ground truth.
• For the safety and electrical performance, the ground truth was compliance with established international standards (IEC 60601 series).
• For software, the ground truth was fulfillment of functional and safety-critical requirements outlined in FDA guidance.

8. The Sample Size for the Training Set

• The iFS Laser System is a physical surgical device with software control. It is not an AI/machine learning model in the typical sense that would require a "training set" for model development. The software updates were to include a new pre-programmed pattern and associated GUI functionality, which would not involve a "training set" in the context of machine learning.

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

• As there is no mention of a machine learning component requiring a "training set," this question is not applicable in the context of the provided document. The ground truth for the development of the new cutting pattern would have been the engineering specifications and clinical requirements for creating an appropriate channel for corneal inlays, but this is distinct from an AI training set.

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