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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)

The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measurement of ocular structures. The IOLMaster 700 is the latest generation device in the IOLMaster series. The version of the IOLMaster 700 that is the subject of this submission is a modified version of the IOLMaster 700 cleared under K170171.

Here's a breakdown of the acceptance criteria and study details for the IOLMaster 700 device, based on the provided FDA 510(k) summary.

It's important to note that this document is for a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely about demonstrating comparability or non-inferiority to the predicate device and established clinical methods, rather than setting absolute performance thresholds for a novel device. The study design reflects this goal.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modified device, the "acceptance criteria" are not explicitly stated as numerical targets in the same way they might be for a de novo device. Instead, the performance data aims to demonstrate that the new features (Total Keratometry and Posterior Corneal Surface measurements) are either:

• Interchangeable with conventional methods for normal eyes.
• Perform better than or comparably to existing history-free approximation methods (like Haigis-L) for post-LVC eyes, especially when historical data is unavailable.
• And that repeatability and reproducibility are comparable to the conventional keratometry.

The reported performance is summarized in the "Results" sections of the clinical studies. For the purpose of this table, I will infer the acceptance criteria from the conclusions drawn by the manufacturer regarding comparability and suitability.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Data):

  • Normal Eyes (Study IOLM71): 142 normal eyes (without previous surgery or pathologies except cataract), 738 measurements. (Provenance: Raw data collected prospectively, non-significant risk clinical study at three sites, described as "normal eyes = without prior Laser Vision Correction").
  • Normal Eyes (Study IOLMaster 2017-01909): 32 non-cataract eyes (281 measurements) and 31 cataract eyes (278 measurements). (Provenance: Prospective, monocentric, non-significant risk clinical R&R study, one eye per patient).
  • Post-LVC Eyes (Study HamburgLVC): 30 eyes, 60 measurements (one pre- and one post-operative measurement for each eye). 29 myopic LASIK, 1 hyperopic LASIK. (Provenance: Prospective, single-site clinical study, one eye per patient).
  • Post-LVC Eyes (Study IOLMaster 2017-01909): 30 post-LVC eyes, 267 measurements. (Provenance: Prospective, monocentric, non-significant risk clinical R&R study, one eye per patient).
  • Country of Origin: Not explicitly stated, but the mention of "HamburgLVC" suggests Germany for at least one study site. The applicant "Carl Zeiss Meditec AG" is based in Germany.

• Training Set: Not explicitly mentioned in this 510(k) summary, as the device improvements are primarily related to algorithms for new measurement calculations (Total Keratometry, Posterior Cornea Surface) derived from existing OCT technology, rather than an AI/ML model that requires explicit "training" in the traditional sense. The software verification and validation are for the overall product, and bench testing with "test targets of known curvatures" was used for accuracy and repeatability of the new measurement calculations.

3. Number of Experts and their Qualifications for Ground Truth

• Not applicable in the context of this 510(k). This device is a measurement instrument. The ground truth for the performance of the measurements is based on:
  • Bench testing with "test targets of known curvatures."
  • Comparison to existing, established clinical measurement methods (conventional keratometry, Gullstrand model, Clinical History Method for post-LVC eyes).
  • The "experts" involved would be the clinicians conducting the clinical studies and presumably validating the established methods used for comparison. The document does not specify the number or qualifications of these clinicians beyond them being study site personnel.

4. Adjudication Method for the Test Set

• Not applicable. This study is focused on the performance of a measurement device. There is no subjective interpretation being adjudicated. The measurements are quantitative.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an imaging device where human readers interpret and then AI assists in that interpretation. It is a biometric measurement device. The studies compare the device's measurements to established measurement methods.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The device itself performs the measurements for Total Keratometry and Posterior Corneal Surface (via its software algorithm). The performance data (Table 1, Figure 1, Figure 2, Tables 2, 3) represent the output of the device's algorithms. There isn't a human-in-the-loop component for these specific measurements; the device generates the numbers. The clinical data then validates these algorithm outputs against established clinical practices.

7. Type of Ground Truth Used

• For Accuracy/Deviation:
  • Known Reference Standards: Bench testing used "test targets of known curvatures."
  • Established Clinical Methods/Models:
    • Conventional keratometry and the Gullstrand model (for normal eyes).
    • Clinical History Method (CHM) for post-LVC eyes, which is considered the "gold standard" when historical data is available.
• For Repeatability & Reproducibility:
  • Multiple measurements on the same patients/eyes using the device itself across different scans, and sometimes different devices/operators.

8. Sample Size for the Training Set

• Not applicable / Not stated. This 510(k) describes a device that utilizes "Spectral domain interferometry (OCT principle)" and "Swept source laser" to obtain biometric measurements. The improvements are primarily algorithmic enhancements to interpret these optical measurements for new parameters (TK, PCS). It's not described as a machine learning model that undergoes a distinct "training set" phase in the typical AI/ML sense. Bench testing and clinical data validate the performance of these algorithms.

9. How the Ground Truth for the Training Set was Established

• Not applicable / Not stated as there is no explicitly defined "training set" for an AI/ML model. The underlying physics and algorithms are based on established optical principles (OCT, interferometry). The validation data compares the device's output to established clinical measurement techniques and physical standards.

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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 image capture tool.

The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measurement of ocular structures. The IOLMaster 700 is the latest generation device in the IOLMaster series. The version of the IOLMaster 700 that is the subject of this submission is a modified version of the IOLMaster 700 cleared under K143275.

The differences between the subject IOLMaster 700 and the predicate IOLMaster 700 that are the subject of this 510(k) submission are:

• . Labeling changes, including inclusion of additional clinical data and minor updates;
• Materials changes to the forehead rest and chin rest ●

The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device.

The provided text is a 510(k) summary for the Carl Zeiss Meditec AG IOLMaster 700 device (K170171). It details a filing for a modified version of an already cleared device (K143275). The modifications are specifically listed as:

• Labeling changes, including inclusion of additional clinical data and minor updates.
• Materials changes to the forehead rest and chin rest.

The document explicitly states that "The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device." This means that performance data related to the core biometric measurements (Lens thickness, Corneal curvature and thickness, Axial length, Anterior chamber depth, Pupil diameter, White-to-white distance, and OCT visualization) is not included as new testing for this specific 510(k) submission (K170171). The substantial equivalence is based on the new version having identical indications for use and principle of operation to the predicate device, with new testing focused on the biocompatibility and electrical safety of the material changes.

Therefore, many of the requested details, such as specific acceptance criteria for biometric performance, sample sizes for test sets, expert qualifications, ground truth establishment for the test set, MRMC studies, or standalone algorithm performance, are not applicable to this particular 510(k) submission (K170171) because the core performance of the device's measurement capabilities was not re-evaluated. The acceptance criteria and studies described here relate to the changes made to the device.

Here's a breakdown of what is provided and what is not provided in the text based on your request:

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for minor modifications (labeling and material changes) to an already cleared device with identical indications for use and principle of operation, the "acceptance criteria" discussed are primarily related to safety and maintainance of equivalence.

Study Details for K170171 (Focus on Modifications)

1. Sample sizes used for the test set and the data provenance:

   • For Biocompatibility: The text doesn't specify sample sizes (e.g., number of material samples or animal tests) for the biocompatibility testing (ISO 10993-10, ISO 10993-5). The data provenance is not specified (e.g., country, retrospective/prospective).
   • For Electrical Safety & EMC: These are compliance tests (pass/fail) against standards, not typically associated with "sample sizes" in the clinical data sense. A representative device unit would be tested.
   • For core biometric performance: No new test set data is provided or relied upon for this specific 510(k) submission (K170171) because the core measurements and principle of operation were not changed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for a 510(k) focused on material and labeling changes. The biocompatibility, electrical safety, and EMC tests rely on established laboratory standards and test methods, not expert consensus on image interpretation.
   • For the original clearance of the device (K143275), clinical studies would have been performed, which might have involved experts, but those details are not provided in this summary.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as the testing described doesn't involve subjective interpretation that would require an adjudication process.

4. 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:

   • Not applicable. The IOLMaster 700 is a biometric measurement device and imaging tool, not an AI-assisted diagnostic device. Its function is to provide objective measurements and images for human clinicians to use. This 510(k) in particular focuses on minor physical changes.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The IOLMaster 700 is a measurement device. Its "algorithm" is for biometric measurement (e.g., calculating axial length, lens thickness from OCT data). The output itself is a measurement or an image, not a diagnostic interpretation. The device's performance stands alone in its ability to accurately measure. No new standalone performance evaluation was required for the changes in K170171 beyond demonstrating that the material changes did not affect existing performance characteristics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Biocompatibility: Ground truth is established by the specified ISO standards for cytotoxicity, skin irritation, and sensitization. These tests have defined endpoints (e.g., cell viability, irritation scores).
   • For Electrical Safety & EMC: Ground truth is defined by the compliance criteria within the IEC standards themselves.
   • For core biometric performance: While not detailed in this summary, the ground truth for biometric measurements (like axial length or corneal curvature) in the original device clearance (K143275) would typically involve comparison to established reference methods or highly accurate clinical gold standards (e.g., pachymetry for corneal thickness, A-scan ultrasonography for axial length, or phakometry for lens thickness, depending on the specific measurement). The document implies that the performance characteristics and measurements produced are identical to the predicate.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model that undergoes a "training" phase. Its measurement algorithms are based on optical principles and engineering.

8. How the ground truth for the training set was established:

   • Not applicable (see point 7).

In summary, the K170171 submission focuses on demonstrating substantial equivalence for minor modifications (labeling and materials) to an already cleared device. Therefore, the acceptance criteria and supporting studies are centered on ensuring these specific changes do not negatively impact safety or the previously established performance characteristics, rather than re-evaluating the foundational biometric measurement capabilities.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

This device will be used in the same manner as all ophthalmic diagnostic devices used to obtain ocular measurements (for axial length, anterior chamber depth and corneal radius), and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

The IOLMaster is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate power of IOL for implantation, (axial eye length, anterior chamber depth, and corneal radius), and for calculating the optimal power of IOL.
Axial eye length is measured using the principle of partial coherence interferometry (also referred to as laser Doppler interferometry), with a Michelson interferometer.

Corneal radius is measured using traditional keratometery principles. whereby light from LEDs is projected on the cornea of the eve, and after image capturing of the reflected marks and image processing provides the measurement.

Anterior chamber depth is measured by slit lamp illumination. The slit light is scattered by the cornea and the eye lens, generating an image of the cornea and the lens. The image is captured by a CCD-camera. Image processing and edge detection algorithms allow for calculation of the distance between the anterior surface of cornea and lens ( == anterior chamber depth).

These three measurements provide the physician with the data required to calculate the power of IOL to use for a patient. The physician can then choose from one of up to five internationally accepted formulas, built into the IOLMaster, to perform the calculation. The IOL power is then calculated according to the IOL type.

Users can also enter information regarding the different IOL types into the IOLMaster database, which can then be used to suggest the optimal IOL. This calculation and selection process is already performed by ultrasound and other diagnostic devices. However, the choice of formula and final determination of the appropriate IOL is at the physicians' discretion.

Here's an analysis of the provided 510(k) summary regarding the IOLMaster device, focusing on its acceptance criteria and the study used to validate its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in a quantitative manner. Instead, it presents the device's performance as the deviation from established comparative devices. This deviation serves as the functional equivalent of performance criteria, where smaller deviations indicate better agreement and thus, acceptable performance relative to the established gold standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • The second stage testing involved 155 human eyes.
  • Prior to this, a "first stage testing" involved 678 human eyes. It's important to note that the detailed performance metrics are given for the 155 human eyes in the second stage testing, which seems to be the primary dataset for the reported deviations.
• Data Provenance: The study was conducted at the University Eye Clinic, Wuerzburg, Germany in February 1999. The data is prospective, as it describes the measurement of human eyes with the IOLMaster prototype and comparative devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish the ground truth. The "ground truth" was established by measurements from existing, cleared devices (Grieshaber Biometry System, AL-1000 A-scan device, ALCON Ocuscan keratometer). These are considered established methods, and the expertise would lie in operating these devices and interpreting their results. There's no mention of a separate expert panel adjudicating the measurements from these objective devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the traditional sense (e.g., 2+1, 3+1). The "ground truth" was established by direct measurements from the comparative devices, not by human consensus or review of IOLMaster results. The study directly compared IOLMaster measurements to these reference device measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the agreement between the IOLMaster device and existing measurement devices, not on the improvement of human readers with or without AI assistance. The IOLMaster is a diagnostic measurement device, not an AI-assisted diagnostic aid for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this was a standalone performance study. The IOLMaster directly generates measurements (axial eye length, corneal radii, anterior chamber depth) using its internal algorithms, and these measurements were directly compared against the measurements obtained from the predicate devices. The performance metrics (deviations) are for the device itself. While physicians use the device, the measurements themselves are output by the algorithm.

7. The Type of Ground Truth Used

The ground truth used was measurements obtained from established, high-accuracy comparative devices.

• For Axial Eye Length and Anterior Chamber Depth, the Grieshaber Biometry System ("GBS"), a high-accuracy ultrasound biometry unit in immersion technique, was used as the ground truth. The TOMEY "AL-1000" A-scan device was also mentioned as a comparative device in the broader first-stage testing.
• For Corneal Radii, the ALCON "Ocuscan" keratometer was used as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a sample size for a training set. The study describes validation and verification testing of a "prototype" with specific performance data. While the device utilizes image processing and algorithms, there's no mention of a separate set of data specifically used for machine learning model training. The development process likely involved an internal testing and calibration process, but this is not detailed as a "training set" in the submission. The "first stage testing of 678 human eyes" could be considered part of an early development or internal validation, but it's not explicitly called a training set.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" is not explicitly described, the method for establishing its ground truth is also not detailed. If the 678 human eyes in the first stage testing served as an internal development/training set, it would likely have used similar comparative devices as the reported validation study.

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