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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 24, 2017

LENSAR, Inc. Keith Peck Director, Quality Assurance 2800 Discovery Drive, Suite 100 Orlando, Florida 32826

Re: K171337/S002

Trade/Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390, 886.4670 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: OOE, HOC Dated: June 16, 2017 Received: June 19, 2017

Dear Keith Peck:

This letter corrects our substantially equivalent letter of August 10, 2017.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Denise L. Hampton -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K171337

Device Name

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

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) SUMMARY

This 510(k) Summary document has been prepared in accordance with the requirements of 21 CFR 807.92.

SUBMITTER INFORMATION 1.0

The submitter of this 510(k) Summary is:

Company:
----------	--

Contact Person:

LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826

Keith Peck (888) 575-6412 (Office) (407) 386-7228 (Fax)

Summary Preparation Date: May 5, 2017

2.0 DEVICE NAME

Trade/Proprietary Name	LENSAR Laser System – fs 3D (LLS-fs 3D)
Common/Usual Name	LENSAR Laser System (LLS)
Classification Name(s)	Ophthalmic Femtosecond Laser (21 CFR 886.4390)Phacofragmentation System (21 CFR 886.4670)
Product Code(s)	OOE; HQC
Review Panel	Ophthalmic
Regulatory Class	II

3.0 PREDICATE DEVICE(S)

The legally marketed (predicate) devices to which LENSAR is claiming substantial equivalence are:

510(k) Number	Device	Date Cleared
K170576 (Primary)	LENSAR Laser System - fs 3D (LLS-fs 3D) (Iris Registrationand i-Optics Cassini, Nidek OPD Scan, Pentacam® HR andAXL, and Topcon Aladdin Topographers)	05/05/2017
K112098	LENSAR Laser System - fs 3D (LLS-fs 3D) (Intended for usein cataract surgery includes anterior capsulotomy and laserphacofragmentation, each of which may be performed eitherindividually or consecutively during the same procedure.)	10/19/2011
K123859	LENSAR Laser System - fs 3D (LLS-fs 3D) (Intended for usein cataract surgery includes anterior capsulotomy, laserphacofragmentation, and the creation of full and partialthickness single-plane and multi-plane arc cuts/ incisions in thecornea, each of which may be performed either individually orconsecutively during the same procedure.)	03/27/2013

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4.0 DEVICE DESCRIPTION

5.0 INDICATIONS FOR 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.

6.0 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

All elements of the proposed device remain unchanged from that cleared in the legally marketed (predicate) devices except for:

an update to the software that allows for a modification to the current capsulotomy . procedure that will place laser marks, using standard pre-operative data, onto the lens capsule as part of the capsulotomy to identify the astigmatic axis as prescribed by the surgeon. The modification allows the user to place two small protuberances/alignment marks created by the laser on the capsular rim on an axis that is defined by the surgeon using pre-operative data already received by the LENSAR Laser System from one of the cleared topographers or as entered by the surgeon.

7.0 PERFORMANCE DATA

The following performance data were undertaken in support of the substantial equivalence determination.

Performance Evaluation of the Capsular IntelliAxis Feature:

Verification and validation testing were completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the LENSAR Capsular IntelliAxis (aka IntelliCap) feature. Each function and/or feature was verified through unit testing and system testing by means of the appropriate test case or test specification. The unit/

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system verification test reports provide the test cases, expected results for each test case, and the actual results obtained. All criteria for this testing were met and the results demonstrate that the LENSAR Capsular IntelliAxis feature meets all performance specifications and requirements. The objectives defined in the validation plan were achieved according to the validation results. The software on the proposed LLS-fs 3D System has been updated in support of the changes outlined above.

Specifically, a study using porcine eyes was undertaken to (a) demonstrate the effectiveness and ease of use of the Capsular IntelliAxis feature as compared to K170576 (use of topographic measurements in pre-operative data entry) and K123859 (Arcuate Incisions) and (b) establish the substantial equivalence of the safety profile comparing the biomechanical strength for the LENSAR laser capsulotomy with alignment marks to that of the standard LENSAR laser capsulotomy cleared by FDA under 510(k) K112098.

The results show that the alignment marks are visible intraoperatively and, therefore, effective in helping surgeons to align the Toric IOL marks along the axis of astigmatism. Furthermore, the tensile test study demonstrates that the capsular rim for capsulotomy with alignment marks or 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. Further, the accuracy of the requirements of the Capsular IntelliAxis feature was validated. The minor differences between the proposed LENSAR device feature and the predicate device do not raise any new questions of safety or effectiveness.

Summary of Clinical Studies

The addition of Capsular IntelliAxis feature of the LENSAR Laser System does not change the indication for use. Clinical performance data to demonstrate substantial equivalence was not required for this product change.

CONCLUSIONS 8.0

Based on the above supportive information, the proposed LENSAR Laser System - fs 3D (LLS-fs 3D) with the Capsular IntelliAxis feature is substantially equivalent with respect to safety and effectiveness and indication for use as cleared in the predicate laser file (K112098, K123859, and K170576).

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.