(247 days)
The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-towhite (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 use dunder the supervision of a physician.
The IOLMaster 500 is a non-contact biometry instrument for measurements of the eve required for preoperative computation of intraocular lens (IOL) type and power. As with the IOLMaster 500 predicate device, the IOLMaster 500 provides measurements of axial length, corneal radius (keratometry), anterior chamber depth and the "white" distance (WTW).
Here's an analysis of the acceptance criteria and the studies performed for the IOLMaster 500, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IOLMaster 500 are implicitly defined by its performance in comparison to established manual keratometers (Marco and Javal). The device is deemed acceptable if its measurements demonstrate a high level of agreement and improved or comparable repeatability/reproducibility compared to these predicate devices.
The text does not explicitly state numerical thresholds as "acceptance criteria" but presents comparative results to demonstrate substantial equivalence. The device's performance is reported in terms of agreement (95% Limits of Agreement), and repeatability/reproducibility (Standard Deviation, Limit, and %COV).
Table 1: Agreement with Marco Keratometer (61 eyes)
| Measurement | Acceptance Criteria (Implicit: High agreement with predicate) | Reported IOLMaster Performance (Difference ± SD, 95% LoA) |
|---|---|---|
| Power in Flat Meridian | (Within clinically acceptable limits for IOL calculations) | +0.24 ± 0.13 D, -0.07 to +0.55 D |
| Power in Steep Meridian | (Within clinically acceptable limits for IOL calculations) | +0.43 ± 0.21 D, +0.02 to +0.84 D |
| Mean Power (P1+P2)/2 | (Within clinically acceptable limits for IOL calculations) | +0.33 ± 0.13 D, +0.05 to +0.63 D |
| Astigmatic Power | (Within clinically acceptable limits for IOL calculations) | -0.18 ± 0.23 D, -0.64 to +0.26 D |
| Axis [°] | (Within clinically acceptable limits for IOL calculations) | 4.00 ± 3.30 °, +10.47 ° (upper limit) |
Table 2: Repeatability and Reproducibility (IOLMaster vs. Marco)
| Measurement | Acceptance Criteria (Implicit: Comparable or better than predicate) | Reported IOLMaster Repeatability | Reported IOLMaster Reproducibility |
|---|---|---|---|
| R1, Radius in Flattest Meridian [mm] | (Better than Marco: SD 0.0381, Limit 0.1068, %COV 0.48%) | SD 0.0154, Limit 0.0431, %COV 0.20% | SD 0.0165, Limit 0.0462, %COV 0.21% |
| R2, Radius in Steepest Meridian [mm] | (Better than Marco: SD 0.0654, Limit 0.1832, %COV 0.86%) | SD 0.0179, Limit 0.0501, %COV 0.24% | SD 0.0192, Limit 0.0539, %COV 0.25% |
| P1, Power in Flattest Meridian [D] | (Better than Marco: SD 0.2201, Limit 0.6162, %COV 0.52%) | SD 0.0686, Limit 0.1921, %COV 0.16% | SD 0.0748, Limit 0.2094, %COV 0.18% |
| P2, Power in Steepest Meridian [D] | (Better than Marco: SD 0.3953, Limit 1.1067, %COV 0.90%) | SD 0.0875, Limit 0.2449, %COV 0.20% | SD 0.1010, Limit 0.2827, %COV 0.23% |
| Mean Power, (P1 + P2)/2 [D] | (Better than Marco: SD 0.2388, Limit 0.6686, %COV 0.56%) | SD 0.0563, Limit 0.1577, %COV 0.13% | SD 0.0663, Limit 0.1855, %COV 0.15% |
| Astigmatic Power [D] | (Better than Marco: SD 0.4249, Limit 1.1896, %COV 30.76%) | SD 0.1369, Limit 0.3833, %COV 8.75% | SD 0.1403, Limit 0.3927, %COV 8.96% |
| Axis [°] | (Similar to Marco: SD 3.1692, Limit 8.8738, %COV 2.86%) | SD 3.9249, Limit 10.9897, %COV 3.44% | SD 4.1737, Limit 11.6863, %COV 3.66% |
Table 3: Agreement with Javal Keratometer (116 eyes)
| Measurement | Acceptance Criteria (Implicit: High agreement with predicate) | Reported IOLMaster Performance (Difference ± SD, 95% LoA) |
|---|---|---|
| Power in Flat Meridian | (Within clinically acceptable limits for IOL calculations) | +0.24 ± 0.16 D, -0.00 to +0.48 D |
| Power in Steep Meridian | (Within clinically acceptable limits for IOL calculations) | +0.25 ± 0.17 D, -0.08 to +0.58 D |
| Mean Power (P1+P2)/2 | (Within clinically acceptable limits for IOL calculations) | +0.24 ± 0.11 D, +0.02 to +0.46 D |
| Astigmatic Power | (Within clinically acceptable limits for IOL calculations) | -0.01 ± 0.19 D, -0.38 to +0.36 D |
| Axis [°] | (Within clinically acceptable limits for IOL calculations) | 3.82 ± 3.51 °, +10.70 ° (upper limit) |
Table 4: Repeatability (IOLMaster vs. Javal)
| Measurement | Acceptance Criteria (Implicit: Comparable or better than predicate) | Reported IOLMaster Repeatability |
|---|---|---|
| R1, Radius in Flattest Meridian [mm] | (Better than Javal: SD 0.0207, Limit 0.0581, %COV 0.26%) | SD 0.0109, Limit 0.0304, %COV 0.14% |
| R2, Radius in Steepest Meridian [mm] | (Better than Javal: SD 0.0252, Limit 0.0706, %COV 0.33%) | SD 0.0180, Limit 0.0503, %COV 0.24% |
| P1, Power in Flattest Meridian [D] | (Better than Javal: SD 0.1104, Limit 0.3091, %COV 0.26%) | SD 0.0587, Limit 0.1644, %COV 0.14% |
| P2, Power in Steepest Meridian [D] | (Better than Javal: SD 0.1387, Limit 0.3885, %COV 0.32%) | SD 0.1023, Limit 0.2864, %COV 0.23% |
| Mean Power, (P1 + P2)/2 [D] | (Better than Javal: SD 0.0919, Limit 0.2574, %COV 0.22%) | SD 0.0583, Limit 0.1632, %COV 0.14% |
| Astigmatic Power [D] | (Better than Javal: SD 0.1709, Limit 0.4787, %COV 13.27%) | SD 0.1192, Limit 0.3337, %COV 9.22% |
| Axis [°] | (Better than Javal: SD 2.8377, Limit 7.9456, %COV 2.74%) | SD 2.4242, Limit 6.7877, %COV 2.37% |
Studies Proving Device Meets Acceptance Criteria:
The IOLMaster 500 underwent two clinical studies to demonstrate its performance and substantial equivalence:
1. Prospective, Single Site Clinical Study - Comparison with Marco Manual Keratometer:
- Sample size used for the test set: 61 astigmatic eyes (with at least 0.75 D of astigmatism).
- Data provenance: Prospective, single site clinical study. The country of origin is not explicitly stated but is implied to be within the scope of Carl Zeiss Meditec AG's operations (Germany/USA).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "ground truth" is effectively the measurements from the Marco manual keratometer, which is a widely accepted clinical device. The study design implies skilled operators were used for both devices.
- Adjudication method for the test set: Not explicitly mentioned, but the Bland-Altman method was used to assess agreement, which is a statistical tool for comparing two measurement methods.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not in the traditional sense of human readers interpreting images. This study compared device measurements. However, the study included evaluation of "inter-operator variability" in Phase 2, which involves multiple operators.
- If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a measurement instrument, not an AI for image interpretation. The study evaluates the accuracy and precision of the device itself compared to manual methods.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device IOLMaster 500 is a standalone measurement device with integrated algorithms. Its performance was tested as a system. The "manual keratometer" serves as the human-in-the-loop comparison.
- The type of ground truth used: The measurements obtained from the Marco manual keratometer, a widely accepted clinical device, served as the comparative standard.
- The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a separate "training set" in the context of machine learning. Its operation is based on established optical biometry principles and integrated algorithms for IOL calculations.
- How the ground truth for the training set was established: Not applicable for this type of device.
2. Retrospective Analysis of a Previously Conducted Prospective, Single Site Clinical Study - Comparison with Javal Manual Keratometer:
- Sample size used for the test set: 116 astigmatic eyes (with at least 0.75 D of astigmatism).
- Data provenance: Retrospective analysis of a previously conducted prospective, single site clinical study. Country of origin not explicitly stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The study states "a single operator" performed five measurements on each eye using both the IOLMaster 500 and the Javal keratometer.
- Adjudication method for the test set: Not explicitly mentioned, but the Bland-Altman method was mentioned for assessing agreement.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The IOLMaster 500 was tested as a standalone measurement device.
- The type of ground truth used: The measurements obtained from the Javal manual keratometer, a widely accepted clinical device, served as the comparative standard.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Overall Conclusion from the Studies:
The studies concluded that the IOLMaster 500 demonstrated excellent agreement with both the Marco and Javal manual keratometers for corneal power, astigmatic power, and axis measurements. Furthermore, the IOLMaster 500 generally showed superior repeatability and reproducibility compared to the manual keratometers, with the exception of axis measurements, where both instruments had similar performance. These results support the claim of substantial equivalence to the predicate device and suitability for toric IOL calculations.
§ 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.