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The LensAR Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

The LensAR Laser System is an ophthalmic surgical laser that has already been cleared for use in anterior capsulotomy in cataract surgery (K090633). It is now intended for additional use in anterior capsulotomy and laser phacofragmentation in cataract surgery, performed individually or consecutively during the same surgery.

The LensAR Laser generates ultrashort laser pulses that are scanned in a three-dimensional pattern in the eye to cut the anterior capsulotomy and to pre-cut the lens into small pieces for easy removal by conventional ultrasound phaco fragmentation. The fragmentation pattern is customized to the patient's eye based on precise measurement of the size, shape and position of the patient's lens by a built-in optical measuring system. During the measurement and subsequent application of the laser pulses, the eye is positioned and immobilized by an off-the-shelf suction ring assembly which is affixed to the eye and which is in turn docked to a refractive index matching eye docking (IMED) device mounted to the laser system.

Here's a breakdown of the acceptance criteria and study information for the LensAR Laser System, based on the provided text:

No acceptance criteria or reported device performance metrics (e.g., success rates, accuracy percentages, safety endpoints with specific thresholds) are explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through a clinical study rather than defining specific performance thresholds for acceptance.

However, it describes the clinical study that provided performance data to support the device's substantial equivalence.

Study that Proves the Device Meets the Acceptance Criteria (Implicitly, for Substantial Equivalence):

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

As mentioned above, no explicit quantitative acceptance criteria or reported device performance metrics are provided in the document. The study aimed to demonstrate the device's clinical performance in comparison to predicate devices, inferring safety and effectiveness for substantial equivalence.

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

• Sample Size (Test Set): 88 subjects (for the primary cohort, one eye per subject) and a control cohort of contralateral eyes in these subjects.
• Data Provenance: Prospective clinical study performed outside the U.S.

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

This information is not provided in the document. The study describes the procedures performed (laser fragmentation/capsulotomy followed by phacoemulsification if needed) and a control group receiving conventional methods. It does not detail who established a "ground truth" or what that ground truth would specifically measure beyond the procedural outcomes themselves (e.g., successful fragmentation, clear capsulotomy).

4. Adjudication method 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

• MRMC Study: No, this was not an MRMC study related to human reader performance with AI. The device is a surgical laser system, not an AI-assisted diagnostic or interpretation tool.
• Effect Size: N/A, as it's not an MRMC study with AI assistance.

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

The device itself is a standalone surgical laser system (an "algorithm" in the sense of its operational program). It performs the laser treatment. The clinical study evaluated the overall surgical procedure where the laser performs its function, followed by human intervention (phacoemulsification if needed). It's not a diagnostic algorithm that assists a human reader.

7. The type of ground truth used

The clinical study evaluated the clinical performance of the surgical procedures using the LensAR Laser System. The "ground truth" implicitly refers to the successful completion and clinical outcomes of anterior capsulotomy and laser phacofragmentation during cataract surgery, as observed by ophthalmologists. The document mentions:

• "Summary of Pre-Clinical Testing": "accuracy and reproducibility of capsulotomy and laser phaco fragmentation incisions in porcine eyes and plastic substrates."
• "Summary of Clinical Studies": describes patients undergoing procedures and follow-up.
  The criteria for "success" or "performance" are not explicitly defined as a specific "ground truth" metric but rather related to the procedural outcomes and comparative performance against conventional methods.

8. The sample size for the training set

This information is not provided in the document. The document describes pre-clinical testing and a clinical study but does not detail a "training set" in the context of machine learning or AI, as this is a surgical device.

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

N/A, as no "training set" in the AI/ML sense is mentioned or relevant for this type of medical device's submission summary. The product development likely involved extensive engineering and testing against design specifications, but this is not framed as a "training set" with ground truth in this context.

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The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of,which may be performed either individually or consecutively during the same procedure.

The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness corneal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens and cornea. Individual photodisruption locations 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 a continuous incisions or tissue separation.

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx Laser is an ophthalmic surgical laser that has previously been cleared for use in:

• • Anterior capsulotomy (K082947), performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule.
• · Phacofragmentation (K090452), performed by delivering series of laser pulses to form two intersecting ellipsoidal planes that divides the lens into quadrants.
• . Cuts/incisions for keratoplasty (K092647) which are performed by delivering a pattern of circles and arcs with programmable incision length and depth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the acceptance criteria for the modified LenSx Laser System were the "same parameter acceptance criteria as established for single plane cuts/incisions" for the predicate LenSx 550 Laser and modified LenSx Laser. However, the document does not provide the specific numerical values or ranges for these acceptance criteria. It only mentions what was evaluated against them.

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

• Test Set Sample Size: The document mentions "Evaluation of stepped cuts/incisions in human cadaver eyes for lamellar keratoplasty, penetrating keratoplasty and cataract surgery." However, the exact number of human cadaver eyes used for this evaluation, or any other test set, is not specified.
• Data Provenance: The only explicit mention of data provenance for testing is "human cadaver eyes." No country of origin is specified. The study is retrospective in the sense that cadaver eyes are used, not living patients.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

The document does not provide any information regarding the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This device is a surgical laser system, not an AI diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

The document describes the performance testing of the device itself, which is a surgical laser system. In this context, "standalone algorithm performance" is not directly applicable in the same way it would be for an AI diagnostic algorithm. The performance tests evaluate the physical capabilities of the laser system (accuracy and reproducibility of cuts), not an algorithm's diagnostic output.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations appears to be based on physical measurements and observations of the cuts and incisions created by the laser system. This would infer measurement of depth, geometry, and potentially histological examination in cadaver eyes, but the document does not explicitly state "pathology" or "outcomes data." It implies objective physical assessment.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is consistent with the nature of the device; it's a physical surgical tool, not an AI algorithm that undergoes a distinct "training phase" on labeled data in the traditional sense. Its development and refinement would involve engineering and testing, rather than algorithmic training.

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

As there is no "training set" in the context of an AI algorithm, the document does not describe how ground truth for a training set was established. The development of the device would rely on engineering principles, iterative design, and performance testing, rather than labeled data for algorithm training.

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The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lamellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

The LenSx 550 Laser is an ophthalmic surgical laser indicated for use in the creation of a penetrating cut/incision for penetrating and lamellar keratoplasty. Consistent with commercially available femtosecond lasers (Product Code GEX, 878.4810 and OOE, 886.4390) the LenSx 550 Laser creates incisions using focused femtosecond laser pulses. Individual photodisruption locations are controlled by repositioning the laser focus in the cornea. 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 a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through an off-the-shelf, disposable contact lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx 550 Laser System is an ophthalmic surgical laser. The provided text outlines a 510(k) summary for this device, focusing on its substantial equivalence to predicate devices for creating penetrating and lamellar keratoplasty incisions. However, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a detailed performance evaluation of a device like an AI algorithm.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It lists general performance areas evaluated but not specific quantitative criteria or results.

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

This information is not provided as a test set in the context of an AI algorithm evaluation. The document refers to "nonclinical tests and results" but provides no details on 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

This information is not provided. As no "test set" in the context of AI evaluation is described, there's no mention of ground truth experts.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an ophthalmic surgical laser, not an AI-assisted diagnostic or interpretative tool.

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

This information is not applicable/provided. The device is a surgical laser, not a standalone algorithm.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, there is no "training set."

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

This information is not provided.

Summary of what is stated regarding performance and evaluation from the document:

The document states that nonclinical tests were performed to support the safety and substantial equivalence of the LenSx 550 femtosecond laser system to predicate devices. These tests demonstrated the following:

• Accuracy and reproducibility of the depth and geometry of penetrating cuts/incisions: This is a key performance aspect for a surgical laser, implying that the device consistently creates cuts with the intended dimensions.
• Ability to create penetrating corneal incisions in opacified corneas: This highlights the device's efficacy across different corneal conditions.
• Limited collateral tissue effects and retained endothelial cell viability adjacent to penetrating laser corneal incisions as compared to manual trephination: This points back to safety and potentially improved outcomes compared to the traditional manual method.

In conclusion, while the document confirms that performance data was generated to support the 510(k) clearance, it does not detail specific acceptance criteria, quantitative performance metrics, or the methodologies (sample sizes, expert involvement, ground truth establishment) typically associated with evaluating AI-driven diagnostic or interpretative devices. The evaluation here is for a surgical instrument, focusing on its physical capabilities and safety profile in comparison to existing technologies.

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