Predicate Devices

Reference Devices

K11157

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard OCT device with simplified analysis features compared to its predicate. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The analysis features listed are standard measurements derived from OCT data.

Therapeutic

No.
The device is described as a "diagnostic device to aid in the detection and management of ocular diseases," which means it helps identify and track diseases, rather than treating them.

Diagnostic

Yes
The 'Intended Use / Indications for Use' section explicitly states: "It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases...".

SaMD (Software as a Medical Device)

No

The device description explicitly states that the PRIMUS device is an ophthalmic instrument composed of electrical, mechanical, and optical subsystems, including an optical head, SD-OCT engine, patient module, and support modules. It is a physical instrument that acquires images, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The PRIMUS instrument is a non-contact, high-resolution tomographic imaging device that performs in-vivo viewing and measurement of posterior ocular structures. This means it directly examines the living eye, not samples taken from the body.
Intended Use: The intended use clearly states "in-vivo viewing" and "measurement of posterior ocular structures."
Device Description: The description emphasizes non-contact scanning of the eye.

Therefore, the PRIMUS instrument falls under the category of an in-vivo diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PRIMUS instrument is a non-contact, high resolution tomographic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.

Product codes (comma separated list FDA assigned to the subject device)

OBO

Device Description

The PRIMUS device is an ophthalmic instrument that provides the essential performance and functionality compared to the Carl Zeiss Meditec CIRRUS™ HD-OCT Model 4000 (K11157), with a separate manually-controlled patient interface and simplified analysis features. PRIMUS uses the same SD-OCT technology from the CIRRUS and offers a simplified user interface. In addition, the camera in the PRIMUS instrument operates at a reduced speed to acquire OCT images at comparable resolution in approximately the same amount of time.

The PRIMUS device is a computerized ophthalmologic instrument that acquires and allows visualization of cross-sectional tomograms of the eye using spectral domain optical coherence tomography (SD-OCT). The instrument is designed to scan the eye in a non-contact manner to acquire detailed cross-sectional images of various posterior ocular structures such as the retina and the optic nerve head. Various retinal structures of the eye from the internal limiting membrane to the retinal pigment epithelium (including layers such as the ganglion and retinal nerve fiber) can be imaged.

The PRIMUS instrument is available in one model, Model 200, which has a manually controlled patient interface and separate enclosure with components used in OCT scanning. The operator utilizes a keyboard, monitor and mouse to interface with the computer. Data acquired can be saved to the computer; PDFs of the reports may be saved to a USB-connected storage device.

The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [spectral domain optical coherence tomography (SD-OCT) to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal nerve fiber layers).

The device consists of two main parts: a manually controlled separate patient interface and an imaging engine box. The system is composed of a number of electrical, mechanical, and optical subsystems that are required to facilitate measurements and aid in patient alignment:

Optical head modules
SD-OCT engine modules
Patient module
Support modules

As part of its report driven workflow, at the completion of scan acquisition, PRIMUS presents the pre-ordered report(s) to the user in a sequential manner. The visualization and analysis reports that available in PRIMUS are as follows:

Macular Thickness Analysis (MTA) Based on 512 X 32 Macular Cube Scan
Optic Nerve Head (ONH) & Retinal Nerve Fiber Layer (RNFL) Analysis Based on 128 X 128 ONH & RNFL Cube Scan
HD 5-line Analysis Based on 5 line HD Raster Scan
HD 1-line Analysis Based on 1 line HD Raster Scan

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Spectral Domain OCT (SD-OCT), Confocal Scanning "Laser" Ophthalmoscope (cSLO)

Anatomical Site

Posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A prospective study was conducted to support the indication for use statement for the PRIMUS with software version 2.0 at Release 1 (R1) and to determine comparability of the measurements obtained from both the PRIMUS 200 and the Cirrus HD-OCT Model 4000 instruments. Clinical data was collected and analyzed to determine the repeatability and reproducibility of the measurements of the PRIMUS 200. The study enrolled normal eyes, eyes with retinal disease and glaucoma.

Comparative analysis for the PRIMUS 200 and CIRRUS Model 4000: A study was performed on total 127 subjects, which included 45 normal subjects, 39 retinal disease subjects and 43 glaucoma subjects. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. The comparative analyses utilized on one PRIMUS 200 device.

Repeatability and Reproducibility Study on the PRIMUS 200: A study was performed to determine the repeatability and reproducibility of the measurements of the PRIMUS 200 by analyzing 125 subjects, which included 44 normal subjects, 38 retinal disease subjects and 43 glaucoma subjects.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparative Analysis for the PRIMUS 200 and CIRRUS Model 4000:

Study Type: Comparative analysis study to evaluate equivalence of 19 measurement parameters between the PRIMUS 200 and Cirrus HD-OCT Model 4000.
Sample Size: 127 subjects (45 normal, 39 retinal disease, 43 glaucoma).
Key Results: The mean values of the 19 thickness parameters (retinal nerve fiber layer thickness (5 parameters), optic nerve head (5 parameters), and macular thickness (9 parameters)) were very similar between the two devices. The study results demonstrate substantial equivalence between the PRIMUS 200 and Cirrus HD-OCT Model 4000.
- Normal eyes (N=45):
  - Macular Thickness Parameters: Central Subfield mean difference 0.1 (SD 5.36), Inner Nasal mean difference -1.1 (SD 6.74), Inner Superior mean difference -3.8 (SD 6.30), Inner Temporal mean difference -2.1 (SD 6.25), Inner Inferior mean difference -2.8 (SD 6.44), Outer Nasal mean difference -3.0 (SD 4.96), Outer Superior mean difference -0.6 (SD 6.71), Outer Temporal mean difference -2.9 (SD 5.11), Outer Inferior mean difference -4.8 (SD 3.78).
  - RNFL Thickness Parameters: Average RNFL Thickness mean difference -2.3 (SD 4.05), Temporal mean difference -1.2 (SD 5.49), Superior mean difference -2.5 (SD 7.41), Nasal mean difference -2.5 (SD 5.06), Inferior mean difference -2.8 (SD 7.14).
  - ONH Parameters: Rim Area mean difference -0.02 (SD 0.057), Disc Area mean difference -0.02 (SD 0.089), Average Cup-to-Disc Ratio mean difference 0.01 (SD 0.026), Vertical Cup-to-Disc Ratio mean difference 0.01 (SD 0.031), Cup Volume mean difference 0.00 (SD 0.018).
- Retinal disease eyes (N=39):
  - Macular Thickness Parameters: Central Subfield mean difference 1.8 (SD 22.06), Inner Nasal mean difference -0.9 (SD 12.28), Inner Superior mean difference -2.2 (SD 16.04), Inner Temporal mean difference -2.3 (SD 15.13), Inner Inferior mean difference -3.1 (SD 14.72), Outer Nasal mean difference -1.9 (SD 7.22), Outer Superior mean difference 1.7 (SD 10.69), Outer Temporal mean difference -2.6 (SD 11.64), Outer Inferior mean difference -6.2 (SD 9.34).
- Glaucomatous eyes (N=43):
  - RNFL Parameters: Average RNFL Thickness mean difference -1.4 (SD 3.34), Temporal mean difference 1.2 (SD 7.62), Superior mean difference -2.1 (SD 6.50), Nasal mean difference -3.0 (SD 6.44), Inferior mean difference -1.2 (SD 5.80).
  - ONH Parameters: Rim Area mean difference 0.00 (SD 0.074), Disc Area mean difference 0.02 (SD 0.110), Average Cup-to-Disc Ratio mean difference 0.00 (SD 0.022), Vertical Cup-to-Disc Ratio mean difference 0.00 (SD 0.037), Cup Volume mean difference 0.01 (SD 0.044).

Repeatability and Reproducibility Study on the PRIMUS 200:

Study Type: Repeatability and reproducibility study.
Sample Size: 125 subjects (44 normal, 38 retinal disease, 43 glaucoma).
Key Results: PRIMUS 200 showed good repeatability and reproducibility for both normal and diseased eyes.
- Normal Eyes (N=44):
  - Macular Thickness Parameters: Repeatability SD range 2.73-4.82, Reproducibility SD range 4.63-6.18.
  - RNFL Thickness Parameters: Repeatability SD range 1.93-3.79, Reproducibility SD range 2.51-5.38.
  - ONH Parameters: Repeatability SD range 0.010-0.058, Reproducibility SD range 0.013-0.072.
- Diseased Eyes (N=38/43):
  - Macular Thickness Parameters: Repeatability SD range 3.66-12.31, Reproducibility SD range 5.10-13.84.
  - RNFL Thickness Parameters: Repeatability SD range 2.12-4.67, Reproducibility SD range 2.73-5.74.
  - ONH Parameters: Repeatability SD range 0.014-0.098, Reproducibility SD range 0.016-0.105.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111157

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.

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

June 21, 2017

Carl Zeiss Suzhou Co., Ltd. % Dong Hua Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568

Re: K163195

Trade/Device Name: PRIMUS Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: Mav 8. 2017 Received: May 9, 2017

Dear Dong Hua:

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 or any Federal statutes and regulations administered by other Federal agencies.

1

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 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 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,

Kesia Alexander

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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Indications for Use

510(k) Number (if known) K163195

Device Name

PRIMUS

Indications for Use (Describe)

The PRIMUS instrument is a non-contact, high resolution tomographic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (Revised)

510(k) SUMMARY (per 21 CFR §807.92)

PRIMUS

GENERAL INFORMATION

| Applicant: | | Carl Zeiss Suzhou Co., Ltd.
Modern Industrial Square 3b
No. 333 Xing Pu Road Sip
Suzhou, Jiangsu 215126 China

86-512-8227-3436 (phone)
86-512-6287-1366 (fax)
Establishment Registration Number: 3008564898 | | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Contact Person: | | Dong Hua
Sr. Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
(925) 557-4204 Phone
(925) 557-4259 Fax
E-mail: dong.hua@zeiss.com | | | |
| Date Prepared: | | June 09, 2017 | | | |
| Common Name: | | Tomography, Optical Coherence | | | |
| Classification Name: | | Ophthalmoscope | | | |
| Product Code and Class: | | OBO - Class II | | | |
| Classification Number: | | 21 CFR 886.1570 | | | |
| Trade/Proprietary Name: | | PRIMUS | | | |
| Model: | | 200 | | | |
| PREDICATE DEVICE | | | | | |
| Company: | | Carl Zeiss Meditec, Inc. | | | |
| Device: | Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic
Nerve Head and Ganglion Cell Normative Databases (K111157) | | | | |

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It is the opinion of Carl Zeiss Suzhou Company, Limited that the PRIMUS instrument is substantially equivalent to the predicate Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases Model 4000 (K111157) for the intended use for imaging and measurements of posterior ocular structures. The PRIMUS device is an ophthalmic diagnostic instrument that provides only the essential performance and functionality compared to Cirrus™ HD-OCT, e.g. with a separate manual-controlled patient interface and basic analysis features.

INDICATIONS FOR USE (21 CFR §807.92(a)(5))

The PRIMUS instrument is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.

DEVICE DESCRIPTION SUMMARY (21 CFR §807.92(a)(4))

The PRIMUS device is an ophthalmic instrument that provides the essential performance and functionality compared to the Carl Zeiss Meditec CIRRUS™ HD-OCT Model 4000 (K11157), with a separate manually-controlled patient interface and simplified analysis features. PRIMUS uses the same SD-OCT technology from the CIRRUS and offers a simplified user interface. In addition, the camera in the PRIMUS instrument operates at a reduced speed to acquire OCT images at comparable resolution in approximately the same amount of time.

Device Overview

The PRIMUS device is a computerized ophthalmologic instrument that acquires and allows visualization of cross-sectional tomograms of the eye using spectral domain optical coherence tomography (SD-OCT). The instrument is designed to scan the eye in a non-contact manner to acquire detailed cross-sectional images of various posterior ocular structures such as the retina and the optic nerve head. Various retinal structures of the eye from the internal limiting membrane to the retinal pigment epithelium (including layers such as the ganglion and retinal nerve fiber) can be imaged.

The PRIMUS instrument is available in one model, Model 200, which has a manually controlled patient interface and separate enclosure with components used in OCT scanning. The operator utilizes a keyboard, monitor and mouse to interface with the computer. Data acquired can be saved to the computer; PDFs of the reports may be saved to a USB-connected storage device.

The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [spectral domain optical coherence tomography (SD-OCT) to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal

5

nerve fiber layers).

The device consists of two main parts: a manually controlled separate patient interface and an imaging engine box. The system is composed of a number of electrical, mechanical, and optical subsystems that are required to facilitate measurements and aid in patient alignment:

Optical head modules
SD-OCT engine modules
Patient module
Support modules

As part of its report driven workflow, at the completion of scan acquisition, PRIMUS presents the pre-ordered report(s) to the user in a sequential manner. The visualization and analysis reports that available in PRIMUS are as follows:

Macular Thickness Analysis (MTA) Based on 512 X 32 Macular Cube Scan
Optic Nerve Head (ONH) & Retinal Nerve Fiber Layer (RNFL) Analysis Based on 128 X 128 ONH & RNFL Cube Scan
HD 5-line Analysis Based on 5 line HD Raster Scan
HD 1-line Analysis Based on 1 line HD Raster Scan

Description of Software

Software version 2.0 at Release 1 (R1) provides functions of patient management, image acquisition, visualization and analysis capabilities that are categorized into the following groups:

Patient Management and Administration
Acquisition
Analysis

CZSC has implemented a software development process according to IEC 62304. With software version 2.0 at Release 1 (R1), PRIMUS offers automatic retinal thickness measurement and quantitative analysis reports.

Risk Management and General Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, ZEISS adheres to recognized and established industry practice and relevant international standards.

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Technological Characteristics and Substantial Equivalence (21 CFR §807.92(a)(6)):

It is the opinion of Carl Zeiss Meditec, Incorporated that the proposed device, the PRIMUS 200, is substantially equivalent to the CIRRUS HD-OCT with Software Version 6.0.

The indications for use for the PRIMUS 200 is similar to the indications for the predicate device CIRRUS HD-OCT with Software Version 6.0.

A technological comparison and clinical testing demonstrate that the PRIMUS 200 system is functionally equivalent to the primary predicate CIRRUS HD-OCT (K111157) and does not raise new questions regarding safety and effectiveness.

Summary of Verification and Validation Activity (21 CFR §807.92(b)):

Bench Testing (21 CFR §807.92(b)(1))

Bench testing in the form of Unit, Integration and System Integration testing was performed to evaluate the performance and functionality of the software version 2.0. The System level software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans.

PRIMUS is designed and tested to applicable standards for electrical and optical safety with established specifications. Performance testing conducted on the PRIMUS instrument was consistent to the intended use claim. The verification testing demonstrates that the device performance complies with specifications and requirements. Results of verification and validation demonstrate safety and effectiveness as the predicate device, tests can be categorized into the following groups:

Device System Verification
Verification According to Harmonized/Recognized Standards
- . Electrical Safety and Electromagnetic Compatibility
- Environmental Simulation .
- . Usability
- Biocompatibility
Software Verification and Validation
Product Validation

Testing to Consensus Standards (21 CFR §807.92(b)(1))

The PRIMUS 200 system has been tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented.

Substantial Equivalence to Predicates (21 CFR §807.92(b)(1))

Verification testing to the system requirements (SRS) for the PRIMUS 200 system and the validation of the intended use is intended to support the claim of substantial equivalence to the following Substantial Equivalence table:

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| Device | PRIMUS
(Proposed Device K163195) | Cirrus HD-OCT with Retinal Nerve Fiber Layer
(RNFL), Macular, Optic Nerve Head and
Ganglion Cell Normative Database (K111157)
[Model: 4000] |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The CirrusTM HD-OCT with Retinal Nerve Fiber |
| Intended Use | The PRIMUS is used for in-vivo
viewing of axial cross-sectional
imaging and measurement of
posterior ocular structures. | Layer (RNFL), Macular, Optic Nerve Head and
Ganglion Cell Normative Databases is indicated
for in-vivo viewing, axial cross-sectional, and
three-dimensional imaging and measurement
of anterior and posterior ocular structures. |
| Indication for Use | The PRIMUS instrument is a non-
contact, high resolution
tomographic and biomicroscopic
imaging device. It is indicated for
in-vivo viewing of axial cross
sections and measurement of
posterior ocular structures,
including retina, retinal nerve
fiber layer, macula, and optic
disc. It is intended for use as a
diagnostic device to aid in the
detection and management of
ocular diseases including, but not
limited to, macular holes, cystoid
macular edema, diabetic
retinopathy, age-related macular
degeneration and glaucoma | The CirrusTM HD-OCT is a non-contact, high
resolution tomographic and biomicroscopic
imaging device. It is indicated for in-vivo
viewing, axial cross-sectional, and three-
dimensional imaging and measurement of
anterior and posterior ocular structures,
including cornea, retina, retinal nerve fiber
layer, ganglion cell plus inner plexiform layer,
macula, and optic nerve head. The Cirrus
normative databases are quantitative tools for
the comparison of retinal nerve fiber layer
thickness, macular thickness, ganglion cell plus
inner plexiform layer thickness, and optic
nerve head measurements to a database of
normal subjects. The Cirrus HD-OCT is
intended for use as a diagnostic device to aid
in the detection and management of ocular
diseases including, but not limited to, macular
holes, cystoid macular edema, diabetic
retinopathy, age-related macular
degeneration, and glaucoma |
| Device Classification | Optical Coherence Tomography | Optical Coherence Tomography (OCT) |
| Name
Generic Common Name | (OCT)
Optical Coherence Tomography
(OCT) | Optical Coherence Tomography (OCT) |
| Classification Product
Code | OBO | OBO |
| Class | II | II |
| Technology | Spectral Domain OCT (SD-OCT) | Spectral Domain OCT (SD-OCT) |
| OCT Imaging | | |
| Methodology | Spectral Domain OCT (SD-OCT) | Spectral Domain OCT (SD-OCT) |
| Optical Source | Super Luminescent Diode, 840nm | Super Luminescent Diode, 840nm |
| Optical Power | ≤ 725 µW at the cornea | 20 Hz |
| Transverse Resolution | Alignment : ≤ 80µm (in Tissue) | 25 µm (in tissue) |
| Fixation | | |
| Internal Fixation Source | Consistently displayed 525 nm Green
colored LED | LCD (green pixels) |
| Internal Fixation Focus
Adjustment | -23D to +17D (diopters) Focus of
Internal Fixation will change
according to different refractive
error adjustment | -20D to +20D (diopters) |
| External Fixation Source | Mechanically adjustable arm with
blinking LED at the tip | Mechanically adjustable arm with blinking
LED at the tip |

Table 1: Substantial Equivalence Table

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Table 1: Substantial Equivalence Table

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CLINICAL EVALUATION

Clinical evaluation performed on the PRIMUS supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness.

A prospective study was conducted to support the indication for use statement for the PRIMUS with software version 2.0 at Release 1 (R1) and to determine comparability of the measurements obtained from both the PRIMUS 200 and the Cirrus HD-OCT Model 4000 instruments. Clinical data was collected and analyzed to determine the repeatability and reproducibility of the measurements of the PRIMUS 200. The study enrolled normal eyes, eyes with retinal disease and glaucoma.

Comparative analysis for the PRIMUS 200 and CIRRUS Model 4000

A study was performed on total 127 subjects, which included 45 normal subjects, 39 retinal disease subjects and 43 glaucoma subjects were analyzed in the study to evaluate equivalence of the means of 19 measurement parameters: retinal nerve fiber layer (RNFL) thickness (5 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the PRIMUS 200 and Cirrus HD-OCT Model 4000.

Two study devices, PRIMUS 200 & Cirrus HD-OCT Model 4000 and each measurement parameter, the mean of the available measurements was calculated for each study eye. The difference in each of the 19 measurement parameters between the PRIMUS 200 and Cirrus HD-OCT Model 4000 was calculated for each study eye. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. The comparative analyses utilized on one PRIMUS 200 device, and the results are presented in Tables 2, 3 and 4 for the normal, retinal disease and glaucoma disease eye studies, respectively. Additionally 95% Cls for the lower and upper limits of agreement are provided in Table 2a (normal eyes), Table 3a (retinal disease eyes) and Table 4a (glaucomatous eyes).

The mean values of the 19 thickness parameters were very similar between the two devices. The results of the study parameters demonstrate substantial equivalence between the PRIMUS 200 and Cirrus HD-OCT Model 4000.

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Table 2: Mean difference in macular thickness, RNFL thickness and ONH measurements between PRIMUS 200 and CIRRUS 4000 (Normal eyes)

| Mean (SD) Mean (SD) | Difference
Mean (SD) | 95%
Confidence
Interval of
Mean
Difference | 95% Limits of
Agreement for
Differences
Between
Subject Means |
|---------------------- | | Central Subfield (µm) | Inner Nasal (µm) | Inner Superior (µm) | Inner Temporal (µm) | Inner Inferior (μm) | Outer Nasal (μm) | Outer Superior (µm) | Outer Temporal (µm) | Outer Inferior (µm) | RNFL Thickness | Average RNFL
Thickness (µm) | 90.6 (10.03) | Temporal (µm) | Superior (µm) | Nasal (µm) | Inferior (µm) | ONH Parameters (N=45) | Rim Area (mm²) | Disc Area (mm²) | Average Cup-to-Disc
Ratio | 0.54 (0.143) | Vertical Cup-to-Disc
Ratio | 0.52 (0.138) | Cup Volume (mm³) | Primus 200
| Cirrus 4000
------------|-------------------------------------|--------------------------|-------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Macular Thickness Parameters (N=45) | | | | |
| 236.1 (19.87) | 236.0 (20.77) | 0.1 (5.36) | (-1.5, 1.7) | (-10.4, 10.6) |
| 315.1 (17.16) | 316.2 (18.14) | -1.1 (6.74) | (-3.1, 0.9) | (-14.3, 12.1) |
| 311.9 (16.11) | 315.6 (16.47) | -3.8 (6.30) | (-5.6, -2.0) | (-16.1, 8.5) |
| 299.4 (16.59) | 301.5 (16.49) | -2.1 (6.25) | (-3.9, -0.3) | (-14.3, 10.2) |
| 309.6 (16.80) | 312.4 (16.96) | -2.8 (6.44) | (-4.7, -0.9) | (-15.4, 9.8) |
| 291.0 (13.47) | 293.9 (14.08) | -3.0 (4.96) | (-4.4, -1.6) | (-12.7, 6.7) |
| 273.5 (11.67) | 274.1 (10.37) | -0.6 (6.71) | (-2.6, 1.4) | (-13.8, 12.6) |
| 252.7 (12.81) | 255.6 (12.02) | -2.9 (5.11) | (-4.4, -1.4) | (-12.9, 7.1) |
| 258.0 (12.18) | 262.8 (13.37) | -4.8 (3.78) | (-5.9, -3.7) | (-12.2, 2.6) |
Parameters (N=45) | | | | | |
| 92.8 (10.00) | -2.3 (4.05) | (-3.5, -1.1) | (-10.2, 5.6) |
| 58.4 (6.11) | 59.7 (8.65) | -1.2 (5.49) | (-2.8, 0.4) | (-12.0, 9.6) |
| 115.5 (16.88) | 118.0 (16.64) | -2.5 (7.41) | (-4.7, -0.3) | (-17.0, 12.0) |
| 71.7 (9.86) | 74.2 (10.93) | -2.5 (5.06) | (-4.0, -1.0) | (-12.4, 7.4) |
| 116.6 (17.20) | 119.5 (16.31) | -2.8 (7.14) | (-4.9, -0.7) | (-16.8, 11.2) |
| | | | | |
| 1.29 (0.194) | 1.31 (0.184) | -0.02 (0.057) | (-0.04, 0.00) | (-0.13, 0.09) |
| 1.94 (0.337) | 1.96 (0.341) | -0.02 (0.089) | (-0.05, 0.01) | (-0.19, 0.15) |
| 0.53 (0.148) | 0.01 (0.026) | (0.00, 0.02) | (-0.04, 0.06) |
| 0.51 (0.145) | 0.01 (0.031) | (0.00, 0.02) | (-0.05, 0.07) |
| 0.21 (0.149) | 0.20 (0.148) | 0.00 (0.018) | (-0.01, 0.01) | (-0.04, 0.04) |

95% Confidence Interval of Mean Difference = mean ± 1.96 x SE.

95% Limits of Agreement = mean ± 1.96 x SD.

11

Table 2a: 95% Limits of Agreement for Difference between PRIMUS 200 and CIRRUS 4000 Means, 95% Cls for the Limits of Agreement (Normal eyes)

| | 95% Limits of
Agreement for
Differences Between
Subject Means | 95% Confidence
Interval for Lower
Limit of Agreement | 95% Confidence
Interval for Upper
Limit of Agreement |
|---------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| Macular Thickness Parameters (N = 45) | | | |
| Central Subfield (µm) | (-10.4, 10.6) | (-13.1, -7.7) | (7.9, 13.3) |
| Inner Nasal (μm) | (-14.3, 12.1) | (-17.7, -10.9) | (8.7, 15.5) |
| Inner Superior (µm) | (-16.1, 8.5) | (-19.3, -12.9) | (5.3, 11.7) |
| Inner Temporal (µm) | (-14.3, 10.2) | (-17.5, -11.1) | (7.0, 13.4) |
| Inner Inferior (µm) | (-15.4, 9.8) | (-18.7, -12.1) | (6.5, 13.1) |
| Outer Nasal (μm) | (-12.7, 6.7) | (-15.2, -10.2) | (4.2, 9.2) |
| Outer Superior (µm) | (-13.8, 12.6) | (-17.2, -10.4) | (9.2, 16.0) |
| Outer Temporal (µm) | (-12.9, 7.1) | (-15.5, -10.3) | (4.5, 9.7) |
| Outer Inferior (μm) | (-12.2, 2.6) | (-14.1, -10.3) | (0.7, 4.5) |
| RNFL Parameter (N = 45) | | | |
| Average RNFL Thickness (μm) | (-10.2, 5.6) | (-12.2, -8.2) | (3.6, 7.6) |
| Temporal (µm) | (-12.0, 9.6) | (-14.8, -9.2) | (6.8, 12.4) |
| Superior (µm) | (-17.0, 12.0) | (-20.7, -13.3) | (8.3, 15.7) |
| Nasal (µm) | (-12.4, 7.4) | (-15.0, -9.8) | (4.8, 10.0) |
| Inferior (µm) | (-16.8, 11.2) | (-20.4, -13.2) | (7.6, 14.8) |
| ONH Parameters (N = 45) | | | |
| Rim Area (mm²) | (-0.13, 0.09) | (-0.16, -0.10) | (0.06, 0.12) |
| Disc Area (mm²) | (-0.19, 0.15) | (-0.24, -0.14) | (0.10, 0.20) |
| Average Cup-to-Disc Ratio | (-0.04, 0.06) | (-0.05, -0.03) | (0.05, 0.07) |
| Vertical Cup-to-Disc Ratio | (-0.05, 0.07) | (-0.07, -0.03) | (0.05, 0.09) |
| Cup Volume (mm³) | (-0.04, 0.04) | (-0.05, -0.03) | (0.03, 0.05) |

95% Limits of Agreement = mean ± 1.96 x SD.

95% Confidence Interval of (Lower/Upper) Limit of Agreement = (Lower/Upper) Limit ± 1.96 x V3*SE.

12

| | Primus 200
Mean (SD) | Cirrus 4000
Mean (SD) | Difference
Mean (SD) | 95%
Confidence
Interval of
Mean
Difference | 95% Limits of
Agreement for
Differences
Between Subject
Means |
|-------------------------------------|-------------------------|--------------------------|-------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Macular Thickness Parameters (N=39) | | | | | |
| Central Subfield (µm) | 308.8 (113.31) | 307.0 (114.32) | 1.8 (22.06) | (-5.1, 8.7) | (-41.4, 45.0) |
| Inner Nasal (µm) | 353.2 (71.61) | 354.2 (67.90) | -0.9 (12.28) | (-4.8, 3.0) | (-25.0, 23.2) |
| Inner Superior (µm) | 349.8 (71.23) | 352.0 (70.01) | -2.2 (16.04) | (-7.2, 2.8) | (-33.6, 29.2) |
| Inner Temporal (µm) | 346.5 (85.67) | 348.8 (87.22) | -2.3 (15.13) | (-7.0, 2.4) | (-32.0, 27.4) |
| Inner Inferior (µm) | 353.2 (81.13) | 356.3 (82.62) | -3.1 (14.72) | (-7.7, 1.5) | (-32.0, 25.8) |
| Outer Nasal (µm) | 322.6 (53.88) | 324.5 (54.96) | -1.9 (7.22) | (-4.2, 0.4) | (-16.1, 12.3) |
| Outer Superior (µm) | 311.6 (70.11) | 309.9 (72.34) | 1.7 (10.69) | (-1.7, 5.1) | (-19.3, 22.7) |
| Outer Temporal (µm) | 289.3 (67.34) | 291.9 (65.99) | -2.6 (11.64) | (-6.3, 1.1) | (-25.4, 20.2) |
| Outer Inferior (µm) | 296.0 (70.34) | 302.2 (70.65) | -6.2 (9.34) | (-9.1, -3.3) | (-24.5, 12.1) |

Table 3: Mean difference in macular thickness measurements between PRIMUS 200 and CIRRUS 4000 (Retinal disease eyes)

95% Confidence Interval of Mean Difference = mean ± 1.96 x SE. 95% Limits of Agreement = mean ± 1.96 x SD.

Table 3a: 95% Limits of Agreement for Difference between PRIMUS 200 and CIRRUS 4000 Means of Macular Thickness Measurements, 95% Cls for the Limits of Agreement (Retinal disease eyes)

| | 95% Limits of
Agreement for
Differences
Between Subject
Means | 95% Confidence
Interval for Lower
Limit of
Agreement | 95% Confidence
Interval for Upper
Limit of Agreement |
|---------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------|
| Macular Thickness Parameters (N = 39) | | | |
| Central Subfield (µm) | (-41.4, 45.0) | (-53.4, -29.4) | (33.0, 57.0) |
| Inner Nasal (µm) | (-25.0, 23.2) | (-31.7, -18.3) | (16.5, 29.9) |
| Inner Superior (µm) | (-33.6, 29.2) | (-42.3, -24.9) | (20.5, 37.9) |
| Inner Temporal (µm) | (-32.0, 27.4) | (-40.2, -23.8) | (19.2, 35.6) |
| Inner Inferior (µm) | (-32.0, 25.8) | (-40.0, -24.0) | (17.8, 33.8) |
| Outer Nasal (µm) | (-16.1, 12.3) | (-20.0, -12.2) | (8.4, 16.2) |
| Outer Superior (µm) | (-19.3, 22.7) | (-25.1, -13.5) | (16.9, 28.5) |
| Outer Temporal (µm) | (-25.4, 20.2) | (-31.7, -19.1) | (13.9, 26.5) |
| Outer Inferior (µm) | (-24.5, 12.1) | (-29.6, -19.4) | (7.0, 17.2) |

95% Limits of Agreement = mean ± 1.96 x SD.

95% Confidence Interval of (Lower/Upper) Limit of Agreement = (Lower/Upper) Limit ± 1.96 x V3*SE.

13

Table 4: Mean difference in RNFL thickness and ONH measurements between PRIMUS 200 and CIRRUS 4000 (Glaucomatous eyes)

| | Primus 200
Mean (SD) | Cirrus 4000
Mean (SD) | Difference
Mean (SD) | 95%
Confidence
Interval of
Mean
Difference | 95% Limits of
Agreement for
Differences
Between Subject
Means |
|-----------------------------|-------------------------|--------------------------|-------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| | RNFL Parameters (N=43) | | | | |
| Average RNFL Thickness (µm) | 71.0 (15.00) | 72.3 (15.78) | -1.4 (3.34) | (-2.4, -0.4) | (-7.9, 5.1) |
| Temporal (µm) | 55.5 (11.51) | 54.3 (9.72) | 1.2 (7.62) | (-1.1, 3.5) | (-13.7, 16.1) |
| Superior (μm) | 85.2 (25.96) | 87.4 (25.51) | -2.1 (6.50) | (-4.0, -0.2) | (-14.8, 10.6) |
| Nasal (µm) | 61.8 (9.16) | 64.8 (12.94) | -3.0 (6.44) | (-4.9, -1.1) | (-15.6, 9.6) |
| Inferior (µm) | 81.6 (26.11) | 82.8 (26.17) | -1.2 (5.80) | (-2.9, 0.53) | (-12.6, 10.2) |
| ONH Parameters (N=43) | | | | | |
| Rim Area (mm²) | 0.83 (0.301) | 0.82 (0.300) | 0.00 (0.074) | (-0.02, 0.02) | (-0.15, 0.15) |
| Disc Area (mm²) | 2.07 (0.367) | 2.05 (0.345) | 0.02 (0.110) | (-0.01, 0.05) | (-0.20, 0.24) |
| Average Cup-to-Disc Ratio | 0.77 (0.106) | 0.76 (0.107) | 0.00 (0.022) | (-0.01, 0.01) | (-0.04, 0.04) |
| Vertical Cup-to-Disc Ratio | 0.76 (0.097) | 0.75 (0.103) | 0.00 (0.037) | (-0.01, 0.01) | (-0.07, 0.07) |
| Cup Volume (mm³) | 0.60 (0.333) | 0.59 (0.335) | 0.01 (0.044) | (0.00, 0.02) | (-0.08, 0.10) |

95% Confidence Interval of Mean Difference = mean ± 1.96 x SE.

95% Limits of Agreement = mean ± 1.96 x SD.

Table 4a: 95% Limits of Agreement for Difference between PRIMUS 200 and CIRRUS 4000 Means of RNFL thickness and ONH Measurements, 95% Cls for the Limits of Agreement (Glaucomatous eyes)

| | 95% Limits of
Agreement for
Differences Between
Subject Means | 95% Confidence
Interval for Lower
Limit of Agreement | 95% Confidence
Interval for Upper
Limit of Agreement |
|-----------------------------|------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| RNFL Parameter ( N = 43) | | | |
| Average RNFL Thickness (µm) | (-7.9, 5.1) | (-9.6, -6.2) | (3.4, 6.8) |
| Temporal (µm) | (-13.7, 16.1) | (-17.6, -9.8) | (12.2, 20.0) |
| Superior (µm) | (-14.8, 10.6) | (-18.2, -11.4) | (7.2, 14.0) |
| Nasal (µm) | (-15.6, 9.6) | (-18.9, -12.3) | (6.3, 12.9) |
| Inferior (µm) | (-12.6, 10.2) | (-15.6, -9.6) | (7.2, 13.2) |
| ONH Parameters (N = 43) | | | |
| Rim Area (mm²) | (-0.15, 0.15) | (-0.19, -0.11) | (0.11, 0.19) |
| Disc Area (mm²) | (-0.20, 0.24) | (-0.26, -0.14) | (0.18, 0.30) |
| Average Cup-to-Disc Ratio | (-0.04, 0.04) | (-0.05, -0.03) | (0.03, 0.05) |
| Vertical Cup-to-Disc Ratio | (-0.07, 0.07) | (-0.09, -0.05) | (0.05, 0.09) |
| Cup Volume (mm³) | (-0.08, 0.10) | (-0.10, -0.06) | (0.08, 0.12) |

95% Limits of Agreement = mean ± 1.96 x SD.

95% Confidence Interval of (Lower/Upper) Limit of Agreement = (Lower/Upper) Limit ± 1.96 x √ 3 *SE.

14

Repeatability and Reproducibility Study on the PRIMUS 200

A study was performed to determine the repeatability and reproducibility of the measurements of the PRIMUS 200 by analyzing 125 subjects, which included 44 normal subjects, 38 retinal disease subjects and 43 glaucoma subjects.

Analysis of variance (ANOVA) with the mixed-effects model was used for the inter-device/operator variability, repeatability SD, the repeatability % COV, and interaction between subject and device/operator variability of each measurement parameter. Since each operator was assigned to a single PRIMUS 200 device, the inter-operator and inter-device variability were not estimated separately. The repeatability and reproducibility standard deviation (SD) and limits for the PRIMUS 200 are shown in Tables 4 and 5. PRIMUS 200 showed good repeatability and reproducibility for both normal and diseased eyes.

	PRIMUS 200
Parameter	Repeatability			Reproducibility
	SD	Limit	COV %	SD	Limit	COV %
Macular Thickness Parameters (N = 44)
Central Subfield ( $μm$ )	3.02	8.46	1.29	4.63	12.96	1.97
Inner Nasal ( $μm$ )	2.81	7.87	0.90	5.52	15.46	1.77
Inner Superior ( $μm$ )	3.30	9.24	1.07	5.53	15.48	1.79
Inner Temporal ( $μm$ )	2.79	7.81	0.94	5.21	14.59	1.75
Inner Inferior ( $μm$ )	3.01	8.43	0.98	5.14	14.39	1.67
Outer Nasal ( $μm$ )	2.73	7.64	0.94	4.75	13.30	1.64
Outer Superior ( $μm$ )	4.82	13.50	1.76	6.18	17.30	2.26
Outer Temporal ( $μm$ )	3.03	8.48	1.20	4.98	13.94	1.97
Outer Inferior ( $μm$ )	3.20	8.96	1.25	4.63	12.95	1.80
RNFL Thickness Parameters (N = 44)
Avg. RNFL Thickness ( $μm$ )	1.93	5.40	2.12	2.51	7.03	2.76
Temporal ( $μm$ )	2.96	8.29	5.01	3.38	9.46	5.72
Superior ( $μm$ )	3.64	10.19	3.14	5.15	14.42	4.44
Nasal ( $μm$ )	3.35	9.38	4.57	3.91	10.95	5.33
Inferior ( $μm$ )	3.79	10.61	3.29	5.38	15.06	4.66
ONH Parameters (N = 44)
Rim Area ( $mm²$ )	0.037	0.104	2.839	0.048	0.134	3.683
Disc Area ( $mm²$ )	0.058	0.162	2.957	0.072	0.202	3.671
Average CD Ratio	0.010	0.028	1.844	0.013	0.036	2.397
Vertical Cup-to-Disc Ratio	0.017	0.048	3.308	0.019	0.053	3.698
Cup Volume ( $mm³$ )	0.014	0.039	6.702	0.016	0.045	7.660

Table 5: PRIMUS 200 repeatability and reproducibility in measuring macular thickness and ONH parameters (Normal eyes)

Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 × Repeatability SD.

Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the square root of the sum of repeatability variance and the variance components of operator, operatorsubjects, device and devicesubjects.

15

Reproducibility Limit is the upper 95 % limit for the difference between repeated results under reproducibility conditions.

Reproducibility Limit = 2.8 ×reproducibility SD.

COV = Coefficient of Variation = SD 🇿🇿ean. 🇿🇿00. SD is either Repeatability SD or Reproducibility SD.

Table 6: PRIMUS 200 repeatability and reproducibility in measuring macular thickness and ONH parameters (Diseased eyes)

	PRIMUS 200
Parameter	Repeatability			Reproducibility
	SD	Limit	COV %	SD	Limit	COV %
	Macular Thickness Parameters (N = 38)
Central Subfield (µm)	12.31	34.47	4.02	13.84	38.75	4.52
Inner Nasal (µm)	5.37	15.04	1.54	6.46	18.09	1.85
Inner Superior (µm)	7.05	19.74	2.04	8.42	23.58	2.43
Inner Temporal (µm)	7.22	20.22	2.10	9.40	26.32	2.73
Inner Inferior (μm)	4.48	12.54	1.28	6.88	19.26	1.96
Outer Nasal (μm)	3.66	10.25	1.14	5.10	14.28	1.59
Outer Superior (µm)	4.16	11.65	1.34	5.08	14.22	1.64
Outer Temporal (µm)	4.73	13.24	1.63	7.69	21.53	2.65
Outer Inferior (µm)	4.35	12.18	1.47	5.17	14.48	1.75
	RNFL Thickness Parameters (N = 43)
Avg. RNFL Thickness (μm)	2.12	5.94	3.02	2.73	7.64	3.89
Temporal (µm)	3.34	9.35	6.10	4.58	12.82	8.36
Superior (μm)	4.67	13.08	5.56	5.74	16.07	6.83
Nasal (μm)	3.47	9.72	5.57	4.19	11.73	6.72
Inferior (µm)	4.47	12.52	5.60	5.39	15.09	6.75
ONH Parameters (N = 43)
Rim Area (mm²)	0.050	0.140	6.028	0.055	0.154	6.631
Disc Area (mm²)	0.098	0.274	4.733	0.105	0.294	5.072
Average CD Ratio	0.014	0.039	1.829	0.016	0.045	2.091
Vertical Cup-to-Disc
Ratio	0.024	0.067	3.173	0.025	0.070	3.305
Cup Volume (mm³)	0.051	0.143	8.645	0.052	0.146	8.814

Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 × Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the square root of the sum of repeatability variance and the variance components of operator, operatorsubjects, device and devicesubjects. Reproducibility Limit is the upper 95 % limit for the difference between repeated results under reproducibility conditions.

Reproducibility Limit = 2.8 × Reproducibility SD.

COV = Coefficient of Variation = SD ÷ Mean. × 100. SD is either Repeatability SD or Reproducibility SD.

16

510(k) Summary (21 CFR §807.92(c))

As described in this 510(k) Summary, all testing deemed necessary was conducted on the PRIMUS 200 with Software Version 2.0 to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use and substantially equivalent to, and performs as well as, the predicate device