Search Results

FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.

FUJIFILM Synapse PACS Software provides toolsets for:

• Performing measurements on DICOM images
• Regional segmentation
• Importing and presenting data from modalities (DICOM and non-DICOM),
• Solving clinical calculations
• Creating and distributing structured reports

FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning.

MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA-cleared, DICOM compatible displays for mammography.

The Synapse PACS is an enterprise-wide medical information and image management software that runs on standard "off-the-shelf" PC hardware and Software (OS, browser). Synapse is intended for communication, storage, display, manipulation, measurement, printing, and processing of images and information acquired from various medical imaging and information systems. As a Software as a Medical Device (SaMD), Synapse PACS performs these purposes without being part of a hardware medical device.

FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.

FUJIFILM Synapse PACS Software provides toolsets for:

• Performing measurements on DICOM images
• Regional segmentation
• Importing and presenting data from modalities (DICOM and non-DICOM),
• Solving clinical calculations
• Creating and distributing structured reports

Here's a breakdown of the acceptance criteria and study details for the Synapse PACS (7.5) device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

The core performance study described pertains to the Bone Removal algorithm.

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

Note: The acceptance thresholds for DSC and 95% HD were determined by reviewing existing bone removal models in scientific literature.

Study Details Proving Device Meets Acceptance Criteria

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

• Test Set Sample Size: 72 patients, each with one image collected.
• Data Provenance: The document states patient demographic distribution from "Midwest" (20 patients), "Southwest" (20 patients), and "Southeast" (32 patients) regions. This indicates the images were collected from various regions within the United States. The document does not explicitly state whether the data was retrospective or prospective, but the description of "collected images" and established ground truth often implies a retrospective study using an existing image archive.

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

• Number of Experts: An initial bone mask was created by a "certified technologist." Then, an "independent dual-reader consensus review" was performed by two U.S. board-certified radiologists.
• Qualifications of Experts:
  • Certified Technologist (specific certification details not provided)
  • Two U.S. Board-Certified Radiologists (specific experience/years not provided, but "board-certified" implies a high level of qualification).

4. Adjudication method for the test set:

• Adjudication Method: A consensus review process was used. After an initial mask by a technologist, two U.S. board-certified radiologists independently evaluated the mask, recorded discrepancies, and iteratively reconciled them until consensus was achieved. This is a form of 2-reader independent reading with a consensus stage.

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 performed as part of this submission's performance testing. The study focused on the standalone performance of the bone removal algorithm against a "definitive ground truth." The document does not describe human reader performance with or without the AI assistance.

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

• Yes, a standalone (algorithm only) performance study was conducted for the Bone Removal feature. The performance metrics (DSC and HD) directly measure the algorithm's output against the established ground truth.

7. The type of ground truth used:

• The ground truth used was expert consensus. Specifically, after an initial mask by a technologist, it was refined and finalized through an "independent dual-reader consensus review" by two U.S. board-certified radiologists.

8. The sample size for the training set:

• The provided document does not specify the sample size for the training set. It only describes the test set. It mentions the "Bone Removal is a tool that enhances the visibility of vessels... based on an AI algorithm cleared and marketed for Synapse 3D (K221677, reference device). It was improved for Synapse PACS 7.5.0." This implies the algorithm was already trained and validated prior to this submission, and this submission focuses on its performance after potential integration and improvements within Synapse PACS 7.5.0.

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

• The provided document does not describe how the ground truth for the training set (if applicable to this version's training) was established. Given that the algorithm was "improved" from a previously cleared device (Synapse 3D), the initial training and ground truth establishment would have occurred during the development and clearance process for that prior version.

Ask a specific question about this device

Double Balloon Endoscope Model EN-840T: 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, large intestine and rectum. Never use this product for any other purposes.

Over-Tube TS-1214C: This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

a. Double Balloon Endoscope Model EN-840T: The insertion portion of the device has a mechanism (hereinafter "the bends the tip from right to left and up and down, and a flexible tube (hereinafter") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane. The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Balloon air feed outlet , Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by knobs on the control portion section to angulate the distal end to certain angles. The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles alow light to travel through the body cavity, thereby providing enough light to the CMOS sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction. The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connects the endoscopes to the light source.

b. Over-tube TS-1214C: The over-tube TS-1214C is introduced in the patient's anatomy with the pairing endoscope. TS-1214C 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-1214C is provided sterile and single-patient use only. This accessory is a Class 2 device.

The provided text is a 510(k) Summary for a medical device (Double Balloon Endoscope EN-840T and Over-tube TS-1214C). It describes the device, its intended use, and a comparison to predicate devices, and lists various non-clinical tests performed to demonstrate substantial equivalence. However, it does not include information about specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment, expert qualifications, or any human reader studies (MRMC or standalone AI performance).

Therefore, based on the provided text, I cannot answer most of your detailed questions about acceptance criteria and the study proving the device meets those criteria. The document focuses on regulatory compliance through substantial equivalence, primarily established through non-clinical testing against recognized standards.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. The document mentions various tests were conducted (EMC, Electrical safety, Biocompatibility, Endoscope specific testing, Sterility, Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output) and states "The subject device met performance specifications" or "Bench testing data demonstrated that the subject devices are substantially equivalent in performance." However, it does not provide specific numerical acceptance criteria or reported performance values in a table format.

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

• Cannot be extracted. The document mentions "Bench testing data" and "Endoscope specific testing" but does not specify the number of samples or units tested for any of these non-clinical tests, nor the data 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. This device is an endoscope and over-tube, which are hardware devices for visualization and intervention, not an AI system that requires expert-established ground truth for diagnostic accuracy. The testing described is non-clinical (electrical, mechanical, biocompatibility, sterility).

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

• Not applicable. As above, this is for non-clinical hardware testing, not diagnostic AI performance assessment requiring 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. The document describes a traditional medical device (endoscope and over-tube) and its non-clinical testing for safety and effectiveness, based on substantial equivalence to predicate devices. There is no mention of AI or assistant features, nor any MRMC studies.

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

• No. This device is not an algorithm or AI system.

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

• Cannot be extracted and not applicable in the usual sense. For non-clinical tests, "ground truth" would correspond to the established measurement standards and specifications (e.g., a caliper for diameter, a force gauge for bending, a flow meter for suction rate, etc.). The document indicates these tests were performed according to recognized consensus standards (e.g., ISO, AAMI).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of the new endoscope and over-tube through engineering and biocompatibility testing against established standards and predicate devices. It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, or reader performance) typically associated with AI/ML-driven diagnostic devices.

Ask a specific question about this device

The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The APERTO Lucent is a modification of the AIRIS Elite MRI System. The APERTO Lucent has been revised to increase the clinical utility as compared to the AIRIS Elite Magnetic Resonance imaging system. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

The provided text describes the FUJIFILM Healthcare Corporation's APERTO Lucent MRI System (K233629) and its substantial equivalence to a predicate device, the AIRIS Elite V4.9 MRI system (K032232).

The document does not describe specific acceptance criteria in terms of numerical thresholds for device performance (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance evaluations.

Here's the information extracted from the document:

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

As mentioned, explicit numerical acceptance criteria for performance metrics are not provided. The performance evaluation focuses on demonstrating that the new features and coils perform as intended and produce acceptable image quality for clinical use.

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

• Test set sample size: Not explicitly stated. The document refers to "clinical image examples" for new features and coils.
• Data provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical image examples" and validation by a radiologist. It is likely prospective, as it involves evaluating new features and coils.

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

• Number of experts: One radiologist.
• Qualifications of experts: "A radiologist." No further details on years of experience or sub-specialty are provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/None mentioned. The document states a single radiologist validated the clinical images for acceptable image quality. There is no indication of multiple reviewers or an adjudication process.

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

• MRMC study: No. This submission is for an MRI system, not an AI-assisted diagnostic device. The document does not describe any AI component or human-in-the-loop performance evaluation.

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

• Standalone performance: Not applicable. This is for an MRI system, not an algorithm.

7. The type of ground truth used

• Ground truth: Clinical images were validated for "acceptable image quality for clinical use" by a radiologist. This can be considered a form of expert assessment/consensus (from a single expert in this case) on image quality rather than a definitive "ground truth" for specific diagnoses, as the purpose was to evaluate system functionality and image quality.

8. The sample size for the training set

• Training set sample size: Not applicable. This document describes an MRI system, not an algorithm that undergoes a "training" phase with a dataset. The software development likely involved internal testing and verification, but not in the context of machine learning training data.

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

• Ground truth for training set: Not applicable (see point 8).

Ask a specific question about this device

The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (TI), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton

Diagnostic uses:

• · TI, T2, proton density weighted imaging
• · Diffusion weighted imaging
• · MR Angiography
• · Image processing
• · Spectroscopy
• · Whole Body

The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static maqnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varving the RF excitation. applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

The provided document describes the Fujifilm ECHELON Synergy V10.0 MRI system, which is an updated version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device (ECHELON Synergy MRI System K223426) by highlighting changes and providing performance evaluations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the overall device in a quantifiable format. Instead, it demonstrates the new features' performance through clinical image testing and phantom studies, comparing them to conventional methods or manual positioning. The acceptance criteria for "DLR Clear" are implied through achieving statistical significance for superiority in certain image quality metrics over conventional imaging and clinical acceptability. For "AutoPose," the criteria are implied through reduction or equivalence in time and steps for slice positioning.

Here's a summary of the performance results for the new features (DLR Clear and AutoPose):

• Truncation artifact reduction, image sharpness, and overall image quality in images with DLR Clear were superior to conventional images with **statistically significant difference (p

Ask a specific question about this device

The FCT iStream system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.

The Low Dose CT Lung Cancer Screening Option for the FCT iStream system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Corporation.

The FCT iStream is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The FCT iStream X-ray source is designed to enable the continuous emission of fan-beam Xrays, and the solid state detector unit is positioned opposite the X-ray source to measure the intensity distribution of the X-rays. The total number of detector channels is 888 channels x 64 rows, and all of the rows are used as 64-slice portions. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. The FCT iStream system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

This appears to be a 510(k) premarket notification summary for a Computed Tomography (CT) system (FCT iStream Phase 1) seeking substantial equivalence to a predicate device (SCENARIA View 4.2). The document primarily focuses on demonstrating the new device's equivalence to an existing one, rather than presenting a detailed study proving novel performance in terms of AI assistance or diagnostic improvement.

Therefore, many of the specific details requested in your prompt (e.g., number of experts for ground truth, MRMC study, effect size of AI assistance, stand-alone performance, training set details) are not typically found or required in a 510(k) submission for a CT scanner that is not inherently an AI/CADe device. The focus here is on the physical and performance characteristics of the CT scanner itself being comparable to a legally marketed predicate.

However, I can extract the relevant information regarding acceptance criteria and performance as presented in this document, inferring the study approach from the context of a 510(k) for a CT system.

Acceptance Criteria and Device Performance for FCT iStream Phase 1

Since this is a 510(k) for a CT system based on substantial equivalence, the "acceptance criteria" are implicitly and explicitly tied to demonstrating that the FCT iStream Phase 1 performs comparably to its predicate device (SCENARIA View 4.2) and adheres to relevant international standards. The "study" proving this largely involves bench testing against specified parameters and compliance with standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the FCT iStream Phase 1 has "equivalent basic performance as the predicate device" and that "the system performance is similar to the predicate device." Instead of specific numerical acceptance criteria for each item, the document lists tested parameters and confirms compliance or equivalence.

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

• Sample Size: The document does not specify a "sample size" in terms of patient cases for clinical evaluation, because the performance testing was primarily bench testing (phantom studies) rather than a clinical study with patient data.
• Data Provenance: Not applicable as the "study" was bench testing. If patient data was used, its origin (country, retrospective/prospective) would be relevant.

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

• Not applicable. For a CT system's core performance evaluation in a 510(k), ground truth is established through physical measurements using phantoms and established metrology standards (e.g., IEC61223-3-5), not by medical experts interpreting images.

4. Adjudication Method for the Test Set

• Not applicable, as there was no expert interpretation or adjudication of patient images mentioned in the context of this 510(k) performance testing.

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 as described. This submission is for a general CT system, not an AI/CADe device. The document does not report any AI-assisted human reader performance improvements.

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

• Not applicable for a standalone diagnostic algorithm. This device is a CT scanner, which generates images for human interpretation. While it contains software (e.g., iTilt, IntelliODM), the performance discussed is of the imaging system itself, not a diagnostic algorithm meant to perform diagnosis or detection independently.

7. The Type of Ground Truth Used

• The ground truth for the performance testing was established through physical phantom measurements and engineering specifications as outlined in the referenced IEC and NEMA standards (e.g., IEC61223-3-5, NEMA XR 25). For example, spatial resolution might be measured using a line pair phantom, noise using a water-equivalent phantom, and CT numbers using specific material inserts.

8. The Sample Size for the Training Set

• Not applicable. This document describes the validation of a CT scanner's performance for 510(k) clearance, not the development or training of a machine learning or AI algorithm in the typical sense that would require a "training set" of clinical data. While the device contains software, the "training set" concept is not relevant to this type of regulatory submission for a CT system.

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

• Not applicable. As a training set for an AI/ML algorithm is not described, the method for establishing its ground truth is also not.

Ask a specific question about this device

Endoscope Model EB-710XT 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.

The proposed device consists of a non-insertion portion. The insertion portion is insertion portion is inserted trans-nasally or perorally into the trachea and bronchial tree during clinical use. The insertion portion is flexible and consists of the bending portion") and the insertion tube (hereinafter "flexible portion"). The bending portion features a mechanism that bends the tip up and down. The insertion portion can also be rotated so that the distal end of the endoscope is steered to the anatomic region of interest. The insertion portion of the endoscopes comes into contact with the mucosal membrane. The tip of the insertion portion is called the "Distal end" which contains the lmaging section, Distal cap, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by lever on the control portion section to angulate the distal end to certain angles. The flexible portion contains light guides), an instrument/suction channel, a complementary metal-oxide semiconductor (CMOS) image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The control portion provides a grip on the endoscopes and contains mechanical parts to operate the endoscopes. The control portion features an angle lever and a rotation ring which control the angulation and the distal end. The instrument/suction channel runs through the control portion for introducing the endoscopic accessories or electrosurgical instrument, as well as providing suction.

The provided text does not contain information about an AI/ML-powered device, a test set, ground truth establishment, or multi-reader multi-case studies. It describes a conventional medical device (FUJIFILM Endoscope Model EB-710XT) and its regulatory clearance process based on substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document pertains to a traditional endoscope and not an AI/ML-powered device.

The document discusses:

• Device: FUJIFILM Endoscope Model EB-710XT
• Classification: Class II Bronchoscope
• Predicate Device: FUJIFILM Endoscope Model EB-710P (K220957)
• Testing: Non-clinical performance testing was conducted according to ISO 8600-1:2015 to demonstrate substantial equivalence, focusing on physical parameters like diameter, working length, bending capability, resolution, etc.

Since the prompt asks for details specifically related to AI/ML device testing (e.g., sample size for test set, expert adjudication, MRMC studies, standalone performance, training set ground truth), and none of this information is present in the provided text, I must state that the information is not available in the given context.

Ask a specific question about this device

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.

Modes of Operation: B-mode

Never use this product for any other purposes.

FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.

Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.

This document describes the Fujifilm Endoscopic Ultrasonic Probe (P2612S-L/P2620S-L), which is a medical ultrasonic probe intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs in adults.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria for performance metrics (like accuracy or sensitivity) for the ultrasound imaging itself. The performance data presented are related to safety and compatibility with regulatory standards.

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

The document does not describe a test set in the context of clinical performance or image analysis. The "testing" mentioned refers to engineering and safety performance evaluations. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided here for clinical performance.

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

As no clinical performance test set involving image interpretation or diagnosis is described, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set:

Since a clinical test set requiring expert adjudication is not present, this information is not applicable and not provided.

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

The document states, "Clinical testing is not applicable to this submission." Therefore, an MRMC comparative effectiveness study was not done, and there is no reported effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasonic probe, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This device is an ultrasonic probe, a hardware component for ultrasound imaging. It does not contain an algorithm for standalone performance evaluation in the context of AI or diagnostic software. Therefore, a standalone performance study was not done.

7. Type of Ground Truth Used:

For the technical and safety evaluations, the "ground truth" was established by adherence to recognized international standards and guidance documents (e.g., ISO 10993, ANSI/AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2) confirmed through specific tests. For example, biocompatibility tests themselves generate the "ground truth" (e.g., cytotoxicity results, sensitization/irritation responses).

8. Sample Size for the Training Set:

This device is a hardware component and is not an AI/ML-driven device that requires a training set in the typical sense. Therefore, information regarding a training set sample size is not applicable and not provided.

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

As there is no training set for an AI/ML algorithm described, this information is not applicable and not provided.

Ask a specific question about this device

The ARIETTA x10 is intended for use by trained personnel (doctor, Sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intraoperative (Specify1), Intra-operative (Neurosurgery), Laparoscopic, Pediatric, Small Organ (Specify2), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (non-Cardiac), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Specify - Gynecological), Other (Specify - Wound), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel, clinical applications.

The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

*1. Includes imaging for organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

*2. Includes thyroid, parathyroid, breast, scrotum, penis.

ARIETTA x10 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA x10 can be used for individual or combined display in the image display model listed below.

• . B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
• M mode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
• . There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
• Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode. Power Doppler Mode. High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 4 methods of electronic scanning are as follows.

• . Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
• . Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
• Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.
• . Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

The provided text describes a 510(k) premarket notification for the ARIETTA x10 ultrasonic pulsed Doppler imaging system. It states that an analysis confirms the performance characteristics of the ARIETTA x10 are comparable to the predicate device and support the conclusion of substantial equivalence. However, it explicitly states that "Clinical testing was not required" and provides no information about any specific study, acceptance criteria, or device performance metrics for the ARIETTA x10. Therefore, the requested information cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device (ALOKA ARIETTA 850, K183456) based on technological characteristics, safety standards conformance, and the lack of new hazards.

The document does not contain the information required to populate the table or answer the specific questions regarding acceptance criteria and a study that proves the device meets those criteria.

Ask a specific question about this device

The SCENARIA View 4.2 system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle quidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Corporation.

The SCENARIA View 4.2 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA View 4.20system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. The SCENARIA View 4.2 system consists of a Gantry, Operator's Workstation, Patient Table, High- Frequency X-ray Generator, and accessories.

Here's a breakdown of the acceptance criteria and study information for the Scenaria View 4.2 CT system, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of document often relies on comparative analysis and verification that new features do not negatively impact existing performance, rather than extensive clinical efficacy studies for the entire device. For a CT Scanner, the primary acceptance criteria revolve around image quality, dose, and safety, often demonstrated through bench testing and compliance with recognized standards.

Acceptance Criteria and Reported Device Performance

• Automatic analysis queue for main recon of original inspection registered and executed.
• Automatic analysis queue for original inspection multi-recon registered and executed after multi-recon.
• Automatic analysis queue for PES registered and executed after Exam Split.
• Exam Split starts after scan, Multi Recon starts after recon completion. All testing passed. |
  | Safety & Standards | Compliance with:
• AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012. C1:2009/(R)2012 and . A2:2010/(R)2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Conformance demonstrated. |
  | | - IEC 60601-1-2 Edition 4.0 (Electromagnetic compatibility) | Conformance demonstrated. |
  | | - IEC 60601-1-3 Edition 2.1 (Radiation protection in diagnostic X-ray equipment) | Conformance demonstrated. |
  | | - IEC 60601-2-44 Edition 3.2 (Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography) | Conformance demonstrated. |
  | | - IEC 62304 Edition 1.1 (Medical device software - Software life cycle processes) | Conformance demonstrated. |
  | | - NEMA XR 25 (Computed Tomography Dose Check) | Conformance demonstrated. |
  | Technological Equivalence| Features (Tilt for helical scan, improved Exam Split, AutoPositioning) do not impact safety and effectiveness compared to the predicate device, and the subject device is substantially equivalent to the predicate device (K213829). | Thorough analysis and comparison conducted. Technological characteristics (e.g., SSD for image storage, new features) do not impact safety and effectiveness. |

Study Details

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

   • The document does not specify a numerical "sample size" in terms of patient cases for testing.
   • The performance evaluations for image quality and dose (Dose Profile, Noise, MTF, Slice Thickness, CT dose index, etc.) are described as "Performance Testing - Bench." This typically involves phantom studies or specified calibration procedures rather than patient data.
   • For the new software features (AutoPositioning, ExamSplit), testing involved "various cases" and "mock procedure," which are likely internal verification and validation tests rather than tests on a diverse patient dataset.
   • Data Provenance: Not explicitly stated as retrospective or prospective patient data, but the descriptions strongly suggest bench testing with phantoms/test objects or internal system validation using mock scenarios/simulated data. No country of origin for patient data is mentioned as no clinical studies with patient data were detailed for the new features.

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

   • This information is not provided in the summary. For performance testing on a CT scanner, ground truth is usually established through physical measurements, calibration standards, and technical specifications, rather than expert interpretation of images for diagnosis. For the software features, the "ground truth" was whether the feature performed as designed based on the functional requirements.

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

   • None is explicitly mentioned. The testing described (bench tests, functional verification) does not typically involve human adjudication in the way clinical studies for diagnostic accuracy would.

4. 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 described. The device is a CT imaging system, and while it has a "Low Dose CT Lung Cancer Screening Option," the submission discusses the system's performance and new software features like AutoPositioning and ExamSplit, not a specific AI-assisted diagnostic tool. There is no mention of AI assistance for human readers or any effect size related to reader improvement.

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

   • The document describes the performance of the CT system and its software features. The "Low Dose CT Lung Cancer Screening Option" is an indication of use for the system, not a separate standalone algorithm whose performance is being evaluated independently. The new features (AutoPositioning, ExamSplit) are functionalities of the CT system itself, not standalone algorithms for diagnosis. The performance testing is focused on the system's technical specifications and the correct functioning of these features. Therefore, this question is not directly applicable in the context of the information provided for this CT device's 510(k).

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

   • For image quality and dose metrics (Dose Profile, Noise, MTF, etc.), the ground truth is established by physical measurements, standardized phantoms, and adherence to technical specifications and industry standards.
   • For the new software features (AutoPositioning, ExamSplit), the ground truth was the pre-defined functional requirements and expected system behavior.

7. The sample size for the training set:

   • This information is not provided as the document describes a CT imaging system and its software features, not a machine learning or AI model that requires a dedicated training set for diagnostic purposes described in the output. The software features mentioned (AutoPositioning, ExamSplit) are likely rule-based or algorithmic improvements, not deep learning models.

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

   • This information is not provided and is not applicable given the absence of a stated training set for a machine learning or AI algorithm.

Ask a specific question about this device

This product is intended to be used in combination with an endoscope insertion into the body. Never use this product for any other purpose. This product is intended for use in medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

FUJILM Over-tube consists of an inserting through the body, a handle portion to be gripped by the operator, a water injection portion for injecting water onto the insertion part, a suction portion for suctioning air from the walls, thereby changing the rigidity of the insertion part, and a hook portion for the control part of the endoscope. The suction portion is formed by a three-way stopcock and can be connected to a suction machine and changing the position of the three-way stopcock lever, the insertion portion can be in the state of vacuum, thereby increasing the rigidty of the insertion portion. The rigid body of the insertion maintains the shape of Over-tube and allow the endoscope insertion to smoothly move back and forth and rotate while decreasing the adverse impact to the patient anatomy. In addition, when water is injected from the water inlet connected to the inside of Over-tube, water enters between the endoscope and Over-tube, reducing friction between the endoscope and the Over-tube.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Over-tube." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about studies involving human readers or AI assistance.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a structured table format. However, it lists various non-clinical tests performed and implies that the device "demonstrated that the design requirements" were met and that there were "no new concerns for the safety and efficacy."

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

• Sample Size for Test Set: The document mentions that Over-tube models TR-1208A and TR-1507A were used as representative models for bench testing. TR-1504A's performance was adopted from TR-1507A because it only differs in working length. For durability and packaging safety, accelerated-aged versions of TR-1208A and TR-1507A were used, respectively. The exact number of units tested for each model is not specified, but it's implied that "models" refers to individual devices. The document does not provide information about the country of origin or whether the data was retrospective or prospective. This is a premarket notification for a device, and the testing described is typically conducted in a controlled lab environment.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The tests conducted are non-clinical, likely laboratory-based.

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)

This information is not applicable to this document. The device is an "Over-tube" (an endoscope accessory), and the testing described is non-clinical performance and safety testing. It does not involve diagnostic interpretations by experts or the establishment of a "ground truth" for a test set in the way an AI-powered diagnostic device would.

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

This information is not applicable to this document. As mentioned above, the testing is non-clinical and does not involve adjudication of expert opinions.

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

This information is not applicable to this document. The device is a physical endoscope accessory, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

This information is not applicable to this document. The device is a physical endoscope accessory, not an algorithm.

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

This information is not applicable to this document. The "ground truth" for the non-clinical tests would be established through engineering specifications, material properties, and physical testing methodologies rather than clinical outcomes or expert consensus. For example, "insertion force" has a measurable target, not an expert consensus.

8. The sample size for the training set

This information is not applicable to this document. The device is a physical endoscope accessory and does not involve a "training set" in the context of machine learning or AI models.

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

This information is not applicable to this document. There is no training set for this device.

Ask a specific question about this device