(238 days)
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:
- Lens thickness
- Corneal curvature and thickness
- Axial length
- Anterior chamber depth
- Pupil diameter
- White-to-white distance (WTW)
For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of:
- measuring distances within the human eye along the visual axis (e.g. axial length, lens thickness, anterior chamber depth),
- measuring the corneal surface with a keratometer,
- measuring distances at the front of the eye with a camera (e.g. white-to-white distance).
The IOLMaster 700 is used for visualization and measurement of ocular structures mainly required for the preparation of cataract surgeries to calculate the refractive power of the intraocular lens (IOL) to be implanted. The IOLMaster 700 device includes a swept source frequency domain optical coherence tomography (OCT) module capable of acquiring tomograms of the eye. The axial measurements are based on those tomograms.
The IOLMaster 700 device is operated via multi touch monitor and alternatively with computer mouse and keyboard. A joystick on the measuring head is used for manual alignment of the device to the patient's eye.
Here's a breakdown of the acceptance criteria and study details for the IOLMaster 700 device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria (e.g., "AL difference must be less than 0.05 mm"). Instead, it focuses on demonstrating comparability to predicate devices and showing good repeatability and reproducibility. The "Limits of Agreement" from the Bland-Altman analysis (which is implied by the report of mean difference and limits of agreement) can be considered as the implicit acceptance ranges for comparability.
| Measured Parameter | IOLMaster 700 vs. IOLMaster 500 (Mean Difference (SD)) | Limits of Agreement (Lower, Upper) | IOLMaster 700 vs. Lenstar LS 900 (Mean Difference (SD)) | Limits of Agreement (Lower, Upper) | IOLMaster 700 Repeatability (SD) | IOLMaster 700 Repeatability (%CV) |
|---|---|---|---|---|---|---|
| Biometry Mode | ||||||
| Axial Length (AL) [mm] | 0.004 (0.025) | -0.045, 0.053 | N/A | N/A | 0.009 | 0.037% |
| Anterior Chamber Depth (ACD) [mm] | 0.017 (0.121) | -0.221, 0.254 | N/A | N/A | 0.010 | 0.314% |
| Lens Thickness (LT) [mm] | N/A | N/A | 0.020 (0.120) | -0.246, 0.256 | 0.019 | 0.410% |
| Central Corneal Thickness (CCT) [µm] | N/A | N/A | 0.116 (4.492) | -8.688, 8.920 | 2.271 | 0.414% |
| Keratometry Mode | ||||||
| R1, Radius in Flat Meridian [mm] | 0.001 (0.044) | -0.086, 0.087 | N/A | N/A | 0.026 | 0.334% |
| R2, Radius in Steep Meridian [mm] | -0.002 (0.046) | -0.093, 0.088 | N/A | N/A | 0.024 | 0.316% |
| Spherical Equivalent (SE) [D] | -0.001 (0.190) | -0.374, 0.371 | N/A | N/A | 0.100 | 0.231% |
| Cylinder (Cyl) [D] | 0.013 (0.318) | -0.610, 0.636 | N/A | N/A | 0.191 | 20.449% |
| Axis (A) [°] | 1.407 (11.388) | -20.91, 23.73 | N/A | N/A | 5.633 | 6.93% |
| WTW Mode | ||||||
| White-to-White (WTW) [mm] | -0.125 (0.167) | -0.452, 0.203 | N/A | N/A | 0.090 | 0.755% |
Acceptance Criteria Implied: The study's conclusion that "The results of the IOLMaster 700 measurements are comparable to those of the predicate devices" and that it "demonstrated good repeatability and reproducibility for all parameters" indicates that the observed differences and variability fall within clinically acceptable ranges, deeming the device substantially equivalent. The p-values for paired t-tests (Table 2) consistently being above 0.05 (except for WTW) further support comparable means, although differences in variability exist.
2. Sample Size and Data Provenance
- Test Set Sample Size: A total of 120 eyes were enrolled in the study. Only one eye of each subject was designated as the study eye.
- Data Provenance: The study was a prospective non-significant risk clinical study conducted at three sites. The document does not specify the countries/regions of these sites, but it is a US FDA submission, implying compliance with US regulations.
3. Number of Experts and Qualifications for Ground Truth for Test Set
The document does not mention the use of experts to establish ground truth for the test set. The study directly compares the IOLMaster 700 measurements against the measurements obtained by the predicate devices (IOLMaster 500 and Lenstar LS 900) as the reference for comparability. For repeatability and reproducibility, the device's own measurements are compared against each other.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of expert review for ground truth, as ground truth was not established by experts. For data quality during analysis, "scans were reviewed using the same quality criteria as described in the User Manual, Software Description." The specific criteria included issues like incorrect caliper placement, blurred images, closed eyelids, and distorted reflections.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study focuses on device biometry measurement accuracy, comparability to predicate devices, and repeatability/reproducibility, not on human reader performance with or without AI assistance. The device is a biometer, not an AI-assisted diagnostic tool for interpretation.
6. Standalone Performance Study
- Yes, a standalone study was performed in the sense that the IOLMaster 700's own measurements were evaluated for repeatability and reproducibility, independent of human interpretation or "human-in-the-loop" performance. The device is intended to provide objective biometric measurements. The comparison to predicate devices also serves as a standalone performance assessment against established benchmarks.
7. Type of Ground Truth Used
The "ground truth" for the comparative study was the measurements obtained from the predicate devices:
- IOLMaster 500 (for AL, ACD, R1, R2, SE, Cyl, A, WTW)
- Lenstar LS 900 (for LT, CCT)
For repeatability and reproducibility, the device's own repeated measurements served as the basis for assessing consistency.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. This device is a measurement instrument based on optical principles, not a machine learning model that requires a separate training data set for its core functionality of measurement.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set for an algorithm, this question is not applicable based on the provided document. The device's measurement algorithms are likely based on physical principles (e.g., optical coherence tomography) rather than being trained on a large dataset with established ground truth in the AI/ML sense.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.