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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 eve 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 ophthalmic surgical microscopes (e.g. ARTEVO 800). 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 surgical microscopes 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

This document is a 510(k) summary for the RESCAN 700 (SW 3.0), a medical device used for ophthalmic imaging. It outlines the reasons for the 510(k) submission, primarily focusing on minor software and component changes, and argues for its substantial equivalence to a previously cleared predicate device (RESCAN 700 Software Version 2.0).

Based on the provided text, the device in question (RESCAN 700 SW 3.0) is an imaging device that captures OCT (Optical Coherence Tomography) and biomicroscopic images of the eye. It is not an AI/ML-driven diagnostic device that would have acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers improving with AI assistance.

The 510(k) submission is for a software and minor component update to an already cleared device, arguing for substantial equivalence. Therefore, the "acceptance criteria" discussed in this document are primarily related to software verification and validation, electrical safety, and electromagnetic compatibility (EMC), ensuring that the updated device remains safe and effective with its existing intended use. It is not a de novo submission for a novel AI/ML algorithm.

Given this context, I will address your prompt based on the information available within the document, explaining why some of your requested points are not applicable to this type of regulatory submission and focusing on the relevant criteria and studies mentioned.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for RESCAN 700 (SW 3.0)

Context: The RESCAN 700 (SW 3.0) is an updated version of an already cleared ophthalmic imaging device. The 510(k) submission primarily addresses minor software changes and component updates. This is a substantial equivalence claim, not a new AI/ML diagnostic or assistive device that would typically involve comparative effectiveness studies with human readers or complex ground truth establishment for novel algorithms. The "acceptance criteria" here refer to regulatory and engineering standards rather than clinical diagnostic performance metrics for an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the context of this 510(k) summary. The document describes a software and hardware update for an imaging device, not a diagnostic AI/ML algorithm requiring a clinical test set of patient data with a specific sample size for performance evaluation (e.g., sensitivity, specificity). The "testing" referred to is primarily engineering verification and validation (V&V) of the software and hardware changes (e.g., unit testing, integration testing, system testing, safety testing), not clinical performance testing on patient data.

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

This is not applicable. As explained in point 2, this submission is for an updated imaging device, not a new AI/ML diagnostic algorithm that would require expert-established ground truth for its performance evaluation on a clinical test set. The validation focuses on engineering and regulatory compliance.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. There is no mention of "adjudication" in the context of a clinical test set for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The RESCAN 700 is an imaging device, providing high-resolution OCT and biomicroscopic images. It is used for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of ocular structures. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images. The document explicitly states that the "assistance system (CALLISTO eye)" provides "non-diagnostic video documentation and image capture."

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

This is not applicable. The RESCAN 700 is an imaging system, not a standalone AI algorithm. Its function is to acquire images, not to provide automated diagnostic interpretations that would be evaluated for standalone performance.

7. The Type of Ground Truth Used

For software verification and validation, the "ground truth" implicitly used would be the functional and performance specifications of the software and hardware. For electrical safety and EMC, the "ground truth" is adherence to international consensus standards (IEC 60601-1-2). There is no patient-data derived "ground truth" (like expert consensus, pathology, or outcomes data) mentioned for the purpose of demonstrating the device's acceptable performance, as this is related to a software update for an imaging system, not a diagnostic AI.

8. The Sample Size for the Training Set

This is not applicable. The RESCAN 700 (SW 3.0) is not an AI/ML algorithm that requires a "training set" of data in the sense of machine learning model development. The software updates are described as "minor software changes" and "changes to components and parts," indicating traditional software development, testing, and hardware modifications, not the training of a learning algorithm.

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

This is not applicable, as there is no mention of a "training set" for an AI/ML algorithm. The "ground truth" for the device's functionality and safety would be established through engineering design specifications, adherence to quality system regulations, and compliance with relevant international standards.

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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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