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The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.

Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.

Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.

Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.

The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.

The modifications to the cleared Mojo Full Face mask (K120463) are:

• Addition of contraindication and updated warning related to presence of magnets
• Change to the headgear material
• Addition of an XL size

The modifications to the cleared Veraseal Full Face mask (K120463) are:

• Modified design, now called the Veraseal 2 Full Face Vented Mask
• . Addition of an XL size

Other modifications include:

• Addition of the Innova Full Face Vented Mask version
• Addition of the Ascend Full Face Vented Mask version

This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).

The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.

Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.

1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):

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The system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The proposed device Revolution Ascend Sliding is a head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections.

Revolution Ascend Sliding generates cross-sectional images of the body by computer reconstruction of xray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.

The provided text does NOT include details about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Here's why and what information IS available:

This device is a Computed Tomography (CT) X-ray System, specifically a hardware modification. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Revolution Ascend, K213938) based on engineering design, performance, and image quality specifications. It's not an AI/CADe device that would typically have the kind of performance metrics (sensitivity, specificity, AUROC) and associated study designs you're asking for.

Therefore, most of the requested fields cannot be filled from this document.

Here's what information I can extract and why other fields are not applicable:

• A table of acceptance criteria and the reported device performance: This detail is not provided. The document states that the device "maintains the identical/equivalent performance and image quality specifications" to its predicate and that "Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device." However, specific numerical acceptance criteria and reported performance values for those criteria are not listed.
• Sample sized used for the test set and the data provenance: Not applicable in the context of this document. This is not a study evaluating diagnostic performance on a dataset of patient cases. The testing mentioned is "engineering design V &V and bench testing."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts is described for a diagnostic performance study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable. No training set is mentioned as this isn't an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

What the document does state about testing and compliance:

• Testing Philosophy: The device was tested through "engineering design V &V and bench testing" to demonstrate substantial equivalence to the predicate device.
• Compliance: The device is "in compliance with AAMI/ANSI ES 60601-1 and IEC60601-1 Ed. 3.2 and its associated collateral and particular standards, 21 CFR Subchapter J, and NEMA standards XR 25, XR 26, and XR 28."
• Image Quality Testing: Image quality testing was done "in accordance with IEC 61223-3-5 ed.2 to demonstrate the overall system performance in a standardized and referenceable manner."
• Clinical Testing: "The Revolution Ascend Sliding CT system can be fully tested on the engineering bench thus no additional clinical testing was required." This indicates that the regulatory body agreed that bench testing was sufficient to demonstrate safety and effectiveness for this type of device modification.
• Quality Assurance Measures: Includes "Risk Analysis and Control, Required Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification)."

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The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.

The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend NanoTec VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.

The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.

The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

This document is a 510(k) premarket notification for a medical device – the Ascend™ VBR System and Ascend™ NanoTec™ VBR System, which are vertebral body replacement devices. The content focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for FDA clearance.

The provided text does not contain any information about an AI/ML-based device or its performance criteria. The entire document pertains to physical medical devices (spinal implants) and their mechanical, chemical, and biological performance characteristics.

Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document details traditional medical device testing, such as:

• Static and Dynamic Axial Compression per ASTM F2077
• Static and Dynamic Torsion per ASTM F2077
• Static Subsidence per ASTM F2267
• Static Push-out
• Gravimetric Analysis per ASTM F1714
• Particulate Analysis per ASTM F1877
• Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
• Biocompatibility Testing per ISO 10993-1

These tests are standard for evaluating the mechanical and biocompatibility properties of physical implants, not the performance of an AI/ML algorithm.

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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The Revolution Ascend is a head and whole-body CT system composed of a gantry, patient table, operator console with a host computer, power distribution unit, and interconnecting cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections. The system has a 75 cm gantry bore and 64-row detector.

Revolution Ascend generates cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.

A design change has been made to the Revolution Ascend with an alternative detector scintillator material prompting this premarket notification. While this change is being made, the design and manufacturing is such that the system performance remains identical to its unmodified predicate. The proposed device carries over all the features, options and specifications of the predicate device, including the Deep Learning Iterative Recon (DLIR) cleared via K212067 without change.

This document is a 510(k) Premarket Notification Summary for the Revolution Ascend CT system. The purpose of this submission is to demonstrate that the proposed device, with a change in detector scintillator material, is substantially equivalent to a legally marketed predicate device. Therefore, the acceptance criteria and study design are focused on proving this equivalence rather than establishing the de novo performance of an AI algorithm or a new medical device.

Based on the provided document, here's a description of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't provide a direct table of specific numerical acceptance criteria for image quality metrics. Instead, the acceptance criteria are implicitly stated as demonstrating equivalence to the predicate device, Revolution Ascend (K203169), across various performance aspects.

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

The document explicitly states that the testing was non-clinical bench testing using "standard IQ, QA phantoms." It does not involve human patient data or a specific "test set" in the context of clinical studies. Therefore, sample size in terms of patient cases is not applicable here.

• Data Provenance: Not applicable as it's non-clinical bench testing with phantoms.

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

Not applicable. As the testing was non-clinical bench testing using phantoms and established metrics (e.g., IEC standards, NEMA standards), the "ground truth" is based on the known physical properties and performance characteristics of the phantoms and the objective measurements derived from them, rather than expert interpretation of patient images.

4. Adjudication method for the test set

Not applicable. Since the testing is non-clinical bench testing with phantoms and objective measurements, there is no need for expert adjudication of image findings.

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. This submission is for a hardware change (detector scintillator material) in a CT system, not for a new AI-powered diagnostic device or a modification to an existing AI feature (DLIR is carried over without change). Therefore, an MRMC comparative effectiveness study regarding human reader performance with/without AI assistance is outside the scope of this particular 510(k) submission. The document explicitly states the DLIR was "cleared via K212067 without change," implying its performance was evaluated in that separate submission.

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

No. This submission is for a CT scanner system that includes hardware and software. It's not for a standalone algorithm. The "Deep Learning Image Reconstruction (DLIR)" component referenced is a reconstruction algorithm within the CT system, and its standalone performance likely would have been assessed in its original 510(k) clearance (K212067). This submission focuses on demonstrating that the change in detector material does not degrade the performance of the overall system, including features like DLIR.

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

For the non-clinical testing, the "ground truth" is based on objective phantom measurements and established engineering metrics as defined by standards like IEC 61223-3-5 Ed. 2. This is not clinical ground truth (e.g., pathology, expert consensus on disease diagnosis). The goal is to demonstrate physical and image quality equivalence.

8. The sample size for the training set

Not applicable. This submission is about a hardware change in an already cleared CT system and is not for training a new AI algorithm. The DLIR component, which involves deep learning, would have had a training set in its original development and clearance (K212067), but details for that are not provided in this document as it's "carried over without change."

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

Not applicable. As above, this pertains to the development of the DLIR algorithm (likely cleared in K212067), not the current submission for a detector material change.

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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The Revolution Ascend CT system is head and whole body CT system incorporating the same basic fundamental operating principles as the predicate device. It is composed of a gantry, patient table, operator console, host computer, and power distribution unit (PDU), and interconnecting cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories, interconnections. Its materials and construction are identical to our existing marketed products.

Identical to the predicate, Revolution Ascend generates cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes. Revolution Ascend's Intended Use and Indications for Use remain identical to those of the predicate device.

Revolution Ascend includes virtually all the available features of the predicate device Revolution Maxima. Compared to the predicate, the changes incorporated into Revolution Ascend are primarily to introduce a widended bore gantry for easy handling of large patient, trauma examinations, interventional procedures and radiotherapy planning, and addition of other existing features already available from GE's other CT systems. These ported features include Auto Pilot workflow enabled by Deep learning based patient Auto Positioning, Intelligent Protocoling enabled by Machine Learning, Smart Plan and Auto Prescription all integrated into the modern software platform and GUI adopted from Revolution CT, and cardiac feature Auto Gating and as well as Interventional feature 3D Guidance.

The provided text describes a 510(k) premarket notification for a Computed Tomography (CT) system, Revolution Ascend, seeking substantial equivalence to a predicate device, Revolution Maxima. This document primarily focuses on demonstrating the new device's equivalence to an already cleared device rather than proving its performance against a new set of clinical acceptance criteria through a standalone study with human readers or specific AI performance metrics.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a study proving a device meets these criteria (especially for a medical AI/CADe device) is largely not present in this document. The submission is for a new iteration of a CT scanner, not a novel AI-powered diagnostic tool requiring specific clinical performance validation for its AI components against a defined ground truth.

However, I can extract the information that is implicitly or explicitly stated, and highlight where the requested information is absent or not applicable to this type of submission.

Acceptance Criteria and Device Performance (Implicit):

Since this is a 510(k) for substantial equivalence to a predicate CT system, the "acceptance criteria" are primarily that the new device, Revolution Ascend, performs as safely and effectively as the predicate device, Revolution Maxima, and other previously cleared GE CT systems for specific features. The performance is assessed through non-clinical bench testing, image quality (IQ) and dose evaluation using phantoms, and verification/validation testing.

Regarding the Study Proving the Device Meets Acceptance Criteria:

The document describes non-clinical testing for substantial equivalence, not a clinical study designed to prove new performance claims or the efficacy of novel AI features in a clinical setting with human readers.

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

   • Test Set Sample Size: No specific number of "cases" or "patients" for a clinical test set is mentioned. The testing involves "standard IQ, QA and ACR phantoms for standard conditions as well as challenging conditions such as with phantoms simulating large patients" and "3D guidance test with phantoms simulating interventional conditions." This indicates laboratory/bench testing using physical phantoms, not a dataset of patient images.
   • Data Provenance: Not applicable as clinical data are not the primary basis for performance evaluation in this submission. The tests are "non-clinical bench test results."

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

   • Not applicable. The "ground truth" for non-clinical phantom testing involves established physical properties, measurements, and engineering specifications, not expert clinical interpretation.

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

   • Not applicable as no human interpretation or adjudication of a test set is described.

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, nor is it described. This submission is for a CT system, not an AI/CADe device requiring direct clinical performance evaluation in synergy with human readers. While the device includes "Intelligent Protocoling enabled by Machine Learning" and "Auto Positioning by Deep Learning," these appear to be workflow/control features, not diagnostic AI features needing MRMC studies for reader performance improvement for a 510(k) submission.

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

   • No standalone performance study of a diagnostic algorithm is detailed. The performance assessment is focused on the CT system's image quality and dose output, verified through phantom studies and engineering testing, ensuring it's equivalent to the predicate.

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

   • For the non-clinical testing, the "ground truth" is based on the known physical properties of the phantoms, established metrics for image quality and dose (e.g., in accordance with IEC 61223-3-5), and design specifications. There's no clinical ground truth (e.g., pathology, expert consensus) involved.

7. The sample size for the training set:

   • The document mentions "Intelligent Protocoling enabled by Machine Learning" and "Auto Positioning by Deep Learning." However, it does not provide any details about the training data size, composition, or provenance for these AI features. As these are described as "workflow features" and integral to the CT system's operation (rather than standalone diagnostic AI tools with independent performance claims), such detail is typically not required for a 510(k) of a CT scanner. They are presented as existing, ported features or minor enhancements that don't alter the fundamental operating principles or intended use.

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

   • Not described/provided in the document. (See point 7).

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ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.

ASCEND Image Viewer is for prescription use only.

The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.

The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:

• . 2D
• Color Doppler
• M-mode
• . Spectral Doppler (Pulsed Wave and Continuous Wave)

The ASCEND Image Viewer provides Cine play review and control.

Standard Review supported study types include:

• TTE
• TEE
• Cath
• . Stress Echo
• Vascular

Supported Measurements include:

• Linear
• . Volume (method of discs)
• Velocity time integral
• Pressure half-time
• . Area
• Time
• Velocity
• Angle (measurement of two lines with a common vertex drawn on the image) .

The user can make measurements which persist for later use within the ASCEND Image Viewer.

Here's a breakdown of the acceptance criteria and study information for the ASCEND Image Viewer, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the ASCEND Image Viewer as a software-only medical device for displaying and measuring echocardiograms. The comparison is made against a predicate device, TomTec-Image Arena (K132544). The clinical testing and "Brief Discussion of Test Results Submitted: Bench Testing" section indicate that the device performed effectively and was found to be substantially equivalent to the predicate where functionality intersected.

However, the document does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., accuracy of measurements, speed of image display) or provide reported numerical performance values for the ASCEND Image Viewer in a table format. Instead, the acceptance is based on demonstrating substantial equivalence in functionality, intended use, technological characteristics, and typical users, along with adherence to design specifications and risk assessment.

The document states:

• "The Graphic User Interface conforms to the ASCEND Image Viewer functional specification."
• "The comparison ASCEND Image Viewer with the predicate devices shows that the ASCEND Image Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices."
• "Verification and validation activities ensure that the design specifications are met, and that ASCEND Image Viewer does not introduce new issues concerning safety and effectiveness."

Given this, I will describe the characteristics compared rather than specific quantitative acceptance criteria and reported performance, as those are not provided in a measurable format.

Study Information

The document describes both Bench Testing and Clinical Testing.

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

   • Test Set Sample Size: Not explicitly stated as a number of cases or images for either bench or clinical testing.
   • Data Provenance:
     • Bench Testing: The test plan covered "all aspects of the functionality, exercising every user interface, all menus and submenus, as well as the measurement tools." No specific data type or origin is given for the bench tests beyond general functional and DICOM compliance verification.
     • Clinical Testing: The testing occurred "in US city-hospital environments." The data used would have been clinical echocardiograms from these environments. The studies appear to be prospective in the sense that the device was evaluated during its development cycle with "clinical testers" in a real-world setting, but it's not a formal prospective clinical trial for efficacy.

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

   • Clinical Testing: The test involved "resident cardiologists, cardiology fellows, and sonographers." The number of these experts is not specified. Their role was to assess the effective performance of the device's intended use and its substantial equivalence to the predicate. The document doesn't explicitly state they established a "ground truth" for specific diagnostic findings, but rather that they evaluated the device's functional performance in a clinical context.
   • Bench Testing: No experts are mentioned for ground truth establishment during bench testing.

3. Adjudication method for the test set:

   • Not specified. The clinical testing describes users evaluating the device's performance, rather than an adjudication process for a diagnostic outcome.

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, a formal MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The ASCEND Image Viewer is described as an image viewing and measurement tool, not an AI-assisted diagnostic algorithm in the sense of providing automated interpretations. The comparison was to a predicate image viewer.

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

   • The device itself is a "software-only medical device intended for use by trained clinicians to display medical images." Its performance is inherently linked to human interaction (displaying images and making measurements). The bench testing would represent a form of standalone functional testing of the algorithm's capabilities (e.g., DICOM compliance, measurement calculations), but not an evaluation of its diagnostic performance in a "standalone" context separate from clinical use. The clinical testing explicitly involved "trained clinicians."

6. The type of ground truth used:

   • For Bench Testing: "Ground truth" was conformity to the ASCEND Image Viewer functional specification and DICOM standard compliance. Risk analysis according to ISO 14971 was also a benchmark.
   • For Clinical Testing: "Ground truth" was implicitly based on the consensus or clinical judgment of the "resident cardiologists, cardiology fellows, and sonographers" during their use of the device, where they determined if it "performed effectively its intended use" and was "substantially equivalent" to the predicate. It was an evaluation of the tool in practice rather than against a predefined diagnostic gold standard (e.g., pathology report) for individual cases.

7. The sample size for the training set:

   • Not applicable/Not provided. The ASCEND Image Viewer is described as an image viewing and measurement system, not a machine learning or AI algorithm that would typically require a "training set" in the context of image analysis. The functionality described (display, measurements, Cine play) suggests a deterministic software rather than one that learns from data.

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

   • Not applicable, as no training set for a machine learning model is mentioned.

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When used as a vertebral body replacement:

The ChoiceSpine Octane-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation to facilitate fusion.

When used as an intervertebral body fusion device:

The Octane-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD), with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Ascendant PC Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant PC Cervical Spacer System is to be used autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Ascendant Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one-disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment.The Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The BLACKHAWK™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The BLACKHAWK™ Cervical Spacer System is to be used autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plated via an open, anterior approach.

The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.

This submission includes 7 subject devices. The device descriptions for each are listed below:

The ChoiceSpine Octane Straight Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The Octane Straight Intervertebral Fusion Device is provided sterile for single use.

The ChoiceSpine Octane Straight PC Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The device is plasma coated with commercial pure titanium (CPTi) per ASTM F1580. The Octane Straight PC Intervertebral Fusion Device is provided sterile for single use.

The BLACKHAWK™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK implant cage per ASTM F2026 with tantalum radiographic markers per ASTM F560, nitinol internal locking components per ASTM F2063 and two internal titanium alloy anchors (Ti-6Al-4V ELI) per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices feature a chamber intended to be filled with autogenous bone and or/allogenic bone graft material. They are used with two internal anchors that lock on deployment and provide additional fixation. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and or/allogenic bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Ascendant® Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material. The Ascendant® Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).

The Ascendant™ PC Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material.

The VEO® Lateral Access & Interbody Fusion System is a multi-component system including instrumentation made of biocompatible materials such as Stainless Steel, Aluminum, and Radel R and implants made of Tantalum (ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).

The ChoiceSpine Octane®-A/T/P Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plain to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The ChoiceSpine Octane Spinal Implant is provided sterile in three (3) styles:

. The Octane-T Spinal Implant, available heights of 7mm to 17mm, in 2mm increments;
. The Octane-P Spinal Implant, available in heights of 7mm to 17mm, in 2mm increments; and
. The Octane-A Spinal Implant, available in heights of 9mm to 19mm, in 2mm increments, and with a convex superior and inferior surface, angled at either 6° or 12° and in Small, Medium, or Large transverse profile.

This FDA 510(k) summary does not contain information regarding the acceptance criteria or a study proving the device meets acceptance criteria. The document is a premarket notification for multiple spinal implant systems seeking clearance for a change in indications for use, specifically to allow the use of autogenous bone and/or allogenic bone graft.

As such, the information typically found in an acceptance criteria and study report for a new medical device (such as those involving performance metrics, clinical trials, sample sizes, expert adjudication, or AI analysis) is not present here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their devices are as safe and effective as existing, legally marketed devices, rather than introducing a novel technology that requires extensive new performance data.

Here's a breakdown of why the requested information is absent and what is covered:

1. A table of acceptance criteria and the reported device performance: Not provided. Substantial equivalence is based on comparing the subject device to predicates, not against specific performance criteria in a new study.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no new test set/clinical study described. The submission relies on the existing safety and effectiveness established for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment is described.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is more common for diagnostic imaging AI devices, not for spinal implants demonstrating substantial equivalence for a change in bone graft material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. There is no AI/algorithm component to train.

9. How the ground truth for the training set was established: Not applicable.

What the document does state about "testing" and "equivalence":

• Non-Clinical Testing: "All subject components have been cleared and therefore do not present a new mechanical worst-case and no non-clinical testing is needed." (Page 13) This indicates that previous testing on the components was deemed sufficient for the initial clearances, and the change in indications for use (specifically related to the type of bone graft) doesn't warrant new mechanical testing.
• Substantial Equivalence Conclusion: The document concludes that the subject devices are substantially equivalent to the predicates in various aspects including "principle of operation, materials, indications for use, biocompatibility, manufacturing and post processing steps, stabilization methods, sterilizations method, anatomic location and approach, product classification and product codes." The only noted difference is the specific wording around bone graft material. (Page 14)

In summary, this document is a 510(k) submission for spinal implants relying on substantial equivalence to existing devices for a minor change in intended use regarding bone graft material. It does not describe new performance studies or acceptance criteria in the manner requested.

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IN ANATOMIC:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator ouff. where it is intended to provide increased mobility and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains.

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.

The Aequalis Reversed Shoulder System is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthroplasty. It is a semi-constrained system composed of a humeral and a glenoid parts.

The Aequalis Ascend Flex Shoulder System consists of:

• In an Anatomic configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
• In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants. The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert. The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere: made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.

This submission corresponds to the addition of 135° & 140° reversed final angle combinations and the Inlay technique, in addition to the existing 145° angle without any change in the implants design.

This FDA 510(k) summary describes a modification to an existing device, the Aequalis™ Ascend™ Flex Shoulder System. The submission adds new reversed final angle combinations (135° & 140°) and an "Inlay" surgical technique to the existing system. The document explicitly states that clinical studies were not required to demonstrate substantial equivalence, relying instead on non-clinical performance testing. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a clinical study is not available in these documents.

Here's a breakdown of the available information based on your request, with explicit notes about what is not provided due to the nature of this 510(k):

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

• No specific acceptance criteria or reported device performance metrics from a clinical study are provided.
• The document states that "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence... Fatigue test in anatomic and reversed configuration." This implies that the acceptance criteria would be related to mechanical properties (e.g., fatigue strength) and met by the test results, but the specific criteria and performance values are not detailed in this summary.

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

• Not applicable. Since clinical studies were not performed, there is no "test set" in the context of human subjects or patient data.
• For the non-clinical bench testing (fatigue testing), the sample size of the devices tested is not specified. The data provenance would be laboratory testing.

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

• Not applicable. No clinical ground truth was established from a patient test set for this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. No clinical ground truth was established from a patient test set, so no adjudication method was employed.

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

• Not applicable. This device is a shoulder prosthesis, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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

• Not applicable. This device is a medical implant, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance in the context of AI.

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

• Not applicable for a clinical ground truth. The "ground truth" for this submission refers to the established safety and effectiveness of the predicate device, which the modified device is compared against. The primary "ground truth" for the new configurations is the demonstration through non-clinical bench testing that they perform equivalently to the predicate.

8. The sample size for the training set

• Not applicable. Since clinical studies were not performed, there is no "training set" in the context of patient data.

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

• Not applicable. As above, no clinical training set was used.

Summary of the study that proves the device meets acceptance criteria (Non-clinical context):

The device (Aequalis™ Ascend™ Flex Shoulder System with new 135° & 140° reversed final angle combinations and Inlay technique) achieves substantial equivalence to its predicate device (Aequalis™ Ascend™ Flex Shoulder System, K122698, K151293) based on non-clinical bench testing.

• Nature of the study: The study involved fatigue testing in both anatomic and reversed configurations.
• Rationale: The submission states, "The new combinations do not raise new issues of safety or effectiveness and are supported by performance testing." It further emphasizes, "The subject device has the same design of implants, the same materials, the same manufacturing principle, the same method of fixation, the same packaging and the same sterilization process as the predicate device."
• Conclusion: The results of the performance testing (specifically, fatigue testing) for the new angle combinations "support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293)."

Essentially, the "study" was a series of mechanical tests to confirm that the new configurations did not compromise the established mechanical integrity and performance of the existing, cleared device. The specific parameters and results of these fatigue tests are not disclosed in this public 510(k) summary, but the FDA's clearance indicates that these tests were sufficient to demonstrate substantial equivalence.

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HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
• O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
• O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
• o A video monitor with optional image recorder - to display the computed image or derived Doppler data

The provided document is a 510(k) premarket notification for the Hitachi HI VISION Ascendus ultrasonic pulsed doppler imaging system. It establishes substantial equivalence to legally marketed predicate devices. The document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial evaluating performance against a predefined metric. Instead, it demonstrates substantial equivalence by comparing the device's features, intended use, and adherence to safety standards with those of predicate devices.

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 specify quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) for the HI VISION Ascendus itself. Instead, the "performance" described is the system's array of features and its substantial equivalence to previously cleared devices.

Here’s a table summarizing the comparison to predicate devices, which serves as the basis for asserting safety and effectiveness:

The acceptance criteria for substantial equivalence are implied through the comparison: the subject device must demonstrate equivalent intended use, technological characteristics, safety, and effectiveness to its predicate devices. The document asserts that "The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis" and "The subject and predicate device(s) have the same gray scale and Doppler capabilities."

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

The document explicitly states: "Clinical testing: None required". This indicates that no clinical "test set" in the sense of patient data was used to prove performance against acceptance criteria for this 510(k) submission. The submission relies on non-clinical testing and substantial equivalence to predicate devices already on the market.

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)

Since no clinical testing was performed for this submission, there is no information provided regarding experts establishing ground truth for a test set.

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

As no clinical testing was performed, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness studies or any AI assistance. The device in question is an ultrasound imaging system, not an AI-based diagnostic tool.

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

This pertains to AI-based algorithms. The document does not describe the device as an AI-based algorithm, but rather an ultrasound imaging system. Therefore, no standalone algorithm performance study was reported.

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

Since no clinical testing data was reported as part of this submission, no type of ground truth for a test set is specified.

8. The sample size for the training set

This is relevant for machine learning models. The document does not indicate the use of such models or discuss a training set.

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

As no training set is discussed, the method for establishing its ground truth is not mentioned.

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SYSTEM INTENDED USE :

The Aequalis Ascend Flex Shoulder System is intended for use as:

A replacement of shoulder joints in primary anatomic or in primary reverse.

A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The Aequalis Ascend Flex System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

IN ANATOMIC : The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-Inflammatory degenerative joint disease (i.e. ostoorthritis and avascular necrosis
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

Notes:

• All components are single use.
• The coated humeral stem is intended for cemented or cementless use
• The non-coated humeral stem is for cemented use only.
• The all-poly glenoid components are intended for cemented use only
• The glenoid sphere implant is anchored to the bone with screws and is for non-cernented fixation.
• Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Indications For Use: Device Name: Aequalis Reversed Shoulder Prosthesis

Cemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for uncemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Note:

• Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. It is a semi-constrained system composed of a humeral and a glenoid parts.

The Aequalis Ascend Flex Shoulder System consists of:

• In an Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr or titanium) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid.
  The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.

• In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter compatible with Aequalis Reversed glenoid implants (consisting of a sphere, a baseplate and screws). The reversed adapter consists of two components: a titanium tray and a UHMWPE reversed insert which includes a titanium locking ring.

This submission corresponds to the addition of new reversed inserts Aequalis Ascend Flex and glenoid spheres Aequalis Reversed II in diameter 33 mm and 39 mm compatible with each other. The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending reversed insert and glenoid spheres are identical or equivalent to the predicate devices.

The provided text describes a 510(k) premarket notification for shoulder prosthesis devices, specifically the "Aequalis™ Ascend™ Flex Shoulder System" and "Aequalis Reversed Shoulder Prosthesis." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth establishment as is common for novel diagnostic or AI-driven devices.

Therefore, the information you've requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for device performance in the context of a new clinical study is not present in this document. This document focuses on demonstrating that the new devices are essentially the same as previously approved devices.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

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

• Not present in the traditional sense. For a 510(k) submission, the "acceptance criteria" are typically met by demonstrating that the new device has "substantially equivalent" technological characteristics and uses as the predicate devices. The "reported device performance" is not from a new clinical study with specific metrics, but rather inferred from the known performance of the predicate devices.
• The document presents tables comparing the "Main features or system characteristics" of the pending devices to their predicates (pages 8-9). This is the closest equivalent to "performance comparison" in this context.

Table of Comparative Characteristics (from document, indicating "performance" by equivalence):

"Acceptance Criteria" for a 510(k) in this context: The device is considered to meet "acceptance criteria" if the FDA determines it is "substantially equivalent" to predicate devices. This is based on:
* Same intended use.
* Similar indications for use.
* Equivalent major technological characteristics (materials, biomechanical features, fixation means, prosthetic dimensions).

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

• Not applicable/Not present. This document does not describe a clinical performance study with a test set of data. The submission is based on engineering design, material specifications, and comparison to existing devices.

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

• Not applicable/Not present. No ground truth establishment from expert review is described for this type of submission.

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

• Not applicable/Not present.

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/Not present. This device is a physical shoulder prosthesis, not an AI-driven diagnostic tool.

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

• Not applicable/Not present. This device is a physical shoulder prosthesis, not a software algorithm.

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

• Not applicable/Not present.

8. The sample size for the training set

• Not applicable/Not present.

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

• Not applicable/Not present.

In summary, the provided document is a 510(k) summary for a medical device (shoulder prosthesis), which focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies involving test sets, expert ground truth, or AI performance metrics.

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