(92 days)
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 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 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.
CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.
Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).
The Carl Zeiss Meditec AG's CALLISTO eye Software, version 5.0, did not conduct a clinical study to prove that the device met the acceptance criteria and was substantially equivalent to the predicate device, CALLISTO eye Software, version 3.7.2.
The submission states: "Animal and Clinical testing was not conducted."
Instead, the submission relied on non-clinical performance testing and risk management to demonstrate substantial equivalence.
Here's the information about the acceptance criteria and the study that was not performed in the traditional sense:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" for clinical performance as no clinical testing was performed. However, the basis for equivalence is the identical indications for use and equivalent technological characteristics and risk profile compared to the predicate device. The performance is deemed to be equivalent to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Identical Indications for Use: CALLISTO eye Software 5.0 will perform precisely the same functions as the predicate in aiding ophthalmic surgical procedures for IOLs, limbal relaxing incisions, and capsulorhexis. | The indications for use are identical to the predicate device, K231676. |
| Equivalent Technological Characteristics: The device will operate with similar functional performance and safety as the predicate device, despite software version update and some hardware connectivity changes. | Software verification and validation activities were successfully completed. The device complies with specifications and requirements. Risk management (ISO 14971) and cybersecurity assessment were performed. |
| Equivalent Risk Profile: The changes to the device will not introduce new safety concerns or modify existing risks such that the device is no longer substantially equivalent. | Risk analysis identified potential hazards and mitigations, controlled by design means, protection measures, and user instructions. Cybersecurity assessment based on VAST Threat Modeling was conducted. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was used for patient data. The "test set" for non-clinical testing refers to software test cases and system verification, not patient data.
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)
Not applicable, as no clinical ground truth was established by experts for a test set. Non-clinical software verification relies on defined specifications and requirements as the "ground truth" for expected software behavior.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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
Not applicable. No MRMC comparative effectiveness study was done as no clinical testing was performed. The device is a "graphical guidance aid" and not an AI that independently diagnoses or drives clinical decisions, nor does it quantify human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for clinical performance. The device is intended as an assistance system with human-in-the-loop (the surgeon). The non-clinical testing focused on software functionality and integration, not standalone clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (software verification and validation), the "ground truth" was established by the pre-defined specifications, requirements, and design documents of the software. Compliance with these internal standards and relevant international standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20) was the basis for verifying performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. It is a software update to an existing medical image management and processing system.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).