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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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The IntraLase Fusion™ Laser 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.

The IntraLase Fusion Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase Fusion Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses 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 IntraLase Fusion Laser, claiming substantial equivalence to a predicate device (IntraLase FS Laser, K060372). The document focuses on regulatory approval rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be found in the provided text.

Here is an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" reported is that the device "perform[s] equivalently" to the predicate for its intended use. Safety compliance is also mentioned as met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "nonclinical tests" but does not detail the methodology, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As a substantial equivalence submission for a surgical laser, ground truth typically would involve physical and operational testing rather than expert-derived ground truth for diagnostic image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This device is a surgical laser, not an AI-powered diagnostic tool. The document describes non-clinical testing for equivalence to a predicate device.

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

This information is not provided related to "algorithm only" performance. The product is a physical laser device, not a standalone algorithm. The non-clinical tests would have evaluated the device's physical performance characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document primarily refers to "nonclinical tests and results" which assessed whether the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections" and its compliance with "applicable safety standards." The "ground truth" here would likely be objective measurements and observations of the physical characteristics and cutting performance of the laser, compared against the known characteristics and performance of the predicate device, rather than a diagnostic "ground truth" like pathology or expert consensus on an image.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is usually applicable to machine learning models, which is not the primary focus of this device's approval process based on the provided text.

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

This information is not provided in the document, as the device is not an AI/ML product for which a training set and its ground truth establishment would be discussed in this context.

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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.

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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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The Pulsion™ FS 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.

The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION 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 Pulsion FS Laser, which is an ophthalmic surgical laser. The document claims substantial equivalence to a predicate device (Pulsion FS Laser with 510(k) K993153). While it states that the device has undergone testing and complies with safety standards, and performs equivalently in "extensive ex vivo and in vivo studies," it does not provide acceptance criteria or a detailed study report that proves the device meets specific performance criteria.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here's an attempt to answer based on the available information, with notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document only mentions "extensive ex vivo and in vivo studies."
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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

• This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• This device is a surgical laser, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's performance relates to its physical action of creating corneal resections.

7. The type of ground truth used

• The document mentions "creation of corneal resections." The ground truth would likely involve measurement of the characteristics of the corneal resections created by the laser (e.g., flap thickness, diameter, smoothness, side-cut angle, tissue integrity) in both ex vivo and in vivo models. However, the specific type of measurement or gold standard definition is not detailed.

8. The sample size for the training set

• This documentation pertains to a surgical device, not a machine learning model that has a "training set." Therefore, the concept of a training set sample size is not applicable.

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

• As a surgical device, there is no "training set" in the context of machine learning. The device's performance is established through direct physical testing and comparison to a predicate device.

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The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

The IntraLase 600C Laser Keratome is a precision ophthalmic surgical laser designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing anterior lamellar corneal resections. The materials, basic scientific concepts and physical properties of the IntraLase 600C are similar to those of the ISL OC2000, while the indication for use and the intended use are identical to those of the Hansatome microkeratome.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the IntraLase 600C Laser Keratome:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K993153) does not explicitly list quantifiable acceptance criteria in a table format. Instead, it claims substantial equivalence to a predicate device based on performance in "extensive ex vivo and in vivo studies."

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

• Sample Size: The document uses the term "extensive ex vivo and in vivo studies" but does not specify the numerical sample size for either.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market clinical investigations. Given the context, they are likely to be prospective studies conducted by the manufacturer to demonstrate equivalence.

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

This information is not provided in the document. The filing focuses on the device's technical characteristics and equivalence to predicate devices rather than a detailed clinical study with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

• Was it done? No. This type of study (MRMC) is typically associated with AI/CAD systems where human readers interpret medical images with and without AI assistance. The IntraLase 600C Laser Keratome is a surgical device, not an AI/CAD system.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted device.

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

• Was it done? Not applicable in the context of an AI algorithm. If "standalone" refers to the device operating independently in the studies, the text implies that the device's performance in creating corneal resections was evaluated, presumably without a human "in the loop" for the creation process itself, but rather human oversight and evaluation of the results. However, this isn't an AI-specific standalone performance evaluation.

7. Type of Ground Truth Used:

The document implicitly uses the "performance...with respect to the creation of corneal resections" as the ground truth. This would likely involve:

• Measurements: Direct measurements of the thickness and diameter of the corneal resections created by the device.
• Visual Inspection/Histopathology: Evaluation of the quality, smoothness, and uniformity of the resections.
• Comparison to Predicate: The ultimate "ground truth" for the submission is the performance of the legally marketed predicate device (Hansatome Microkeratome).

8. Sample Size for the Training Set:

This information is not applicable as the IntraLase 600C Laser Keratome is a physical surgical device, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this device.

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