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FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

Never use this product for any other purposes.

FUJIFILM Endoscope Model EI-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processor, FUJIFILM's light sources and peripheral devices such as monitor, printer, foot switch, and cart.

This document is a 510(k) summary for the FUJIFILM Endoscope Model EI-740D/S, seeking to prove substantial equivalence to a predicate device (Endoscope Model EI-740D/S, K210162). The focus of this submission is on demonstrating safety and performance equivalence, primarily through reprocessing validation and electrical/photobiological safety.

Therefore, the information typically found in a clinical study for an AI/ML powered device, which would include detailed acceptance criteria for diagnostic performance, sample sizes, expert adjudication, and ground truth establishment, is not present in this document.

The document details the following regarding the device and its validation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on the equivalence of the proposed device to the predicate device, especially concerning reprocessing validation and safety standards, rather than diagnostic performance criteria in the context of an AI/ML algorithm.

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

This document does not provide information on a "test set" in the context of an AI/ML diagnostic study. The performance evaluation is based on technical and safety validations rather than a clinical outcome study with a patient data test set.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable, as this is a 510(k) submission for an endoscope demonstrating substantial equivalence, not an AI/ML diagnostic study requiring expert ground truth establishment for clinical performance.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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

No MRMC study was conducted or reported in this 510(k) summary. The device is an endoscope, not an AI-powered diagnostic tool for which MRMC studies are typically performed to assess human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device (endoscope), not a standalone AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering and medical device standards for safety and performance (e.g., successful reprocessing, adherence to electrical safety standards). There is no "ground truth" derived from patient outcomes or expert consensus on disease diagnosis for an AI algorithm.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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Endoscope EN-580T: This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and rectum. Never use this product for any other purposes.

Over-tube TS-1314B: This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Balloon BS-4: This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Tube Kit TY-500D: This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.

The endoscope EN-580T is inserted both perorally and transanally into the gastrointestinal tract during clinical use. The insertion of the device has a mechanism which bends the tip from right to left and up and down, and a flexible tube consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.

The over-tube TS-1314B is introduced in the patient's anatomy with the pairing endoscope. TS-1314B is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1314B is provided sterile and single-patient use only.

The balloon BS-4 is attached to the balloon-compatible endoscope. The balloon air feed outlet should be contained inside BS-4. The accompanying fixing rubber is used to affix the scope balloon in place. The fixing rubbers are made specifically for BS-4 but should not be mixed with the fixing rubber of other scope balloons. BS-4 is provided sterile and single-patient use only.

The tube kit TY-500D consists of a set of two tubes connects the over-tube to the balloon controller by its air inlet. The other tube connects the same balloon controller to the endoscope by its balloon air feed inlet. TY-500D is only compatible with PB-30, cleared K153483. TY-500D is provided non-sterile. The tubes are not patient-contacting and reusable, but each filter is single-patient use only.

This document does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically seen for AI/ML-driven devices. Instead, it describes a 510(k) premarket notification for updated medical devices (Endoscope and accessories) that aim to demonstrate substantial equivalence to previously cleared predicate devices.

The "acceptance criteria" here are inherent to the regulatory process of demonstrating substantial equivalence for traditional medical devices, focusing on safety and effectiveness compared to existing devices rather than a performance benchmark against a clinical gold standard using a specific test set.

Here's an breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table with specific numerical performance metrics (like sensitivity, specificity, AUC), the "acceptance criteria" are compliance with relevant safety and performance standards for medical devices, and the "reported device performance" is the successful completion of testing to demonstrate this compliance and substantial equivalence to predicate devices.

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

This document does not describe a "test set" in the context of AI/ML evaluation (e.g., a set of medical images or patient cases). The performance data cited refers to standard engineering and biological testing (sterility, biocompatibility, endoscope-specific tests). Therefore, information on sample size or data provenance for such a "test set" is not applicable or provided here.

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

Not applicable. Ground truth, in this context, would imply expert annotations or diagnoses on patient data. This document describes the substantial equivalence of physical medical devices and their components, not an AI/ML algorithm's diagnostic performance. Therefore, no experts were used to establish ground truth for a test set in this manner.

4. Adjudication Method for the Test Set

Not applicable, as there is no diagnostic "test set" to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

No. This document does not pertain to AI or an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document does not pertain to an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with established international and FDA standards for medical device safety and performance. This is confirmed through laboratory testing for sterility, biocompatibility, and functional performance, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable, as there is no AI/ML algorithm involved, and thus no "training set."

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

Not applicable, as there is no AI/ML algorithm and training set.

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FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.

Never use this product for any other purposes.

FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.

The provided text describes the 510(k) premarket notification for the FUJIFILM Endoscope Model EB-710P. It details the device, its intended use, comparison to predicate/reference devices, and performance data. However, the document does not describe an AI/ML-driven device or a study involving human readers and AI assistance.

Therefore, many of the requested criteria related to AI/ML performance, human reader studies, ground truth establishment for AI models, and sample sizes for training/test sets for AI are not applicable to this document. This document pertains to a traditional medical device (an endoscope) and its clearance based on substantial equivalence.

I will address the applicable criteria based on the information provided in the document.

Analysis of Acceptance Criteria and Device Performance (FUJIFILM Endoscope Model EB-710P)

This document describes the 510(k) premarket notification for a physical medical device, the FUJIFILM Endoscope Model EB-710P, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study described are for the physical performance and safety of the endoscope itself, primarily through bench testing and compliance with recognized standards, rather than clinical performance metrics of an AI model like sensitivity, specificity, or reader improvement.

The "acceptance criteria" here refer to meeting performance specifications and regulatory standards demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications and states that the proposed device met them. It does not present a formal "acceptance criteria vs. reported performance" table in the way one might for an AI model's accuracy metrics, but rather as statements of compliance.

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

The document does not specify a "sample size" in the context of clinical studies for diagnostic accuracy, as it is a device clearance for an endoscope based on engineering and bench testing, and demonstrating substantial equivalence. The "test set" here refers to the physical units and materials used for various engineering and safety tests. No patient data or clinical imagery is referenced for performance testing in this document.

• Sample Size: Not applicable in the context of a clinical test set for AI/ML. The tests are performed on the device itself and components.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory/bench tests on the device.

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

Not applicable. Ground truth for an AI/ML model for diagnostic purposes is not relevant for the clearance of a physical endoscope itself. The "ground truth" for this device's performance would be the objective measurements and accepted standards in engineering and medical device testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret medical images, often to establish ground truth or evaluate reader performance. This is not describing such a study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention an MRMC study. MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI affects reader performance.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's regulatory clearance is established by:

• Performance Specifications: The defined objective measurements and technical requirements for the endoscope's functions (e.g., resolution, field of view, bending capability).
• Consensus Standards: Adherence to recognized national and international standards for medical device safety, biocompatibility, electrical safety, software, and reprocessing (e.g., ISO, IEC, ANSI/AAM).
• Predicate Device Performance: The performance characteristics of the previously cleared predicate device, which the proposed device must be substantially equivalent to.
• Bench Testing Data: Direct measurements obtained from laboratory testing of the device.

8. The Sample Size for the Training Set

Not applicable. This is not describing an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process as defined for AI/ML.

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FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.

Video Laparoscope EL-R740M30 is comprised of a rigid insertion portion, cable portion, and scope connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light guide fiber bundles are connected to the scope connector through the laparoscope.

The provided text describes the 510(k) summary for the FUJIFILM Video Laparoscope Model EL-R740M30. However, it does not include the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria for AI/ML-based medical devices.

The document discusses:

• Device Identification: FUJIFILM Video Laparoscope Model EL-R740M30
• Intended Use: Minimally invasive observation, diagnosis, and treatment in general abdominal, gynecologic, and thoracic areas.
• Device Description: Rigid insertion portion, cable portion, scope connector, optical system, CCD image sensor, electrical circuits.
• Predicate Device: FUJIFILM Video Laparoscope EL-R740M (K202130)
• Technological Characteristics Comparison: Highlights differences like viewing direction (0 degrees for predicate, 30 degrees for subject device) and presence of an adjustment ring.
• Performance Data: Mentions conformity to various electrical safety, biocompatibility, endoscope-specific, cleaning/sterilization, and software standards (e.g., ANSI/AAMI ES60601-1, ISO 10993, ISO 8600-1, ANSI/AAMI/IEC 62304). It also mentions cybersecurity controls.

Crucially, this document pertains to a traditional medical device (a video laparoscope) and not an AI/ML-based medical device. Therefore, it does not include information on acceptance criteria for AI performance, sample sizes for AI test sets, expert adjudication, MRMC studies, or standalone AI performance.

The "Performance Data" section describes compliance with electrical and biocompatibility standards, and validation of reprocessing protocols, which are typical for hardware medical devices, not AI/ML algorithm validation. There is no mention of an algorithm or AI component in the device.

Therefore, I cannot provide the requested information based on the provided text.

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Processor VP-7000:
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope).

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with montor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices.

The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.

Light Source BL-7000X:
The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Processor VP-7000 relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. VP-7000 also incorporates internal digital storage capacity. VP-7000 controls the light projected to the body cavity. VP-7000 provides for optional structural enhancement through user modes FICE (Flexible spectral-Imaging Color Enhancement), BLI (Blue Light Imaging), BLI-brt (Blue Light Imaging-Bright) and LCI (Linked Color Imaging) at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60Hz, 0.8A. VP-7000 is housed in a steel-polycarbonate case measuring 390x485x110mm. Optional Image Processing Unit EX-0 receives image data from the VP-7000, and displays an OXEI image on a LCD monitor. The OXEI image is a color-coded digital image showing tissue oxygen saturation (StO2). EX-0 incorporates an internal digital storage capacity. The device is AC-operated at a power setting of 120V/60Hz, 1.0A. EX-0 is housed in a steel-polycarbonate case measuring 320x165x340 mm.

The Fujifilm endoscopes employ fiber bundles to transmit light from Light Source BL-7000X and subsequently to the body cavity. BL-7000X employs five LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 120V / 60Hz 1.2A. BL-7000X is housed in a steel polycarbonate case measuring 395x485x155mm.

Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 are used as a system in conjunction with a compatible video laparoscope or endoscope for visualization of tissue oxygen saturation (StO2) levels.

The provided document describes the Fujifilm Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0. The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

Based on the provided information, the acceptance criteria and the study proving the device meets them can be summarized as follows:

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

2. Sample size used for the test set and the data provenance:

• Bench Testing: 7 different blood-based phantoms. Data provenance is not explicitly stated but implies laboratory (benchtop) testing.
• Animal Testing:
  • Study 1 (Laparoscopic): Number of animals not specified, but involved "a visualization study."
  • Study 2 (Endoscopic): 4 female Göttingen minipigs.
  • Study 3 (Open Surgery): 3 swine.
• Data Provenance (Animal Studies): Live animal studies, likely conducted in a controlled laboratory environment. No specific country of origin is mentioned for the animal studies, but the entire submission is to the U.S. FDA. The details provided (e.g., "female Göttingen minipigs at 11 months of age") suggest prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Bench Testing: A "dissolved oxygen meter" was used as the "gold standard" for StO2 measurements. This is an objective measurement tool, not human experts.
• Animal Testing: The document does not specify the use of human experts to establish ground truth for the StO2 measurements. The reference device (T-Stat 303 Microvascular Tissue Oximeter) served as a comparator, and the study focused on the comparability of the subject device's measurements to the reference device and, implicitly, to the physiological changes induced (e.g., decreased arterial oxygen saturation).

4. Adjudication method for the test set:

Not applicable. The ground truth for StO2 measurement was established by an objective "gold standard" (dissolved oxygen meter in bench testing) or by comparison to a legally marketed predicate/reference device and physiological changes in animal models. No human adjudication is mentioned for the StO2 measurements.

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, an MRMC comparative effectiveness study was not done. The device (Image Processing Unit EX-0) acts as an "adjunctive monitor" of StO2. The studies described focus on the device's ability to measure StO2 accurately and comparably to a reference device, not on improving human reader performance in interpreting images with AI assistance versus without it. This device itself is an "adjunctive tool," not specifically an AI assisting human interpretation of images for diagnosis, but rather providing a quantifiable physiological parameter (StO2).

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

Yes, the performance testing of the StO2 measurement function appears to be a standalone evaluation of the device's capability to measure and display StO2 levels. The bench testing directly compared the device's output to a gold standard, and the animal studies evaluated the device's measurements against a reference device's measurements and induced physiological states. The language suggests the device outputs StO2 values or color-coded images autonomously, without direct human intervention in the measurement process itself, though a human interprets the displayed information.

7. The type of ground truth used:

• Bench Testing: Dissolved oxygen meter (objective measurement, considered a "gold standard").
• Animal Testing:
  • Comparison to a legally marketed reference device (T-Stat 303 Microvascular Tissue Oximeter).
  • Induced physiological states (e.g., decreasing arterial oxygen saturation (SpO2) to simulate ischemic states). These physiological changes and the measurements from the reference device serve as the de-facto ground truth for evaluating the subject device's performance in a living system.

8. The sample size for the training set:

Not applicable. The document describes performance testing for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. This typically involves verification and validation testing, not the development and training of an AI algorithm from a training set. The Image Processing Unit EX-0 processes existing endoscopic image data to display StO2; it is not presented as a machine learning or AI-driven diagnostic tool that requires a training set in the conventional sense.

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

Not applicable, as no training set is described for this device in the provided document.

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Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including: Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart.

-Functional cardiac analysis for MR heart images: which is intended to evaluate the functional characteristics of heart. -Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.

-Coronary artery analysis for MR heart images: which is intended for the qualitative analysis of coronary arteries.

-Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.

-Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

-Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the valves, measurement of the calcification area in the aorta and the valves. Placement of a virtual prosthetic valve.

-MR parametric maps: which is provided for pixel maps for myocardial MR relaxation times.

Synapse 3D Cardiac Tools (V5.4) is an optional software module that works with Synapse 3D Base Tools (V3.0) (cleared by CDRH via K120361 on 04/06/2012) that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools (V5.4) accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA. The main functions of Synapse 3D Cardiac Tools are shown below.

• Cardiac Function (CT)
• Cardiac Function (MR)
• Coronary Artery Analysis (CT)
• O Calcium Scoring
• Cardiac Fusion
• Coronary Artery Analysis (MR)
• 0 Aortic Valve Analysis
• MR Flow Analysis (MR)
• 4-Chamber Analysis (CT)
• Cardiac Ablation Analysis (CT)
• Cardiac Tx-maps
• Mitral Valve Analysis

Synapse 3D Cardiac Tools runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices to create reports or develop treatment plans.

The provided text confirms that the device, Synapse 3D Cardiac Tools (V5.4), was tested for functionality to support its claim of substantial equivalence to its predicate device, Synapse 3D Cardiac Tools (V3.2). However, the document does not provide explicit acceptance criteria in a table format, nor does it detail a specific study with quantitative results to prove the device meets such criteria. It primarily focuses on comparing features and technical characteristics with its predicate and outlines general software development and testing processes.

Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "benchmark performance testing" for segmentation, detection, and registration, implying a quantitative assessment (achieved "expected accuracy"). However, the specific numerical acceptance criteria or performance metrics are not disclosed in this document. The "All tests passed successfully" statements refer to the system-level validation against general design specifications and intended use, not necessarily against predefined numerical accuracy thresholds for clinical tasks.

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

• Sample Size: The document mentions "actual clinical images" were used for benchmark performance testing. However, the sample size (number of cases/images) used for any of the testing (system-level, benchmark, etc.) is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only states "actual clinical images."

3. Number of Experts and Qualifications for Ground Truth

The document states that "Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning." However, it does not specify how many experts were used to establish the ground truth for the test set, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not described in the provided text. The document does not mention any studies evaluating human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The text describes "benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection, and registration functions implemented in Synapse 3D Cardiac Tools achieved the expected accuracy performance." This implies a standalone evaluation of the algorithm's performance for these specific functions. However, the results (e.g., specific accuracy metrics) of this standalone performance are not provided.

7. Type of Ground Truth Used

For the "benchmark performance testing" of segmentation, detection, and registration, it implies a ground truth was used to assess "expected accuracy performance." However, the exact type of ground truth (e.g., expert consensus, pathology, outcome data) is not explicitly stated. It's common in such tools for ground truth to be established by expert manual annotation or consensus, but this is not confirmed in the text.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set, its sample size, or how its ground truth was established. This suggests that the device, or at least the version being evaluated, might be more of a sophisticated image processing and visualization tool with semi-automatic functions rather than a deep learning-based AI device requiring extensive training data in the modern sense. The "benchmark performance testing" focuses on the accuracy of its segmentation, detection, and registration functions, which could be rule-based or model-based, but the origin of any models is not described.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not available in the provided text.

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