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The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates.

The TrueVision® 3D Visualization and Guidance System is a stereoscopic highdefinition digital video camera and workstation, which operates as an adjunct to the surgical microscope during cataract surgery and the slit lamp microscope during pre-operative and post-operative image capture. The visualization system displays real-time images during eve surgery on a flat-panel, high-definition digital 3D display device positioned for live video image viewing by the surgeon and surgical personnel in the operating room.

The Cataract and Refractive Toolset system combines the TrueVision FDAregistered Class 1 Device (TrueVision® 3D Visualization System for Microsurgery) with proprietary TrueWare™ software (controlled via remote keyboard with included touchpad mouse) to provide enhanced visualization and surgical quidance assistance to the surgeon during specific procedures such as Limbal Relaxing Incision, Capsulorhexis, and toric IOL positioning.

Using standard pre-operative clinical data, together with surgeon-driven, onscreen templates and guides, the Refractive Cataract Toolset provides graphical assistance to the surgeon as desired during the surgery. Guidance applications include incision templates to optimize the position of limbal relaxing incisions, sizing and positioning of capsulorhexis tears, and rotational alignment of toric intraocular lenses (toric IOL).

The provided 510(k) summary for the TrueVision 3D Visualization and Guidance System (K101861) includes some details about performance testing but does not provide a table of acceptance criteria with specific numeric targets or detailed reported device performance against those targets. It also lacks granular information on some of the requested study parameters.

Here's a breakdown of the available information and what is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the TrueVision® 3D Visualization and Guidance System. This was accomplished by software verification testing and a non-significant risk clinical study. All criteria for this testing were met and results demonstrate that the TrueVision® 3D Visualization and Guidance System meets all performance specifications and requirements."

However, specific acceptance criteria (e.g., minimum accuracy percentages, error margins) and the quantitative results validating these criteria are not provided. The summary only confirms that "All criteria for this testing were met."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions a "non-significant risk clinical study" but does not provide details about its sample size.
• Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or the country of origin. Given the device's intended use in surgical settings, it's likely prospective for the clinical study aspect, but this is an inference.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated.

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

• MRMC Study Done: Not explicitly stated. The focus is on the device's performance in providing "onscreen guidance" and assisting the surgeon, not on comparing human reader performance with and without AI assistance.
• Effect Size: Not applicable, as an MRMC study is not described.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, implicitly. The document mentions "software verification testing" to demonstrate compliance with specifications. This would typically involve testing the algorithm's performance independent of human interaction for its guidance functions. The "non-significant risk clinical study" would then likely evaluate the overall system (device + human interaction) in a real-world setting. However, specific performance metrics for the standalone algorithm are not presented.

7. Type of Ground Truth Used

• Type of Ground Truth: The document states that the system "utilizes surgeon confirmation at each step for planning and positioning of guidance templates." This suggests that the ground truth for evaluating the guidance features (e.g., accuracy of incision templates, capsulorhexis sizing, IOL alignment recommendations) would be based on surgeon confirmation/expert judgment during the clinical study. It is not explicitly stated if pathology or outcomes data were used directly for ground truth establishment.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not mentioned or applicable. The device primarily functions as a "visualization and guidance system" with "surgeon-driven, onscreen templates and guides." There is no indication that it uses a machine learning algorithm that requires a separate "training set" in the context of typical AI device development. The software likely implements pre-defined algorithms based on known surgical parameters and anatomical measurements, rather than learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there's no mention of a training set in the context of machine learning. The guidance templates are described as "surgeon-driven" and utilizing "standard pre-operative clinical data," implying that the accuracy of the guidance is based on established surgical principles and measurements, confirmed by the surgeon.

In summary, while the K101861 document states that performance testing, including software verification and a clinical study, was conducted and that all criteria were met, it lacks the detailed quantitative data and specific methodological descriptions required to fully populate the requested information.

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