(15 days)
The Spectralis Anterior Segment Module is an accessory to the Spectralis HRA+OCT, and is indicated for imaging the anterior segment of the eye.
The Spectralis Anterior Segment Module (Spectralis ASM) is an accessory to the Spectralis HRA+OCT device cleared under K101223. The Spectralis HRA+OCT is a diagnostic device for imaging the human eye and for aiding in the assessment and management of various diseases of the posterior segment of the eye. Addition of the Spectralis ASM provides the user the additional ability to image and examine the anterior segment of the eye using simultaneous OCT and infrared reflectance imaging with OCT B-scan lengths of 8 mm, 11 mm, and 16 mm. Available OCT scan patterns are single line scans and volume scans.
Here's a breakdown of the acceptance criteria and the study demonstrating the Spectralis Anterior Segment Module (ASM) meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a substantial equivalence pathway for the Spectralis ASM. This means the primary acceptance criterion is demonstrating that the new device performs as intended and is substantially equivalent to a legally marketed predicate device for viewing ocular structures of the eye.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to image and view the anterior segment of the eye. | Confirmed through a side-by-side comparison study. |
| Substantial equivalence to predicate device (RTVue 100/CA) for viewing ocular structures. | Concluded based on the side-by-side image comparison study, and similar technology characteristics (design, materials, energy source). |
Study Details
The study described is a non-clinical bench testing and comparison study to demonstrate equivalence in viewing the anterior segment.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 29 subjects. The number of eyes would be 29 * 2 = 58 eyes, as images from "both eyes of 29 subjects" were compared.
- Data Provenance: Not explicitly stated, but implies prospective data collection for the comparison study. No country of origin is specified.
- Types of cases: "healthy eyes and eyes with pathology".
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: One ophthalmologist.
- Qualifications: "an ophthalmologist." No specific years of experience or subspecialty are provided.
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Adjudication Method for the Test Set:
- Method: None explicitly stated. Since only one ophthalmologist performed the comparison, no adjudication method was necessary as there were no multiple independent assessments requiring resolution.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not described. The study involved a single ophthalmologist comparing images. There is no mention of measuring the effect size of human readers improving with or without AI assistance, as this is not an AI-assisted device.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm-only device. The Spectralis ASM is an accessory that enables a human user (ophthalmologist) to view the anterior segment of the eye. Its performance is tied directly to its ability to generate images that can be interpreted by a human.
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The Type of Ground Truth Used:
- Expert Consensus/Opinion: The ground truth for the comparison was based on the opinion of a single ophthalmologist, who "concluded" equivalence between the images. This is essentially an expert interpretation of image quality and anatomical representation.
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The Sample Size for the Training Set:
- Not Applicable: This device does not use machine learning or AI, so there is no "training set."
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How the Ground Truth for the Training Set was Established:
- Not Applicable: As there is no training set, there is no ground truth establishment for it.
§ 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.