(190 days)
The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
This device is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.
The IOLMaster 500 is a non-contact biometry instrument for measurements of the eye required for preoperative computation of intraocular lens (IOL) type and power. As with the IOLMaster predicate device, the IOLMaster 500 provides measurements of axial length, corneal radius (keratometry), and anterior chamber depth. In the new model of the IOLMaster, the optical measurement technology has remained the same and the measurements of axial length, corneal radius and anterior chamber depth are achieved in the same fashion. In addition to these three parameters, using the same optical techniques with advances in software, the modified IOLMaster also has the capability to measure a fourth parameter, i.e., the "white-to-white" distance (WTW). Incorporation of this additional information extends the physician's choice of computational formulas.
Here's a breakdown of the acceptance criteria and the studies conducted for the IOLMaster 500, based on the provided 510(k) summary:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
The submission does not explicitly state acceptance criteria in terms of specific thresholds for agreement or variability. Instead, it presents the results of studies and implies that these results demonstrate substantial equivalence and acceptable performance. Therefore, the "acceptance criteria" listed here are inferred from the demonstrated performance that led to 510(k) clearance.
| Measurement Parameter | Implied Acceptance Criterion (from demonstrated performance) | Reported Device Performance (Mean Difference / Standard Deviation / Repeatability / Reproducibility) |
|---|---|---|
| Agreement with Other Instruments | ||
| Axial Length (vs. GBS) | Agreement with predicate/reference device (Grieshaber Biometric System) indicating minimal mean difference and low standard deviation. | -0.01 mm ±0.19 mm |
| Corneal Curvature (vs. Manual Keratometer) | Agreement with predicate/reference device (manual keratometer) indicating minimal mean difference and low standard deviation. | -0.01 mm ±0.05 mm |
| Anterior Chamber Depth (vs. GBS) | Agreement with predicate/reference device (Grieshaber Biometric System) indicating minimal mean difference and low standard deviation. | +0.03 mm ±0.18 mm |
| White-to-White (vs. Lenstar LS900) | Agreement with predicate/reference device (Lenstar LS900) indicating minimal mean difference and low standard deviation. | +0.06 mm ±0.33 mm |
| Repeatability and Reproducibility | ||
| Axial Length | High repeatability (low SD, low limit) within a single instrument/operator and high reproducibility (low SD, low limit) across instruments/operators. | Repeatability SD: 0.0206 mm / Limit: 0.0577 mm |
| Reproducibility SD: 0.0222 mm / Limit: 0.0623 mm | ||
| Corneal Curvature | High repeatability (low SD, low limit) within a single instrument/operator and high reproducibility (low SD, low limit) across instruments/operators. | Repeatability SD: 0.0162 mm / Limit: 0.0455 mm |
| Reproducibility SD: 0.0167 mm / Limit: 0.0468 mm | ||
| Anterior Chamber Depth | High repeatability (low SD, low limit) within a single instrument/operator and high reproducibility (low SD, low limit) across instruments/operators. | Repeatability SD: 0.0347 mm / Limit: 0.0972 mm |
| Reproducibility SD: 0.0494 mm / Limit: 0.1383 mm | ||
| White-to-White | High repeatability (low SD, low limit) within a single instrument/operator and high reproducibility (low SD, low limit) across instruments/operators. | Repeatability SD: 0.0558 mm / Limit: 0.1562 mm |
| Reproducibility SD: 0.0647 mm / Limit: 0.1811 mm |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Agreement Studies (Test Set):
- Axial Length: 146 phakic eyes (from an initial 189 consecutive eyes).
- Corneal Curvature: 154 eyes.
- Anterior Chamber Depth: 151 eyes.
- White-to-White: 112 cataract surgery eyes.
- Data Provenance: The studies referenced are:
- Haigis W, Lege B (2000) - This implies a German origin given the journal title.
- Buckhurst PJ et al. (2009) - This is a British Journal of Ophthalmology paper, suggesting UK or international data.
- All referenced studies compared measurements from eyes evaluated for cataract surgery. The studies appear to be retrospective literature reviews of previously published comparisons, rather than a new prospective study specifically for this 510(k).
-
Repeatability and Reproducibility Study (Test Set):
- Sample Size: 30 subjects.
- Data Provenance: "Carl Zeiss Meditec, Inc., Clinical Study: Repeatability of IOLMaster 500; 2010." This suggests a prospective study conducted specifically for this device by the manufacturer, likely in the USA where Carl Zeiss Meditec, Inc. is located. Subjects were 18 years or older with healthy eyes and no ocular opacities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No explicit ground truth experts or their qualifications are mentioned for the agreement studies, as these studies compared the IOLMaster 500 to established reference devices (Grieshaber Biometric System for AL/ACD, manual keratometer for corneal curvature, Lenstar LS900 for WTW). These reference devices are themselves considered "ground truth" or highly accurate measurement methods in their respective fields.
For the repeatability and reproducibility study, there is no "ground truth" in the sense of expert annotation, but rather statistical analysis of repeated measurements. The study involved "one operator" for inter-device variability and "each of three operators" for inter-operator variability, but their specific qualifications are not detailed beyond "operator."
4. Adjudication Method for the Test Set
No adjudication method is described for the test sets. The agreement studies directly compared measurements between devices, and the repeatability/reproducibility study analyzed variations in measurements.
5. 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 MRMC comparative effectiveness study was done. This device is a measurement instrument, not an AI-assisted diagnostic tool that requires human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the device operates in a standalone capacity for measurement. The performance tables (Table 1 and Table 2) reflect the inherent accuracy and precision of the device's measurements, independent of human interpretation or intervention beyond performing the measurement itself.
7. The Type of Ground Truth Used
- Agreement Studies: The ground truth was effectively established by comparison with established, high-precision, and clinically accepted reference devices for ocular measurements:
- High precision immersion ultrasound system (Grieshaber Biometric System) for axial length and anterior chamber depth.
- Handheld keratometer (Renaissance, Alcon) for corneal curvature.
- Optical low coherence reflectometry (Lenstar LS900, Haig-Streit) for white-to-white measurements.
- Repeatability and Reproducibility Study: The "ground truth" here is the true underlying measurement of the subject, with the study assessing the variability around that true value by repeated measurements from the device itself.
8. The Sample Size for the Training Set
No explicit training set is mentioned in the provided document. The IOLMaster 500's measurement technology (partial coherence interferometry and traditional ophthalmic biometry) remained the same as the predicate device, with software advances primarily improving the Graphical User Interface (GUI) and adding the white-to-white measurement. It's possible the core algorithms for AL, corneal radius, and ACD were "trained" or validated during the development of the original IOLMaster (K993357), but this document doesn't detail it. The IOLMaster 500's white-to-white measurement uses "the same optical techniques with advances in software," implying it leverages existing optical principles rather than requiring a large separate training set for a new AI model.
9. How the Ground Truth for the Training Set Was Established
As no specific training set for a machine learning model is described, there's no information on how its ground truth was established. The device relies on established biophysical principles and optical measurements.
§ 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.