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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.

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