The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:

Axial eye length
Corneal thickness
Anterior chamber depth
Aqueous depth
Lens thickness
Radii of curvature of flat and steep meridian
Axis of the flat meridian
White to white distance
Pupil diameter

Device Description

The LENSTAR LS 900 is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate IOL for implantation and to calculate the optimal power of the IOL. The LENSTAR LS 900 measures: axial eye length, corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat or step meridian, white to white distance and pupil diameter.

AI/ML Overview

Acceptance Criteria and Device Performance for LENSTAR LS 900

This report details the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Haag-Streit LENSTAR LS 900 to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the LENSTAR LS 900. Instead, it focuses on demonstrating "substantive equivalence" to existing, legally marketed predicate devices through a comparison of measurement data. The "acceptance criteria" can therefore be inferred as demonstrating a high degree of statistical correlation or agreement in measurements between the LENSTAR LS 900 and the predicate devices.

Measurement Parameter	Acceptance Criteria (Inferred from Study Design)	Reported Device Performance (Summary from Clinical Study)
Axial eye length	Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR, Accusonic A-Scan).	Analysis of clinical data substantiates equivalence to all predicates.
Corneal thickness	Data demonstrates substantial equivalence to predicate devices (OLCR, Accusonic A-Scan).	Analysis of clinical data substantiates equivalence to all predicates.
Anterior chamber depth	Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR).	Analysis of clinical data substantiates equivalence to all predicates.
Lens thickness	Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR).	Analysis of clinical data substantiates equivalence to all predicates.
Radii of curvature (flat/steep)	Data demonstrates substantial equivalence to predicate devices (IOLMaster, Keratron).	Analysis of clinical data substantiates equivalence to all predicates.
Axis of flat meridian	Data demonstrates substantial equivalence to predicate devices (IOLMaster, Keratron).	Analysis of clinical data substantiates equivalence to all predicates.
White to white distance	Data demonstrates substantial equivalence to predicate devices (IOLMaster).	Analysis of clinical data substantiates equivalence to all predicates.
Pupil diameter	Data demonstrates substantial equivalence to predicate devices (IOLMaster).	Analysis of clinical data substantiates equivalence to all predicates.
Aqueous depth	Data demonstrates substantial equivalence to predicate devices. (No specific predicate mentioned, but included in the list of measured parameters.)	Analysis of clinical data substantiates equivalence to all predicates.
IOL Power Calculation Aid	Functionality in assisting IOL power determination demonstrates substantial equivalence to predicate devices that provide similar assistance (e.g., IOLMaster).	The device performs calculations to assist in IOL determination, similar to predicate devices, and its measurements contribute to this equivalence.

2. Sample Size and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size for the test set of patients used in the clinical studies. It only states that "Two prospective, non-randomized, single site comparison studies were performed."
Data Provenance: The studies were conducted in Berne, Switzerland. The data is prospective, as indicated by "Two prospective... studies were performed."

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The study design primarily focuses on comparing measurements obtained by the LENSTAR LS 900 with those from established predicate devices. The "ground truth" for the test set is effectively derived from the measurements produced by these predicate devices.

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. The clinical summary indicates "comparison studies" were performed, meaning the data from the LENSTAR LS 900 was directly compared to the measurements from the predicate devices.

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

No, an MRMC comparative effectiveness study was not done. The studies described are focused on the equivalence of device measurements, not on the improvement of human reader performance with AI assistance. The LENSTAR LS 900 is a measurement device, not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done implicitly. The clinical studies evaluated the LENSTAR LS 900's ability to measure various ocular parameters independently and then compared these measurements to those obtained by predicate devices. This constitutes a standalone performance evaluation in terms of its ability to produce measurements, even if the "algorithm" is inherent to the optical low coherence reflectometry technology itself rather than a distinct AI algorithm. The performance of the device's measurements was compared directly without human interpretation of its outputs in the validation.

7. Type of Ground Truth Used

The "ground truth" for the comparison studies was derived from the measurements obtained by legally marketed predicate devices. This means that the established and accepted accuracy of these existing devices (IOL-Master, OLCR, Accusonic A-Scan, Keratron) served as the reference for determining the equivalence of the LENSTAR LS 900's measurements.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. This is expected as the LENSTAR LS 900 is based on established optical principles (Optical Low Coherence Reflectometry) and does not describe a machine learning algorithm requiring a distinct training phase. Its development would involve engineering and calibration, not traditional machine learning training.

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

As there is no mention of a training set for a machine learning algorithm, there is no corresponding description of how ground truth for a training set was established. The device relies on physical principles and instrument calibration rather than data-driven learning for its primary function.

Summary

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K082891

510(K) SUMMARY

Date Prepared

October 16, 2009

SPONSOR/510(K) OWNER/ MANUFACTURER

Haag-Streit AG Gartenstadtstrasse 10 Koeniz, Berne, Switzerland CH-3098 011-41319780209 Telephone: 011-41319780286 Facsimile: rudolf.waelti@haag-streit.ch Email: Establishment Registration Number: 1000176188

OCT 20 2009

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 (440) 554-3706 Telephone: Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com

COMMON/USUAL NAME

Device, Analysis, Anterior Segment

PROPRIETARY NAMES

LENSTAR LS 900 Allegro Biograph

CLASSIFICATION INFORMATION

Classification Name: Medical Specialty: Device Class: Classification Panel: Product Codes:

Device, Analysis, Anterior Segment Ophthalmic II Ophthalmic Device Panel MXK - Device, Analysis, Anterior Segment

PRODUCT CODE: CLASSIFICATION / CFR TITLE

MXK:

Class II § 21 CFR 886.1850

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LEGALLY MARKETED PREDICATE DEVICES

Trade/Device Name: Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code:

Establishment Registration number:

Trade/Device Name:

Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:

Trade/Device Name:

Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:

Trade/Device Name: Applicant: 510[k] Premarket Notification number: Classification: FDA Product Code: Establishment Registration number:

IOLMaster Carl Zeiss Inc. K993357 Class II HJO - Biomicroscope, Slit Lamp, AC Powered 9615030

Optical Low Coherence Reflectometry Pachymeter (OLCR) Haag-Streit AG K030393 Class II MXK - Device, Analysis, Anterior Segment 1000176188

Accusonic A-Scan Model 24-4000 Accutome K032956 Class II IYO - System, Imaging, Pulsed echo 2521877

Keratron Alliance Medical Marketing K944616 Class I HLQ-Keratoscope 1058327

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GENERAL DEVICE DESCRIPTION

INDICATIONS FOR USE

Axial eye length b
ë Corneal thickness
Anterior chamber depth も
� Aqueous depth
Lens thickness .
Radii of curvature of flat and steep meridian �
� Axis of the flat meridian
White to white distance .
Pupil diameter .

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The LENSTAR LS 900 and the predicate devices are substantially equivalent because they use similar technology and perform similar functions to provide the ocular measurements and to perform calculations needed to allow a physician to choose the appropriate power and type of IOL for a patient eye.

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CLINICAL SUMMARY

Two prospective, non-randomized, single site comparison studies were performed to substantiate equivalence of the LENSTAR LS 900 to the stated predicate FDA approved medical devices including the IOL-Master (Carl Zeiss Meditec AG), the OLCR (Haag-Streit AG), the Accusonic A-Scan (Accutome) and Keratron (Alliance Medical Marketing). The studies were approved by an ethics committee. The studies were conducted in Berne, Switzerland.

Data includes measurements of axial length, central corneal pachymetry, anterior chamber depth, central lens thickness, average corneal radius, flat corneal axis, white-towhite distance and pupillometry.

Analysis of clinical data substantiates equivalence between the measurement data of the LENSTAR LS 900 with the all predicates.

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

Haag-Streit AG c/o Ms. Lena Sattler Official Correspondent Orasi Consulting, LLC 1667 Ridgewood Road Wadsworth, OH 44281

OCT 2 0 2009

Re: K082891

Trade/Device Name: Haag-Streit LENSTAR LS 900 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slitlamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: October 16, 2009 Received: October 19, 2009

Dear Ms. Sattler:

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 Foend, Or re 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.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Kessa Alexander for

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _K082891

Device Name: LENSTAR LS 900

Indications for Use:

Axial eye length .
. Corneal thickness
. Anterior chamber depth
. Aqueous depth
. Lens thickness
Radii of curvature of flat and steep meridian .
Axis of the flat meridian .
White to white distance
. Pupil diameter

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K 042891

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.