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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.

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.

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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 operates as an adjunct to the ZEISS's family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). Specifically, the subject device has the functionality to be connected to an OCT camera (such as in RESCAN 700 (K180229)), a phaco machine (such as in QUATERA 700 (K212241), as well as MIMPS (such as FORUM (K213527).

CALLISTO eye Software must be installed on a computer with a touchscreen; this Panel PC (ORPC) is offered as an accessory. The current model of the ORPC is the CALLISTO eye Panel PC Model II. OPRC function and configuration has been modified since the last CALLISTO eye 510(k) by upgrading electronics components to accommodate lifecycle management needs.

CALLISTO eye 3.7.2 has the same functionalities as CALLISTO eye 3.6 (K180858). These functionalities include patient data management and transmission via DICOM protocol, interfaces to ZEISS's ophthalmic microscopes with/without OCT camera (RESCAN 700) and assists with overlay function for markerless marking to support IOL alignment.

Additional functionalities unique to CALLISTO eye 3.7.2 are inclusion of changes occurring from software version 3.6 to 3.7.1 and additional support of language packages, bug fixes, cybersecurity enhancements and interoperability abilities with a phaco system (OUATERA 700).

The subject device, CALLISTO eye 3.7.2, provides connectivity to the following surgical microscopes from ZEISS:

• . OPMI LUMERA 700 with Integrated Data Injection System (IDIS)
• OPMI LUMERA T with External Data Injection System (EDIS) ●
• OPMI LUMERA I with External Data Injection System (EDIS) .
• OPMI LUMERA 700 with OCT camera (RESCAN700)
• ARTEVO 800 with 3D monitor cart (3DIS) .
• ARTEVO 800 with OCT camera (RESCAN700) .

The software can acquire photo and videos from all surgical microscope listed above and can remote control these microscopes apart from the OPMI LUMERA T and I.

All OPMI LUMERA family surgical microscopes have been covered by the predicate device CALLISTO eye 3.6 (K180858). With the subject device the range of supported surgical microscopes was extended to the ARTEVO 800 with and without RESCAN700 as principal successor of the OPMI LUMERA 700.

The intended use and indications for use of OPMI LUMERA and ARTEVO 800 are identical and the microscopes can be applied for the same surgical procedure.

CALLISTO eye allows the connection and remote control of a surgical microscope with or without OCT Camera and thus operates as an adjunct to the family of ZEISS surgical microscopes. Functionalities such as light intensity, camera parameters, start/stop recording, zoom, focus, diaphragm, start/stop OCT scanning, etc. of the surgical microscope, including the configuration of the foot control panel and handgrips, can be accessed and managed by the user in CALLISTO eye.

CALLISTO eye Software is an assistance, information system to support ophthalmic surgical procedures. It provides an interface to other devices to facilitate the:

• Display and recording of video data provided by ZEISS surgical microscopes (OPMI) .
• Display of assistance functions (graphical guidance templates) and device information (cockpits) to aid the surgeon in the implantation of intra ocular lenses; e.g., used for the alignment for toric intraocular lenses.
• . Display and recording of OCT image data provided by ZEISS RESCAN 700
• Display and exchange data with the ZEISS OUATERA 700 phacoemulsification and vitrectorny system .
• . Retrieval and storage of patient data from and to the FORUM MIMPS system
• . Configuration of ZEISS surgical microscopes, including the assignment of functions to OPMI handgrips and foot control panel

The provided text is a 510(k) summary for the Carl Zeiss Meditec AG's CALLISTO eye (Software Version 3.7.2). It primarily focuses on demonstrating substantial equivalence to a predicate device (CALLISTO eye, Software Version 3.6) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.

The document discusses functional equivalence and safety, but not performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. The device is described as an "assistance system" providing "non-diagnostic video documentation and image capture" and "graphical guidance aid." Therefore, the typical diagnostic performance acceptance criteria and study design (like MRMC studies) are not applicable here.

However, I can extract information related to the device's functional performance and the verification/validation activities performed, which serve as proof that the device meets its functional specifications.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a diagnostic device with performance metrics like sensitivity/specificity, the "acceptance criteria" are related to its functional specifications and safety. The "reported device performance" refers to the successful verification and validation of these functions.

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

Not applicable or not specified in the context of a "test set" for diagnostic performance. The document describes software verification and validation, which typically involves internal testing against specifications and requirements, often using simulated data, test cases, and potentially real (but de-identified) operational data. The document does not specify a "test set" in the sense of clinical study data with provenance.

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 a non-diagnostic assistance system, there is no "ground truth" to establish for diagnostic outcomes in the context of the device's stated functions. The validation focuses on whether the software performs its intended functions correctly (e.g., displays images, provides graphical guidance correctly).

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

Not applicable, as there's no diagnostic ground truth being established via expert adjudication.

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

No MRMC comparative effectiveness study was done or mentioned. The device's indications for use emphasize "graphical guidance aid" and "assistance system," not a primary diagnostic tool. The submission states, "Animal and Clinical testing was not conducted."

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

This concept is not directly applicable. The CALLISTO eye software is designed as an "assistance, information system to support ophthalmic surgical procedures" with "graphical guidance aid." Its function is inherently human-in-the-loop, providing information to the surgeon. Standalone performance for a predictive or diagnostic algorithm is not its purpose. The document details "software verification activities" and "validation," which confirm the software's functional correctness.

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

For the functional validation of this device, the "ground truth" would be the expected correct behavior of the software according to its design specifications and user requirements. This is established through:

• Design specifications: The software behaving as programmed.
• User requirements: The software meeting the needs of trained clinical personnel for guidance and control.

There is no mention of external clinical ground truth like pathology or outcomes data in this submission for assessing the device's inherent performance.

8. The sample size for the training set

Not applicable. This device is described as software that provides graphical guidance and remote control, not a machine learning or AI algorithm that is "trained" on a dataset for diagnostic or predictive tasks in the conventional sense described by these questions.

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

Not applicable, as there is no "training set" for an AI model mentioned in the submission. The "ground truth" for the software's functional correctness is simply its design specifications and user requirements, as verified and validated through software testing.

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RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.

RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with the assistance system, CALLISTO eye, OCT images taken intra-operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.

The proposed RESCAN 700 device and its primary functionality remain unchanged from the previously cleared device while including the following modifications:
Improvement of OCT Visualization
Increased Power of OCT Beam
Increased Scan Depth

RESCAN 700 is used with CALLISTO eye Software version 3.6.

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 real-time videos and OCT data (B-Scan images). CALLISTO eye must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory.

In conjunction with RESCAN 700 the following modifications were added to CALLISTO eye Software version 3.6.
Ability to record surgical videos directly to a connected USB hard drive.
The OCT function was enhanced by adding OCT XY-tracking for the Scan Location Marker. The functionality is similar to the Z-tracking function but works in the XY-plane instead of the Z-axis.

Here's a breakdown of the acceptance criteria and study information for the RESCAN 700 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner for the changes made to RESCAN 700. Instead, it describes general improvements and then presents a clinical study to confirm the acceptability of these changes. The core "acceptance criteria" for this submission would be that the modifications do not raise new issues of safety or effectiveness and that the upgraded device performs at least as well as, or better than, the predicate device, especially regarding image quality at new scan depths.

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

• Sample Size (Clinical Study): 22 participants
  • 11 with corneal conditions
  • 7 with glaucoma
  • 4 with retina conditions
  • A total of 84 images were obtained.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a "clinical study" and "participants were enrolled," it suggests a prospective study. The location is not specified, but the manufacturer is Carl Zeiss Meditec AG, Germany, with a US contact, so it could be in either region or internationally.

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

• Number of Experts: Three (3) independent, masked graders.
• Qualifications: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of ocular surgery and OCT images, it's highly probable these were ophthalmologists or similarly qualified eye care specialists with experience in interpreting OCT images. The term "graders" typically implies expertise in evaluating clinical images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal adjudication method (like 2+1, 3+1). However, the document mentions "fair to good concordance between graders," suggesting that while there were three independent graders, a formal resolution process for disagreements is not detailed. The results likely involved an analysis of the ratings from all three for each image.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• MRMC Study: Yes, a type of MRMC study was conducted. The study compared the visualization quality of OCT images from two RESCAN 700 systems (predicate vs. modified with new software/capabilities) using three independent graders across multiple cases (22 participants, 84 images).
• Effect Size of Human Readers' Improvement with AI vs. without AI Assistance: This specific information is not provided. The study aimed to compare image quality between different device versions and scan depths, not explicitly to measure the improvement of human readers with AI assistance versus without. The CALLISTO eye system provides "assistance" (non-diagnostic video documentation, image capture, remote control, and new "Cockpits" for information visualization), but the study's focus was on the inherent image quality differences produced by the hardware/software modifications, not on a human-AI interactive improvement metric.

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

• Standalone Performance: No, a standalone algorithm performance study was not explicitly described for diagnostic purposes. The CALLISTO eye is an "assistance system" that provides "non-diagnostic video documentation and image capture." The "improvement of OCT Visualization" involved optimized standard image processing methods for noise reduction, which could be considered an algorithmic enhancement, but its performance was evaluated via the clinical study where human graders assessed the resulting images. There is no mention of the device making automated diagnoses or measurements that were evaluated in a standalone manner against a ground truth.

7. The Type of Ground Truth Used

• Ground Truth: The clinical utility and quality of the images were assessed by expert consensus/opinion (three independent, masked graders). There's no mention of pathology, long-term outcomes data, or other objective measures being used for ground truth in this specific image quality study.

8. The Sample Size for the Training Set

• Training Set Sample Size: This information is not provided in the document. The general description focuses on the verification and validation of the modified device, not on the development or training of specific machine learning models within the device that would require a distinct training set. The "optimized image processing methods for noise reduction" likely involved internal development and testing, but details on a formal training set for this are not disclosed.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth: As the training set size is not provided, how its ground truth was established is also not described. If "optimized image processing methods" involved machine learning or AI, the ground truth for such internal training would have typically involved expert-labeled images or simulations. However, this level of detail is absent from the 510(k) summary.

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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.

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RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.

RESCAN 700 uses an assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with software version 3.2 of an assistance system, CALLISTO eye, OCT images taken intra operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.

RESCAN 700 is used with CALLISTO eye software version 3.2.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the RESCAN 700 device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies against specific acceptance criteria.

The "PERFORMANCE DATA" section (page 7) briefly mentions that:

• RESCAN 700 was designed and tested to applicable standards for electrical and optical safety.
• Performance testing was conducted, and the device was found to perform as intended.
• Each function/feature was tested by an appropriate test case or specification.
• Testing demonstrated conformance to IEC 60601-1 and IEC 60601-1-2 standards.
• Software verification activities included tests accompanying development, integration tests, and system verification.
• Validation and usability testing were conducted with RESCAN 700 in conjunction with CALLISTO eye to ensure it meets product and user requirements.

However, this section does not provide:

• A table of specific acceptance criteria.
• Reported device performance against numerical targets.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any specific performance study.
• Information on MRMC comparative effectiveness studies or standalone performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and the study proving the device meets them based on the text provided.

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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.

• 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.

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