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The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices:

IOLMaster 500: The IOLMaster is intended for the biometric determination of ocular measurements of 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.

CALLISTO eye: CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope. The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis. The system utilizes surgeon information for position of graphical guidance tools.

The markerless toric IOL alignment workflow provided with the ZEISS Cataract Suite markerless is a series of medical devices integrated into one workflow for use by a cataract surgeon. The workflow comprises an optical biometric device with green LED image capture from the IOLMaster 500 (K122418) with an optional accessory (Option Reference Image). The captured image is transferred to a cataract surgery assistance system, the CALLISTO eye (K123464), which operates in conjunction with ophthalmic surgical microscopes. Integrated or external data injection systems (IDIS or EDIS) are capable of displaying the graphical templates of the CALLISTO eye in the right ocular of the ophthalmic surgical microscopes.

The provided text describes the regulatory clearance of the ZEISS Cataract Suite markerless, which is a system comprising the IOLMaster 500, CALLISTO eye, and ophthalmic surgical microscopes, intended to aid in cataract surgery, particularly for toric IOL alignment.

However, the document is a 510(k) summary for regulatory clearance and does not contain the detailed study information as requested. It focuses on demonstrating substantial equivalence to a predicate device and outlines general software and safety testing, but lacks specific performance data, acceptance criteria, study methodologies, or ground truth establishment details.

Therefore, I cannot fulfill all the requested information. Below is what can be inferred or explicitly stated from the provided text, and where information is missing.

Missing Information Disclaimer:

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and statistical analysis as would be found in a clinical trial report. As such, much of the requested information (e.g., specific acceptance criteria values, reported device performance metrics against those criteria, sample sizes for test/training sets, details of ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance) is not present in this document.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified. The document mentions "appropriate bench testing" and software testing. It does not indicate the nature, origin, or type (retrospective/prospective) of any clinical data used for performance evaluation, if any.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

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

• Adjudication Method: Not specified in the document.

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

• MRMC Study: Not specified in the document. The document describes the CALLISTO eye as an "assistance system" and states its graphical tools "aid the surgeon." However, it does not provide details of any MRMC study comparing surgeon performance with and without the system, nor an effect size.

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

• Standalone Performance: The document does not describe a standalone performance study of the algorithm (e.g., a specific "AI" component's accuracy without a human surgeon's input beyond providing the initial images). The system is presented as an "assistance system" for human surgeons.

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

• Type of Ground Truth: Not specified in the document. The document focuses on software verification and validation, and safety testing, which typically involve testing against predefined specifications or known correct outputs, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the document. It's unclear if machine learning models requiring training sets were central to the "AI" component, but even if so, no such details are provided.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not specified in the document.

Summary of what is known from the document:

• Device: ZEISS Cataract Suite markerless, comprising IOLMaster 500, CALLISTO eye, and ophthalmic surgical microscopes.
• Purpose: Markerless toric IOL alignment workflow, visualization, and guidance during cataract surgery.
• Regulatory Basis: Substantial equivalence to predicate device (TrueVision 3D Visualization and Guidance System K101861).
• Testing Mentioned: Software testing (according to FDA Guidance for Software in Medical Devices and IEC 62304:2006), electromagnetic compatibility, safety testing, and "appropriate bench testing."
• Conclusion: The device is deemed "safe and effective with respect to their Indications for Use" based on the mentioned testing and comparison to the predicate.

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