Measuring the refraction of the eye giving both lower and higher order aberrations
Measurement of the shape of the cornea
Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation.
Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.
Full corneal thickness map.
Scheimpflug imaging.
Anterior chamber imaging.
Pupil image.
Image of the cornea relative to the iris.

Device Description

The VX130 is a multifunctional ophthalmic diagnostic device.
The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: VX130 Ophthalmic Diagnostic Device
Primary Function under review (for the comparison study): Pachymetry (corneal thickness measurement)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device (Galilei G4). The implicitly accepted performance is that the VX130's measurements are not significantly different from those of the predicate device, across various anterior segment parameters, and that it demonstrates sufficient repeatability.

Parameter	Acceptance Criteria (Implicit: No significant difference from predicate / Adequate repeatability)	Reported Device Performance (VX130 vs. Galilei G4 - Average Difference)	Reported Device Performance (VX130 Repeatability - Std Dev 1 / Std Dev 2)
K1 Anterior (D)	Should be comparable to predicate; good repeatability.	-0.27	0.173 / 0.132
K2 Anterior (D)	Should be comparable to predicate; good repeatability.	-0.29	0.095 / 0.237
Cyl Anterior (D)	Should be comparable to predicate; good repeatability.	-0.03	0.166 / 0.229
K1 Posterior (D)	Should be comparable to predicate; good repeatability.	-0.09	0.031 / 0.075
K2 Posterior (D)	Should be comparable to predicate; good repeatability.	-0.01	0.093 / 0.107
Cyl Posterior (D)	Should be comparable to predicate; good repeatability.	0.08	0.103 / 0.112
CCT (Central Corneal Thickness, µm)	Should be comparable to predicate; good repeatability.	-0.43	2.89 / 3.68

Interpretation of Performance: The average differences between the VX130 and Galilei G4 are quite small (e.g., -0.43 µm for CCT), and the 95% confidence intervals (not explicitly provided for CCT, but -15.03 to 14.16 µm for CCT suggests the differences are within a clinically acceptable range for equivalence, especially considering the standard deviations). The repeatability standard deviations for the VX130 are also small, indicating consistent measurements.

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

Comparison Study (VX130 vs. Galilei G4):
- Sample Size: Not explicitly stated, however, Table 2 (Repeatability of VX130) mentions "42 eyes were measured 3 times each". It is highly probable that the comparison study (Table 1) also used these 42 eyes, or a similar sample size, as it's part of the same "Tests for pachymetry" section. Assuming 42 subjects, likely n = 42 eyes.
- Data Provenance: Not specified; retrospective or prospective is not mentioned. Country of origin not mentioned.
Repeatability Study (Table 2 - Std dev 1):
- Sample Size: "a single eye was measured ten times".
Repeatability Study (Table 2 - Std dev 2):
- Sample Size: "42 eyes were measured 3 times each".

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

The document does not mention the use of experts to establish ground truth for the test set. The study design is a comparison between two devices (VX130 and Galilei G4) and a repeatability assessment of the VX130 itself. The Galilei G4's measurements serve as the reference for comparison, not an expert-derived ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there were no human readers/interpreters involved in establishing the ground truth for the measurement comparison. The comparison is between automated device measurements.

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

No MRMC study was done. This study focuses on device performance for automated measurements, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the pachymetry function of the VX130 in two ways:

Comparison to a predicate device: This evaluates the VX130's agreement with an established device (Galilei G4). The results are presented in Table 1, showing "small differences between the devices."
Repeatability study: This demonstrates the consistency of the VX130's own measurements. The results are presented in Table 2, showing low standard deviations for repeated measurements.

7. Type of Ground Truth Used

The ground truth for the comparison study was the measurements obtained from a legally marketed predicate device (Galilei G4). This is a common approach for demonstrating substantial equivalence for quantitative diagnostic devices. For the repeatability study, the "ground truth" is inferred from the consistency of the device's own measurements over multiple trials.

8. Sample Size for the Training Set

The document does not mention a training set. This is not an AI/Machine Learning device that requires a training set in the conventional sense. The device's functionality is based on established optical and measurement principles (Shack-Hartmann, Placido disk, Scheimpflug), and its performance is evaluated against a predicate device and through repeatability.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 24, 2017

Luneau SAS Isabelle Durand Quality/ RA Manager 1 Ave de Malaguet Prunay-Le-Gillon, FR 28360

Re: K162067

Trade/Device Name: VX130 Ophthalmic Diagnostic Device Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX Dated: March 15, 2017 Received: March 17, 2017

Dear Isabelle Durand:

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.

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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 devicerelated 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 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. 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 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 yours.

Denise L. Hampton -S

for Malvina B. 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

510(k) Number (if known)

K162067

Device Name VX130

Indications for Use (Describe)

The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-

illuminator, tonometer and pachymeter, indicated for:

Measuring the refraction of the eye giving both lower and higher order aberrations

Measurement of the shape of the cornea

Retro-illumination imaging of the eye

Measuring the intraocular pressure without contacting the eye for glaucoma evaluation.

Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.

Full corneal thickness map.

Scheimpflug imaging.

Anterior chamber imaging.

Pupil image.

Image of the cornea relative to the iris.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Expiration Date: January 31, 2017

See PRA Statement below.

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510(k) Summary

VX130 ophthalmic diagnostic device

April 24th, 2017

l. SUBMITTER

LUNEAU SAS 1 avenue de Malaguet 28360 Prunay le Gillon France Phone : +33 (0)2 37 25 25 25 Fax: +33(0)2 37 25 75 99

Contact person: Isabelle Durand

DEVICE II.

Name of Device: VX130 ophthalmic diagnostic device Common name: Ophthalmic diagnostic device Classification: tonometer , AC powered Regulatory class: II Product code: HKX Requlation number: 886.1930

III. PREDICATE DEVICES

The VX130 is claimed to be substantially equivalent to the following currently marketed devices:

. VX120 Ophthalmic Diagnostic Device

Manufacturer: LUNEAU SAS FDA K143086 issued June 1, 2015. Product code: HKX

. CM3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (Galilei G4)

Manufacturer: SIS LTD. SURGICAL INSTRUMENT SYSTEMS Allmendstrasse 11 Port Bern, SWITZERLAND CH - 2562 FDA K051940 issued July 15, 2005. Product code: MXK

The VX130 is equivalent to VX120 for tonometry and pachymetry functions and other functions not subject to 510(k) : combined wave front aberrometer, corneal topographer and retroilluminator. It is equivalent to CM3910 for its pachymetry function.

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DEVICE DESCRIPTION IV.

The VX130 is a multifunctional ophthalmic diagnostic device.

The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.

The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

V. INDICATIONS FOR USE:

The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

Measuring the refraction of the eye giving both lower and higher order aberrations Measurement of the shape of the cornea

Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.
Full cornea thickness map
Scheimpflug imaging
Anterior chamber imaging
Pupil image
Image of the cornea relative to the iris

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VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Comparison with VX120

The VX130 has same hardware as VX120. The difference is that VX130 provides multi-slits of the Scheimpflug camera resulting of multiple results of the same indication in different place in the cornea as well as additional maps, while VX120 provides only one Scheimpflug image. That doesn't affect indications for use below:

"Indications for use:

The VX120 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the cornea."

This variant doesn't impact on performances and safety. VX130 is not different in safety or efficacy, and is substantially equivalent to VX120

Comparison with Galilei

Indications for use:

The pachymeter function of the VX130 has the same intended use as the Galilei G4 for photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.

Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil image Image of the cornea relative to the iris

Characteristics	VX130	Galilei
References	User manualUM30200013	510(k) K051940
Measuring Principle	Linear scanningScheimpflug principle forslit image photography	Rotational scan ofDouble-Scheimpflug slitimages merged withPlacido disk images.
Viewing Means	Display on built inLCD screen 10.1"	LCD on MeasurementUnit, 17" monitor ontable
ObservationIllumination	Infrared LED 880nm forpupil and cornealillumination	Infrared LED 810nm

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Flash OutputIllumination	Blue LED light (UV free)455nm, max 50μW	Blue LED light (UVfree) 470nm max,15mW sec
PhotographyCamera	CMOS camera	CCD camera
Display	Data digital	Data digital, displayedon a CPU
Image Resolution	1600 × 1000 pixels	1004 × 1004 pixels
Image Size	9 × 6mm	7.4 × 7.4 mm
Photographic Range	Linear 6mm	Eligible 0 to 180°
Photographic Series	30	1 to 60 images
Slit Length	8mm	15mm
Power Requirement	100-240 VAC, 50/60Hz	110/220 VAC 50/60Hz
Weight	25 kg	10Kg (MeasurementUnit)

Rationale for Substantial Equivalence

The pachymeter function of the VX130 has the same intended use as the Galilei G4 for photographing the eye and taking images of the anterior segment of the eye to evaluate the thickness of the cornea.

The Galilei G4 and the VX130 systems are based on the Scheimpflug Principle for slit image photography. The measurement systems use blue light (UV-free) through a slit to illuminate the eye, and a Camera for photography. The devices take a series of images of the anterior segment of the eye and analyse the images.

The devices have the same intended use
The devices utilize the same measuring principles (Slit Scan)
The devices utilize the same photographic medium
. Similar measurement wavelengths are used

The devices use the same features like a

Head stabilizing device
. Fixation target
All devices are considered "non-invasive" as defined in 21 CFR §812.3(k)

The VX130 for all functions other than pachymetry is identical to the VX120

Safety

The VX130 is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The VX130 does not present or pose any new or additional risks for the prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The VX130 is proven effective for its intended uses through internal performance tests.

The following performance data were provided in support of the substantial equivalence determination:

1. Electrical safety and EMC testing were conducted on the VX130. The device complies with IEC60601-1:2006, and the IEC60601-1-2 for EMC.
1. Software verification and validation testing was done according to IEC62304.

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1. Risk management: VX130 was evaluated according to ISO14971: 2012. All risks have been reduced to safe levels thus there is no conflict between risk and benefit.
1. Tests for ophthalmic products: VX130 was evaluated in accordance with ISO15004-1:2009 and ISO15004-2:2007 standards and was found to meet all requirements of the standards.
1. For optical hazards, VX130 was evaluated in accordance with IEC60825-1: 2008: the result is VX130 is laser class 1.

Tests for pachymetry:

1. A comparison study of anterior segment parameters done with VX130 and Galilei G4 shows that there are only small differences between the devices. Table 1 shows the differences between the two devices for a range of anterior segment parameters. Table 2 shows a repeatability measurement of the VX130. There is not a significant difference between the repeatability measurement and the comparison measurement. The two devices can therefore be considered equivalent.

			95% CL
Parameter	Average	Std dev	min	max
K1 Anterior (D)	-0.27	0.17	-0.59	0.06
K2 Anterior (D)	-0.29	0.16	-0.62	0.03
Cyl Anterior (D)	-0.03	0.24	-0.51	0.45
K1 Posterior (D)	-0.09	0.06	-0.21	0.03
K2 Posterior (D)	-0.01	0.14	-0.29	0.28
Cyl Posterior (D)	0.08	0.12	-0.15	0.30
CCT ($\mu$m)	-0.43	7.45	-15.03	14.16

Table 1: Summary of the comparison of anterior segment parameters between the VX130 and Galilei G4 showing the average difference between the devices, the standard deviation of the difference and the 95% confidence levels.

Parameter	Std dev 1	Std dev 2
K1 Anterior (D)	0.173	0.132
K2 Anterior (D)	0.095	0.237
Cyl Anterior (D)	0.166	0.229
K1 Posterior (D)	0.031	0.075
K2 Posterior (D)	0.093	0.107
Cyl Posterior (D)	0.103	0.112
CCT (μm)	2.89	3.68

Table 2: Repeatability of VX130,

a single eye was measured ten times and the std dev was calculated.

1. 42 eyes were measured 3 times each the average std dev is shown.

VII. CONCLUSIONS

The VX130 has the same intended use, technological characteristics, and principles of operation as its predicate devices.

The technological differences between the VX130 and its predicates raise no new issues of safety and effectiveness.

Performance data demonstrates that the VX130 is as safe and effective as the predicate devices.

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.