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The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Deqenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The Life Spine Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the components with components from any other system or manufacturer. The Cervical Plating System components should never be reused under any circumstances.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Plating System, specifically noting what information is available and what is not present in the given document.

It's important to understand that the provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report for AI/software devices. Therefore, many of your requested items, particularly those related to AI algorithm performance, human expert evaluation, and training data specifics, will not be found as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For mechanical testing of physical implants, "sample size" would refer to the number of implants tested per configuration. The document does not specify these details or data provenance beyond stating that testing was done according to ASTM F1717.

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

This information is not applicable/provided. This device is a physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical properties and mechanical performance determined through standardized experimental testing, not human expert consensus on medical images.

4. Adjudication method for the test set

This information is not applicable/provided. No adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis.

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

This information is not applicable/provided. This document concerns a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be part of this submission.

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

This information is not applicable/provided. This document concerns a physical medical implant, not an algorithm, so standalone algorithm performance is irrelevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized mechanical testing according to ASTM F1717. This provides quantitative data on the device's physical properties and performance under various loads, which is compared against established engineering standards and the performance of predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device as it is a physical implant, not a machine learning model.

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

This information is not applicable/provided. As there is no training set mentioned, the method of establishing its ground truth is also not relevant.

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The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

3° Anterior Cervical Plating System - The 3° Anterior Cervical Plating System is a temporary titanium alloy (Ti6Al-4V ELI, per ASTM F136) system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assists in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Reliant Anterior Cervical Plating System - The Reliant Anterior Cervical Plating System is temporary, titanium alloy system comprised of a variety of single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assist in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Unity Lumbosacral Fixation System - The Unity Lumbosacral Fixation System consists of the Unity 51 Lumbosacral Fixation Plate for lumbosacral fixation and the Unity LX Lumbar Fixation Plate for anterior or anterolateral fixation above L5-S1.

The Unity 51 Lumbosacral Fixation Plate is designed specifically for supplemental fixation of anterior lumbar fusions at the L5-S1 level. The plate is contoured to the unique anatomy of the L5-S1 segment. The Unity 51 Plate is available in six heights: 17mm to 25mm in 2mm increments and one additional plate at 28mm.

The Unity LX Lumbar Fixation Plate is designed for lumbar levels above L5-S1 in 2 configurations - anterior and anterolateral. In the anterolateral configuration, the plate allows surgeons lateral-to-medial placement of the self-neuro foramen. The Unity LX Plate is available in six heights: 19mm to 25mm in 2mm increments and two additional plates at 28mm and 31mm.

Hallmark Anterior Plate System – The Hallmark Anterior Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V-ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

NewBridge Laminoplasty Fixation System – The NewBridge Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium alloy components. The specially shaped plates, made of commercially pure (CP) titanium conforming to ASTM F67, are designed to fit the anatomy of a dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.

The screws, made of titanium alloy (Ti-6AI-4V ELI, per ASTM F136) are available in a variety of lengths and diameters in order to meet individual anatomical requirements.

The NewBridge Laminoplasty Fixation System must always be used with an allograft.

CETRA Anterior Cervical Plate System – The CETRA Anterior Cervical Plate System is comprised of an assortment of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.

The provided document describes the addition of MR Conditional labeling to several spinal fixation systems and details the non-clinical tests performed to support this claim. It does not contain information about a study proving the device meets clinical acceptance criteria or comparative effectiveness with human readers. The information below is based only on the provided text, focusing on the MR Conditional aspect.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria for MR Conditional labeling:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Labeling)

Note: The document states that the devices "met requirements necessary for MRI Conditional labeling", implying that the performance in each test fell within the acceptable limits defined by the respective ASTM standards for MR Conditional compatibility. Specific quantitative values for displacement force, torque, artifact size, or temperature rise are not provided in this summary.

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

• Sample Size: Not explicitly stated for each test. The testing was conducted on the "subject devices," referring to the various components of the 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, and CETRA Anterior Cervical Plate System. Typically, MR safety testing involves multiple samples of the actual devices or representative worst-case configurations.
• Data Provenance: The tests conducted are non-clinical, controlled laboratory experiments. No human patient data (retrospective or prospective) or country of origin for such data is relevant for these specific MR safety tests.

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

• Not applicable. The ground truth for MR Conditional testing is established by recognized international standards (ASTM). The tests are performed by qualified testing laboratories or personnel following these standardized protocols, not by clinical experts establishing a ground truth based on patient cases.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study endpoints, especially when expert consensus is needed to establish ground truth or resolve discrepancies in interpretations of medical images or patient outcomes. For non-clinical, standardized engineering tests, the results are objectively measured against the criteria defined in the ASTM standards.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for the addition of MR Conditional labeling, which relies on non-clinical engineering tests to ensure device safety in the MR environment. It does not involve AI or human-in-the-loop performance evaluation.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone study in the context of an algorithm or AI performance was not done. The tests performed are engineering-based evaluations of physical device properties in an MR environment.

7. The Type of Ground Truth Used

• The ground truth used for this determination is explicit, objective criteria defined by internationally recognized consensus standards for MR safety: ASTM F2052-15, ASTM F2213-17, ASTM F2119-07, ASTM F2182-19E2, and ASTM F2503. These standards specify the methods and acceptable limits for magnetically induced displacement, torque, image artifacts, and radiofrequency induced heating.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device. Therefore, there is no "training set" in the conventional sense.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is not relevant.

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The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1). The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion. The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle. All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) summary for the Mediant™ Anterior Cervical Plating System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not describe the acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the way you've outlined for diagnostic AI/medical imaging systems.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical orthopedic implant (spinal plating system), not a diagnostic device or software (like an AI algorithm for medical imaging). The regulatory pathway and substantiation methods differ significantly.
• Performance Metrics: The performance data provided is mechanical testing (Static Compression Bending, Static Torsional Bending, Dynamic Compression Bending) to assess the strength and safety of the implant, not diagnostic accuracy metrics (sensitivity, specificity, AUC) or human reader performance.
• Clinical Study Absence: There is no mention of a human clinical study in the context you described (e.g., test set, ground truth, experts, MRMC studies) because it's not relevant to demonstrating substantial equivalence for this type of device based on mechanical properties.

Therefore, I cannot populate the table or answer the specific questions because the provided text pertains to a different type of medical device and a different kind of performance evaluation.

If you have a document related to a diagnostic AI or medical imaging device, I would be happy to analyze it according to your requested format.

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The Spider® Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: degenerative disc disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal tumors, deformity (e.g., kyphosis, lordosis, scoliosis), pseudarthrosis, and/or failed previous fusion.

The Spider® Cervical Plating System consists of titanium alloy (Ti 6Al 4V ELI) anterior cervical plates and bone screws, allowing for fixation between one and four intervertebral segments. The plates attach to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The titanium alloy conforms with ASTM F136, Standard Specification Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surgical Implant Applications (UNS R56401).

The system does not contain software/firmware.

The provided text is a 510(k) summary for the Spider® Cervical Plating System. This document describes a medical device, specifically an implant for spinal fixation, and compares it to previously cleared predicate devices to demonstrate substantial equivalence.

The content focuses on mechanical and material properties of the device (e.g., titanium alloy, screw lengths, pullout testing) to support its safety and effectiveness for its intended surgical purpose. It does not contain information related to AI/ML or software-based medical devices, nor does it describe clinical studies for such devices.

Therefore, I cannot extract the information requested about acceptance criteria and a study proving device performance in the context of AI/ML devices, including:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results for a physical implant, not performance metrics like sensitivity, specificity, or AUC for an AI/ML algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no test set of image data or patient data referenced in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would involve expert annotations or clinical outcomes, which are not described here.
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: Not applicable, as this is not an AI-assisted diagnostic device.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. The "ground truth" for this device's performance would be engineering specifications and biomechanical test results.
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

The document states: "The system does not contain software/firmware." This explicitly confirms that the device described is a purely mechanical implant and not a software/AI/ML device.

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The Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Trifore™ Cervical Plating System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Trifore™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Trifore™ Cervical Plating System implant components are made from titanium alloy such as described by ASTM F136.

The provided text describes a medical device, the Trifore™ Cervical Plating System, and its substantial equivalence to predicate devices, but it does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a spinal fixation device, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "performance data" section only mentions mechanical testing to ASTM F1717-14 standards, which are general engineering standards for spinal implant constructs, not specific clinical or diagnostic performance criteria.

Therefore, I cannot extract the requested information from the provided text.

The information I can confirm from the text is:

• Device Name: Trifore™ Cervical Plating System
• Regulatory Class: Class II (Product Code: KWO, although later listed as KWQ in the 510(k) summary)
• Indications for Use: Anterior cervical fixation (C2-T1) for degenerative disc disease (DDD), spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.
• Materials: Titanium alloy such as described by ASTM F136.
• Predicate Devices: Transom™ Cervical Plating System (K142060), Tempus™ Cervical Plating System (K120515, K131374), CSLP System (K030866).
• Performance Data Type: Non-clinical mechanical testing (Static axial compression bending, Static torsion, Dynamic axial compression bending fatigue per ASTM F1717-14).
• Conclusion: The device is substantially equivalent to predicate devices based on overall technology characteristics and mechanical performance data.

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The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis

The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm to 96mm for the four-level plates. A locking screw is utilized as an anti-backout mechanism to lock the bone screws in place. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants (bone screws and cervical plates) are provided as single-use, sterile devices manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

This document is a 510(k) summary for the Stryker Corporation's ACP 1™ Anterior Cervical Plating System. The information provided heavily emphasizes the substantial equivalence of the new device to previously cleared predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, the response below is structured to reflect the information available in the provided text, primarily focusing on the comparison to predicate devices and the mechanical testing performed, as a direct AI-style acceptance criteria and study section isn't explicitly present.

Acceptance Criteria and Study for the ACP 1™ Anterior Cervical Plating System

The ACP 1™ Anterior Cervical Plating System's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to existing predicate devices through risk analysis and mechanical testing, rather than a clinical performance study with specific diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The provided document describes a "510(k) Summary" process which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the assessment performed to support this claim.

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

• Sample Size for Mechanical Testing: The document does not specify the exact number of test samples (e.g., number of plates or constructs) used for the static and dynamic mechanical tests per ASTM F1717-14.
• Data Provenance: The data provenance for the mechanical testing is not explicitly stated (e.g., country of origin, specific lab). It is implicitly prospective testing conducted by the manufacturer to support the 510(k) submission. There is no patient data involved in this assessment as it's a mechanical device.

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

This type of information is not applicable for the ACP 1™ Anterior Cervical Plating System as described in this document. The assessment is for a physical implantable medical device and relies on engineering principles and mechanical testing standards (ASTM F1717-14), not on expert clinical interpretation of data or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This is not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication, as the study involves mechanical performance testing of a physical device against predefined engineering standards.

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

An MRMC study is not applicable here. This study type is typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance. The ACP 1™ System is an implantable surgical device, not a diagnostic tool.

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

This concept is not applicable to the ACP 1™ Anterior Cervical Plating System. The device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing and comparison to predicate devices, not as a standalone AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the ACP 1™ System is based on established engineering standards and requirements for spinal intervertebral body fixation orthoses, specifically the ASTM F1717-14 standard for static and dynamic compression and torsion testing. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices, meaning the new device performs as safely and effectively as the existing ones.

8. Sample Size for the Training Set:

This is not applicable. The ACP 1™ System is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable, as there is no "training set."

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The Atrax Anterior Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or Failed previous fusion.

The Atrax Anterior Cervical Plating System consists of screws and plates offered in various sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The Atrax System allows for anterior fixation of between one and four intervertebral segments between C2 and C7.

The Atrax Anterior Cervical Plating System implants are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided sterile (gamma irradiation). All implants are intended for single use only and should not be reused under any circumstances.

The system includes a series of manual surgical instruments intended to assist the insertion and placement of the implants. The instrumentation will be packaged and sold clean but non-sterilization cycle is recommended in the Atrax System draft Instructions for Use.

The provided text is a 510(k) summary for the Atrax™ Anterior Cervical Plating System and does not contain information about an AI/ML powered device or software.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI/ML device. The document describes a medical device (spinal intervertebral body fixation orthosis) and its substantial equivalence to predicate devices based on material biocompatibility and mechanical performance tests. It does not mention any AI or machine learning components.

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When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods: The hooks and rods are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors: The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors: The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links). These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only. The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.

This document is a 510(k) Pre-Market Notification from Zimmer Spine, Inc. to the FDA. The purpose of this submission is not to introduce a new device or a new algorithm, but rather to update the product-specific package inserts (IFU) with MRI Conditional language only for existing pedicle screw-rod systems. Therefore, the traditional acceptance criteria and study design for a new medical device would not apply in the same way.

The "study" conducted here is a series of performance tests to demonstrate the MRI compatibility of the existing devices.

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

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

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

• Sample Size: The document does not specify the exact number of individual screws and rods tested from each system. It states "Magnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately." This implies representative samples of the various components were used.
• Data Provenance: The testing was likely conducted in a controlled laboratory environment by Zimmer Spine or a contracted test facility in the USA (given the submitter's location in Minneapolis, Minnesota, USA, and submission to the FDA). The tests themselves are prospective in nature, as they involve actively conducting measurements on physical devices.

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 to this submission. The "ground truth" in this context is established by adherence to recognized ASTM standards for MRI compatibility testing, which are objective, quantifiable measurements. There is no subjective expert interpretation of output data in the same way there would be for image analysis or clinical diagnosis.

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

Not applicable. This type of testing involves objective physical measurements according to standardized protocols, not subjective expert review or adjudication.

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

Not applicable. This submission is for MRI compatibility of hardware (pedicle screw-rod systems), not an AI device or a diagnostic tool that involves human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this performance testing is defined by the objective pass/fail criteria established within the referenced ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213). These standards provide quantitative thresholds for magnetic field interactions (displacement, torque, heating) and qualitative assessments of image artifact.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable.

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The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.

The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.

The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.

The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths. The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred. The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone. The subject implants are provided non-sterile and must be sterilized by the enduser/healthcare facility prior to use. The subject implants are designed for single-use only. The system's instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.

This document describes a 510(k) premarket notification for several Zimmer Spine Anterior Cervical and Lumbar Plate Systems. The purpose of this submission is not to introduce a new device or change the design/performance of existing devices, but solely to update the product-specific package inserts (Instructions for Use - IFU) with MRI Conditional language. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to MRI compatibility, rather than the primary biomechanical function of the implants.

Here's an analysis based on the provided text, addressing your points:

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

The acceptance criteria here are implicitly meeting the standards for MRI compatibility for passive implants. The reported performance is that the devices were tested according to these standards and found to be MRI Conditional.

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

• Sample Size: The document does not specify the exact number of devices (plates and screws) tested for each MRI compatibility standard. It refers to "Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested." This suggests representative samples were used for each type of implant.
• Data Provenance: Not explicitly stated, but typically, such testing is conducted in controlled laboratory environments in the country of manufacturing or a certified testing facility. The context is a US FDA submission, so the testing would have been to US-recognized standards. The testing is prospective in nature, as it's a specific set of tests performed on the physical devices for this submission.

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 question is not applicable to this submission. The "ground truth" here is the physical interaction of the medical devices with magnetic fields, measured by engineering and physics principles, not by expert interpretation of clinical data or images. The standards (ASTM) themselves define the methodology and acceptable limits, which are established by relevant technical experts in the field of MRI safety and medical devices.

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

Not applicable. This is not a clinical study involving human assessment of outcomes or images. The results of the MRI compatibility tests are objective measurements against defined ASTM standards.

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 submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

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

Not applicable. This submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

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

The "ground truth" used for this submission is based on scientific and engineering principles outlined in the referenced ASTM standards for MRI compatibility testing. These standards define the acceptable limits for magnetically induced displacement, torque, heating, and image artifact generation for passive medical implants.

8. The sample size for the training set

Not applicable. This submission is for MRI conditional labeling updates for existing devices, not for a device developed using a training/test set methodology (e.g., AI/ML).

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

Not applicable. See point 8.

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The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:

• Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Spondylolisthesis, .
• Trauma (i.e. fracture or dislocation), .
• Spinal Stenosis.
• Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
• . Tumors.
• . Pseudoarthrosis as a result of failed spine surgery,
• Failed previous fusions, ●
• Symptomatic cervical spondylosis, ●
• Instability following surgery for the above indications. .
  Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
  Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.

Here's a summary of the acceptance criteria and study findings based on the provided document:

This 510(k) submission (K121801) is for minor changes to the Quintex Cervical Plating System and seeks to demonstrate substantial equivalence to a previously cleared device (K100243). Therefore, the "acceptance criteria" are generally that the modified device performs similarly to or better than the predicate device in specified biomechanical tests.

Acceptance Criteria and Reported Device Performance

• Off-axis screw insertion
• Redirection of screw trajectory
• Intentional pry-out | The results of these tests showed that the subject device meets or exceeds the performance of the predicate device, and is therefore found to be substantially equivalent. |

Regarding the study proving the device meets acceptance criteria:

The study referenced is a non-clinical biomechanical testing program.

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

   • The document does not specify the exact sample size (e.g., number of screws, plates, or constructs tested) for each biomechanical test.
   • The data provenance is not explicitly stated beyond being "non-clinical testing" conducted as recommended by FDA Guidance for Spinal System 510(k)s. It's safe to assume this testing was conducted in a laboratory setting, likely in the US or a country with similar regulatory standards, but the specific location is not provided. The data is prospective in the sense that the tests were specifically designed and executed for this submission.

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

   • This question is not applicable in this context. Biomechanical testing of a medical device (like a spinal plating system) does not typically involve human experts establishing a "ground truth" for the test set in the way that image interpretation or diagnostic performance studies do. The "ground truth" here is the physical performance under controlled mechanical conditions, measured against engineering standards and comparison to a predicate device.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where human interpretation or clinical outcomes need to be resolved. For biomechanical testing, the "adjudication" is based on objective, quantifiable measurements and engineering analysis.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices, not for a spinal implant system undergoing biomechanical testing for substantial equivalence.

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

   • This question is not applicable. This device is a passive mechanical implant, not an algorithm or a device with AI components.

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

   • The "ground truth" for this study is the objective, quantitative performance data obtained from standardized biomechanical tests (e.g., force, displacement, failure load, rigidity, etc.), as measured and analyzed by engineers and compared against the performance characteristics of the predicate device and relevant engineering standards.

7. The sample size for the training set:

   • This question is not applicable. There is no "training set" in the context of biomechanical testing for a mechanical implant. Training sets are used in machine learning for AI algorithms.

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

   • This question is not applicable as there is no training set for this type of device and study.

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