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Manufacturer

Date Cleared

2018-08-09

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K173346

Intended Use

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.

Device Description

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.

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.

AI/ML Overview

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

Performance Metric	Acceptance Criteria (Implied/Derived)	Reported Device Performance
New elliptical PID Modification:
IOP Rise	Consistent with existing LENSAR PID (cleared in K173346).	The new proposed elliptical PID was consistent with LENSAR's existing PID regarding IOP pressure rise.
Eye Stability (during surgery)	Comparable minimum force necessary to detach the eye from the suction ring as existing LENSAR PID.	The minimum force necessary to detach the porcine eye from the suction ring was comparable to that of LENSAR's existing PID.
Corneal Folds	No visible corneal folds compared to existing LENSAR PID.	Using OCT images, no visible folds were noted.
Iris Registration and Limbus Detection	All specifications of Iris Registration and Limbus Detection functions achieved with elliptical PID.	The analysis incorporated images of eyes with the elliptical PID and showed that all specifications of the Iris Registration and the Limbus Detection functions were achieved.
Hazard Analysis	All potential hazards have acceptable levels of probability/severity characteristics with the proposed changes.	The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.
General Performance (new elliptical PID)	Meets all performance specifications and requirements.	All criteria for unit/system verification testing were met, and the results demonstrate that the LENSAR System with the new elliptical PID meets all performance specifications and requirements.
Biocompatibility:
New elliptical PID (materials)	No new biocompatibility testing deemed necessary (due to no material changes from existing PID).	Biocompatibility risk evaluation indicated no new biocompatibility testing was necessary.
Molded PMMA contact lens	Materials used are biocompatible, passing cytotoxicity, irritation, and sensitization tests.	Based on testing (cytotoxicity, irritation, and sensitization), no issues were found, and all testing passed.
Software Verification and Validation:
All changes and updates	Complies with specifications and requirements, follows FDA guidance.	Complete software verification and validation testing was conducted covering all cited changes and updates, and documentation was provided as recommended by FDA guidance. The software was considered "major" level of concern.

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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K Number

K173346

Device Name

LENSAR Laser System fs 3D (LLS-fs 3D)

Manufacturer

Lensar, Inc.

Date Cleared

2018-03-02

(128 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K141476

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Accuracy of depth	Achieved depth within established requirements	Achieved depth well within established requirements for both pocket and flap.
Parallelism of bed	Achieved depth at multiple points (tangential/sagittal planes) within specification of measured depth	Achieved depth at several points of both tangential and sagittal planes (i.e., parallelism) was well within the specification of the measured depth for both the pocket and flap.
Effect on endothelial cells	No loss of endothelial cell density	No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained (from a previous study).
IOP rise	Consistent with commercially available applanating PIDs	Consistent with other commercially available applanating PIDs.
Eye stability during surgery	Minimum force to detach eye from suction ring for new PID higher or equivalent to existing PID	Minimum force necessary to detach the porcine eye from the suction ring was higher for the curved contact PID versus that of LENSAR's existing PID.
Retinal burn hazard	No increase in hazard	No increase in hazard following a retinal burn hazard analysis for the addition of corneal pockets and flaps.
Incision quality (Pocket/Flap)	Acceptable ease of opening, ease of separation, smoothness of bed surface	Judgement of a board-certified ophthalmic surgeon indicated "Yes" for acceptability for each factor, consistent with the predicate device.
Bed smoothness (Pocket/Flap)	Consistent with predicate device	Judgement of the same surgeon indicated bed smoothness was consistent with that of the predicate device using donor eyes.
Corneal folds	No visible folds	No visible folds noted in OCT images when compared to a commercially available applanating PID.

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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K Number

K171337

Device Name

Manufacturer

Date Cleared

2017-08-10

(94 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K170576,K123859,K112098

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implicit from V&V)	Reported Device Performance
Compliance with specifications for Capsular IntelliAxis feature	All criteria for unit testing and system testing were met, and results demonstrate the LENSAR Capsular IntelliAxis feature meets all performance specifications and requirements. Objectives defined in the validation plan were achieved.
Effectiveness and ease of use in helping surgeons align Toric IOLs	Alignment marks are visible intraoperatively and are therefore effective in helping surgeons align Toric IOL marks along the axis of astigmatism. (Demonstrated against K170576 and K123859)
Substantial equivalence of safety profile (biomechanical strength)	The capsular rim for capsulotomy with alignment marks/nubs is substantially equivalent in elongation and tensile strength (ability to elongate and resistance to tearing under a radial force) to the standard capsulotomy with no alignment marks. (Demonstrated against K112098)
Accuracy of Capsular IntelliAxis feature requirements	The accuracy of the requirements of the Capsular IntelliAxis feature was validated.
No new questions of safety or effectiveness compared to predicate device	Minor differences between the proposed LENSAR device feature and the predicate device do not raise any new questions of safety or effectiveness. (This is a core conclusion for 510(k) clearance, implying the device meets the safety/effectiveness profile of the predicate).

Study Details

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.
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.
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.
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.
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.
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.
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.
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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K Number

K170576

Device Name

Manufacturer

Date Cleared

2017-05-05

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K143010,K152453

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Modified Algorithm)
i-Optics Cassini Topographer
Correct Cyclotorsion Angle	High (e.g., ≥ 97%)	≥ 98.97%
Cannot Determine an Angle	Low (e.g., ≤ 3%)	≤ 1.03%
Incorrect Cyclotorsion Angle	Very Low (e.g., ≤ 0.01%)	≤ 0.002%
Nidek OPD Scan Topographer
Correct Cyclotorsion Angle	High (e.g., ≥ 97%)	≥ 98.52%
Cannot Determine an Angle	Low (e.g., ≤ 3%)	≤ 1.48%
Incorrect Cyclotorsion Angle	Very Low (e.g., ≤ 0.01%)	≤ 0.002%
Topcon Aladdin Topographer
Correct Cyclotorsion Angle	High (e.g., ≥ 97%)	≥ 97.17%
Cannot Determine an Angle	Low (e.g., ≤ 3%)	≤ 2.83%
Incorrect Cyclotorsion Angle	Very Low (e.g., ≤ 0.01%)	≤ 0.002%
OCULUS Pentacam® HR Topographer
Correct Cyclotorsion Angle	High (e.g., ≥ 97%)	≥ 97.50%
Cannot Determine an Angle	Low (e.g., ≤ 3%)	≤ 2.50%
Incorrect Cyclotorsion Angle	Very Low (e.g., ≤ 0.01%)	≤ 0.002%
OCULUS Pentacam® AXL Topographer
Correct Cyclotorsion Angle	High (e.g., ≥ 97%)	≥ 98.33%
Cannot Determine an Angle	Low (e.g., ≤ 3%)	≤ 1.67%
Incorrect Cyclotorsion Angle	Very Low (e.g., ≤ 0.01%)	≤ 0.002%

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.

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K Number

K152453

Device Name

Manufacturer

LENSAR Laser System - fs 3D

Date Cleared

2015-10-15

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K143010

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Performance Specification)	Reported Device Performance (Nidek OPD Scan Topographer)
Algorithm determines the correct cyclotorsion angle	≥ 99.26%
Algorithm cannot determine an angle

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K Number

K143010

Device Name

Manufacturer

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS

Date Cleared

2015-03-20

(151 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K123859

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Feature Evaluated	Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	Compliance with ANSI/AAMI/ISO 10993-1, 10993-5, 10993-10 standards. Sterility Assurance Level (SAL) of $10^{-6}$ for PID Kit. Cleaning validation for PID Interface Arm per AAMI TIR30:2011.	All standards and criteria were met.
Electrical Safety & EMC	Compliance with UL 60601-1, EN 60601-1, EN 60601-1-2, and IEC 60601-1-2007 (3rd Edition for EMC) requirements.	System met or exceeded all requirements.
Eye Safety Analysis	Compliance with ISO 15004-2:2007 for the Super Luminescent Diode (SLD).	SLD was determined to be safe using the described methods.
Software Verification & Validation	Compliance with specifications and requirements, as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "major" level of concern.	All cited changes and updates since prior clearance were verified and validated. Documentation provided.
Iris Registration Feature	Device performance complies with identified specifications and requirements for iris registration.	All criteria were met; results demonstrate the feature meets all performance specifications and requirements.
Cataract Density Imaging Feature	Device performance complies with identified specifications and requirements for cataract density imaging.	All criteria were met; results demonstrate the feature meets all performance specifications and requirements.
Beam Delivery & Placement (Ex vivo)	Confirmation of capsule clearance (anterior and posterior), corneal incisions for fixed/proportional depth for arcuate incisions, and selected proportional depth of clear corneal incisions.	Verification demonstrated compliance with requirements.
Residual Stroma Override (Ex vivo)	Demonstration of the safety feature's ability to override fixed depth selection to maintain a user-specified minimum residual stromal bed.	Performance demonstrated.

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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K Number

K122829

Device Name

Manufacturer

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

Date Cleared

2012-12-03

(77 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120214,K101626

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance (LLS-fs 3D vs. Manual/Predicate)
Safety:
Ocular safety	The femtosecond laser, biometric system scanning diode light source, and patient eye illumination were determined to be eye safe under all normal operating and known fault conditions. The optical radiation hazard analysis confirmed continuing ocular safety and equivalence to the predicate device (K120214). (Section 2, para 1)
Hazard analysis	A hazard analysis of all potential hazards (to patient, surgeon, other operators) considered all changes between current and predicate LLS-fs 3D, demonstrating all potential hazards have acceptable levels of probability/severity characteristics. (Section 2, para 5)
Effectiveness/Performance:
Accuracy & Reproducibility of Corneal Incisions	Accuracy: Mean incision length for laser incisions was statistically significantly closer to the target length than for manual CCIs. Reproducibility: Variance of angles of entrance and exit planar incisions relative to the corneal surface showed laser incisions had statistically significantly lower variance for these geometry parameters compared to manual incisions. (Section 2, para 3)
Endothelial Cell Safety	On ex vivo porcine eyes, laser corneal incisions resulted in statistically smaller percentage losses of endothelial cells compared to the manual incision method when the exit of the incision was normal to the surface. No significant difference was observed when the exit incision geometry was at 45° to the surface. (Section 2, para 4)
Incision Seal Integrity & Wound Structure	No difference in susceptibility to leakage between laser and manual incisions for cataract surgery. Testing showed manual and laser methods are statistically equivalent in sealability, but the laser method produces more consistent wound geometry. (Section 2, para 5)
Equivalence to Predicate	The LLS-fs 3D laser technology and mechanism of laser-tissue interaction are unchanged from the femtosecond laser cleared under K120214. The indication for use statement for anterior capsulotomy and laser phacofragmentation is the same as predicate devices. Incision of the cornea in cataract surgery is the same as the LenSx laser (K101626). Differences between modified LLS-fs 3D and predicates are insignificant and do not affect safety or effectiveness. (Section 2, paras 1-4)
System Functionality	The biometric system, patient interface device (PID), controlled force docking mechanism, and moveable optical head are unchanged from the predicate K120214, except for software modifications to analyze peripheral cornea. (Section 0, Section 1)

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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K Number

K102727

Device Name

Manufacturer

Date Cleared

2011-03-16

(175 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K090633,K094052,K082947,K021566,K082845

Intended Use

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.

Device Description

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.

AI/ML Overview

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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K Number

K090633

Device Name

LENSAR LASER SYSTEM

Manufacturer