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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)

Table 2: Repeatability and Reproducibility (IOLMaster vs. Marco)

Table 3: Agreement with Javal Keratometer (116 eyes)

Table 4: Repeatability (IOLMaster vs. Javal)

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.

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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.

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.

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