(209 days)
The Tomey Corneal Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicrosopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Corneal Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.
The Tomey Cornea/Anterior Segment OCT CASIA2 (CASIA2) is a non-contact, high resolution tomographic and biomicrocopic device indicated for in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings. CASIA2 consists of several components: the main unit, AC input power source, a touch panel LCD monitor, an external hard drive (HDD), a mouse and a keyboard. CASIA2 is an anterior segment OCT that obtains images by A-scanning with swept-source OCT. OCT images are created by the intensity of the light (backscattered light) that returns in the same path as that of incident light among the scattered light of each tissue. Thus, it is created with higher intensity in the tissues that generate strong backward scattering.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided text doesn't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, it describes a comparative clinical study where the Tomey Cornea/Anterior Segment OCT CASIA2 was compared against a predicate device (Optovue RTVue XR OCT Avanti) for image quality and visualization of anatomical structures and pathologies. The "acceptance criteria" are implicitly demonstrated by showing that the CASIA2 performs at least as well as and in many cases better than the predicate device for its intended use of visualizing anterior segment findings.
The following table summarizes the reported device performance and the implicitly met acceptance criteria of being comparable or superior to the predicate device.
| Performance Metric (Implicit Acceptance Criteria: Comparable or Superior to Predicate) | Reported Device Performance (Tomey CASIA2) |
|---|---|
| Overall Image Quality (compared to Avanti) | Better overall image quality in comparison to Avanti in the pooled population for the grader average score, and in the majority of individual grader comparisons. Similar results were found across normal, cataract, and glaucoma groups. |
| Visibility of Pathology (compared to Avanti) | Allowed for the observance of pathology more often than Avanti images for all scan types compared. |
| Visibility of Angle (compared to Avanti) | Observed more often with CASIA2 in comparison to Avanti. |
| Visibility of Lens (compared to Avanti) | Observed more often with CASIA2 in comparison to Avanti. |
| Visibility of Cornea (compared to Avanti) | Observed as often with CASIA2 as with Avanti. |
| Visibility of Iris (compared to Avanti) | Observed either as often as or more often with CASIA2 in comparison to Avanti, depending on the scan types. |
| Image Quality of CASIA2-only Scans | The 5 additional scans available only for CASIA2 (with no Avanti comparison) were also assessed for image quality, and scores varied from average to good. This implicitly demonstrates sufficient performance for these unique features. |
| Safety and Effectiveness | The differences between the proposed device and the predicate device are not significant and do not raise new issues of safety or effectiveness. The Tomey CASIA2 is deemed as safe and effective as the predicate device. This is a direct statement of meeting the "substantial equivalence" criteria. |
Study Proving Device Meets Acceptance Criteria
2. Sample Size and Data Provenance:
- Test Set Sample Size: 134 subjects.
- 45 Normal subjects
- 46 Cataract subjects
- 43 Glaucoma subjects
- Data Provenance: The text states it was a "prospective comparative clinical performance study." While the specific country of origin isn't stated for the clinical data, Tomey Corporation is based in Japan (as per the submitter information), and the consultant ORA, Inc. is in the USA. Clinical studies for FDA submissions typically involve diverse populations or are clearly described if conducted solely in one region. However, the text only specifies "subjects."
3. Number of Experts and Qualifications:
- Number of Experts: 3 masked graders.
- Qualifications of Experts: Not explicitly stated beyond "masked graders." It is highly probable, given the nature of the study, that these graders were ophthalmologists or optometrists with expertise in interpreting OCT images of the anterior segment. The term "masked graders" implies they were blinded to key study parameters (subject, disease population, device, and results from other graders).
4. Adjudication Method for the Test Set:
- The image grading procedure was "pre-specified in the study protocol."
- Images were assessed by 3 masked graders.
- The results report "grader average score" and "individual grader comparisons." This indicates that the individual scores of the three graders were analyzed, and a pooled average was used for comparison. There is no explicit mention of an "adjudication" process in the sense of a definitive consensus or tie-breaking mechanism if graders disagreed. The reporting suggests independent grading followed by aggregation or direct comparison of individual scores.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Yes, a multi-reader, multi-case comparative study was conducted, as 3 masked graders evaluated images from 134 subjects across different disease states and scan types.
- Effect Size (Human Readers Improvement with AI vs. No AI): This study does not involve AI assistance for human readers. It is a comparison of two different OCT devices (Tomey CASIA2 vs. Optovue Avanti) for image quality as assessed by human readers. Therefore, there is no effect size related to human reader improvement with AI assistance. The study implicitly shows that the CASIA2 enables human readers to observe pathology and anatomical structures better or as often as the predicate device due to its image quality.
6. Standalone (Algorithm Only) Performance:
- The text describes the device as providing "imaging of ocular structures" and being "an aid in the visualization of anterior segment findings." The performance evaluation focuses on the quality of these images as assessed by human graders. There is no mention of an embedded algorithm providing automated diagnoses or measurements that would require a standalone performance study. The device itself is the imaging system, not an AI diagnostic algorithm.
7. Type of Ground Truth Used:
- The ground truth for the assessment of image quality, visibility of structures, and pathology was expert perception/consensus through grading by 3 masked experts. The study directly compared the ability of the new device's images versus the predicate device's images to allow observation by these experts. Patients were categorized by clinical diagnosis (normal, cataract, glaucoma), implying these clinical diagnoses served as the underlying "truth" for evaluating the device's utility in those populations, though the primary outcome was image quality.
8. Sample Size for the Training Set:
- The document does not provide information regarding a training set sample size. This is expected as the Tomey CASIA2 is an imaging device, not an AI algorithm that requires a dedicated training set to learn patterns. The study focuses on the performance of the device's output (images) rather than the performance of a learned model.
9. How Ground Truth for Training Set was Established:
- Since there's no mention of an AI algorithm requiring a training set, this information is not applicable and not provided in the document.
§ 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.