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

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

The iFS Laser System intended use is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser. The iFS Laser System uses focused femtosecond laser pulses to create incisions and separates 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.

Acceptance Criteria and Device Performance for iFS Laser System

The provided text describes the 510(k) summary for the iFS Laser System, focusing on its safety and effectiveness, particularly for additional indications like arcuate incisions. While explicit acceptance criteria values for clinical outcomes are not presented in a direct table format, the document outlines various tests and their successful completion, implying meeting predefined safety and performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly met by the reported results. The document states that "All results met the 95% confidence acceptance criteria" for pattern fidelity tests. For clinical trials, safety variables were met, and no statistically significant worsening of symptoms was observed.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Human Cadaver Eye Testing: The exact sample size is not specified, but it involved multiple human cadaver eyes used to create intrastromal and penetrating arcuate incisions.
  • Animal Testing (Rabbits): A "series of studies" were conducted, including a "GLP rabbit study." The exact number of rabbits is not specified beyond "rabbits."
  • Clinical Trial: A total of 21 subjects (presumably 21 eyes) were enrolled.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were conducted under U.S. or international standards recognized by the FDA.
  • Retrospective or Prospective: The "Clinical Trial" section describes a study with "baseline and post-operative visits," indicating a prospective study design. The human cadaver and animal studies would also be prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

• The document primarily describes engineering and performance characteristics, as well as clinical safety outcomes. It does not mention the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging devices (e.g., radiologists interpreting images).
• For the clinical trial, the "ground truth" was established by objective clinical measurements and assessments (e.g., BSCVA, astigmatism, endothelial cell counts, adverse event reporting, symptom questionnaires) and the "Adjudication of outcomes" would be based on the pre-defined study endpoints and statistical analysis.

4. Adjudication Method for the Test Set

• For the clinical trial, the adjudication method is not explicitly detailed in the provided text in terms of reader consensus (e.g., 2+1, 3+1).
• However, standard clinical trial methodology would involve:
  • Objective measurements: Data for outcomes like BSCVA, astigmatism, and endothelial cell counts are objective and would not require reader adjudication in the same sense as image interpretation.
  • Adverse event reporting: Likely adjudicated by the investigative site and/or sponsor according to predefined criteria.
  • Symptom questionnaires: Patient-reported outcomes.
• The phrase "AMO directed study" and "one investigative site" suggests internal oversight and data collection, rather than a multi-center adjudication panel for subjective measures.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was conducted or reported.
• This device is a surgical laser, not an AI-assisted diagnostic tool for image interpretation, so an MRMC study comparing human readers with and without AI assistance is not applicable to the context of this device. The study focuses on the device's ability to perform surgical actions and the resulting clinical outcomes.

6. Standalone (Algorithm Only) Performance

• This concept is not directly applicable in the same way as for an AI diagnostic algorithm. The iFS Laser System is a surgical instrument. Its "performance" is inherent in its ability to execute precise laser cuts.
• The "Pattern Fidelity Testing" could be considered a form of standalone performance evaluation for the device's mechanical and optical precision, demonstrating that the laser itself performs according to its design specifications (e.g., depth, position, angle, diameter).

7. Type of Ground Truth Used

• Engineering/Physical Ground Truth: For "Pattern Fidelity Testing," the ground truth was established by precise measurements of the actual laser cuts against predefined specifications.
• Clinical/Physiological Ground Truth: For the "Human Cadaver Eye Testing" and "Animal Testing," the ground truth was the observable ability of the laser to create the desired incisions in biological tissue and the safety profile (e.g., no perforation, tissue response).
• Clinical Outcome Ground Truth: For the "Clinical Trial Results," the ground truth was based on:
  • Objective clinical measurements: BSCVA, manifest refractive astigmatism, endothelial cell counts.
  • Patient-reported outcomes: Ophthalmic symptoms and vision quality.
  • Adverse events: Clinically observed and reported events.

8. Sample Size for the Training Set

• The text does not provide information on a "training set" in the context of machine learning or AI.
• This 510(k) summary describes a traditional medical device (a surgical laser) and its validation through engineering tests, ex-vivo studies (cadaver/animal), and a clinical trial. It does not appear to involve an AI algorithm that would require a separate training set.

9. How Ground Truth for the Training Set Was Established

• Since there is no mention of an AI algorithm or a training set, the question of how its ground truth was established is not applicable based on the provided document. The device's development and validation follow conventional medical device pathways rather than AI model development pathways.

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

• In the creation of a corneal flap in patients undergoing LASIK 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
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
• In lamellar keratoplasty and corneal harvesting
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty

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

• In the creation of a corneal flap in patients undergoing LASIK 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;
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
• In lamellar keratoplasty and corneal harvesting;
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the . creation of a penetrating cut/incision for penetrating keratoplasty.
  Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.

The provided text describes a 510(k) summary for the iFS Laser System, an ophthalmic surgical laser. While it details the device, its intended use, and claims substantial equivalence to predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria, study details, and performance metrics.

The document primarily focuses on establishing regulatory equivalence and does not elaborate on clinical studies, performance metrics, ground truth establishment, or sample sizes beyond stating that the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections."

Therefore, I cannot provide the requested information from the given text.

In a real-world scenario, such information would typically be found in detailed clinical study reports, performance testing reports, or more extensive sections of a 510(k) submission that are not included in this summary.

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