Search Results

CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.

CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

CALLISTO eye Software, version 3.6, is an assistance, information, and documentation system to support ophthalmic surgical procedures. CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). CALLISTO eye Software must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory. The software enables the visualization of the anterior and posterior segments of the eye and allows the connection and remote control of a surgical microscope.

CALLISTO eye software is provided with differing levels of functionality based on the option licensed. Some of these configurations provide a variety of assistant functions (tools) to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses (tIOL). These tools are comprised of graphical templates including Incisions to insert a toric intraocular lens. Rhexis for opening the capsular bag. Z ALIGN for the alignment of toric intraocular lens, and LRI for the planning of limbal relaxing incisions.

The provided text describes the CALLISTO eye Software and its substantial equivalence determination by the FDA. However, the document primarily focuses on regulatory approval and comparisons to predicate devices based on functionality and features, rather than presenting a performance study with specific acceptance criteria and detailed study results from a test set.

Therefore, I cannot fully address all parts of your request as the information is not present in the provided text. Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Sample sizes used for a test set (only "verification and validation testing" is mentioned generally).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance study.
• Specific types of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses "Verification and Validation Activity" and states that "Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 3.6, meets the stipulated requirements and performs as intended." This general statement indicates that performance testing was done internally to meet specifications, but it does not provide the specific details of such a study that you requested.

The document focuses on the software's functionality, its integration with other devices, and its compliance with standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM). The "performance data" section largely refers to software verification and validation activities rather than a clinical performance study with defined acceptance criteria for specific clinical metrics.

In summary, the provided FDA 510(k) summary does not contain the detailed performance study information with Acceptance Criteria, test set details, ground truth establishment, or clinical outcome effect sizes as requested. It only broadly states that the device was verified and validated to meet its requirements.

Ask a specific question about this device