Search Results

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:

• . 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 corneal flap in patients undergoing LASIK surgery or other o treatment requiring initial lamellar resection of the cornea:
• . 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 IntraLase FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. 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 510(k) summary for the IntraLase FS Laser (K060372) does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

Instead, this 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices (K993153, K001211, K002890, K013941, K031960, K041893). The summary explicitly states:

• "The IntraLase FS Laser has undergone testing and is in compliance with applicable safety standards."
• "The IntraLase FS and the accessory IntraLase Patient Interface were found to perform equivalently to the predicate Laser for the creation of corneal resections with respect to incremental changes."
• "Thus, the IntraLase FS Laser and the predicate device have similar safety, effectiveness and performance profiles."
• "The changes made to the labeling do not alter the performance or indication of this device."

This means the submission's evidence for performance is based on the prior clearance and established safety/effectiveness of the predicate devices, rather than a new clinical study with defined acceptance criteria for this specific submission.

Therefore, many of your requested items about a standalone study, acceptance criteria, sample sizes, ground truth, and expert adjudication cannot be extracted from this document because such a study is not described.

However, based on the information available, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, etc.) for a new performance study are not provided in this 510(k). The primary "acceptance criterion" demonstrated is substantial equivalence to predicate devices. The reported "performance" is that it performs "equivalently" to the predicate in creating corneal resections with respect to incremental changes.

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

• Test Set Sample Size: Not specified. The document refers to "testing" but does not detail the size or nature of any test set used in a clinical or performance study for this specific 510(k).
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable, as detailed clinical efficacy data with expert ground truth is not provided.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable, as detailed clinical efficacy data with expert ground truth is not provided.

5. 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:

• MRMC Study: No. This device is a surgical laser, not an AI-assisted diagnostic device.

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

• Standalone Study: The submission describes bench testing and compliance with safety standards and states the device performs "equivalently" to predicate devices. This implies non-clinical performance evaluation, but it's not a "standalone" clinical efficacy study as typically understood for diagnostic AI devices. The laser operates as a standalone surgical tool.

7. The type of ground truth used:

• Type of Ground Truth: Not explicitly stated as "ground truth" in the context of clinical outcomes. The "equivalency" claim implies that the performance (e.g., quality of corneal resections) in non-clinical testing was assessed against established standards or performance of the predicate device.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set and ground truth establishment.

Ask a specific question about this device