(116 days)
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 positioning of graphical guidance tools.
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 evepiece of the OPMI LUMERA 700 surgical microscope. CALLISTO eve provides enhanced visualization and guidance tools to assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (IOL). All treatment templates are based on preoperative clinical data of a particular patient and defined by the surgeon prior to the surgery. These templates can be displayed on the CALLISTO eve panel PC and through the eyepiece of the OPMI LUMERA 700 surgical microscope.
CALLISTO eye consists of two product variants: CALLISTO eye BASIC and CALLISTO eye ASSISTANCE.
CALLISTO eve BASIC displays video images and patient data, stores patient data and video recordings, imports and exports patient data and exports videos and images after the surgery. This product variant also allows the remote control of the OPMI LUMERA 700 surgical microscope as well as data injection through the eyepiece via the Integrated Data Injection System (IDIS).
CALLISTO eye ASSISTANCE provides the graphical assistance tools to aid the surgeon during various ophthalmic procedures including limbal relaxing incisions (LRIs), capsulorhexis and toric IOL positioning. The assistance functions include Reference, Rhexis, Incision/LRI, Z-Align and K-track. These functions aid the surgeon in the opening of the capsulorhexis, making incisions and LRIs, aligning the toric intraocular lenses, and estimating a local corneal curvature during surgery.
For CALLISTO eye BASIC and ASSISTANCE, a database called OR database contains the patient data. The OR database is installed on the integrated PC. Documentation of videos and images can then be stored in this database as standard (SD) or high definition (HD) format.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for CALLISTO eye™ (K123464)
The provided documentation, a 510(k) Summary, describes the CALLISTO eye™ as an assistance system for ophthalmic surgeries. Crucially, this document does not explicitly state quantitative acceptance criteria in the typical format of a table with specific metrics and thresholds.
Instead, the submission for CALLISTO eye demonstrates substantial equivalence to a predicate device (TrueVision® 3D Visualization and Guidance System, K101861). The "acceptance criteria" and "performance demonstration" are framed in terms of meeting specifications and requirements, functional equivalence to the predicate, and not raising new safety or effectiveness concerns.
From the provided text, we can infer the following about the device's performance and the general approach to demonstrating its acceptability:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly tied to the functional equivalence and safety/effectiveness of the predicate device. Quantitative metrics for specific performance characteristics are not provided in this summary.
| Acceptance Criterion (Inferred from 510(k) Summary) | Reported Device Performance (Summary Statements) |
|---|---|
| Functional Equivalence to Predicate Device: |
- Provide non-diagnostic video documentation and image capture for ophthalmic surgeries.
- Allow remote control of the surgical microscope.
- Display graphical guidance tools for surgeon assistance (insert, align, position, register artificial lens).
- Intended for anterior segment ophthalmic surgical procedures (toric IOL positioning, limbal relaxing incisions, capsulorhexis).
- Utilize surgeon information for positioning of graphical guidance tools. | "The fundamental technological characteristics of CALLISTO eye with software version 3.0 are similar to the predicate device... Both CALLISTO eye and TrueVision 3D Visualization and Guidance System are devices that work in conjunction with a surgical microscope to assist the surgeon during ophthalmic procedures."
"Both are used in ophthalmic imaging applications and provide the means for capture, storage, or manipulation of image data and processing of patient information."
"Both provide the surgical guidance templates and documentation of treatments to aid the surgeon during anterior segment ophthalmic surgical procedures."
"All systems provide two dimensional graphical templates... to aid the surgeon during anterior segment ophthalmic surgical procedures, to make an incision, to perform a capsulorhexis, or to position a toric intraocular lens." |
| Meets Specifications and Requirements: - (Implicit) Compliance with design specifications for all functions/features. | "Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye."
"All criteria for this testing were met and the results demonstrate that CALLISTO eye meets all performance specifications and requirements." |
| Meets Customer Requirements: - (Implicit) Device performs as expected for the end-user. | "Validation was also conducted for CALLISTO eye according to the Validation Plan to ensure that the device meets the customer's requirements with respect to performance. The objectives defined in the validation plan were achieved according to the validation results." |
| No New Questions of Safety or Effectiveness: - (Implicit) Any differences from the predicate device do not introduce new risks. | "The minor differences between CALLISTO eye and the predicate device do not raise any new questions of safety or effectiveness in comparison to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) Summary does not specify a sample size for a "test set" in terms of patient data or clinical cases. The testing described is primarily "bench testing" focusing on software verification and system validation against internal specifications and customer requirements. It is not a clinical study involving a patient cohort for performance evaluation in the traditional sense of a diagnostic or therapeutic device.
The data provenance is not applicable here as a clinical test set with patient data is not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document describes internal verification and validation against specifications and customer requirements, not a study where experts established ground truth for a clinical dataset.
4. Adjudication Method
Not applicable. No clinical test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device itself is an "assistance system" that aids the surgeon, but a study comparing human performance with and without this specific AI's assistance (or another AI) is not detailed.
6. Standalone Performance Study
Yes, in the context of "bench testing" and system validation. The document states: "A portion of software verification may be considered 'bench testing'. Each function and/or feature was tested by means of the appropriate test case or test specification. The system verification test report provides the test cases, expected results for each test case and the actual results obtained. All criteria for this testing were met and the results demonstrate that CALLISTO eye meets all performance specifications and requirements." This indicates that the algorithm/system was tested on its own to ensure it met its defined specifications.
7. Type of Ground Truth Used for the Test Set
The "ground truth" for the internal verification and validation of the CALLISTO eye was based on pre-defined specifications and requirements for the device's functions and features. For example, a graphical guidance tool designed to show a specific angle would be tested to ensure it correctly displays that angle as per its design specification.
8. Sample Size for the Training Set
Not applicable. The document does not describe the use of machine learning or AI models requiring a "training set" in the common sense of supervised learning with labeled data. The system uses "surgeon information for positioning of graphical guidance tools" and "preoperative clinical data of a particular patient" for its templates, implying a rule-based or data-driven display system rather than a machine learning model trained on a large dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. As no training set for a machine learning model is described, there's no information on how its ground truth would have been established. The system relies on surgeon input and pre-operative data, which forms the basis of the "templates" rather than being a training set for an AI to learn from.
§ 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).