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

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

• In patients undergoing surgery or other treatment requiring intial 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 the corneal ring segments
• In lamellar keratoplasty 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 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 and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions 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 a medical device for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices for expanded indications for use. It does not contain information about explicit acceptance criteria or a study designed to prove the device meets specific performance metrics in the way modern AI device submissions do.

Instead, the submission relies on the fact that the technological characteristics of the INTRALASE FS Laser were already cleared for a primary indication (corneal harvesting under K002890) and that the design, materials, and characteristics of the laser are the same regardless of the indication. The "study" mentioned implicitly is essentially a comparison to predicate devices, asserting equivalent performance based on existing safety standards and the device's inherent characteristics.

Therefore, many of the requested categories cannot be directly answered from the provided text, as they pertain to a different type of performance validation (e.g., for AI or diagnostic devices).

Here's an attempt to answer as much as possible based on the provided text, with clear indications where information is not present:

Acceptance Criteria and Device Performance Study (K041893: INTRALASE FS Laser)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not provided. The submission describes nonclinical testing and comparison to predicates, not a clinical study with a specified "test set" in the context of AI or diagnostic device evaluation.
• Data Provenance: Not applicable/Not provided. The evaluation is based on technical characteristics and equivalence, not patient data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not provided. This type of evaluation (expert consensus for ground truth) is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of a physical surgical laser tool.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. This concept is typically relevant to clinical studies involving human observers or diagnostic assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study was not conducted as this is a surgical laser device, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission does not mention human readers or AI assistance.

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

• No. This device is a surgical laser, not an algorithm. The concept of "standalone performance" for an algorithm is not applicable here.

7. The Type of Ground Truth Used

• Equivalence/Performance to Predicate Devices and Safety Standards: The "ground truth" implicitly used for this submission is the established performance and safety of legally marketed predicate devices, along with compliance with applicable safety standards for the device itself. The assessment relies on the device's ability to perform the same surgical cuts as the predicates and its adherence to safety requirements.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."

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

• Not applicable/Not provided. This device is not an AI algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device