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The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The Isolator Synergy EnCompass Clamp and Guide System (OLH, OSH, GPM100) is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH), each with an accessory Glidepath Magnetic Guide (GPM100). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The clamp features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. When activated, the generator delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch connected to the generator. The Guide is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The guide has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the clamp jaws inside the jaw magnet cups.

The provided FDA 510(k) clearance letter and summary for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056) describe modifications to an existing device, rather than a novel device requiring extensive clinical or AI-based performance studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device through bench testing and non-clinical performance evaluations, rather than establishing performance against specific diagnostic accuracy or clinical outcome metrics.

The document primarily focuses on ensuring the device modifications do not negatively impact the safety and effectiveness compared to the predicate device. As such, there is no mention of AI integration, MRMC studies, or extensive human reader performance evaluations typically associated with AI/CADe devices.

Here's the breakdown of the information as requested, tailored to what is provided in this specific 510(k) summary:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056)

The acceptance criteria and supporting studies for this device are designed to demonstrate substantial equivalence to its predicate device (Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System, K210477) following minor design and manufacturing changes. The focus is on ensuring the updated device maintains the same safety and effectiveness profile.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for minor modifications, the "acceptance criteria" are implied by the specific performance tests conducted to show that the modified device performs similarly to the predicate and meets relevant safety standards. The reported device performance indicates that the device met these implicit criteria.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., number of clamps tested for mechanical properties, number of cadavers for usability). It refers to "bovine tissue" for ex vivo ablation and "cadaver lab" for usability. Given the nature of a 510(k) for minor device modifications, this level of detail regarding sample size for bench testing is typical.
• Data Provenance: The studies are primarily bench testing and laboratory-based non-clinical performance studies.
  • Ex vivo ablation: "bovine tissue"
  • Usability testing: "cadaver lab"
  • Biocompatibility: In vitro and some in vivo tests (implied by ISO 10993 standards, typically not human data unless specified).
  • Sterilization: Tests conducted at Steris Isomedix Operation (Spartanburg, SC).
  • Retrospective/Prospective: Not applicable as these are laboratory and bench studies for device changes, not clinical data from patients.
  • Country of Origin of Data: Not explicitly stated for all tests, but given the manufacturer (AtriCure, Inc., Ohio, USA) and sterilization vendor location (Spartanburg, SC, USA), the direct tests were likely conducted in the USA.

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

This type of information is generally not applicable to a 510(k) submission for minor device modifications based on bench and non-clinical testing. "Ground truth" in this context refers to established scientific and engineering principles, and performance standards (e.g., ISO, IEC). For the usability study, "participants" are mentioned, implying a group of users (likely surgeons or clinical personnel) who operated the device in a simulated environment, but their number and specific qualifications beyond being "users" are not detailed.

4. Adjudication Method for the Test Set

Not applicable. As these are technical, mechanical, and biological tests, "adjudication" in the sense of expert review for ambiguous cases (like in diagnostic image interpretation studies) is not relevant. The results are objective measurements against predefined acceptance criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of a diagnostic aid (e.g., AI in image interpretation) on human reader performance. The Isolator® Synergy™ EnCompass Clamp and Guide System is an electrosurgical instrument, not a diagnostic device, and the modifications are minor, so such a study would not be relevant or required.

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

Not applicable. This device does not incorporate an AI algorithm or software that operates independently to produce a diagnostic or analytical output. All testing pertains to the physical and functional performance of the medical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on:

• Regulatory Standards: Compliance with recognized standards like ISO 10993 (Biocompatibility), IEC 60601 (Electrical Safety), and ANSI/AAMI/ISO 11135 (Sterilization).
• Engineering Specifications: Predetermined design life, mechanical limits (e.g., force, jaw aperture), and functional requirements for the device.
• Established Medical Practice: The ability to create "transmural lesions" in tissue (ex vivo), reflecting the intended therapeutic effect.
• Predicate Device Performance: The underlying "ground truth" for demonstrating substantial equivalence is often the proven safety and effectiveness of the legally marketed predicate device. The new device must perform in a "substantially equivalent manner" in relevant aspects.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrosurgical clamp and guide system, not an AI/ML-driven software device that requires a "training set" of data.

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

Not applicable, for the same reason as point 8.

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EMS is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

TENS is used for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable.

EVE Synergy has Synergy mode and Pro mode.

Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.

Pro mode has low frequency function that uses the Pro handpiece with tip.

It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the EVE Synergy (EVE-20M) device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI assistance or human-in-the-loop performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, specific study designs (MRMC, standalone), ground truth establishment for AI training/test sets, and sample sizes for these, are not present in this type of regulatory submission. This document primarily describes the physical and electrical characteristics of the device and compares them to predicate devices, along with standard electrical safety, EMC, and software validation testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not present "acceptance criteria" in the traditional sense of a specific performance metric (like accuracy, sensitivity, specificity) for a clinical outcome or an AI model's performance. Instead, it demonstrates compliance with safety and performance standards and similarity to predicate devices.

The "acceptance criteria" are implicitly met by showing:

• Compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) for electrical safety, EMC, and software.
• The device's technical specifications (e.g., output voltage, current, pulse width, frequency, power density) are comparable to or within the safe limits established by the predicate devices.

Table of Performance (extracted from comparison tables):

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The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.

The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

The provided FDA 510(k) clearance letter and summary for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) describes the device and its indications for use, but does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically, the document states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This implies that performance data demonstrating device capabilities against specific acceptance criteria (beyond general functional testing and compliance with standards) were not generated through clinical studies or animal studies for this submission.

However, based on the information provided, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Since no human or animal clinical studies were performed, there appears to be no specific clinical performance acceptance criteria listed in this document. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing.

Study Details (Based on Provided Document and Inferences)

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

   • Test set sample size: Not applicable for clinical performance as the document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."
   • Data provenance: Not applicable for clinical performance. The data provenance for engineering tests (e.g., EMT, EMC, software) would be internal Arthrex testing labs.

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

   • Not applicable as no human clinical studies establishing ground truth for clinical performance were conducted for this submission. Ground truth for engineering tests is established through technical specifications and industry standards.

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

   • Not applicable for clinical performance.

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 study was done. The device description does not indicate AI assistance features. The system is described as an endoscopic video camera and imaging system, not an AI-powered diagnostic aide.

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

   • Not applicable. The device is hardware (imaging system) with associated software, not a standalone algorithm.

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

   • For the engineering and regulatory compliance tests: Ground truth was established by adherence to design specifications, industry standards (e.g., for biocompatibility, sterility, EMT, EMC), and internal product requirements.
   • For clinical performance (e.g., diagnostic accuracy for a specific disease): No such ground truth was established or presented as no clinical studies were performed.

7. The sample size for the training set:

   • Not applicable, as this device does not appear to utilize machine learning for clinical interpretation or outcome prediction in a way that requires a "training set" in the context of AI/ML models. "Software testing" refers to verification against technical requirements, not AI model training.

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

   • Not applicable for the same reasons as #7.

Summary of Key Takeaways from the Document:

The 510(k) clearance for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) is based on substantial equivalence to existing predicate devices (K241361 and K243008). The justification for this clearance relies heavily on:

• Similar intended use and indications for use.
• Similar technological characteristics (e.g., components, imaging modes, specifications).
• Successful completion of engineering and regulatory compliance testing (e.g., functional testing, biocompatibility, sterility, EMT, EMC, software).

Crucially, the document explicitly states that no animal testing or human clinical studies were required or performed to demonstrate the device meets acceptance criteria related to clinical performance. This means the clearance is not based on a study proving diagnostic accuracy or clinical effectiveness in patients, but rather on the device's technological similarity and safety/performance in a non-clinical, engineering test environment compared to previously cleared devices.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.

The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following:

• 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
• 2. To address several iterative legacy design changes made to the subject hip system components.

This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.

The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.

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The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.

The provided text describes a 510(k) premarket notification for the AtriCure Isolator Synergy EnCapture Ablation System (EMH). It primarily focuses on demonstrating substantial equivalence to a predicate device (Isolator Synergy Surgical Ablation System, K211311) rather than presenting a study proving a device meets specific acceptance criteria based on human expert performance in image analysis or similar tasks.

Therefore, many of the requested details about acceptance criteria for AI/image analysis devices, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training sets are not applicable to this document. This document details the clearance of a surgical ablation system, which is a physical device used to ablate cardiac tissue during surgery, not a software or AI-driven diagnostic/image analysis tool.

However, I can extract and present the relevant performance data and "acceptance criteria" (in the context of substantial equivalence) as described in the provided text.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Context: The device in question is the "AtriCure Isolator Synergy EnCapture Ablation System (EMH)," an electrosurgical instrument for cardiac tissue ablation. The regulatory submission is a 510(k), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute performance against a predefined clinical metric as one might for a novel AI diagnostic. The "acceptance criteria" here therefore relate to demonstrating this substantial equivalence through various performance tests.

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

The document doesn't provide a direct table of "acceptance criteria" with numerical performance targets in the way one would for an AI diagnostic (e.g., AUC > 0.9). Instead, it presents various non-clinical and animal studies conducted to demonstrate that the new device performs "substantially equivalent" to its predicate. The acceptance for these tests is implicitly that the device performs comparably to the predicate and raises no new safety or effectiveness concerns.

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

• In Vivo GLP Animal Study: 12 pigs were used.
  • 6 pigs for the subject device (Isolator Synergy EnCapture Ablation System EMH).
  • 6 pigs for the predicate device (Isolator Synergy Surgical Ablation System EMR2/EML2).
• Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. No information about country of origin, or retrospective/prospective human data is relevant as this is an animal study for a physical device.

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

• Not Applicable. This is a physical surgical device, not an AI/image analysis product requiring human expert interpretation for ground truth. The "ground truth" in the animal study would be the physiological and pathological outcomes measured directly from the animals (e.g., "conduction block" and "macroscopic and microscopic analysis").

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

• Not Applicable. As per point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device. No MRMC study was performed because the device does not involve human readers interpreting cases/images.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the In Vivo GLP Animal Study: The ground truth was based on direct physiological outcomes (evidence of conduction block) and histopathology (macroscopic and microscopic analysis of tissue) post-ablation from the animal subjects. For the other tests (mechanical, biocompatibility, electrical safety), the "ground truth" is adherence to established engineering and safety standards.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in the context of this regulatory submission.

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

• Not Applicable. As per point 8.

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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.

The provided document is a 510(k) summary for the FUJIFILM Healthcare Corporation's ECHELON Synergy MRI System. This document asserts substantial equivalence to a predicate device and primarily focuses on technical characteristics and adherence to standards rather than detailed performance studies with acceptance criteria for a diagnostic aid.

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

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

The document doesn't explicitly state quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's a 510(k) submission for an MRI system with an added coil, not a diagnostic algorithm. The acceptance criteria for the added Breast Coil 17 are implicitly tied to the performance and safety standards of the predicate device (ECHELON Synergy V10.0 K233687).

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

• Sample size for test set: Not explicitly stated as a number of cases or patients. The document mentions "Clinical image examples."
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It only states that "Clinical images were collected and analyzed."

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" validated the clinical images. No further details on experience level are provided.

4. Adjudication method for the test set:

• Adjudication method: None mentioned beyond a single radiologist's validation of image quality for clinical use.

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, an MRMC comparative effectiveness study was not explicitly mentioned or implied. This submission is for an MRI system with an added coil, not an AI-powered diagnostic algorithm.

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

• Standalone performance: Not applicable. This device is an MRI system, not a standalone AI algorithm. The performance evaluation focused on the technical aspects and image quality of the MRI machine and its new coil.

7. The type of ground truth used:

• Type of ground truth: Expert opinion (a single radiologist's validation of "acceptable image quality for clinical use"). This is tied to the demonstrative aspect of clinical image examples, rather than a definitive diagnostic truth for a disease state.

8. The sample size for the training set:

• Sample size for training set: Not applicable. This document is about a hardware modification (an added coil) to an existing MRI system. It does not involve machine learning models that require training sets in the conventional sense.

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

• How ground truth for training set was established: Not applicable, as there is no mention of a training set or machine learning model.

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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

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The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The Arthrex Synergy Vision Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and endoscope. The system integrates ultra-high-definition camera technology, light emitting diode (LED) lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging.

The Arthrex Synergy Vision Endoscopic Imaging System interacts with the laser light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed, and displayed on a monitor.

The provided text describes the Arthrex Synergy Vision Endoscopic Imaging System. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that would demonstrate the device meets such criteria in terms of clinical performance or diagnostic accuracy.

Instead, the document focuses on regulatory clearance for a medical device by demonstrating substantial equivalence to a predicate device. The "Performance Data" section details non-clinical testing related to safety and functionality, rather than clinical efficacy or accuracy.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

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

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

• Not applicable for clinical performance testing. The reported "testing" refers to non-clinical engineering and safety validations. No patient data or clinical test sets are mentioned.

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. No expert review or ground truth establishment for clinical performance is mentioned.

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

• Not applicable. No adjudication method for clinical performance is mentioned.

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 such study was done. The document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."

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

• Not applicable. The device is an imaging system providing visible and near-infrared fluorescence imaging, not an AI-driven diagnostic algorithm that would typically have standalone performance.

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

• Not applicable for clinical performance. The "ground truth" for the non-clinical tests involved compliance with engineering standards and predefined design specifications.

8. The sample size for the training set

• Not applicable. The non-clinical testing does not involve training data in the context of machine learning.

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

• Not applicable.

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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, 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 ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON OVAL V6.0A MRI system. The ECHELON Synergy has been designed to enhance clinical utility as compared to the ECHELON OVAL V6.0A by taking advantage of open architecture.

The provided document, K223426, is a 510(k) premarket notification for the FUJIFILM Healthcare Corporation's ECHELON Synergy MRI system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (ECHELON OVAL V6.0A MRI system, K172110) rather than presenting a detailed performance study with explicit acceptance criteria for an AI/ML powered device as typically required for novel AI products.

However, the document mentions several new features powered by Machine Learning (ML), specifically Deep Learning Reconstruction (DLR), AutoClip, AutoPose Spine, AutoPose Shoulder, and AutoPose Knee. For DLR, some form of evaluation was performed. For AutoClip and AutoPose functions, performance comparisons were made against manual operations.

Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as one would expect for a dedicated AI/ML device approval, is not explicitly stated with numerical thresholds. The evaluations are largely qualitative or comparative to existing methods.

Below is an attempt to extract the closest information to your request, specifically focusing on the DLR, AutoClip, and AutoPose functions, as they are the only "AI/ML powered" components mentioned with specific evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria are not provided for the AI/ML components, the table below consolidates the stated evaluative goals and findings from the "Summary of Clinical Testing" section.

• SNR: Equivalent or better in 81 out of 81 cases.
• Sharpness: Equivalent or better in 80 out of 81 cases.
• Lesion Conspicuity: Equivalent or better in 45 out of 45 cases (with pathology).
• Overall Image Quality: Equivalent or better in all cases.
  Motion Artifact Handling: Rated as better or equivalent image quality in all 3 image pairs with motion artifacts, indicating DLR did not significantly change their appearance.
  Shorter Scan Time Efficacy: DLR images with shorter scan times were rated "acceptable for routine examinations" in all 18 cases.
  Resolution Improvement: High-resolution DLR images were rated "better or equivalent" image quality in all cases compared to low-resolution conventional images. |
  | AutoClip | Performance Equivalence: Performance should be "substantially equivalent" to manual clipping. | Confirmed that the performance of AutoClip was "substantially equivalent to that of manual clipping." |
  | AutoPose (Spine, Shoulder, Knee) | Efficiency Improvement/Equivalence: Should reduce time and number of steps in slice positioning compared to manual, or at least show the "same time and number of steps." | Spine, Shoulder, and Knee:
• Many cases were able to reduce the time and number of steps in slice positioning compared to manual.
• Remaining cases showed the same time and number of steps as manual slice positioning. |

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

• Deep Learning Reconstruction (DLR):

  • Number of cases: 110 cases for DLR image quality evaluation (including 81 cases for SNR/sharpness/overall IQ, 45 cases with pathology for lesion conspicuity, 3 cases for motion artifacts, and 18 cases for shorter scan time evaluation). The exact breakdown per sub-analysis is specified.
  • Data Provenance: ECHELON OVAL, ECHELON Smart, and ECHELON Synergy MRI systems (all FUJIFILM Healthcare Corporation 1.5T MRI systems). Data acquired at "FUJIFILM Healthcare Corporation and clinical site."
  • Subject Type: Healthy volunteer and patient.
  • Anatomical Coverage: Head, Spine, Cardiac, Breast, Abdomen, Pelvis, Shoulder, Wrist, Knee, Ankle.

• AutoClip:

  • Number of cases: 40 cases.
  • Data Provenance: ECHELON Synergy MRI system (FUJIFILM Healthcare Corporation 1.5T MRI system). Data acquired at "FUJIFILM Healthcare Corporation."
  • Subject Type: Japanese healthy volunteers.
  • Anatomical Coverage: Brain (using 3D TOF, 3D Soft TOF scan sequences).

• AutoPose (Spine, Shoulder, Knee):

  • Number of cases: Spine (146 cases), Shoulder (48 cases), Knee (38 cases).
  • Data Provenance: ECHELON Synergy MRI system (FUJIFILM Healthcare Corporation 1.5T MRI system). Data acquired at "FUJIFILM Healthcare Corporation."
  • Subject Type: Japanese healthy volunteers.
  • Anatomical Coverage: Spine, Shoulder, Knee.

Note: The document does not explicitly state if the data was retrospective or prospective. Given the nature of performance testing within a company and potentially a clinical site, it could be a mix or internal prospective collection, but it's not specified. The country of origin for the "clinical site" data is also not explicitly stated beyond "Japanese healthy volunteers" for AutoClip/AutoPose, implying at least part of the data is from Japan for those features.

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

• Deep Learning Reconstruction (DLR):

  • Number of Experts: Three (3) US certified radiologists.
  • Qualifications: "US certified radiologists." No specific years of experience or subspecialty are provided, beyond their certification.

• AutoClip & AutoPose (Spine, Shoulder, Knee):

  • Number of Experts: Not specified as "experts" establishing ground truth, but rather "certified radiological technologists" performed the performance comparison/evaluation. The ground truth for performance was implicitly "manual operation" by these technologists. Their qualifications are listed as "certified radiological technologists."

4. Adjudication Method for the Test Set

• Deep Learning Reconstruction (DLR): The document states "Readers compared pairs of DLR images and conventional images (without DLR) for each case to evaluate image quality of DLR images." It does not specify an explicit adjudication method (e.g., 2+1, 3+1). It merely presents the results as derived from the collective evaluation of the three radiologists. It's unclear if consensus was required, or if individual ratings were aggregated.

• AutoClip & AutoPose: The evaluation was done by "certified radiological technologists" comparing against manual operation. No formal adjudication process is described.

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

• Deep Learning Reconstruction (DLR): A study involving multiple readers (3 US certified radiologists) and multiple cases (110 cases in total for DLR evaluation) was performed, which aligns with the spirit of an MRMC study. However, it's not explicitly labeled as such, and the methodology primarily focuses on qualitative comparison of image quality between DLR and conventional images rather than a comparative effectiveness study of human reader diagnostic performance with vs. without AI assistance for a specific diagnostic task.

  • Effect Size of Human Reader Improvement: This type of effect size (e.g., AUC uplift) is not reported. The study focused on assessing image quality attributes and acceptability for routine examinations from the DLR images themselves, as perceived by radiologists, not on how DLR assistance changes a radiologist's diagnostic accuracy or efficiency on a specific clinical task. The evaluation was primarily about the AI's impact on image characteristics, not human diagnostic performance.

• AutoClip & AutoPose: These evaluations were focused on the efficiency and equivalence of the automated process compared to manual operation, as assessed by technologists. They were not MRMC studies designed to measure impact on human readers' diagnostic effectiveness.

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

• The document implies a standalone assessment of the DLR output quality (SNR, sharpness, etc.) against conventional images, as rated by radiologists. The AutoClip and AutoPose functions are also inherently standalone algorithms that automate tasks, with their performance evaluated against manual methods. However, no formal "standalone performance study" with typical metrics like sensitivity, specificity, or AUC for a diagnostic task is presented for these AI/ML components in isolation. The evaluation focuses on product-level performance and usability.

7. The Type of Ground Truth Used

• Deep Learning Reconstruction (DLR): The ground truth for evaluation was expert consensus/opinion (or individual expert assessment) of the image quality attributes (SNR, sharpness, lesion conspicuity, overall image quality) when comparing DLR images to conventional images. The underlying "ground truth" for the cases themselves (e.g., presence of pathology) would presumably come from standard clinical diagnostic reports or other confirmed findings, but the DLR study's focus was on image quality as assessed by experts.

• AutoClip & AutoPose: The ground truth for these functions was the manual operation by certified radiological technologists. The evaluation aimed to determine if the automated function delivered equivalent or better performance (in terms of results and/or efficiency) compared to the human-performed task.

8. The Sample Size for the Training Set

• The document does not provide any details on the sample size used for the training set for DLR, AutoClip, or AutoPose. This information is typically proprietary and not included in 510(k) summaries unless specifically requested by the FDA or deemed critical for demonstrating substantial equivalence for a novel AI/ML device.

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

• Similar to the training set sample size, the document does not provide any details on how the ground truth for the training set was established for DLR, AutoClip, or AutoPose.

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