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The INTRALASE® FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LA'SIK surgery or other treatment requiring initial lamellar resection of the cornea.

The INTRALASE FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

The provided text is a 510(k) summary for the INTRALASE FS Laser, which is an ophthalmic surgical laser. The submission focuses on demonstrating substantial equivalence to a predicate device (Pulsion FS Laser, K013941) rather than presenting a study to prove acceptance criteria based on specific performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not explicitly available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for the INTRALASE FS Laser. Instead, it asserts equivalence to a predicate device.

Note: The 510(k) process for this type of device often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if the technological characteristics are different, that the differences do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device. Quantitative performance metrics as acceptance criteria are typical for de novo or PMA submissions, or specific performance standards.

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

The document mentions "extensive ex vivo and in vivo studies" but does not provide specific sample sizes or details about data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.

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

Not applicable. The document does not describe a study involving expert readers establishing ground truth for a test set in the context of diagnostic accuracy or a similar evaluation that would require expert consensus. The device is a surgical laser, and its performance evaluation likely centered on surgical outcomes or physical properties, not diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no indication of an adjudication method as it relates to expert review of a test set, as this is not a diagnostic imaging device undergoing such an evaluation.

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

Not applicable. The document does not describe a MRMC comparative effectiveness study, as the device is a surgical laser, not a diagnostic tool requiring human-in-the-loop performance evaluation in that context. The "comparative effectiveness" mentioned is in relation to the predicate device's overall safety and performance, not specifically human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable in the typical sense for AI/diagnostic devices. The INTRALASE FS Laser is a surgical device. Its "performance" would be assessed in terms of its ability to create corneal resections, not as a standalone algorithm analyzing data. The "ex vivo and in vivo studies" likely assessed the physical outcomes of the laser's operation.

7. Type of Ground Truth Used

The term "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not explicitly defined here for the "extensive ex vivo and in vivo studies." However, given the nature of the device (a surgical laser creating corneal resections), the "ground truth" would likely relate to objective measurements of the quality and accuracy of the resections created, which could involve:

• Histopathology or microscopy: To assess the precision, smoothness, and depth of the resections.
• Biomechanical testing: To evaluate the integrity of the created flap.
• Clinical outcomes in vivo: Such as flap characteristics, healing, and refractive results, compared against expected outcomes or those achieved by the predicate device.

8. Sample Size for the Training Set

Not applicable/Not provided. The document does not describe an AI/machine learning model with a training set. The "extensive ex vivo and in vivo studies" are likely performance validation studies, not training of an algorithm.

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

Not applicable/Not provided. As there is no mention of a training set for an AI/machine learning model, the establishment of ground truth for such a set is not discussed.

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