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The ALLY™ Adaptive Cataract Treatment System is an ophthalmic surgical laser indicated for use:

• · in the creation of an anterior capsulotomy.
• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens.
• · in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and full and partial thickness 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 provided text describes the LENSAR ALLY™ Adaptive Cataract Treatment System and its substantial equivalence to a predicate device, the LENSAR Laser System – fs 3D (LLS-fs 3D). However, it does not contain a specific study demonstrating performance against acceptance criteria in the way typically required for AI/ML device evaluations (e.g., diagnostic performance metrics like sensitivity, specificity, or AUC).

Instead, the document focuses on demonstrating that the ALLY™ System is substantially equivalent to its predicate device through non-clinical performance data, ensuring it meets safety and effectiveness requirements.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a specific task. Instead, it describes various non-clinical tests conducted to ensure the device's safety, effectiveness, and equivalence to the predicate. The "performance" here refers to meeting engineering and safety standards.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not applicable in the context of diagnostic performance studies. The "test set" here refers to various samples used for non-clinical engineering and safety testing (e.g., material samples for biocompatibility, packaging samples for integrity). Specific sample sizes for each non-clinical test are not detailed in this summary.
• Data Provenance: The nature of the non-clinical tests implies that the data was generated specifically for the ALLY™ device during its development and testing phases. There is no mention of external, retrospective, or prospective patient data sets for performance evaluation in the diagnostic sense. The testing was conducted by LENSAR, Inc., likely in the US, as suggested by the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission focuses on engineering and safety validation, not on diagnostic performance or interpretation by human experts.

4. Adjudication Method

Not applicable. There is no mention of expert adjudication for ground truth for diagnostic or interpretative tasks.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the document. The device is a surgical laser system, and the evaluation focuses on its technical performance and safety, not on improving human reader performance in interpreting medical images with AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone algorithm-only performance study (in the context of AI/ML diagnostic or interpretative algorithms) was not explicitly conducted or described. The document describes the performance of the integrated ALLY™ system itself through various engineering and safety tests. While the system uses "automated precision" and "treatment planning tools for precision-guided laser treatments," the evaluation presented is not a standalone AI algorithm performance study in the typical sense of measuring diagnostic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests would be the established engineering standards, safety regulations, and predetermined specifications that the device had to meet. For example:

• Eye Safety: ANSI Z-136.1:2014 standards.
• Biocompatibility: ISO 10993-1 standards.
• Sterile Device Packaging: ISTA 3A, ASTM F2096, ASTM F88 standards.
• EMC & Electrical Safety: ANSI/AAMI/IEC 60601-1-2:2014, ANSV/AAMI/ES 60601-1:2005 A1:2012 standards.
• Software: IEC 62304 standard and FDA guidance.

8. Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML model that would require a distinct "training set" of data for diagnostic or interpretative learning. The "automated precision" and "treatment planning tools" are likely based on deterministic algorithms and calibrated parameters from engineering design, not deep learning from a large training dataset.

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

Not applicable, as no AI/ML training set is described.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

• in the creation of an anterior capsulotomy;
• in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
• in the creation of a corneal flap in patients undergoing 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; and
• in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness 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 device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts.

The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

Acceptance Criteria and Study for LENSAR Laser System - fs 3D (LLS-fs 3D)

The information provided describes the performance evaluation conducted for the LENSAR Laser System - fs 3D (LLS-fs 3D) to support its substantial equivalence, particularly concerning new indications for use related to corneal ring segments and radial incisions.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of eyes, but the studies were conducted on porcine ex vivo eye models.
• Data Provenance: The data is from pre-clinical testing on porcine ex vivo eye models. This indicates an in vitro or ex vivo setting, not human clinical data.

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

• For the assessment of incision quality (corneal tunnel and radial incisions), a "trained biomedical scientist" was used.
• No further details are provided regarding the number of scientists, their specific qualifications, or years of experience.

4. Adjudication Method for the Test Set

• Not explicitly stated. For the incision quality assessment, it mentions "A trained biomedical scientist... assessed the acceptability," implying a single assessor or a consensus not detailed.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The addition of the added indications for use and other minor changes... did not require clinical performance data to demonstrate substantial equivalence to the predicate device."
• Therefore, there is no effect size of human readers improving with or without AI assistance.

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

• The performance data presented focuses on the device's ability to create precise cuts and tunnels. While the device uses software and imaging for guidance (Iris Registration, IntelliAxis, CustomFrag), the performance evaluation described directly assesses the physical outcomes of the laser treatment on anatomical models. It does not describe a "standalone" algorithmic performance in the typical sense of an AI model making diagnostic or prescriptive decisions without human oversight or direct intervention. The device itself is a surgical tool controlled by a surgeon.

7. The Type of Ground Truth Used

• Instrumental measurements: For depth accuracy, an optical coherence tomographer was used.
• Expert assessment: For incision quality, a trained biomedical scientist performed the assessment.
• Biological assessment: Evaluation of endothelial cells of ex vivo eyes for cell density loss.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for any training set. The performance data presented is for verification and validation testing, which often refers to testing on a held-out set after development. There is no information provided about how the device's algorithms or parameters (e.g., for depth placement, cut patterns, image analysis) were internally trained or developed.

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

• This information is not provided in the document. As no training set size is stated, the method for establishing its ground truth is also absent. The document focuses on the validation studies performed to demonstrate the device meets specifications, rather than the internal development or training processes of its embedded software/algorithms.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

· in the creation of an anterior capsulotomy;

• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• · in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and
• · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness 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 device is also intended for use in the creation of pocket cuts/ incisions in the cornea in patients undergoing ophthalmic surgery, and in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, each of which may only be performed individually.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket and flap cuts.

The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™, an ophthalmic surgical laser. The submission is a 510(k) for changes to an already cleared device (K173346), specifically the introduction of a new elliptical-shaped Patient Interface Device (PID) Kit, a software change related to Limbus detection, and a change in manufacturing process for the PMMA contact lens of the Curved Contact PID.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• IOP Rise, Eye Stability, Corneal Folds: Tested in vitro using porcine eyes. The specific number of porcine eyes is not provided in the document.
• Iris Registration and Limbus Detection: Analysis incorporated images of eyes with the elliptical PID. The specific number of images or eyes is not provided.
• Biocompatibility (Molded PMMA): Testing was performed for cytotoxicity, irritation, and sensitization. The sample size or specific test protocols are not detailed.
• Software Verification and Validation: Conducted through unit and system testing, implying internal testing and validation against specifications. No specific "test set" size in terms of patient data is mentioned for this aspect.

The data provenance for the in vitro studies (porcine eyes) is not specified further than "porcine eyes." No human patient data is mentioned for testing these specific device modifications.

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

The document does not detail the use of external experts to establish ground truth for the test set.

• For the in vitro studies (IOP, stability, corneal folds), the assessment seems to be based on direct measurement or observation (e.g., OCT images for corneal folds) conducted by the manufacturer's testing personnel.
• For Iris Registration and Limbus Detection, "specifications...were achieved," suggesting internal verification against defined parameters.
• Hazard analysis was performed, likely by an internal risk management team.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The assessments appear to be based on internal testing and compliance with specifications.

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

There is no mention of an MRMC comparative effectiveness study or any study involving human readers and AI assistance. This submission focuses on hardware and software changes to an existing laser system, not an AI diagnostic or assistive tool for human interpretation.

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

The device is a surgical laser system; therefore, the concept of "standalone performance" for an algorithm in the typical sense (e.g., diagnostic AI) does not directly apply. The software performance described is integrated into the operation of the laser system (e.g., Limbus detection, Iris Registration). Its performance is evaluated within the context of the device's functional operation, not as a standalone interpretive algorithm.

7. The Type of Ground Truth Used

• For IOP, eye stability, and corneal folds, the ground truth is derived from direct physical measurements and observations on porcine eyes, compared against the performance of the predicate device's existing PID.
• For Iris Registration and Limbus Detection, the ground truth is adherence to pre-defined technical specifications for these functions.
• For biocompatibility, the ground truth is the results of standardized biocompatibility tests (cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This document does not describe the use of a "training set" in the context of machine learning or AI development. The software updates mentioned are likely modifications to existing algorithms or new implementations based on deterministic logic, rather than machine learning algorithms requiring large training datasets.

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

As no training set is described in the context of machine learning, this question is not applicable. The software changes are verified against internal specifications and by demonstrating that they do not compromise the safety and effectiveness of the existing system.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

• · in the creation of an anterior capsulotomy;
• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and
• · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness 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 device is also intended for use in the creation of pocket cuts/ incisions in the cornea in patients undergoing ophthalmic surgery, and in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, each of which may only be performed individually.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket and flap cuts.

The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal and capsule marking for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) and its performance data in support of its 510(k) submission (K173346) for new indications: creation of corneal pockets and corneal flaps.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study primarily utilized a porcine ex vivo eye model for most of the performance evaluations related to corneal pockets and flaps. Specific sample sizes for each test are not explicitly provided in the document.
Data provenance is retrospective as it refers to testing done in support of the submission. The origin of the porcine eyes is not specified. For some tests, human donor eyes were also used, but their provenance is not detailed either.

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

For the evaluation of incision quality and bed smoothness, the ground truth was established by:

• A board-certified ophthalmic surgeon.
  The document does not specify the number of years of experience of the surgeon, nor if multiple surgeons were involved for different assessments.

4. Adjudication Method for the Test Set:

For the human-graded assessments (incision quality and bed smoothness), the adjudication method appears to be none, as the decisions were based on the "judgement of the surgeon," implying a single expert opinion without a formal consensus or tie-breaking process.

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

No MRMC comparative effectiveness study was done to assess the improvement of human readers with AI vs. without AI assistance. The device is a surgical laser system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Yes, a standalone study was conducted as the performance data directly assesses the capabilities of the laser system itself (e.g., accuracy of depth, parallelism, incision quality) rather than its interaction with human interpretation or decision-making in a diagnostic context. This is a surgical device performing physical actions.

7. Type of Ground Truth Used:

The ground truth used was a combination of:

• Measurement against intended specifications: For objective metrics like depth accuracy, parallelism, and IOP rise.
• Expert subjective assessment: For qualitative metrics like incision quality (ease of opening, separation, smoothness) and bed smoothness, evaluated by a board-certified ophthalmic surgeon.
• Imaging (OCT): For assessing corneal folds.
• Biological effects: For endothelial cell density, based on previous studies.

8. Sample Size for the Training Set:

This information is not provided in the document. The document describes performance testing for new indications, not a machine learning model that would typically have a separate training set. The "software verification and validation testing" refers to the system's software, not an AI/ML algorithm that is trained on a dataset.

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

As no training set is mentioned for an AI/ML model, this information is not applicable. The ground truth establishment described above pertains to the validation of the device's physical performance characteristics.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane are cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness 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. Use of the laser provides automated precision control of the size of the capsular opening: the type and parameters of laser fragment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions. The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline" includes the integration with preop analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal and capsule marking for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LENSAR Laser System - fs 3D (LLS-fs 3D) with the Capsular IntelliAxis feature:

It's important to note that the provided document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with extensive statistical data. As such, some of the requested information (especially quantitative data like effect size in MRMC studies or large sample sizes for training sets) is not explicitly present.

Acceptance Criteria and Reported Device Performance

The document describes the verification and validation (V&V) testing for the Capsular IntelliAxis feature. The acceptance criteria are implicitly tied to the performance specifications and requirements identified for this feature. The reported device performance is that these criteria were met.

Study Details

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

   • Test Set Sample Size: The document mentions "a study using porcine eyes." It does not specify the exact number of porcine eyes used for this study.
   • Data Provenance: Porcine eye study. This indicates the data is from an animal model, not human clinical data, and is prospective experimentation.

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

   • The document does not specify the number or qualifications of experts involved in the porcine eye study. The evaluation likely involved technical personnel and potentially ophthalmologists, but this is not detailed.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. Given this was a technical/biomechanical study on porcine eyes, it's less likely to involve a complex expert adjudication process typically seen in image interpretation or clinical outcomes.

4. 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, an MRMC comparative effectiveness study was not done. The document states: "Clinical performance data to demonstrate substantial equivalence was not required for this product change." The study described is a technical and biomechanical evaluation using porcine eyes for the Capsular IntelliAxis feature, not an evaluation of human reader performance.

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

   • Yes, in essence. The "Performance Evaluation of the Capsular IntelliAxis Feature" involved "unit testing and system testing" to verify the software performance against specifications. The biomechanical testing on porcine eyes also evaluated the device's direct output (capsulotomy strength) rather than human interpretation. While a surgeon is "in the loop" for the overall procedure, the evaluation of the feature's effectiveness (mark visibility, capsulotomy strength) is akin to a standalone assessment of the device's functional output.

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

   • For effectiveness and ease of use: The ground truth for "effectiveness and ease of use" (i.e., visibility of marks intraoperatively and ability to align Toric IOLs) was likely observational by surgeons during the porcine eye study.
   • For biomechanical strength: The ground truth was established through tensile testing (force required to tear and elongation before tearing) to objectively measure biomechanical properties of the capsular rim.

7. The sample size for the training set:

   • The document does not provide details on a separate "training set" sample size. The description of the device is that it "allows for a modification to the current capsulotomy procedure" and uses "standard pre-operative data" or data "entered by the surgeon." This suggests the algorithm is rules-based or relies on existing pre-operative data sources, rather than being a deep learning model requiring a large training dataset. The verification and validation are described as software testing and a porcine eye study.

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

   • Given the absence of a described "training set" for a machine learning model, this question is not directly applicable. If the system uses established pre-operative data and surgeon input, the "ground truth" for its operation is inherent in those inputs and the validated surgical parameters that the device is programmed to execute.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness 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 LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness 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. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions. The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline" includes the integration with preop analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal marking for simple alignment of Toric IOLs as well as corneal treatment planning tools for precision guided laser treatments.

Here's an analysis of the provided text regarding the LENSAR Laser System - fs 3D (LLS-fs 3D), specifically focusing on the Iris Registration feature and its performance data:

The document describes performance data for the Iris Registration feature after an update that includes:

• Addition of Topcon Aladdin, OCULUS Pentacam® HR, and Pentacam® AXL topographers.
• An additional routine to the Iris Registration function to improve robustness to pupil center drift and gaze direction for cyclotorsion angle identification.
• Updated software for improved user interaction.

The study presented focuses only on the performance evaluation of the Iris Registration feature, not the overall device. Clinical performance data was not required for the changes described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics. The goal is for the algorithm to correctly determine the cyclotorsion angle and minimize cases where it cannot determine an angle or determines an incorrect one.

Note: The document states "All criteria were met" (page 5), implying these reported values meet the internal specifications.

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

The document does not explicitly state the sample size (number of images or patients) used for the test set for any of the topographers. It refers to "re-running the respective data sets," implying pre-existing datasets were used.

Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.

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

This information is not provided in the document. The method for establishing the "correct cyclotorsion angle" (ground truth) is not described.

4. Adjudication Method for the Test Set

The adjudication method is not specified.

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

No, an MRMC comparative effectiveness study was not done. The performance data specifically evaluate the algorithm's performance (standalone) for Iris Registration, comparing it to an "Original Algorithm" in some tables, but not involving human readers.

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

Yes, a standalone study of the algorithm's performance was done. The tables clearly present the performance metrics of the algorithm itself in determining the cyclotorsion angle. The comparison tables for i-Optics Cassini and Nidek OPD Scan also show the performance of the "Original Algorithm" versus the "Modified Algorithm," indicating an algorithm-to-algorithm comparison.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. It can be inferred that it relates to the "Correct Cyclotorsion Angle," but how this "correct" angle was determined (e.g., by manual expert annotation, a different validated instrument, or pathology) is not described.

8. Sample Size for the Training Set

The sample size for the training set is not provided. The document details changes to an existing algorithm and its performance, but not its development or training details.

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

This information is not provided in the document.

Ask a specific question about this device

The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness 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 LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.

Here's an analysis of the acceptance criteria and study information for the LENSAR Laser System - fs 3D (LLS-fs 3D), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness 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 LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.

The LLS-fs 3D is a laser system designed for non-invasive treatment of the crystalline lens by photo-disruptive laser cutting of the lens tissue. The LLS-fs 3D may replace the conventional manual capsulorrhexis procedure with an automated. laser assisted capsulotomy procedure and laser phaco fragmentation.

A key function in the LLS-fs 3D is the Augmented Reality™ Imaging System, which uses precise biometric data collected at multiple angles and optical ray-tracing technology to form a 3-D model of each individual patient's eve. Accurate biometric measurements are required to ensure accurate placement of the femtosecond laser pulses used for various surgical procedures. The Augmented Reality " Imaging System uses enhanced depth of field of ocular structures and super luminescent diode (SLD) illumination to generate an in-focus image from the anterior cornea to the posterior lens capsule. The SLD is a continuous wave (cw) device with a beam emitting from the same aperture as the treatment laser. Variable-rate scanning ensures optical contrast to capture all ocular structures within the anterior segment of the eye. Using the biometric data collected, the LLS-fs 3D has the ability to detect even the smallest amount of lens tilt from the optical axis.

The LLS-fs 3D operates in the following manner: After dilation of the pupil, the laser is "docked" to the eye, and the eye is then optically scanned to determine the location, size, and shape of the crystalline lens and the cornea. The treatment parameters are entered by the user, and with the information from the scan. the control system computes a custom treatment pattern of photodisruptive laser pulses tailored to the individual eye.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values for the Lensar Laser System - fs 3D. Instead, it states that "All criteria were met" for specific features. However, we can infer the acceptance criteria from the descriptions of the performance evaluations.

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

• Biocompatibility Testing: Not specified in terms of number of samples, but materials coming in contact with patient fluid path were tested.
• Electrical Safety and EMC: Not specified, but involved testing of the LLS-fs 3D system.
• Eye Safety Analysis: Not specified, but involved evaluation of the Super Luminescent Diode (SLD).
• Software Verification and Validation Testing: Not specified for individual test cases, but covered all cited changes and updates.
• Performance Evaluation of Iris Registration Feature: Not specified.
• Performance Evaluation of Cataract Density Imaging Feature: Not specified.
• Animal Study (Ex vivo): "Porcine eyes" were used, but the specific number is not provided. This is retrospective as the tissue is already excised.
• Clinical Studies: No clinical evaluations were performed for this submission as the additional features and software updates did not change the Indications for Use.

The document does not explicitly state the country of origin for the data, but the company (LENSAR, Inc.) is based in Orlando, Florida, USA.

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

The document does not explicitly state the number or qualifications of experts used for establishing ground truth for the device's technical performance evaluations. However, given the nature of the tests (biocompatibility, electrical safety, eye safety, software validation, ex vivo animal studies), the ground truth for these would typically be based on established scientific principles, engineering specifications, and regulatory standards, rather than expert consensus on individual cases. For the ex vivo animal studies, qualified personnel would have performed the evaluations based on anatomical and surgical standards.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or data by multiple readers. Since this submission did not involve clinical studies with human readers, and the performance evaluations were primarily technical or ex vivo, no such adjudication method was mentioned or appears to have been applied.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "These additional features and software updates do not change the Indication for Use. Thus no clinical evaluations are required as part of this submission." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

Yes, the performance evaluations described, particularly for the "Iris Registration Feature" and "Cataract Density Imaging Feature," assess the device's capabilities and "compliance with specifications and requirements." This suggests an evaluation of the algorithm's direct output or performance against predefined metrics, independent of human interaction during the measurement process itself. The "Beam Delivery and Placement" and "Residual Stroma Override" features in the ex vivo animal studies also represent standalone performance evaluations of the laser system's mechanics and software logic.

7. Type of Ground Truth Used:

The types of ground truth used primarily include:

• Regulatory Standards and Specifications: For biocompatibility (ISO 10993 series), electrical safety and EMC (UL, EN, IEC 60601 standards), and eye safety (ISO 15004-2:2007).
• Internal Specifications and Requirements: For software verification and validation, Iris Registration, and Cataract Density Imaging features.
• Anatomical and Surgical Principles: For evaluations in ex vivo porcine eyes (capsule clearance, corneal incision depth, residual stroma override).
• Predefined Acceptance Criteria: For all the evaluated features, the "criteria were met per the specified criteria."

8. Sample Size for the Training Set:

The document does not mention any "training set" or explicit machine learning model training in the context of this 510(k) submission. The performance evaluations described are for the validation and verification of the device's features and overall safety/effectiveness, not for the training of an AI algorithm. The device includes an "Augmented Reality™ Imaging System" which uses biometric data and optical ray-tracing to form a 3-D model, but the specifics of any training data for such a system are not provided in this document.

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

As no training set is mentioned, information on how its ground truth was established is not applicable or provided in this document.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness 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 predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.

The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (

Acceptance Criteria for LENSAR Laser System - fs 3D (LLS-fs 3D)

Based on the provided 510(k) summary, the acceptance criteria for the LLS-fs 3D, specifically regarding the new indication of partial thickness corneal incisions, revolve around demonstrating comparable or superior accuracy and safety compared to conventional manual techniques and the previously cleared predicate devices.

The primary performance metric evaluated for the new indication of partial thickness corneal incisions appears to be accuracy of incision depth. The goal was to show that laser-created partial thickness incisions (PTIs) achieved depths much closer to the target than manually-created PTIs, and that there was no significant difference in accuracy or variance between human and porcine eyes, and no detrimental effect on endothelial cells.

Here's a breakdown of the acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Porcine ex vivo eyes: "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model." (Specific number of eyes not quantified, but tested).
  • Human donor globes: "The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes." (Specific number of globes not quantified, but referred to as "smaller number").
  • Endothelial cell study: "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes..." (Source of ex vivo eyes not specified, but likely porcine or human donor as implied by other tests. Specific number not quantified).
• Data Provenance:
  • The studies were "ex vivo," meaning performed on excised tissues, not live subjects.
  • The origin (e.g., country) of the porcine or human donor eyes is not specified.
  • The studies were likely retrospective in nature, as they utilize ex vivo samples for controlled measurements. They are presented as performance tests supporting a 510(k) submission, typical of pre-market validation.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth for the test set.
• It also does not specify the qualifications of any experts involved in defining or adjudicating the ground truth. The ground truth ("measured depths") was established using an "optical coherence tomographer" which implies objective measurement, rather than expert interpretation of images.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for the test set. The ground truth for incision depth was established through objective measurement using "an optical coherence tomographer," which typically involves automated or semi-automated measurement, reducing the need for human adjudication of subjective interpretations.

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

• No, an MRMC comparative effectiveness study was not done. The studies described were primarily technical performance evaluations (e.g., measuring incision depth accuracy), and safety assessments (e.g., endothelial cell integrity), rather than studies evaluating the impact of AI assistance on human reader performance. This device is not an AI-assisted diagnostic tool that would typically warrant such a study.

6. Standalone Performance Study (Algorithm Only)

• Yes, in essence, standalone performance was assessed for the laser's ability to create incisions. The studies evaluated the LLS-fs 3D's performance in creating incisions (accuracy of depth, effect on tissue) in ex vivo eyes, independent of a human surgeon's real-time interaction beyond initiating the procedure. The "Localized Imaging" functionality, which uses the biometric system to image and analyze laser marks to guide subsequent incisions, represents the device's internal "algorithm" controlling the laser's output. The accuracy reported for laser PTIs and the "Localized Imaging" feature ("

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The LensAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of single-plane and multi-plane cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

The predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K 120214 (LensAR Laser System - fs 3D).

The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LensAR device cleared via 510(k) K120214. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that described in 510(k) K120214. The Indication for Use is now expanded to include creation of the incisions for entry to the eye in cataract surgery.

The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea.

Here's a breakdown of the acceptance criteria and study information for the LensAR Laser System - fs 3D (LLS-fs 3D), based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial with specific performance metrics and acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are more about demonstrating safety and equivalence to established methods/devices, and the "reported device performance" reflects findings from comparative tests. Many of the requested details (like sample size for test set, number of experts, adjudication, effect size for human readers, etc.) are not explicitly stated in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, the "acceptance criteria" are implied to be achieving equivalence to or improvement over predicate devices and established manual methods in terms of safety and key performance aspects.

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

• Sample Size for Test Set: Not explicitly stated. The studies mentioned (e.g., "evaluation of the effect of the laser vs. manual incisions at the corneal periphery on endothelial cells of ex vivo porcine eyes") describe the type of study but not the number of samples/eyes used.
• Data Provenance:
  • One study explicitly mentions "ex vivo porcine eyes," indicating animal tissue.
  • Other studies (e.g., accuracy and reproducibility of planar corneal cuts/incisions, incision seal integrity) do not specify if they were performed on human eyes (cadaveric or live) or animal models, or a simulation. This information is usually more detailed in a full submission rather than a summary.
  • The document implies lab-based testing rather than clinical trials with retrospective or prospective human patient data for the specific claims related to corneal incisions.

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

Not explicitly stated. The document describes technical performance evaluations and comparisons rather than expert-derived ground truth on clinical images. For instance, "mean incision length" or "variance of angles" are objective measurements rather than expert interpretations.

4. Adjudication Method for the Test Set

Not applicable/Not stated. Since the studies involved objective measurements of physical parameters rather than subjective interpretations needing reconciliation, an adjudication method for ground truth is not described.

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 an ophthalmic surgical laser system, not an AI-assisted diagnostic imaging device. Therefore, a MRMC study involving human "readers" (experts interpreting data) is not relevant or described.
• Effect Size of Human Reader Improvement: Not applicable.

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

Yes, in essence. The performance data presented (e.g., accuracy of laser incisions, endothelial cell loss, seal integrity) describes the device's performance itself (the laser system) in creating incisions compared to manual methods. This is an "algorithm only" or "device-only" performance in the sense that it's evaluating the system's capabilities to execute specific surgical tasks, rather than human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests appears to be:

• Objective Measurements: Directly measured physical parameters like incision length, angle variance, percentage of endothelial cell loss, and leakage.
• Comparison to Established Manual Methods: The performance of the laser incisions was compared against "manual CCIs" (Corneal Clear Incisions/Corneal Cataract Incisions) as a benchmark or "ground truth" for comparison.
• Predicate Devices: The safety and some aspects of performance were compared to the cleared predicate LensAR Laser System (K120214) and the LenSx Laser System (K101626).

8. The Sample Size for the Training Set

Not applicable/Not stated. This medical device is a surgical laser system, not a machine learning or AI-based diagnostic tool that typically requires a "training set" for model development. The software modifications mentioned are likely deterministic algorithms for controlling the laser based on biometric measurements, not a learned model.

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

Not applicable. As there is no described "training set" in the context of machine learning, there is no ground truth established for it.

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