(182 days)
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 retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and nonmydriatic conditions.
P200TE 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 includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics.
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.
The 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 eve 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. A Reference Database enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population. Segmentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.
P200TE automatic seqmentation provides comprehensive retinal and optic nerve head information, including:
- . Full Retinal Thickness (FRT)
- . Ganglion Cell Complex Thickness (GCC)
- ONH 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.
The provided text describes the P200TE device, a non-contact scanning laser ophthalmoscope and optical coherence tomographer. The primary purpose of the submission K233602 is to introduce a Reference Database (RDB) feature to the previously cleared P200TE, enabling the comparison of OCT segmentation analysis results to a known healthy population.
The acceptance criteria for the P200TE with the Reference Database are not explicitly stated in a quantitative table format with pass/fail metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Optovue iVue and previous P200TE) by showing that the updated P200TE has the same intended use, technological characteristics, principles of operation, and similar indications. The "acceptance criteria" are implied to be centered around the clinical performance testing of the Reference Database, specifically its ability to establish reliable cut-off values for various retinal and optic nerve head measurements based on a healthy cohort, and the effective color-coding of results for interpretation.
Here's an attempt to structure the information based on the provided text, inferring acceptance criteria from the study's design and reported results:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Acceptance Criteria (Inferred from Study Design) | Reported Device Performance (Summary Statistics and Percentiles) |
|---|---|
| Reference Database (RDB) Establishment: | |
| Ability to define statistically sound cut-off values (1%, 5%, 95%, 99%) for various OCT measurements to differentiate "normal" from "borderline" or "outside normal" based on a healthy population. These cut-offs must be suitable for color-coding. | Full Retinal Thickness (FRT) Measurements: |
- Central Foveal Thickness: Mean 247.04, 1st %ile: 195.74, 5th %ile: 212.32, 95th %ile: 283.34, 99th %ile: 302.84.
- Superior Parafoveal Thickness: Mean 315.00, 1st %ile: 278.64, 5th %ile: 290.54, 95th %ile: 339.33, 99th %ile: 351.57.
- And similar detailed statistics for Temporal, Inferior, Nasal Parafoveal, and Perifoveal thicknesses (see Table 4).
Color-coding implemented: Values below 5% light blue, below 1% dark blue; values above 95% amber, above 99% red. |
| Ganglion Cell Complex (GCC) Thickness Measurements:
Ability to define statistically sound cut-off values for GCC measurements to differentiate "normal" from "borderline" or "outside normal." | GCC Thickness Measurements: - Total Average: Mean 108.03, 1st %ile: 88.01, 5th %ile: 95.31, 95th %ile: 120.45, 99th %ile: 124.09.
- Superior Hemiretina: Mean 107.90, 1st %ile: 87.88, 5th %ile: 95.65, 95th %ile: 120.09, 99th %ile: 124.37.
- Inferior Hemiretina: Mean 108.16, 1st %ile: 87.22, 5th %ile: 94.20, 95th %ile: 121.44, 99th %ile: 125.07.
Color-coding implemented: Values below 5% amber, below 1% red. |
| Retinal Nerve Fiber Layer (RNFL) Measurements:
Ability to define statistically sound cut-off values for RNFL measurements, considering optic disc size, to differentiate "normal" from "borderline" or "outside normal." | RNFL Measurements (stratified by optic disc size): - Average RNFL, Temporal, Superior, Inferior, and Nasal Quadrant RNFL over TSNIT Circle (see Table 6 for detailed percentiles and means for Small, Medium, and Large optic disc groups).
Color-coding implemented: Values below 5% amber, below 1% red. |
| Optic Nerve Head (ONH) Analysis:
Ability to define statistically sound cut-off values for ONH parameters (C/D Vertical, C/D Horizontal, C/D Area, Rim Area), considering optic disc size, to differentiate "normal" from "borderline" or "outside normal." | ONH Measurements (stratified by optic disc size): - C/D Vertical, C/D Horizontal, C/D Area, Rim Area (see Table 7 for detailed percentiles and means for Small, Medium, and Large optic disc groups).
Color-coding implemented: Values above 95% amber, above 99% red. |
| Non-clinical Performance:
Device meets defined functional and non-functional specifications.
Compliance with relevant electrical, laser, and EMC standards.
Software verification and validation. | Non-clinical system testing showed the system met defined specifications, with no concerns.
Type tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and ANSI Z80.36-2021.
Software V&V conducted according to QMS processes.
All testing passed with no additional safety or performance concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 860 eyes for full retina thickness and GCC measurements. For RNFL and ONH measurements, the sample was stratified by optic disc size:
- Small optic disc ( 2.15 mm2): 254 eyes for RNFL, 255 eyes for ONH.
- Overall, 879 eyes were enrolled in the study.
- Data Provenance: The document does not explicitly state the country of origin. It describes the age distribution as "skewed toward older eyes...to better match the age distribution typically found in eye clinics," implying a focus on a patient population that would likely use the device. It also mentions "good racial and ethnic diversity" (15% Hispanic, 16% Asian, 14% Black or African American, and 57% White), which suggests a US-based or diverse multinational cohort. The study was prospective in the sense that it established a reference database from healthy eyes for future comparison, effectively a one-time data collection for the database.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The ground truth for the reference database was established by collecting data from "healthy eyes." The criteria for defining an eye as "healthy" for inclusion in the reference database are not detailed (e.g., based on clinical examination by ophthalmologists, absence of specific diseases).
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method for the test set. The study describes the creation of a "reference database of healthy eyes" and the use of "non-parametric analysis to determine the 1%, 5%, 95%, and 99% cut off values." This suggests a statistical approach to defining "normalcy" from the collected data, rather than individual case adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance and the establishment of a reference database for interpretation by human users, not on the improvement of human readers with AI assistance beyond providing a data comparison tool. The device provides "automatic segmentation" but the core of the submission (K233602) is the RDB facilitating comparison guidance, not an AI-assisted diagnostic workflow assessment involving human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in essence, the study evaluated the standalone performance of the algorithm's segmentation and RDB comparison feature by establishing the statistical distribution and cut-offs from a healthy population. The "clinical performance testing" section primarily details the generation of these normative values and their statistical validity. The device performs "automatic segmentation," and the RDB then compares these segmented measurements to a normative dataset. The study does not describe a human-in-the-loop performance study for this specific submission's purpose (adding the RDB).
7. The Type of Ground Truth Used
- The ground truth for the Reference Database was derived from clinical data collected from a cohort of "healthy eyes." The specific criteria for "healthy" status and whether this involved expert consensus, clinical outcomes, or other methods are not detailed. It is explicitly stated that the "age distribution was intentionally skewed toward older eyes... Because of this, age-related corrections were not necessary for this database," suggesting the definition of "healthy" for each age group was considered stable across the cohort.
8. The Sample Size for the Training Set
- The document refers to the data collected as the basis for the "reference database." This dataset of 879 eyes (with 860 eyes analyzed for FRT and GCC, and stratified numbers for RNFL and ONH based on disc size) effectively serves as the "training set" or "normative dataset" from which the cut-off percentiles were derived.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for the "training set" (the healthy reference database) was established through a clinical study that enrolled "healthy eyes." The data from these eyes were then used in a non-parametric statistical analysis to determine the 1st, 5th, 95th, and 99th percentile cut-off values for various OCT measurements. The document states, "The cut-off values were determined using a non-parametric analysis to reduce potential bias introduced when using standard parametric techniques due to their underlying assumptions." For RNFL and ONH measurements, the database was further partitioned into three strata based on optic disc size to account for its influence. This statistical derivation from a healthy population defines the "ground truth" for the RDB's comparative function.
§ 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.