(71 days)
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.
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.
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
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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.
- Sample Size: 106 subjects.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.