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The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.

The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.
The INTRABEAM 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.
The main components of the INTRABEAM 700 system are:

• INTRABEAM Workplace - mobile cart containing the following:
  • Control Console 700 (CC700)
  • Computer with Software Version 5.0
  • Touchscreen monitor and mouse
  • UNIDOS Romeo Electrometer
  • V-guide
• XRS 4 X-ray Source
• Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization Chamber Holder
• radiance Third party treatment planning simulation software
  The INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
  The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
  The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
  The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (INTRABEAM 700) to a legally marketed predicate device (INTRABEAM 600). The document focuses on regulatory compliance, safety, and performance testing to demonstrate equivalence, rather than providing details of a clinical study designed to prove the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria and the specifics of a study proving the device meets those criteria, particularly in the context of AI assistance or human reader performance. The "Performance Testing - Bench" section describes non-clinical system testing, software verification, and compliance with various IEC standards (EMC, Electrical, Mechanical, Thermal Safety, Radiation Safety, Usability/Human Factors), which are important for device safety and functionality but are not clinical performance "acceptance criteria" as would be evaluated in a multi-reader multi-case (MRMC) study or a standalone AI performance study.

The document primarily relies on demonstrating substantial equivalence to a predicate device through:

• Identical or equivalent indications for use.
• Similar technological characteristics.
• Compliance with relevant safety and performance standards (e.g., IEC 60601-series).

In summary, none of the requested information regarding acceptance criteria for clinical performance, test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details are present in the provided text. The document focuses on bench testing and regulatory compliance, not clinical efficacy or AI performance metrics.

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VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina

• Trabeculoplasty
• · Iridotomy
• · Posterior capsulotomy
  · Posterior membranectomy

This device is Prescription Use (Rx) only.

VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:

• single-spot mode (software license VERTE) -
• multi-spot mode (software license VITE)
• YAG disruption mode (software license YAG). -

VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.

However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.

Here's an analysis of the provided text:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.

• Trabeculoplasty
• Iridotomy
• Posterior capsulotomy
• Posterior membranectomy (combines indications of both predicates) |
  | Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled
• Photodisruption: Q-switched Nd:YAG laser |
  | Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm
• Photodisruption: 1064 nm |
  | Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW
• Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJ
  Pulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJ
  Pulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
  | Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation)

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BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.

The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries.

Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes.

BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.

The provided FDA 510(k) summary (K240215) describes the Carl Zeiss Meditec AG BLUE 400 and BLUE 400 S accessories to surgical microscopes for fluorescent visualization of grade III and IV gliomas.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (BLUE 400, K211346) through technical and performance testing, rather than defining explicit clinical acceptance criteria in terms of sensitivity, specificity, or other diagnostic measures for identifying gliomas. The acceptance criteria used are in the form of "Passed" results for various technical and functional tests.

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

The document describes non-clinical performance testing (bench testing) using "ZEISS fluorescence target," "spatial test target," "photometric resolution test target," "test target with a circle," "white sheet of paper," and "ZEISS BLUE 400 test phantom."

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for bench validation of optical and system parameters. These are physical components being tested, not patient samples.
• Data Provenance: The tests are described as bench/non-clinical system testing. This indicates the data was generated in a lab setting by the manufacturer (Carl Zeiss Meditec AG, Germany, based on manufacturer details). It is not derived from patient data.
• Retrospective/Prospective: Not applicable as it's bench testing, not clinical studies.

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

• Not applicable. This submission relies on technical bench testing against predefined engineering specifications and comparison to a legally marketed predicate device. The "ground truth" for these tests is the physical measurement of optical properties and system functions, validated against engineering requirements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for establishing ground truth (e.g., determining disease presence in an image) based on multiple readers. This submission describes bench testing where the outcome is a "Passed" result based on meeting physical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical technical equivalence and performance of the device's optical and system functions. It does not evaluate human reader performance with or without AI assistance. The device itself (BLUE 400/BLUE 400 S) is a filter accessory, not an AI-powered diagnostic tool aiming to improve reader interpretation.

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

• No, a standalone algorithm performance study was not done. This device is an accessory to a surgical microscope. It enhances visualization for a human surgeon; it is not a standalone algorithm that provides diagnoses or interpretations. The software verification testing mentioned is for the device's control software, not a diagnostic algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing is engineering specifications and measurements of optical, electrical, and mechanical properties. For example, excitation wavelength range is validated against the known excitation peak of PpIX, and image properties (resolution, brightness, lack of deformation) are validated against defined standards for surgical microscopes. The comparison to the predicate device also serves as a benchmark for equivalence.

8. The Sample Size for the Training Set

• Not applicable. The BLUE 400 and BLUE 400 S are physical filter accessories for a surgical microscope, not an AI/machine learning device that requires a training set. The software mentioned is for the device's operation and control, not for image analysis or diagnostic inference that would necessitate a training set.

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

• Not applicable. As the device is not an AI/ML system requiring a training set, there is no ground truth established for such a set.

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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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The QEVO System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectory, and foraminotomy.

The QEVO System comprises of the QEVO ECU (Endoscope Control Unit) and QEVO endoscope. The system is intended for viewing internal surgical sites and for use in visualization during general and certain neurosurgical and spinal procedures. The QEVO System has to be installed and integrated with a host display device (surgical microscope, a monitor, etc). Requirements for physical integration, connectivity, power supply, display resolution, and software integration are established and tested.

The provided document is a 510(k) premarket notification summary for the QEVO System, declaring its substantial equivalence to a predicate device (QEVO System with KINEVO 900). This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed device, primarily by showing similar technological characteristics and intended use.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance testing. The "Summary of Studies" section only mentions:

• Sterilization and Shelf Life: The device is reusable and the reprocessing instructions are identical to the predicate device.
• Biocompatibility: Testing was done in accordance with ISO 10993 for the patient-contacting component (insertion tube).
• Performance Testing - Bench: Optical safety was assessed according to IEC 62471:2006. It explicitly states: "The determination of substantial equivalence was not based on an assessment of performance data." This indicates that no clinical performance study (like an MRMC study or standalone algorithm performance) was submitted or required for this 510(k) clearance, as the device is an endoscopic visualization system, not an AI/ML diagnostic tool.

Therefore, I cannot extract the information required to answer your prompt because the provided text pertains to a traditional medical device (an endoscope system) clearance, not an AI/ML-driven device that would involve the rigorous testing methodologies you've asked about (e.g., ground truth, reader studies, test set sizes, etc.).

To summarize why I cannot provide the requested information based on the given text:

• No AI/ML Component: The QEVO System is described as a visualization system (endoscope) that displays images. There's no mention of an embedded AI/ML algorithm for image analysis, diagnosis, or decision support.
• No Performance Data for Clinical Effectiveness: The submission explicitly states that the substantial equivalence determination was not based on performance data. This implies a reliance on technological similarity to the predicate and standard bench testing for safety (electrical, optical) and functionality (image resolution, field of view, etc.).
• Focus on Substantial Equivalence: The entire document is about demonstrating that the new QEVO System is "substantially equivalent" to an existing predicate device, primarily by comparing their specifications and intended use, rather than proving a new diagnostic capability through clinical performance studies.

If you have a document related to an AI/ML medical device, please provide that, and I would be able to address your specific questions about acceptance criteria, study design, and ground truth establishment.

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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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QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.

This device is for Prescription Use (Rx) only.

QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.

QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.

QUATERA 700 has the following functions:

• · Irrigation and Aspiration
• · Ultrasound Capability
• · Diathermy
• · Anterior Vitrectomy
• Reflux

QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

The provided text is an FDA 510(k) clearance letter for a medical device called QUATERA 700. It asserts the device's substantial equivalence to a predicate device (also a QUATERA 700, but with older software) rather than presenting a performance study against specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable or not present in this document.

The document focuses on non-clinical performance testing and substantial equivalence to an existing device, primarily due to minor software changes and component updates. There is no mention of an AI/machine learning component that would require the rigorous performance evaluation typically outlined by the questions.

However, I can extract and infer information relevant to the types of "acceptance criteria" and "study" that were performed to demonstrate substantial equivalence, based on the provided text, even if not in the AI-specific format you requested.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative performance metrics against specific predefined acceptance criteria in the way one would for an AI algorithm's diagnostic accuracy. Instead, the "acceptance criteria" for this 510(k) are essentially the demonstration of compliance with established medical device standards and the maintenance of equivalence to the predicate device. The "performance" is a statement of compliance or "passed."

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

• Sample Size for Test Set: Not applicable in the context of an AI model's performance on a dataset. The "tests" performed here are primarily engineering verification and validation (e.g., software testing, electrical safety, bench testing for performance against standards). The document does not specify "sample sizes" for these types of tests (e.g., how many times an electrical test was run, or how many components were tested for sterility).
• Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The "data" here refers to test results from engineering and lab assessments.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The "ground truth" for this filing is compliance with engineering standards, functional equivalence to a predicate device, and successful verification/validation testing. This is typically established through documented test procedures and adherence to regulatory guidelines, not clinical expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of discrepancies in expert readings for clinical test sets.

5. MRMC Comparative Effectiveness Study:

No. The document explicitly states: "Animal and Clinical testing was not conducted." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone Performance:

Not applicable in the context of an AI algorithm's standalone performance. The device itself (QUATERA 700) performs specific surgical functions. Its "performance" is demonstrated through engineering tests and comparison to a predicate device, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international and national standards (e.g., ISO, IEC, FDA guidance documents).
• Successful completion of verification and validation testing protocols.
• Functional equivalence to the legally marketed predicate device, demonstrated through comparative tables of specifications.

8. Sample Size for the Training Set:

Not applicable. This device is a phacofragmentation system, not an AI/machine learning model that undergoes a "training" phase on a dataset of clinical cases.

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

Not applicable, as there is no training set for an AI model.

In summary: The K230858 clearance for QUATERA 700 is for a surgical device that has undergone minor software and component changes. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating continued safety, efficacy, and substantial equivalence to an existing predicate device through engineering verification and validation, rather than a clinical performance study of a novel AI component.

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FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace).

FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.

FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments.

This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates.

This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It usually doesn't contain a detailed breakdown of a separate clinical study with acceptance criteria, sample sizes, and expert adjudication in the same way an AI/ML device would. Instead, it relies on extensive software verification and validation to demonstrate safety and effectiveness.

Based on the provided text, a direct answer to all your questions in the typical format for a clinical study is not explicitly available for this specific type of device (a medical image management and processing system). However, I can extract the relevant information and infer what's implied.

Acceptance Criteria and Device Performance Study for FORUM (K213527)

This submission for FORUM (K213527) is a 510(k) Pre-market Notification for a medical image management and processing system. The acceptance criteria and "study" are primarily focused on demonstrating substantial equivalence to a predicate device (FORUM Archive and Viewer, K122938) through software verification and validation, rather than a traditional multi-reader multi-case clinical study for a diagnostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a software system intended for managing and processing existing image data, not generating new diagnostic conclusions, the "acceptance criteria" are related to its functional performance, safety, and equivalence to its predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of cases or patients. The "test set" here refers to the software verification and validation activities. These typically involve diverse test cases covering various functionalities, edge cases, and potential failure points, rather than a "patient test set" in a clinical study.
• Data Provenance: Not specified. For software verification and validation, the "data" would be test data (simulated or real but de-identified) used to exercise the software's functions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or specified. For this type of software, "ground truth" relates to the expected behavior of the software according to its design specifications. It doesn't involve medical experts adjudicating diagnoses in a test set.
• Qualifications of Experts: N/A for establishing "ground truth" in this context. Experts would be software engineers, quality assurance personnel, and potentially clinical subject matter experts for reviewing the functional requirements and outputs.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for software verification is the expected output according to the design specification and requirements. Verification and validation are performed against these predetermined requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No. This type of study is typically performed for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. FORUM is a management and processing system, not an AI diagnostic algorithm that provides assistance to human readers in the diagnostic task itself.
• Effect Size of Human Readers' Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? No, not in the sense of a standalone diagnostic algorithm's performance. The "standalone" performance for this device would refer to its ability to perform its specified functions (managing, processing, displaying data) correctly and reliably, which was assessed through software verification and validation. It's not a diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Software functional specifications and requirements documents. The "truth" is whether the software behaves as designed and meets its technical and safety requirements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. FORUM is a medical image management and processing system, not a machine learning model that requires a "training set."

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

• How Ground Truth Established: Not applicable, as there is no training set for this type of device.

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BLUE 400 is an accessory of the surgical microscope and allows the fluorescence observation of fluorophores with an excitation peak between 400 mm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.

The ZEISS BLUE 400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 is an accessory to the Zeiss surgical microscopes (OPMI PENTERO 800, OPMI PENTERO 900, and KINEVO 900), intended to allow intraoperative viewing of malignant glioma tissue under fluorescence. The BLUE 400 accessory is entirely composed of optical filters: the "Excitation" filter and the "Emission" filters. The Excitation filter is designed to filter all light wavelengths except 400 - 470 nanometers and is optimized to pass light between 400 - 410 nanometers. The Emission filters are designed to filter all light wavelengths except 430 - 800 nanometers and is optimized to pass light between 620 - 710 nanometers.

When installed in the surgical microscopes (class I), the BLUE 400 introduces optical filters to the illumination and viewing optical paths. The BLUE 400 includes installation of a software license that facilitates use of the accessory. After the SW license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the BLUE 400 mode.

The BLUE 400 accessory, when installed in the surgical microscopes, is intended to be used in conjunction with an approved optical imaging agent that is excited mainly in the wavelength range of 400 – 410 nanometers and fluoresces in the wavelength range of 620 - 710 nanometers.

Here's a breakdown of the acceptance criteria and study information for the BLUE 400 device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., specific thresholds for irradiance or power). Instead, they are implied by the "Passed" result for each test, indicating that the device met the defined specifications for each performance parameter. The study is a bench performance test comparing the subject device (BLUE 400) to a predicate device (Leica FL400).

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

The document describes bench performance testing. Therefore, the "test set" in the traditional sense of patient data is not applicable. The testing involves:

• Test Sets: The devices themselves (subject device BLUE 400 and predicate device Leica FL400) and various optical components (filters, light sources, specialized targets/phantoms).
• Data Provenance: The tests were conducted internally by Carl Zeiss Meditec AG, as part of their 510(k) submission. This is a prospective bench study. No external data sources or patient data are mentioned.

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

Not applicable. This was a bench performance study assessing physical and optical properties, not a clinical study requiring expert interpretation of patient data to establish ground truth. The "ground truth" was established by the physical measurements and calculations against defined specifications.

4. Adjudication Method for the Test Set

Not applicable. This was a direct measurement and comparison bench study, not a clinical study requiring adjudication of expert readings.

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. This device is an accessory (an optical filter) to a surgical microscope, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study for diagnostic accuracy or human performance improvement.

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

The device itself is an optical filter system for a surgical microscope. It does not have an "algorithm" in the sense of an AI or software that performs standalone interpretation. Its function is to modify light for improved visualization by a human surgeon. Therefore, standalone algorithm performance is not applicable. The document does mention Software verification testing was performed in accordance with FDA Guidance to demonstrate the software (for the license installation and mode switching) is performing as intended. This is analogous to a standalone performance check for the software component, but not for an interpretative algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench performance tests, the "ground truth" was established by:

• Physical measurements: Using calibrated instruments like spectrometers, power meters, and thermopiles to measure optical properties (irradiance spectrum, power, density, emission spectrum).
• Calculations: Such as calculating the 50% decrease edges of spectral peaks and optical path loss.
• Comparison to predefined specifications: The results were evaluated against specific technical requirements and specifications for each test.
• Comparison to a predicate device: For certain tests like maximum excitation power density and system sensitivity, the performance of the subject device was compared directly to the predicate device (Leica FL400).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set."

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

Not applicable. As above, there is no training set for this device.

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