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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 LensAR Laser System is intended for use in anterior capsulotomy during cataract surgery.

The LensAR Laser System is an ophthalmic surgical laser intended for use in anterior capsulotomy in cataract surgery. The System employs a mode-locked Nd: Y VO4 laser which generates a high frequency series of ultrashort, low energy pulses at a wavelength of 1064 nm. The system is designed to cut the lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy is generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location of the anterior capsulotomy. The laser energy is delivered to the eye through a disposable, patient interface device consisting of an Index Matched Eye Docking device (IMED) designed to match the refractive index of the cornea to optimize beam targeting accuracy. The IMED device is docked to the eye via an accessory component comparable to those used with other ophthalmic lasers used as keratomes.

This document describes the premarket notification 510(k) for the LensAR Laser System for Anterior Capsulotomy.

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Creation of uniform, accurate, and predictable anterior capsulotomies (size and depth).	The data demonstrated the LensAR produces anterior capsulotomies that are uniform, accurate, and predictable in size (based on testing in porcine eyes and plastic substrates). Clinical analysis included pointing accuracy and performance characteristics for achieving an effective anterior capsulotomy cut.
   Safety with respect to corneal endothelium (acoustic and thermal profile).	Evaluation on ex vivo porcine eyes confirmed the safety with respect to corneal endothelium.
   Successful performance of anterior capsulotomy, with successful intraocular lens placement.	Anterior capsulotomy was successfully performed in eyes using the LensAR Laser, with intraocular lenses successfully placed. Postoperatively, the course of follow-up through 3 months was unremarkable. The intraocular lens was centered in all study eyes. All capsulotomies were judged well-centered by visual inspection.
   Ease of removal of capsules comparable to or better than Continuous Curvilinear Capsulorhexis (CCC).	The ease of removal scores were 5 or better (on a scale of 1 to 10, where 1 = CCC/manual removal, 10 = easiest), with the most common score being 10.
   Anterior capsules from laser-treated eyes should be equivalent or better with respect to dimension and conformance to circularity than those done manually.	The removed anterior capsules from the laser-treated eyes were demonstrated to be equivalent or better with respect to dimension and conformance to circularity than those done manually.
   No significant difference in clinical outcomes from the sequelae of cataract surgery between treatment and conventional cataract surgery (CCC) populations.	No significant difference in clinical outcomes from the sequelae of cataract surgery was demonstrated between the Treatment and Treated Control populations.

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

   • Test Set (Clinical): The study was a "prospective, single-center, multiple surgeon clinical trial." No specific sample size is provided for the number of eyes or patients in the LensAR Laser arm. The report mentions a "contralateral control population," suggesting at least some patients had one eye treated with LensAR and the other with CCC, but also states "not all fellow eyes underwent cataract surgery in the context of the clinical study."
   • Data Provenance: The clinical trial was a prospective, single-center study. The country of origin is not explicitly stated, but the submission is to the FDA in the USA.
   • Pre-Clinical Testing: Porcine eyes and plastic substrates were used for accuracy, reproducibility, acoustic, and thermal profile testing.

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

   • The document does not explicitly state the number of experts or their qualifications for establishing ground truth.
   • However, it does mention that "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope," indicating that the treating surgeons provided some form of assessment.

4. Adjudication method for the test set

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). The assessment of capsulotomy centering was done by the operating surgeon via visual inspection.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device used by human readers.

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

   • Yes, the device's performance was evaluated in a standalone manner. The LensAR Laser System performs the anterior capsulotomy itself, and its performance characteristics (accuracy, reproducibility, safety, quality of cut) were assessed pre-clinically and clinically. The laser is a computer-controlled system for creating the cut.

7. The type of ground truth used

   • Clinical Ground Truth: Surgical success (successful capsulotomy and IOL placement, unremarkable postoperative course, centered IOLs), surgeon's visual inspection for capsulotomy centering, and subjective surgeon judgment for ease of capsule removal. The removed anterior capsules were also physically analyzed for dimension and circularity.
   • Pre-Clinical Ground Truth: Measurements of capsulotomy size and depth in porcine eyes and plastic substrates, and evaluation of acoustic and thermal profiles in ex vivo porcine eyes.

8. The sample size for the training set

   • No information is provided regarding a separate "training set" for the device itself. The device is a surgical instrument with computer control, not a machine learning algorithm that requires a distinct training dataset in the same sense as an AI diagnostic tool. The development process likely involved internal testing and refinement (bench testing and ex vivo studies) that could be considered analogous to iterative development, but it's not described as a formal "training set."

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

   • As there's no explicitly defined "training set" in the context of an AI algorithm, details on how ground truth was established for it are not applicable here. The device's design and parameters were likely optimized through engineering and bench testing, for which the "ground truth" would be objective measurements of physical parameters and cut quality against design specifications.

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This device will be used in ophthalmic applications, including:

• . Posterior Capsulotomy
• Peripheral Iridotomy .
• Pupillary Membranectomy .

The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has the form of a table containing supply and control electronics and supporting a headrest where the head of the patient is placed, as well as a movable housing that is controlled by a joystick. The housing comprises a biomicroscope with a slit-lamp illumination (Haag-Streit), a Qswitched Nd:YAG laser, a laser diode producing a red (635 nm) aiming beam and optical, mechanical and electronics elements necessary to control the parameters and geometry of the laser beams.

The integrated Q-switched Nd:YAG laser emits short pulses of light at wavelength of 1064 nm. This light is focused in the plane of observation of the ophthalmic microscope. The irradiance at the focal point is high enough to cause optical breakdown, thus permitting the disruption of tissues.

The MICRORUPTOR V allows the physician to adjust the energy delivered to the target tissue and to precisely control and visualize the position of the beam focus, thus allowing a precise and noninvasive dissection of tissues inside the eye of the patient.

This document is for a medical device cleared in 2002, which is before the current requirements for AI/ML device submissions. Therefore, the document does not contain the detailed information typically expected for AI/ML device studies, such as specific acceptance criteria tied to performance metrics, sample sizes for training/test sets, ground truth establishment methods for AI, or comparative effectiveness studies with human readers.

The information provided focuses on demonstrating substantial equivalence to a predicate device, as was the standard practice at that time.

Here's an analysis based on the provided text, highlighting the absence of AI/ML-specific details:

Device: MICRORUPTOR V (Q-switched Nd:YAG laser)
Intended Use: Noninvasive tissue/membrane dissection (photodisruption) in the eye, including posterior capsulotomy, peripheral iridotomy, and pupillary membranotomy.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission from 2002 for a laser device (not an AI/ML device), the "acceptance criteria" are not framed in terms of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, they revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

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

• Not Applicable. This device is a laser system, not an AI/ML algorithm that operates on a "test set" of data. The submission relies on engineering specifications and comparison to the predicate device, not on data-driven performance metrics from a test set.

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

• Not Applicable. As above, there is no "test set" in the context of an AI/ML algorithm for which ground truth would be established by experts.

4. Adjudication Method for the Test Set

• Not Applicable. There is no test set or adjudication method described for an AI/ML algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a hardware device, not an AI/ML system. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a standalone medical device (laser system), not a standalone AI/ML algorithm intended to analyze data without human intervention. The device is operated by a "skilled Physician."

7. The Type of Ground Truth Used

• Not Applicable. For this laser device, "ground truth" would relate to its physical properties (e.g., energy output, wavelength, beam focus accuracy) and its ability to achieve tissue disruption safely when operated by a physician. This is established through engineering testing and clinical experience with the predicate device, not through expert consensus, pathology, or outcomes data in the context of an AI's diagnostic or predictive output.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device. There is no "training set" in the context of machine learning.

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

• Not Applicable. As above, there is no training set for an AI/ML algorithm.

Summary regarding AI/ML Device Study Information:

The provided 510(k) summary for the MICRORUPTOR V laser system does not contain any of the requested information pertaining to AI/ML device studies because the device itself is a traditional medical hardware device, not an AI/ML-driven diagnostic or therapeutic tool. The clearance is based on demonstrating substantial equivalence to a predicate device, which primarily involves comparing specifications, intended use, and technological characteristics.

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