(289 days)
Each and all above listed RetCam Systems are indicated for:
- General ophthalmic imaging including retinal, corneal, and external imaging; .
- Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). .
- Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.
RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer (RetCam II and RetCam 3) or laptop computer (RetCam Shuttle and RetCam Portable) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam configurations to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available with the RetCam II and RetCam 3 configurations. Light intensity, camera focus, and image capture are controlled by the use of a footswitch on all configurations and can also be controlled by a keyboard on the RetCam II and RetCam 3 consoles. Console monitors are provided with the RetCam II and RetCam 3 configurations for viewing images. The laptop monitor is used for viewing images with the RetCam Shuttle and RetCam Portable. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.
Here's a breakdown of the acceptance criteria and the study that supports the RetCam Ophthalmic Imaging System, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner as "acceptance criteria" but are implied by the reported performance metrics of the device in screening for ROP. The study establishes the device's accuracy by demonstrating high sensitivity and acceptable specificity for identifying specific stages of ROP.
| Acceptance Criteria (Implied) | Reported Device Performance (Sensitivity and Specificity for Type 2 Threshold ROP Or Worse) |
|---|---|
| Sensitivity for Type 2 pre-threshold or worse ROP in 35-37 week postmenstrual infants. | |
| Defined as: |
- Type 2 pre-threshold ROP (Zone 1, Stage 1 or 2, without plus disease, or Zone 2, Stage 3, without plus disease)
- Treatment-requiring ROP (Type 1 ROP: Zone 1, any stage, with plus disease; Zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease)
- Threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) | Grader A: 1.0 (26/26)
Grader B: 1.0 (26/26)
Grader C: 1.0 (26/26) |
| Specificity for Type 2 pre-threshold or worse ROP in 35-37 week postmenstrual infants.
Same definition as above. | Grader A: 0.883 (83/94)
Grader B: 0.851 (80/94)
Grader C: 0.851 (80/94) |
| Image Quality: Technical quality of images captured at 35-37 weeks PMA by trained NICU nurses. | 93.3% to 100% of images found to be "adequate" or "possibly adequate" |
Study Details
The study referenced is:
Chiang, et. al. (Telemedical Retinopathy of Prematurity Diagnosis Accuracy and, Reliability, and Image Quality: Archives of Ophthalmology; 2007;125(11):1531-1538)
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Sample size used for the test set and the data provenance:
- Test set sample size: Images from 67 consecutive infants were used. While the text refers to "eyes," the performance data is given for "26 cases of Type 2 Threshold ROP Or Worse" and "94 cases of no Type 2 Threshold ROP Or Worse," suggesting a total of 120 eyes/instances for the performance evaluation against the reference standard.
- Data provenance: Prospective trial. Country of origin not explicitly stated, but the journal (Archives of Ophthalmology) is a US-based publication, suggesting US data or an internationally recognized standard of practice.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts for image interpretation: Three expert retinal specialist graders interpreted the images. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert retinal specialist graders."
- Number of experts for ground truth (reference standard): "Experienced pediatric ophthalmologists" performed binocular indirect ophthalmoscopy (BIO) to establish the reference standard. The number of these ophthalmologists is not specified.
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Adjudication method for the test set:
- The text describes three individual expert retinal specialist graders (Grader A, B, C) interpreting the images, and their findings were compared to a reference standard. It does not indicate an adjudication method (like 2+1 or 3+1 consensus) among these three graders to form a single "AI" diagnosis. Instead, the performance is reported per grader. The reference standard itself was established by experienced pediatric ophthalmologists using BIO.
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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, this was not an MRMC comparative effectiveness study involving human readers with vs. without AI assistance. The study evaluates the standalone performance of reading RetCam images by human experts against a clinical gold standard (BIO). The RetCam system itself produces the images, which are then interpreted by human experts; it does not feature an AI component that assists human interpretation in the sense of a diagnostic algorithm providing results.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The study describes human interpretation of images captured by the RetCam device. The RetCam is an imaging system, not an AI algorithm that provides diagnostic output. The "performance" refers to the accuracy of human graders interpreting the images acquired by the device.
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The type of ground truth used:
- Clinical Gold Standard: Binocular Indirect Ophthalmoscopy (BIO) performed by experienced pediatric ophthalmologists. This is a direct clinical assessment by experts, considered the gold standard for ROP diagnosis.
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The sample size for the training set:
- The text does not mention a training set. This study describes a clinical validation of an imaging device where human experts interpret the images, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model is described or implied.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.