(489 days)
The ClearPath DS-120® Lens Fluorescence Biomicroscope is indicated for use to detect autofluorescence of the crystalline lens.
The major functional components of the ClearPath DS-120® Lens Fluorescence Biomicroscope are an optics unit and a laptop personal computer. The only components that contact the patient are a manually adjustable headrest (in/out) and a motorized adjustable chin rest (up/down). The adjustable optics window does not contact the patient.
Acceptance Criteria and Study Details for ClearPath DS-120® Lens Fluorescence Biomicroscope
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a clinical precision study designed to evaluate the repeatability and reproducibility of the ClearPath DS-120® Lens Fluorescence Biomicroscope. The study's purpose was to characterize the variability of measurements, not to establish diagnostic or prognostic utility, and thus does not explicitly state acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or accuracy.
Instead, the acceptance criteria implicitly relate to the variability of measurements (repeatability and reproducibility), which indicates the device's consistency and reliability as a measurement tool. The "fitness for purpose as a measurement tool" suggests that the variability should be within an acceptable range for clinical use in detecting lens autofluorescence.
Based on the "RESULTS" and "SUDY CONCLUSION" sections, the device is deemed to meet its purpose if its repeatability and reproducibility (expressed as standard deviation (SD) and Coefficient of Variation (%CV)) are within acceptable limits for a clinical measurement tool. The study did not define specific numerical thresholds for these values as "acceptance criteria" but rather presented them as characterizations of the device's performance.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (All Devices Combined) |
|---|---|---|
| Repeatability SD | Acceptable level for a clinical measurement tool (not explicitly quantified, but demonstrated as "fit for purpose") | 0.01034 |
| Repeatability %CV | Acceptable level for a clinical measurement tool (not explicitly quantified, but demonstrated as "fit for purpose") | 5.779% |
| Reproducibility SD | Acceptable level for a clinical measurement tool (not explicitly quantified, but demonstrated as "fit for purpose") | 0.01153 |
| Reproducibility %CV | Acceptable level for a clinical measurement tool (not explicitly quantified, but demonstrated as "fit for purpose") | 6.443% |
| Safety (Adverse Events) | No adverse events observed | No adverse events were observed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 27 participants.
- Data Provenance: Prospective, single-site study in humans. The country of origin of the data is not explicitly stated, but the submission is to the FDA (USA), implying the study was likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study was a precision study evaluating the repeatability and reproducibility of the device's measurements of lens autofluorescence. It was not designed to establish diagnostic or prognostic utility, and therefore, it did not use expert-established ground truth in the typical sense (e.g., for disease diagnosis). The "ground truth" for this study was the measurement itself as performed by the device under different conditions, which was then analyzed for variability.
4. Adjudication Method for the Test Set
Not applicable. As this was a precision study evaluating direct measurements from the device, rather than diagnostic classifications requiring expert interpretation and adjudication, no adjudication method was used. The study involved multiple operators and devices taking measurements, and the variability across these measurements was analyzed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly stated or performed. The study described is a precision study focused on the device's measurement consistency. It investigated inter-operator and inter-device variability but did not compare human reader performance with and without AI assistance, nor did it measure an effect size for human improvement with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The ClearPath DS-120® is a measurement device that computes the ratio of lens autofluorescence to scattered light. The "summary of protocol" describes operators taking measurements, implying human interaction is part of its intended use. The study evaluates the device's performance as used by operators, rather than a standalone algorithm performance without any human interaction. The device performs automatic tracking and computation, but human operators position the patient and initiate scans. Therefore, a purely standalone algorithm evaluation was not the focus.
7. The Type of Ground Truth Used
The "ground truth" for this precision study was the repeated measurements of lens autofluorescence and scattering response in human crystalline lenses themselves. The study aimed to characterize the natural variability of these measurements taken under controlled conditions, not to correlate them with an independent "true" clinical state (like the presence or absence of a disease).
8. The Sample Size for the Training Set
The document describes a clinical precision study rather than a study involving machine learning model training. Therefore, there is no mention of a training set in the context of an algorithm or model development. The data collected was for evaluating the device's precision, not for training it.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set mentioned for machine learning model development.
§ 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.