The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions.

It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.

The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

Device Description

P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals.

The P200TE delivers images in the following image modes:

Scanning Laser Ophthalmoscopy
. Reflectance imaging
Autofluorescence imaging
. Optical Coherence Tomography

The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.

The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.

The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user.

The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eye by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the images are generated from the captured detector data.

P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.

P200TE automatic segmentation provides comprehensive retinal and optic nerve head information, including:

. Full Retinal Thickness (FRT)
. Ganglion Cell Complex Thickness (GCC)
. ONH Cup and Disc Analysis
. ONH Nerve Fiber Layer Thickness

The P200TE refers to the scan head component of the system, together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems.

The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.

Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the P200TE device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The study for the P200TE focused on demonstrating agreement and precision compared to the predicate device, Optovue iVue, across various measurement parameters. The performance goals for acceptance were met for these parameters, with specific quantitative targets implied by the "Limit (Ratio)" in the precision tables, representing the upper limit of the coefficient of variation (CV%) or similar measure relative to an acceptable threshold.

Table of Acceptance Criteria and Reported Device Performance

Measurement Parameter Category	Acceptance Criteria (Implicit from Study Goals)	Reported Device Performance (P200TE)
Agreement (P200TE vs. iVue)	Excellent agreement expected, assessed via Bland-Altman and Deming Regression analysis.	Met for FRT, RNFL, ONH parameters.
		Not met for GCC due to a fundamental difference in scan location (P200TE's GCC grid is not shifted 1mm temporally from fovea, unlike iVue's).
Precision (Repeatability)	Performance goals set (values not explicitly stated, but represented by "Limit (Ratio)" in tables). Lower variability desired.	Met for all parameters (FRT, RNFL, GCC, ONH) across all groups.
Precision (Reproducibility)	Performance goals set (values not explicitly stated, but represented by "Limit (Ratio)" in tables). Lower variability desired.	Met for all parameters (FRT, RNFL, GCC, ONH) across all groups.
Comparative Variability	P200TE expected to have comparable or better variability than the iVue.	P200TE had lower variability than iVue in 96% of repeatability parameters and 94% of reproducibility parameters.

Note on "Limit (Ratio)": The tables provide values like "6.2813 (1.1660)" for Fovea Thickness Repeatability. While the exact acceptance threshold isn't explicitly stated, the presented values (e.g., CV% and the Limit Ratio) are the reported performance that met the performance goals for the study.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 106 subjects.
  - 35 subjects without ocular pathology (normal)
  - 35 subjects with glaucoma
  - 35 subjects with retinal pathology
  - (One subject was withdrawn, making the effective test set 105 or 106, depending on when the withdrawal occurred relative to analysis; the document states "106 subjects were enrolled" and then "one subject was withdrawn" without specifying if the analysis excludes this subject, but typically enrolled subjects would be analyzed or replaced.)
- Data Provenance:
  - Country of Origin: Not explicitly stated. The applicant is based in the United Kingdom, but the study type ("single site study") does not specify location.
  - Retrospective or Prospective: Prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state that experts were used to establish ground truth for the test set. The study focuses on agreement and precision between the P200TE and the predicate iVue device, rather than against an external expert-derived ground truth. The disease classifications (normal, glaucoma, retinal pathology) would have been determined by clinical diagnosis, presumably by qualified ophthalmologists, but the methods for this are not detailed as a separate "ground truth" establishment process for the measurements themselves.
Adjudication method for the test set:
- None was explicitly described for establishing ground truth for the measurements. The study design involved three operators acquiring scans on three P200TE devices and three iVue predicate devices (a "3x3 crossed study"). Analysis focused on repeatability (within-device/operator consistency) and reproducibility (between-device/operator consistency) and agreement between the P200TE and iVue.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No explicit MRMC comparative effectiveness study was done focusing on human readers improving with AI assistance. This study was a technical performance comparison between two devices (P200TE and iVue) and their measurement consistency, not an evaluation of human-in-the-loop performance. While the devices provide "analysis" and "aid in detection, diagnosis, documentation and management," the study did not measure clinical outcomes or the impact of the device on human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted for the P200TE's segmentation and measurement capabilities. The study evaluated the "agreement and precision analysis...on all measurement parameters for Full Retina Thickness (FRT), Retinal Nerve Fiber Layer (RNFL) thickness, Ganglion Cell Complex (GCC) thickness, and Optic Nerve Head (ONH) measurements" directly from the device's output, comparing it to the predicate device's output. The automatic segmentation and analysis features of the P200TE are central to this.
The type of ground truth used:
- For the quantitative measurements (FRT, RNFL, GCC, ONH), the "ground truth" in this comparative study was effectively the measurements obtained from the legally marketed predicate device (Optovue iVue), to which the P200TE's measurements were compared for agreement. The study also evaluated the device's own internal consistency (repeatability and reproducibility).
- For subject classification (normal, glaucoma, retinal disease), this would be based on clinical diagnosis, which serves as the categorization of the patients.
The sample size for the training set:
- The document does not provide information on the sample size for the training set for the P200TE's automatic segmentation or analysis algorithms. This section focuses solely on the clinical performance testing for device validation.
How the ground truth for the training set was established:
- The document does not provide information on how the ground truth for the training set was established, as details about the training set itself are not included.

Summary

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August 18, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Optos Plc Rachel Reay Senior Regulatory Affairs Specialist Queensferry House, Carnegie Campus Enterprise Way Dunfermline, Fife KY11 8GR United Kingdom

Re: K231673

Trade/Device Name: P200te (a10700) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: June 7, 2023 Received: June 8, 2023

Dear Rachel Reay:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Elvin Y. Na -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K231673

Device Name

P200TE (A10700)

Indications for Use (Describe)

The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

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

1. Contact Details

Applicant	Optos PlcQueensferry HouseCarnegie CampusEnterprise WayDunfermline, FifeScotland, UKKY11 8GR
Primary Correspondent	Rachel ReaySr. Regulatory Affairs Specialist, Optos PlcTel: 0044 1383 843300E-mail: RA@optos.com (preferred)
Date Prepared	July 24th 2023

2. Subject Device

Device Trade Name	P200TE (A10700)
Common Name	Ophthalmoscope
Classification	Tomography, Optical Coherence
Regulatory Class	886.1570
Product Code	OBO

3. Legally Marketed Predicate Devices

Predicate #	K173707	K121739
Device Trade Name	P200TE (A10700)	iVue
Product Code	OBO	OBO

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Image /page/4/Picture/1 description: The image contains the logo for Optos. The logo features a stylized eye symbol on the left, followed by the word "optos" in a bold, sans-serif font. A registered trademark symbol is placed to the upper right of the word "optos".

4. Device Description

The P200TE delivers images in the following image modes:

Scanning Laser Ophthalmoscopy
. Reflectance imaging
Autofluorescence imaging
. Optical Coherence Tomography

The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.

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P200TE 510(k) Summary Optos Plc K231673

Image /page/5/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye on the left and the word "optos" in blue letters on the right. The eye is light blue and gray, and the word "optos" is in a bold, sans-serif font. There is a registered trademark symbol to the right of the word "optos".

P200TE automatic segmentation provides comprehensive retinal and optic nerve head information, including:

. Full Retinal Thickness (FRT)
. Ganglion Cell Complex Thickness (GCC)
. ONH Cup and Disc Analysis
. ONH Nerve Fiber Layer Thickness

lmages can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.

5. Indications for Use

The P200TE is a non- contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and non-mydriatic conditions.

It is indicated for producing high resolution, ultra- widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.

The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

6. Substantial Equivalence to Predicate

The updated P200TE has all the same indications for use as P200TE and alongside this introduces the capability to produce retinal layer boundary analysis, optic nerve head analysis and thickness maps, present in the second predicate device, iVue. In other words, the P200TE has the same intended use its predicate devices, and thus satisfies the first criterion for a finding of substantial equivalence.

Both P200TE and iVue are Spectral Domain optical coherence tomographers intended for in- vivo digital imaging and measurement of posterior ocular structures, with retinal layer boundary analysis, optic nerve head analysis and thickness maps.

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Image /page/6/Picture/0 description: The image contains the logo for Optos, a company specializing in retinal imaging technology. The logo features a stylized eye symbol in light blue on the left, followed by the company name "optos" in dark blue. A registered trademark symbol is located to the upper right of the company name.

Technological implementation of SLO and OCT imaging is identical between the cleared P200TE and the submitted P200TE with segmentation. Both the current and updated devices are operated by touchscreen and hand controller. GUls are presented to the user with branding and presentation styles consistent across the Optos range of devices.

Technological implementation of OCT imaging in the iVue is comparable to the P200TE in that both systems operate via a superluminescent diode (SLD) light source of equivalent wavelengths and a splitter to divide wavelengths spatially, based on optical interference principles and under the umbrella classification of Fourier Domain OCT.

P200TE with segmentation is substantially equivalent to the previously cleared P200TE, and segmentation functionality is also substantially equivalent to the Optovue iVue. Minor differences in segmentation implementation do not present different questions of safety or effectiveness than the predicate device because there are no novel technological principles or applications introduced.

Device	OPTOS P200TE withsegmentation	OPTOS P200TE	Optovue iVue
510(k)Number	---	K173707	K121739
IndicationsFor Use	The P200TE is a non-contact scanning laserophthalmoscope and opticalcoherence tomographer. Itis intended for in-vivoviewing, digital imaging,and analysis of posteriorocular structures, includingthe retina, retinal nerve fiberlayer, ganglion cell complex(GCC) and optic disc, undermydriatic and non-mydriaticconditions.It is indicated for producinghigh resolution, ultra-widefield, en facereflectance images,autofluorescence images,axial cross-sectionalimages, three-dimensionalimages, retinal layerboundary analysis, opticnerve head analysis andthickness maps.The P200TE is indicated foruse as a device to aid in thedetection, diagnosis,documentation andmanagement of retinalhealth and diseases thatmanifest in the retina.	The P200TE is a non-contact scanning laserophthalmoscope andoptical coherencetomographer intended forin-vivo viewing and digitalimaging of posteriorocular structures,including the retina,retinal nerve fiber layerand optic disc. It isindicated for producinghigh-resolution, widefield,en face reflectanceimages, autofluorescenceimages, and axial, cross-sectional images of theposterior ocularstructures.	The iVue is a non-contact,high resolution tomographicimaging device. It isintended for in vivo imaging,axial cross-sectional, andthree-dimensional imagingand measurement ofanterior and posteriorocular structures, includingretina, retinal nerve fiberlayer, ganglion cell complex(GCC), optic disc, cornea,and anterior chamber of theeye. The iVue withNormative Database is aquantitative tool for thecomparison of retina, retinalnerve fiber layer, ganglioncell complex, and optic discmeasurements to adatabase of known normalsubjects.The iVue with NormativeDatabase is indicated foruse as a device to aid in thediagnosis, documentation,and management of ocularhealth and diseases in theadult population.
ProductCode	MYC, OBO	MYC, OBO	HLI, OBO
RegulationNumber	21 CFR 886.1570	21 CFR 886.1570	21 CFR 886.1570
DeviceClassification	II	II	II
Components	ScanheadHeadrest and chinrestPowered Table(separate)Computer	ScanheadHeadrest and chinrestPowered Table(separate)Computer	ScannerComputerControl boxFootswitch (optional)Joystick and chinrestassembly
	SLO Technology characteristics
Light Source	Laser	Laser	N/A
Wavelengthand Color ofLight	532nm ±5nm: green635nm ±5nm: red	532nm ±5nm: green635nm ±5nm: red	N/A
Laser Class	Class 1 to ISO 60825	Class 1 to ISO 60825	N/A
Number oflasers usedper Scan	1 or 2	1 or 2	N/A
External Fieldof View	120°	120°	N/A
Internal Fieldof View	200°	200°	N/A
Wide AngleDigitizedImage Size	3900x3072 pixels	3900x3072 pixels	N/A
ScanPatterns	2 axis scanner	2 axis scanner	N/A
Software	Embedded andApplication	Embedded andApplication	N/A
	OCT Technology characteristics
Method ofOperation	Spectral Domain OCT	Spectral Domain OCT	Spectral Domain OCT
Light Source	SLD 830-850nmSuper LuminescentDiodeNominal centerwavelength 840nm50nm FHWMbandwidth782nm ±3nm: infra-red	SLD 830nm SuperLuminescent DiodeSLD 828 to 837nmcenter wavelength with>15nm FHWMbandwidth782nm ±3nm: infra-red	SLD 830 nm to 850 nmSuper LuminescentDiode
Scan Rate	70,000 A-scans/s	70,000 A-scans/s	25,000 A-Scans/s
ScannerType	Galvanometric mirrorpair	Galvanometric mirrorpair	Lens based system
Light SourceClassification	Class 1	Class 1	Class 1
TransverseResolution	20µm	20µm	15µm
AxialResolution	< 7µm	< 10µm	5µm
Transversescan range	5.28 mm to 12 mm	6 mm to 12 mm	2 mm to 12 mm
ScanPatterns	LineVolumeCircle	LineVolumeCircle	LineVolumeCircle

Depth Range(in tissue)	2.3mm	2.3mm	2.3mm
Acquisitiontime	≤2s	≤2s	≤2s
RetinalTracking	Yes	Yes	No
Ergonomics	Tabletop ScannerHeadrest and ChinrestTouchscreen & Handcontroller	Tabletop ScannerHeadrest and ChinrestTouchscreen & Handcontroller	Tabletop ScannerComputerControl boxFootswitch (optional)Joystick and chinrestassembly
Cleaning anddisinfection /sterilization	Sterilization notrequired. Clean/disinfect contact points	Sterilization notrequired. Clean/disinfect contact points	Sterilization not required.Clean/disinfect contact points
SafetyFeatures	Laser & SLD shutdownon light sourceoverpower and/orincorrect functioning of	Laser & SLD shutdownon light sourceoverpower and/orincorrect functioning ofscanning elements	Halt to operation forstatus abnormality
Software	Embedded andApplication	Embedded andApplication	Embedded andApplication
OperatingSystem	Linux (SLO)Windows (Application &OCT)	Linux (SLO)Windows (Application &OCT)	32 or 64 bit Windows XPPro. Ed./Win 7
OCT Analysis
Retinal Thickness
Full RetinalThickness	9 sector ETDRS	N/A	9 sector ETDRS
GCCThickness	Averaged;Fovea-centeredHemifields	N/A	Averaged;Temporally OffsetHemifields
Optic Disc Analysis
RNFLperipapillary	Averaged, Quads,TSNIT	N/A	Averaged, quads, TSNIT
Disc area	Yes	N/A	Yes
Rim area	Yes - reference planemodel	N/A	Yes - fixed offset model
C/D area	Yes	N/A	Yes
C/Dhorizontalratio	Yes	N/A	Yes
C/D verticalratio	Yes	N/A	Yes

Table 1: Substantial Equivalence Chart

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Image /page/7/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left, followed by the word "optos" in a sans-serif font. A registered trademark symbol is located to the upper right of the "s" in "optos". The logo is rendered in a blue color.

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Image /page/8/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left, followed by the word "optos" in a sans-serif font. A registered trademark symbol is located to the upper right of the "s" in "optos". The logo is in a blue color.

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Image /page/9/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue letters on the right. A registered trademark symbol is located to the upper right of the word "optos".

Table 2: The physical principles of operation for each modality, consistent with the predicate

device P200TE

Modality	Imaging mode	Physical principle	Output	Use scenario
Reflectanceimaging(SLO)	Optomap UWFcomposite Red /Green retinalimagingOptomap/Optomapplus resolutionmodes	Point by pointmapping ofreflected lightintensity frommulti-channellaser incidenton retina.	2D image ofthe retina.	To enable UWFvisualization andquantitative assessment ofthe retina, choroid, opticnerve head and nerve fiberlayer when viewed in acompatible DICOM viewer.
Fluorescenceimaging(SLO)	Optomap UWFAuto-Fluorescence(AF) imagingOptomap/Optomapplus resolutionmodes	Point by pointmapping offluorescencelight intensityfrom multi-channel laserincident onretina.	2D image ofthe retina.AF relies onnaturalfluorophorespresent inretina.	To enable UWFvisualization andquantitative assessment ofthe health of the cells whenviewed in a compatibleDICOM viewer. Areas ofHypo and Hyperfluorescence are used bypractitioners to assess themetabolism of the eye.
OpticalCoherenceTomography(OCT)	Central PosteriorOCT Imaging	Point by pointmapping ofback-scatteredlight intensity,resolved in theaxial directionthroughcoherencegating.Coherencegating isachievedthrough low-coherenceinterferometry.Low coherencelight is incidenton the retina foraxial mapping	2D axial crosssection (B-scan) or 3Dvolume (C-scan) of retina.Providesstructuralinformation ofretina in theaxial andtransversedirection	To support investigation ofanomalies found in the SLORG or AF, and to broadlyassess the health at theMacula and through theONH.Providing 3D structuralinformation in the macularand ONH regions, throughsingle scans or acombination ofscans. For use inconjunction with Red-Greenand Auto FluorescenceSLO images to assess eyehealth

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Image /page/10/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue letters on the right. A registered trademark symbol is located to the upper right of the word "optos".

7. Summary of Studies

Non-Clinical Performance Testing

Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. with no concerns raised in relation to key non-functional performance parameters.

Design Verification of the A10700 P200TE including the following Non-functional performance parameters recommended for all OCT devices, in line with FDA's OCT Pilot Guidance document:

. Spatial performance testing (Lateral range; Lateral resolution; Axial range; Axial resolution)
. Sensitivity (Signal-to-Noise ratio, depth attenuation)
. Auxiliary Functions

The P200TE is type tested in accordance with the following standards:

IEC 60601-1:2015+A11:2021 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
. IEC 60601-1-2:2014+A1:2020 Medical electrical equipment – Part 1.2: General requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and tests
. IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification and requirements

Safety Calculations are also provided with reference to ANSI Z80.36-2021 Ophthalmics -Light Hazard Protection for Ophthalmic Instruments.

Sterility, Shelf-Life, Biocompatibility and Animal Testing was not required for this submission.

Software verification and validation has been conducted in accordance with QMS processes and documentation has been provided with this submission.

All testing has passed with no additional safety or performance concerns raised.

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Image /page/11/Picture/1 description: The image shows the logo for Optos, a company specializing in retinal imaging technology. The logo features a stylized eye symbol in blue, followed by the company name "optos" in a matching blue font. A registered trademark symbol is placed next to the company name.

Clinical Performance Testing

This was a prospective, single site study. A total of 106 subjects were enrolled: with 35 subjects without ovular pathology, 35 with glaucoma, and 35 with retina pathology. One subject was withdrawn because they did not meet the inclusion criteria. Mean age for all subjects was 46.8 years with a range from 22 to 75 years of age. Mean age for the normal group was 36 years with a range from 23 to 59 years of age, mean age for the glaucoma group was 61.7 years with a range from 37 to 75, and mean age of the retina group was 42.4 with a range from 22 to 74. There were 44 male subjects (41.5%) and 62 female subjects (58.5%). There were 12 Asian subjects (11.3%), 39 White subjects (36.8%), and 54 Black subjects (50.9%) with 1 other (0.9%). For the P200TE. 85.6 % of scans were acceptable, and for the iVue, 94.0% of scans were acceptable. The most common reasons for scans not beinq acceptable included eye blinks, eye movements, low signal strength, clipping, and poor centration.

The study design was a 3 x 3 crossed study with 3 P200TE devices and 3 iVue predicate devices with 3 operators assigned to image on a fixed pair of P200TE and iVue devices. Three acceptable scans of each scan type were acquired on each of the study devices. Analysis of variance was performed to determine the repeatability and reproducibility as well as the variance associated with the combination of operator and device. Agreement between the P200TE and iVue was evaluated with a Bland Altman analysis and Deming Regression analysis.

Agreement and precision analysis was performed on all measurement parameters for Full Retina Thickness (FRT), Retinal Nerve Fiber Layer (RNFL) thickness, Ganglion Cell Complex (GCC) thickness, and Optic Nerve Head (ONH) measurements.

This study found excellent agreement and precision of the Optos P200TE compared to the Optovue iVue. The performance goals for agreement were met for all FRT, RNFL, and ONH parameters for all groups. Because the iVue GCC grid is shifted 1 mm temporally from the fovea, it is in a more peripheral region where the layer is thinner, therefore the agreement performance goals were not met for GCC, due to the difference in scan location.

For precision, performance goals were met for all parameters and all groups. When directly comparing coefficient of variation calculations, the P200TE had lower variability than the iVue in 96% of the parameters for repeatability and 94% of the parameters for reproducibility.

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Image /page/12/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left, followed by the word "optos" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "optos".

Precision Details

Table 3 Summary of Repeatability and Reproducibility for Full Retinal Thickness (FRT) for
Optos P200TE

		Repeatability			Reproducibility
	Overall Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Device: P200TE
	Parameter: Normal: N = 35
Fovea Thickness (μm)	245.4708	2.2433	6.2813 (1.1660)	0.91%	2.7779	7.7782 (1.0573)	1.13%
Superior Inner (μm)	317.3858	1.6796	4.7028 (0.6021)	0.53%	2.0305	5.6855 (0.5618)	0.64%
Temporal Inner (μm)	304.2953	1.7876	5.0053 (0.7547)	0.59%	2.0236	5.6660 (0.6153)	0.66%
Inferior Inner (μm)	314.8044	1.6508	4.6223 (0.6242)	0.52%	1.8993	5.3179 (0.5401)	0.60%
Nasal Inner (μm)	318.5472	1.9892	5.5698 (0.7057)	0.62%	2.318	6.4903 (0.5800)	0.73%
Superior Outer (μm)	278.9673	1.2313	3.4476 (0.5243)	0.44%	1.7878	5.0058 (0.5467)	0.64%
Temporal Outer (μm)	259.5717	1.2305	3.4454 (0.5375)	0.47%	1.6091	4.5055 (0.5728)	0.62%
Inferior Outer (μm)	266.6306	1.1131	3.1166 (0.5191)	0.42%	1.1957	3.3480 (0.4207)	0.45%
Nasal Outer (μm)	294.5348	1.1008	3.0822 (0.5624)	0.37%	1.3478	3.7738 (0.5173)	0.46%
Device: P200TE
	Parameter: Glaucoma: N = 35
Fovea Thickness (μm)	228.5799	2.2461	6.2889 (0.9031)	0.98%	3.0542	8.5518 (0.9603)	1.34%
Superior Inner (μm)	288.5327	1.8753	5.2509 (0.6844)	0.65%	2.2643	6.3401 (0.6051)	0.78%
Temporal Inner (μm)	275.6294	1.4952	4.1867 (0.5483)	0.54%	2.089	5.8491 (0.5933)	0.76%
Inferior Inner (μm)	281.5857	1.5804	4.4251 (0.6852)	0.56%	1.9364	5.4219 (0.5649)	0.69%
Nasal Inner (μm)	292.4215	1.8424	5.1587 (0.7236)	0.63%	2.3546	6.5928 (0.6083)	0.81%
Superior Outer (μm)	251.375	1.467	4.1077 (0.6151)	0.58%	2.1399	5.9916 (0.6439)	0.85%
Temporal Outer (μm)	238.2408	1.2304	3.4451 (0.5954)	0.52%	1.5154	4.2432 (0.5437)	0.64%
Inferior Outer (μm)	235.0803	1.5295	4.2826 (0.6384)	0.65%	1.7507	4.9020 (0.6040)	0.74%
Nasal Outer (μm)	264.0763	1.292	3.6176 (0.6870)	0.49%	1.6679	4.6701 (0.6651)	0.63%
Device: P200TE
	Parameter: Retinal Disease: N = 35
Fovea Thickness (μm)	245.9433	2.313	6.4763 (0.9118)	0.94%	2.7517	7.7047 (0.8704)	1.12%
Superior Inner (μm)	311.8596	2.0411	5.7151 (0.6354)	0.65%	2.402	6.7257 (0.5319)	0.77%
Temporal Inner (μm)	300.1217	1.6941	4.7435 (0.5355)	0.56%	2.0316	5.6885 (0.4459)	0.68%
Inferior Inner (μm)	305.6997	1.6879	4.7260 (0.6365)	0.55%	1.8264	5.1138 (0.4837)	0.60%
Nasal Inner (μm)	310.089	2.1686	6.0721 (0.6474)	0.70%	2.5049	7.0138 (0.5858)	0.81%
Superior Outer (μm)	278.7518	1.7344	4.8564 (0.7350)	0.62%	2.4046	6.7330 (0.7199)	0.86%
Temporal Outer (μm)	258.385	1.4445	4.0446 (0.6087)	0.56%	1.9443	5.4441 (0.6241)	0.75%
Inferior Outer (μm)	262.6416	1.3213	3.6997 (0.5266)	0.50%	1.6081	4.5028 (0.5164)	0.61%
Nasal Outer (μm)	287.4438	1.1278	3.1579 (0.4773)	0.39%	1.3735	3.8459 (0.4738)	0.48%

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Image /page/13/Picture/0 description: The image contains the logo for Optos, a company specializing in retinal imaging technology. The logo features a stylized eye symbol on the left, followed by the company name "optos" in a bold, sans-serif font. A registered trademark symbol is placed to the upper right of the company name.

Table 4 Summary of Repeatability and Reproducibility for Retinal Nerve Fiber Layer (RNFL)

Averaged Thickness for Optos P200TE

	OverallMean	Repeatability			Reproducibility
		SD	Limit(Ratio)	CV%	SD	Limit(Ratio)	CV%
Device: P200TE	Parameter: Normal: N = 35
Temporal (µm)	87.8741	2.193	6.1404(0.8004)	2.50%	2.8603	8.0090(1.0286)	3.26%
Superior (µm)	129.4382	2.9074	8.1408(0.8801)	2.25%	3.8931	10.9007(1.0362)	3.01%
Inferior (µm)	138.4245	3.0448	8.5253(0.8551)	2.20%	3.5419	9.9174(0.8626)	2.56%
Nasal (µm)	82.417	2.3247	6.5091(0.9594)	2.82%	2.6403	7.3928(0.9873)	3.20%
Average RNFL (µm)	109.532	1.2388	3.4687(0.7844)	1.13%	1.613	4.5163(0.8380)	1.47%
Device: P200TE	Parameter: Glaucoma: N = 35
Temporal (µm)	66.6774	1.9836	5.5540(0.5751)	2.97%	2.4773	6.9365(0.7074)	3.72%
Superior (µm)	93.9096	2.5423	7.1184(1.0900)	2.71%	3.1287	8.7603(1.1456)	3.33%
Inferior (µm)	94.4738	2.4156	6.7635(0.8296)	2.56%	2.7131	7.5967(0.8421)	2.87%
Nasal (µm)	71.6069	2.2444	6.2843(0.7771)	3.13%	2.6327	7.3715(0.9115)	3.68%
Average RNFL (µm)	81.6628	1.1553	3.2349(0.7899)	1.41%	1.4947	4.1850(0.9208)	1.83%
Device: P200TE	Parameter: Retinal Disease: N = 35
Temporal (µm)	86.1527	2.3445	6.5646(0.8329)	2.72%	2.7795	7.7825(0.9831)	3.23%
Superior (µm)	126.8979	2.8994	8.1183(1.0058)	2.28%	3.7232	10.4251(1.0630)	2.93%
Inferior (µm)	136.4571	3.0268	8.4750(0.9686)	2.22%	3.3728	9.4439(0.8796)	2.47%
Nasal (µm)	83.8697	2.4993	6.9979(0.8994)	2.98%	2.8858	8.0804(0.9923)	3.44%
Average RNFL (µm)	108.3317	1.3505	3.7813(0.9465)	1.25%	1.6093	4.5060(0.9242)	1.49%

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Image /page/14/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left, followed by the word "optos" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "optos". The eye symbol and the word "optos" are both in a dark blue color.

			Table 5 Summary of Repeatability and Reproducibility for GCC thickness for Optos P200TE
--	--	--	-----------------------------------------------------------------------------------------	--

		Repeatability		Reproducibility
Overall Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Device: P200TE	Parameter: Normal: N = 35
Superior Average (µm)	108.8597	0.9591	2.6854(1.0811)	0.88%	1.3697	3.8351(1.2665)	1.26%
Inferior Average (µm)	111.2212	0.9649	2.7019(0.9984)	0.87%	1.2174	3.4087(1.0866)	1.09%
Inner Retina Average (µm)	110.0406	0.8493	2.3780(0.9799)	0.77%	1.1677	3.2696(1.1220)	1.06%
Device: P200TE	Parameter: Glaucoma: N = 35
Superior Average (µm)	90.5858	1.0657	2.9840(0.8296)	1.18%	1.6234	4.5456(1.1003)	1.79%
Inferior Average (µm)	87.2697	1.1786	3.2999(1.0180)	1.35%	1.4879	4.1662(1.1289)	1.70%
Inner Retina Average (µm)	88.9275	0.9498	2.6593(0.8537)	1.07%	1.3659	3.8246(1.0608)	1.54%
Device: P200TE	Parameter: Retinal Disease: N = 35
Superior Average (µm)	107.1894	1.3174	3.6888(0.9058)	1.23%	1.7787	4.9805(1.0089)	1.66%
Inferior Average (µm)	107.0354	1.1198	3.1356(0.8096)	1.05%	1.4884	4.1674(0.9341)	1.39%
Inner Retina Average (µm)	107.1125	0.9591	2.6856(0.8219)	0.90%	1.3467	3.7706(0.9607)	1.26%

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Image /page/15/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue letters on the right. The eye symbol is a blue gradient, with the darkest blue in the center and lighter blues towards the edges. The word "optos" is in a bold, sans-serif font, and there is a registered trademark symbol next to the "s".

Table 6 Summary of Repeatability and Reproducibility for Optic Nerve Head (ONH) Measurements for Optos P200TE

		Repeatability			Reproducibility
	Overall Mean	SD	Limit (ratio	CV%	SD	Limit (ratio	CV%
Device: P200TE
	Parameter: Normal: N = 35
C/D Horizontal Ratio	0.2946	0.0203	0.0567(0.4455)	6.88%	0.0234	0.0656(0.5128)	7.96%
C/D Vertical Ratio	0.315	0.0176	0.0492(0.3909)	5.57%	0.0199	0.0558(0.4347)	6.33%
C/D Area Ratio	0.1292	0.0095	0.0266(0.5033)	7.35%	0.0113	0.0317(0.5699)	8.75%
Disk Area (mm2)	1.7287	0.0615	0.1721(0.5668)	3.56%	0.082	0.2297(0.6130)	4.75%
Rim Area (mm2)	1.4957	0.0568	0.1592(0.5424)	3.80%	0.0767	0.2146(0.5922)	5.12%
Device: P200TE
	Parameter: Glaucoma: N = 35
C/D Horizontal Ratio	0.7711	0.0229	0.0641(0.9152)	2.97%	0.0254	0.0712(0.9872)	3.30%
C/D Vertical Ratio	0.7942	0.0247	0.0691(0.9424)	3.11%	0.0255	0.0714(0.9116)	3.21%
C/D Area Ratio	0.6211	0.0235	0.0657(0.9719)	3.78%	0.0264	0.0740(1.0315)	4.25%
Disk Area (mm2)	2.2241	0.0632	0.1769(0.5605)	2.84%	0.0712	0.1994(0.5707)	3.20%
Rim Area (mm2)	0.831	0.0596	0.1670(0.7388)	7.18%	0.0654	0.1832(0.7656)	7.87%
Device: P200TE
	Parameter: Retinal Disease: N = 35
C/D Horizontal Ratio	0.4494	0.0221	0.0618(0.5038)	4.91%	0.0244	0.0682(0.4848)	5.42%
C/D Vertical Ratio	0.4686	0.0214	0.0600(0.4484)	4.58%	0.0238	0.0667(0.4974)	5.09%
C/D Area Ratio	0.2381	0.0148	0.0414(0.5324)	6.22%	0.0181	0.0507(0.6515)	7.61%
Disk Area (mm2)	1.8689	0.0608	0.1701(0.5058)	3.25%	0.0754	0.2112(0.5528)	4.04%
Rim Area (mm2)	1.3939	0.0578	0.1618(0.4883)	4.15%	0.075	0.2099(0.5739)	5.38%

8. Conclusion

The existing and updated P200TE devices have the same intended use, technological characteristics and principles of operation, and similar indications. Additionally, the updated P200TE incorporates the Segmentation functionality of the iVue.

Minor differences in segmentation implementation do not present different questions of safety or effectiveness than the predicate device because there are no novel technological principles or applications introduced. Functionality has been demonstrated against statistical performance goals and comparison to the predicate. Thus, the P200TE is substantially equivalent to the stated predicates.

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.