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The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur, distal humerus, proximal ulna, and proximal radius plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, distal humerus, proximal ulna, proximal radius, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The implants are available in various sizes and shapes, and may be contoured or straight, with various lengths to accommodate patient anatomy. The subject ANTHEM® plates are manufactured from titanium alloy per ASTM F136 or stainless steel as specified in ASTM F138 and F139. Plates are also available additively manufactured from titanium alloy powder per ASTM F3001.

I am sorry, but based on the provided FDA clearance letter for the ANTHEM® Fracture System, I cannot extract the information you requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning human-in-the-loop performance, ground truth establishment, or training set details.

This document is a 510(k) clearance letter for a physical medical device (bone fixation system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and mechanical testing of the physical components. It does not appear to involve any AI/software component that would require the kind of performance study details you are asking for (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or different types of ground truth like pathology or outcomes data).

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies. The "Performance Data" section solely refers to mechanical testing according to ASTM F382 and biocompatibility, which are standard for physical implants.

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ExcelsiusXR™, when used in conjunction with ExcelsiusHub™ and/or ExcelsiusGPS®, is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. This system is indicated for the placement of spinal and orthopedic (Sacroiliac, Ulna, and Tibia) bone screws, and interbody fusion devices.

The ExcelsiusXR™ Headset displays 2D stereotactic images and 3D virtual anatomy images, and displays the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display.

ExcelsiusXR™ is a head-mounted navigation device, or headset, that is used in conjunction with ExcelsiusHub, and ExcelsiusGPS if robotic guidance is desired, as an aid for precisely locating anatomical structures in open or percutaneous procedures, and for precisely positioning compatible surgical instruments or implants (screws and interbody devices) during surgery. ExcelsiusXR™ includes hardware and software that enables real-time surgical visualization using radiological patient images (preoperative CT, intraoperative CT, and fluoroscopy), provides tracking and planning capabilities for a series of compatible instruments, and contains hand tracking cameras for manipulation of the head-mounted display by the user. The Headset displays 2D stereotactic images and provides a 3D visual, or virtual image, of the patient anatomy in the lower region. The 2D data and 3D model, along with tracking information, are projected to the surgeon's retina from the transparent near-eye-display Headset, allowing the surgeon to look at the patient and the navigation data at the same time.

The provided FDA 510(k) Clearance Letter for ExcelsiusXR™ describes performance testing in a general manner but does not contain the specific details required to fully address all parts of your request for acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with numerical acceptance criteria and corresponding performance metrics. It generally states that "Verification and validation testing were conducted on ExcelsiusXR™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system."

It mentions the types of tests performed:

• Non-clinical system, software, and instrument verification and validation – demonstrated compliance with user needs and corresponding design inputs
• Surgical simulations conducted on phantom models
• Qualitative and quantitative validation to confirm intended use and accuracy
• Optical bench testing to evaluate the image quality characteristics of the head mounted display
• Electrical Safety and Electromagnetic Compatibility (compliance with standards)
• Software Verification and Validation Testing (compliance with FDA guidance)

Without specific numeric thresholds or results, a detailed table cannot be created. However, generally, for a navigation system like this, key performance metrics and their associated acceptance criteria would typically include:

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

• Sample Size: The document does not specify the sample size used for any of the performance tests (e.g., number of phantom models, number of tests, number of unique cases).
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Phantom studies are typically prospective tests under controlled lab conditions.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience").
• Given that "surgical simulations conducted on phantom models" were performed, the "ground truth" would likely be established by the physical measurements taken from the phantom and the known ideal trajectory/placement, often assessed by engineers and potentially verified by clinically experienced personnel.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. This is generally more relevant for studies involving human interpretation of medical images. For phantom studies, ground truth is typically precisely measured rather than adjudicated in the same way.

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

• The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• There is no information provided on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study would typically be done if the device were primarily an AI-driven diagnostic or interpretative tool, which this navigation system is not. Its primary function is to aid surgical guidance.

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

• The document describes the device as "an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments." It also states "This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display."
• This strongly indicates that the device is intended for human-in-the-loop use, assisting the surgeon.
• While there are "software verification and validation testing" and "surgical simulations on phantom models," these would assess the algorithm's performance within the system context, but the document does not present a standalone, algorithm-only performance metric separate from its intended use as a surgeon's aid. The emphasis is on the system's performance when used by surgeons.

7. Type of Ground Truth Used

• Based on "surgical simulations conducted on phantom models" and "qualitative and quantitative validation," the ground truth was likely established through physical measurements and known anatomical references on the phantom models. This is a form of objective, fabricated ground truth suitable for evaluating a navigation system's precision and accuracy in a controlled environment. It is not expert consensus, pathology, or outcomes data in the traditional sense, though expert surgical opinion would guide the design and interpretation of phantom studies.

8. The Sample Size for the Training Set

• The document does not provide any information regarding the training set size. The FDA 510(k) summary focuses on the "performance testing" (verification and validation), which relates to the test set that demonstrates the device's capabilities post-development. Information about model training (if applicable for any AI components involved in image processing or tracking) is typically not included in such summaries unless it's a primary AI/ML device where the training data directly impacts the cleared function.

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

• Since no information about a training set is provided, there is no information on how its ground truth was established.

In summary, the 510(k) summary provides a high-level overview of the types of performance tests conducted (phantom models, software V&V, electrical safety), but it lacks the detailed quantitative data, sample sizes, and specific methodologies for ground truth establishment that would be found in a full study report. This level of detail is typically contained in the more comprehensive "Basis for Substantial Equivalence" documentation submitted to the FDA, which is not fully replicated in the public 510(k) summary letter.

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ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Subject ExcelsiusGPS® instruments consist of array sleeve adapters and surgical instruments, including drivers, drills, taps, and probes, that may be used manually or navigated with the use of ExcelsiusGPS® or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

The provided document is a 510(k) premarket notification for the ExcelsiusGPS® Instruments, specifically for additional instruments to be used with the existing ExcelsiusGPS® or ExcelsiusHub™ systems for navigating and/or guiding compatible surgical instruments for the placement of spinal and orthopedic bone screws.

There is no mention of an AI/ML component in this document. The device is a set of surgical instruments (array sleeve adapters, drivers, drills, taps, probes) that can be used manually or navigated with the existing ExcelsiusGPS® or ExcelsiusHub™ systems. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI algorithms, test set sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The "Performance Testing" section describes verification tests including "instrument integration and comparison to the predicate devices" to confirm the instruments meet performance requirements. However, specific acceptance criteria and the results of these tests are not detailed in this summary. Biocompatibility was also confirmed by using materials consistent with predicate devices.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the document does not indicate that the ExcelsiusGPS® Instruments or its associated systems utilize AI/ML technology subject to such evaluation.

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The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.

This document pertains to the 510(k) premarket notification for the COSINE™ Spacer, an intervertebral body fusion device. Regulatory information for the device is provided in the document. However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document states that:

• Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.
• The subject implants have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• The subject interbody devices have been found substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

To answer your request, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions mechanical testing was performed in accordance with standards, but it does not list specific acceptance criteria (e.g., minimum compression strength, subsidence limits) or the actual performance values achieved by the COSINE™ Spacer.
2. Sample size used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the "ground truth" for mechanical testing is typically defined by engineering standards, not expert interpretation.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is not applicable as the device is a physical implant, not an AI or imaging system requiring human reader interaction.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ASTM standards and FDA guidance. Specific quantitative values are not given.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA communication confirms the clearance of the COSINE™ Spacer based on its substantial equivalence to predicate devices through mechanical testing. However, it does not detail the specific acceptance criteria, test results, or methodology (beyond mentioning adherence to standards) that would allow for a complete answer to your request.

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The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document is a 510(k) clearance letter for a device called "DuraPro™ Oscillating System," which is a surgical tool.

The document discusses:

• Device Name: DuraPro™ Oscillating System
• Regulation Number: 21 CFR 882.4560 (Stereotaxic Instrument)
• Indications for Use: Drilling, burring, manipulating hard and soft tissue, bone during spinal and orthopedic procedures. It also mentions its use with ExcelsiusGPS® and ExcelsiusHub™ for navigation and guiding surgical instruments for screw and interbody fusion device placement.
• Technological Characteristics: States it has similar characteristics to predicate instruments in design, intended use, material composition, function, and range of sizes.
• Performance Testing: "The navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification."
• Electrical Safety/EMC: Confirmed to meet all standards.

However, none of this information outlines specific acceptance criteria for performance metrics usually associated with AI/ML devices (e.g., sensitivity, specificity, AUC), nor does it describe a study using human readers, ground truth establishment by experts, or training/test set details that would be relevant to an AI/ML performance evaluation. The "Performance Testing" section is very high-level and does not provide the granular details requested in your prompt regarding AI/ML device evaluation.

Therefore, I cannot provide the requested table and details because the source document does not pertain to the evaluation of an AI/ML medical device's performance in the way your prompt describes.

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VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided nonsterile and are reusable. Burs are provided sterile and are single-use.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called "VERZA™ High Speed Drills". This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML-based medical device.

The document mentions that "The navigation and guidance accuracy of VERZA™ High Speed Drills was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Details about standalone (algorithm-only) performance.
• The type of ground truth used (beyond "accuracy verification testing" and meeting "product requirement specification").
• Sample size for the training set.
• How ground truth for the training set was established.

This device appears to be a surgical tool (drills) that may be navigated using existing systems (ExcelsiusGPS® or ExcelsiusHub™), rather than a new AI/ML software device that diagnoses or predicts outcomes based on data. Therefore, the types of studies and information you are requesting are not typically found in a 510(k) for this kind of physical medical device.

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CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

CAPTIVATE® Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE® implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, and F138.

The provided document describes the FDA 510(k) clearance for Globus Medical Inc.'s CAPTIVATE® Compression Screws. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices through performance testing rather than a study involving human subjects or AI algorithms assessing medical images.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI algorithms, sample size for test sets, expert ground truth, MRMC studies, training set details) are not applicable to this type of regulatory submission. The information provided heavily emphasizes the mechanical and material performance of the screws.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

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

The document describes performance testing to demonstrate substantial equivalence, rather than setting specific clinical acceptance criteria in terms of accuracy or sensitivity/specificity for an AI. The performance criteria are mechanical, comparing the new screws to existing predicates.

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

This information is not provided in the summary. For mechanical testing, "sample size" would refer to the number of screws tested for each mechanical property. Data provenance would refer to the lab where the testing was conducted. This is typically found in the detailed test reports submitted to the FDA, not in the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for a bone screw is its physical and mechanical properties, not an assessment made by human experts on an image or clinical case. The ground truth is established through standardized laboratory testing.

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

This is not applicable. As this is mechanical testing, there is no human "adjudication" in the sense of clinical agreement. Lab testing results are objective measurements.

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

This is not applicable. This document describes a medical device (bone screws), not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted or relevant.

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

This is not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" in this context is established via standardized mechanical and material property testing according to ASTM standards (ASTM F543, ASTM F2193) and FDA guidance for orthopedic non-spinal metallic bone screws. This is objective laboratory-measured data, not clinical ground truth.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable.

Summary of Device Performance Study:

The study proving the device meets the (implied) acceptance criteria is a series of mechanical and biocompatibility tests performed according to recognized industry standards (ASTM) and FDA guidance.

• Test Performed: Static torsion, insertion/removal force, axial pullout strength, and cantilever bending strength. Biocompatibility was also assessed by confirming material compliance with standards and prior FDA clearances.
• Purpose: To demonstrate substantial equivalence of the CAPTIVATE® Compression Screws to legally marketed predicate devices (CAPTIVATE® Compression Screws K162825, Zimmer Biomet Cannulated Screw System K140891, Paragon 28 Monster® Screw System K190586).
• Result: The performance data supported the claim of substantial equivalence, indicating the device performs comparably to existing devices in terms of its mechanical properties and material safety.

In essence, this document is a regulatory submission for a physical medical device, and the "study" is a collection of engineering and material science tests, not
a clinical efficacy or AI performance study.

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CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

CORBEL™ Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant.

CORBEL™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws and/or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

CORBEL™ Spacers are manufactured from titanium alloy, as specified in ASTM F136. The mating screws and anchors are manufactured from titanium alloy, per ASTM F136 and F1295, and/or cobalt chrome alloy, per ASTM F1537. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating, per ASTM F1185.

The provided document is a 510(k) summary for the CORBEL™ Spacers, an intervertebral body fusion device. It details the device's purpose, description, indications for use, and the basis for substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The "Performance Data" section briefly mentions mechanical testing and bacterial endotoxin testing, but these relate to the physical and material properties of the implant, not to the performance of a diagnostic or prognostic AI/ML algorithm.

Therefore, I cannot provide the requested information, particularly:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance (algorithm only).
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a traditional medical device (an implant), not an AI/ML-driven device.

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis. and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition. the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE®, or ELLIPSE® system package insert for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (OUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CREO® Preferred Angle Screws are polyaxial screws with a preferred angle in one direction. They are composed of titanium alloy or cobalt chrome molybdenum alloy as specified in ASTM F136 and F1537, and are available with optional hydroxyapatite (HA) coating per ASTM F1185.

Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill that are intended to be used with the Medtronic StealthStation® System.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

The provided document is a 510(k) summary for the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and mechanical testing. The document does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML-based medical devices.

Here's why and what can be extracted:

Why the requested information is not available in the provided text:

The request asks for details typically found in studies for AI/ML-based medical devices, such as:

• Acceptance Criteria/Reported Device Performance (Table): This would typically include metrics like sensitivity, specificity, AUC, or accuracy for a diagnostic/predictive AI. The document discusses mechanical testing criteria for spinal implants and instruments, not performance metrics for an AI system.
• Sample size and data provenance for test set: Relevant for AI algorithm performance evaluation.
• Number of experts and qualifications for ground truth: Essential for establishing ground truth in AI studies.
• Adjudication method: How disagreements among experts are resolved for ground truth.
• MRMC comparative effectiveness study: Measures the improvement in human reader performance with AI assistance.
• Standalone performance: Performance of the algorithm without human intervention.
• Type of ground truth: Pathology, expert consensus, outcomes data.
• Training set sample size and ground truth establishment: Details about the data used to train an AI algorithm.

The devices described (CREO® Stabilization System, various Navigation Instruments, and ExcelsiusGPS®) are spinal implants and surgical navigation systems, which are hardware devices. The text mentions "precisely locating anatomical structures" and "spatial positioning and orientation," which are functions of a navigation system, but it doesn't describe the use of an AI algorithm for diagnostic or predictive purposes that would necessitate the above detailed performance metrics. The navigation systems are designed for use with existing systems like Medtronic StealthStation® and ExcelsiusGPS® robotic arm.

What can be extracted or inferred:

While a table of acceptance criteria for an AI study cannot be created, here's what the document implies about how substantial equivalence was demonstrated:

Addressing the specific questions based on the provided text:

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

   • Acceptance Criteria: Mechanical testing (static and dynamic compression, static torsion) per ASTM F1717 and FDA Guidance for Spinal System 510(k)s. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
   • Reported Device Performance: The document states that the testing was conducted "to demonstrate substantial equivalence" and that the "information provided within this premarket notification supports substantial equivalence to the predicate devices." Specific numerical performance data is not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission which relies on mechanical testing rather than clinical data or AI algorithm performance data. The "test set" here refers to the physical devices and materials tested.

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. Ground truth as understood in AI/ML is not established for mechanical testing of physical medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not done as this is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm. The ExcelsiusGPS® is a navigation system that aids surgeons, but its function as described does not involve an AI algorithm that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical testing would be the engineering specifications and established standards (ASTM F1717, ANSI/AAMI ST-72:2011).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided FDA 510(k) document is for a traditional medical device (spinal implants and surgical navigation instruments) and not an AI/ML-based device. Therefore, the bulk of the questions asking about AI-specific validation metrics cannot be answered from this text.

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The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text describes a medical device's 510(k) submission, specifically the ASSURE® Anterior Cervical Plate System, and its modification, the ASSURE®-T Translational Anterior Cervical Plates. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from this document, as it pertains to a clinical trial design and execution, which is not present here. The document details the device's indications for use, its classification, and notes that mechanical testing was performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not specify quantitative clinical acceptance criteria (e.g., success rates, complication rates) or reported device performance in a clinical setting. It mentions mechanical testing:

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

The document does not describe a clinical test set or its sample size. The testing mentioned is mechanical.

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

Not applicable as no clinical test set or ground truth determination by experts is described.

4. Adjudication method for the test set

Not applicable as no clinical test set or adjudication method is described.

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 physical medical implant (anterior cervical plate), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

Not applicable. This device is a physical medical implant, not an algorithm.

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

For the mechanical testing performed, the "ground truth" would be the engineering specifications and performance benchmarks established by ASTM F1717 and the FDA guidance for spinal systems. There is no clinical ground truth discussed in this document.

8. The sample size for the training set

Not applicable. The concept of "training set" is relevant for machine learning algorithms, which this device is not. For a physical device, development and design are based on engineering principles and regulatory requirements, not a data training set.

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

Not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing would be established through engineering design specifications, material properties, and manufacturing quality control, all conforming to established standards and regulations.

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