The Macular Integrity Assessment (MAIA™) is indicated for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

Device Description

The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry"). MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing: - images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination; - recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics; - measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina; - comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles. MAIA 100 works with no pupil dilation (non-mydriatic). MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MAIA™ device are not explicitly stated in terms of specific performance thresholds (e.g., "accuracy must be >X%"). Instead, the study focuses on demonstrating the precision (repeatability and reproducibility) of the device's measurements for macular sensitivity. The reported device performance is presented as standard deviations (SD) for both overall mean thresholds and individual grid point thresholds.

Metric	Acceptance Criteria (Implicit: demonstrate acceptable precision)	Reported Device Performance (Normal Eyes)	Reported Device Performance (Pathology Eyes)
Overall Mean Threshold	-	29.7 dB (Mean)	23.5 dB (Mean)
Overall Standard Deviation	-	1.14 dB	4.23 dB
Repeatability SD*	-	0.42 dB	0.75 dB
Reproducibility SD**	-	0.96 dB	0.75 dB
Individual Grid Point Results	-
Repeatability SD (Minimum)	-	0.94	1.33
Repeatability SD (Median)	-	1.40	2.36
Repeatability SD (Maximum)	-	2.43	3.16
Reproducibility SD (Minimum)	-	1.06	1.33
Reproducibility SD (Median)	-	1.80	2.43
Reproducibility SD (Maximum)	-	2.70	3.24

estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.
** estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.

The study's conclusion states that "all testing deemed necessary was conducted on the MAIA™ to ensure that the device is safe and effective for its intended use," implying that these precision results met the internal acceptance benchmarks for demonstrating substantial equivalence.

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

The "test set" in this context refers to the subjects used in the precision study.

Sample Size:
- Normal Subjects: 12 subjects (each tested on one eye only).
- Pathology Subjects: 12 subjects (each tested on one eye only).
- Each subject/eye was tested 3 times within a session (3 repeated measures).
Data Provenance: The subjects were enrolled at two different clinical sites. The document does not specify the country of origin of these clinical sites, but the company is based in Italy. The study appears to be prospective, as subjects were enrolled for the purpose of this precision study.

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

The document does not describe the establishment of ground truth for the test set (the precision study participants) in terms of expert consensus for specific macular sensitivity measurements. Instead, for the pathology group, the "diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The number and specific qualifications (e.g., years of experience) of these ophthalmologists are not specified.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The study focuses on the device's precision in measuring macular sensitivity, rather than on a diagnostic performance where multiple expert opinions would need to be adjudicated.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document does not mention human readers or AI assistance in the context of the MAIA™ device's operation or evaluation in this submission. The device itself is an automated perimeter and ophthalmoscope.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm-based system for measuring macular sensitivity and fixation. The precision study evaluates the performance of this system independently. There is no "human-in-the-loop" component described that would alter or assist the device's primary measurements of macular sensitivity and fixation.

7. Type of Ground Truth Used

For the Precision Study (Test Set):
- For normal subjects, the implication is that they had no known retinal pathology.
- For pathology subjects, the ground truth for their pathological status was established by "a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The specific values of macular sensitivity measured by the MAIA™ are the output being evaluated for precision, not compared against an external "ground truth" measurement for sensitivity.
For the Reference Database (Training Set - described in section 9): The ground truth for the reference database was established by measuring threshold sensitivity in subjects deemed "normal subjects" (see point 9).

8. Sample Size for the Training Set

The document mentions a "reference database" that serves as the equivalent of a training or reference set for the device's normative comparison.

Sample Size: 494 eyes of 270 normal subjects.

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

The "ground truth" for the reference database (training set) was established by measuring threshold sensitivity data from:

"Normal subjects": These subjects were enrolled at 4 different clinical sites.
Age Range: 21-86 years (mean 43, std. dev. 15).
Recruitment: Among the clinics' personnel and relatives of the clinics' regular patients.

The implication is that these subjects were screened and determined to be without ocular pathology affecting macular sensitivity, thus providing a "normal" baseline for comparison. The specific criteria for deeming a subject "normal" (e.g., visual acuity, fundus examination results) are not detailed beyond "normal subjects."

Summary

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mmary of safety and effectiveness

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SUBMITTER INFORMATION

A. Company name:	CenterVue SpA
B. Company address:	via Tommaseo 77, 35131, Padova, ITALY
C. Company phone:	+39 049 781 1828
Company fax:	+39 049 781 1899
D. Contact person:	Giuliano BarbaroManaging Director
E. Date summary prepared:	4 April 2010

DEVICE IDENTIFICATION

Ophthalmoscope, AC-powered; Automated Perimeter, AC-powered Generic Device Name: A.
MAIA™, Macular Integrity Assessment Trade/proprietary name: в.
C. Classification: Class II
HLI, HPT Product Code: D.

DEVICE DESCRIPTION

MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing:

images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination;
recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics;
measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina;
comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles.

MAIA 100 works with no pupil dilation (non-mydriatic).

MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.

INDICATIONS FOR USE

CenterVue SpA

ia Tommaseo. 7 35131 Padova, Italy www.centervue.com

0 +30 Mg 781 1829 fax +39 049 781 1899 e-mail: info@centervue.com 378243 CCIAA PD oc .: € 480.000,00 i.v.

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centervue

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that is a quantitative tool for the comparison of macular sensitivity to a database of known

JIVALENCE

device is substantially equivalent to the combination of the following predicate devices with regard to intended use, operating principle, function:

Predicate Device	510(k) Holder	510(k) No.	Date cleared
MP-1 MICROPERIMETER	Nidek Technologies Srl	K023719	December 23rd 2002
MP-1 MICROPERIMETER	Nidek Technologies Srl	K061768	September 28th 2006
CIRRUS HD-OCT(*)	Carl Zeiss Meditec Inc.	K063378	January 26th 2007

(*) only with regard to its retinal imaging sub-system

CLINICAL EVALUATION

Clinical data was collected and evaluated to support the indications for use statement for MAIA™ and to demonstrate substantial equivalence to the above predicate devices.

In particular, the reference database was developed by obtaining threshold sensitivity data from 494 eyes of 270 normal subjects, enrolled at 4 different clinical sites. The age range of the measured population was 21-86 (mean 43, std. dev. 15). Subjects were recruited among the clinics' personnel and among the relatives of the clinics' regular patients. The following MAIA perimetric grid and other device settings were used for the measurements:

Number of stimuli: 61; .
Macular coverage: 10°; .
Size of stimulus: Goldmann III; .
Duration of stimulus: 200 ms; ●
. Background luminance: 4 asb;
Maximum luminance: 1000 asb; .
Threshold algorithm: standard 4-2 staircase; ●
. Measurement scale: 0 to 36 dB;
. Fixation target: central circle of 1° diameter.

PRECISION

A precision study was conducted which measured both individual location thresholds (n = 37 per eye) and average threshold over all locations. Three devices were used, each operated by a different operator. The study included 24 subjects, each tested on one eye only: 12 without pathology and 12 with bathology. Each subject/eye was tested 3 times within a session (3 repeated measures for each subject). Subjects were nested within each configuration, that is, each subject appears in one, unique device-operator configuration only. The design was repeated twice: once for healthy eyes and once for eyes with pathologies.

CenterVue SpA

ia Tommasoo, 77 35131 Padova, Italy www.centervue.com

tel +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com

A 478243 COLA PO CF /P VA 04296580287 Cap. soc .: € 480.000.00 i.v.

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ubiect selection criteria

Twelve subjects with normal eyes and 12 subjects with retinal pathologies were enrolled at two different clinical sites based on the following criteria:

4 normal subjects and 4 subjects with retinal pathologies enrolled at site 1 and measured with device 1 by operator 1;
4 normal subjects (different from above) and 4 subjects with retinal pathologies (different from above)enrolled at site 1 and measured with device 2 by operator 2;
4 normal subjects and 4 subjects with retinal pathologies enrolled at site 2 and measured with device 3 by operator 3;

Within each pathology category, subjects with varying parameters including age and visual acuity were enrolled. For the pathology group, subjects with early and intermediate age-related macular degeneration as well as with mild, moderate, severe and proliferative diabetic retinopathy were enrolled. Diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history. Subjects met defined inclusion criteria, but none of the exclusion criteria.

Precision results

	Normal	Pathology
# subjects	12	12
Overall Mean	29.7 dB	23.5 dB
Overall Standard deviation	1.14 dB	4.23 dB
Repeatability SD*	0.42 dB	0.75 dB
Reproducibility SD**	0.96 dB	0.75 dB

estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.

** estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.

Individual Grid Point Results

Group/Parameter	Repeatability SD	Reproducibility SD
Normal	Minimum	0.94	1.06
	Median	1.40	1.80
	Maximum	2.43	2.70
Pathology	Minimum	1.33	1.33
	Median	2.36	2.43
	Maximum	3.16	3.24

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the MAIA™ to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

CenterVue SpA

via Tommaseo. 77 35131 Padova, Italy www.centervue.com

tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com REA: 378243 CCIAA PD CFJP, NA: 04296580287 Cap. soc.: € 480.000,00 i.v.

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

CenterVue SpA c/o Mr. Giuliano Barbaro Managing Director Via Tommaseo 77 Padova, Italy 35131

MAY -2 7 2010

Re: K092187

Trade/Device Name: Macular Integrity Assessment (MAIA ") Device Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter, Automatic, AC-powered Regulatory Class: Class II Product Code: HPT, HLI Dated: April 22, 2010 Received: April 26, 2010

Dear Mr. Barbaro:

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 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 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/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 Small Manufacturers, International and Consumer Assistance 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,

Kesia Alexander

for

Ma
Dir
Div

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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centervue at the center of vision

Indications for use statement

510(k) Number: K092187

Device Name: Macular Integrity Assessment (MAIATM)

Indications for use:

Prescription Use M

AND/OR Over-The-Counter Use

Callaway

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

510(k) Number K092187

via Tommaseo, 77 35131 Padova, Italy www.centervue.com tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com

REA: 378243 CCIAA PD C.F./P. IVA: 04296580287 Cap. soc.; € 480,000,00 i.v.

Regulation Number and Section

§ 886.1605 Perimeter.

(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.