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The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical vertebrectomy

The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.

The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the "Hyper-C Anterior Cervical Plate System." This document is a regulatory approval letter and a summary of the device, not a study report demonstrating the device meets specific acceptance criteria through clinical or AI performance metrics.

Therefore, I cannot extract the information required to answer your questions as they pertain to the evaluation of an AI/ML-driven device or a medical imaging study. The document explicitly states:

• Non-Clinical Performance Testing Conclusion: "Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed: Static and dynamic compression testing per ASTM F1717, Static torsion testing per ASTM F1717, Screw strength via ASTM F543, Push-out testing for Locking Screws."

This indicates that the device's performance was evaluated through mechanical and material testing (non-clinical), not studies involving image analysis, AI algorithms, human readers, or clinical outcomes that would generate the kind of data you're asking for.

The questions you've posed (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are highly relevant for the assessment of AI/ML-enabled medical devices, especially those involved in diagnostic imaging or similar analytical tasks. However, the Hyper-C Anterior Cervical Plate System is a physical orthopedic implant, and its approval is based on demonstrating substantial equivalence to existing devices primarily through mechanical integrity and biocompatibility, as outlined in the non-clinical testing section.

In summary, the provided document does not contain the information needed to answer your questions because it describes the regulatory clearance of a physical medical implant, not an AI/ML diagnostic or image analysis system.

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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 indicated for use 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 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), 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 inViZia 10 Anterior Cervical Plate System is a temporary implant system used to facilitate the biological process of spinal fusion. This system consists of plates, screws and instruments and is intended for anterior use in the cervical spine. Surgical instruments are provided to facilitate placement of the implants.

The implants consist of plates of varying length, fixed and variable screws of varying diameter and length. Components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion.

The Zimmer Spine inViZia Anterior Cervical Plate System is a temporary implant system for spinal fusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes in vitro mechanical testing rather than a study involving human subjects or patient data. Therefore, there isn't a "test set" in the traditional sense of patient data. The "samples" would refer to the physical devices or components tested. The document does not specify the exact number of devices or components tested for each mechanical test.

• Data Provenance: Not applicable in the context of in vitro mechanical testing. The testing was conducted according to recognized ASTM standards.

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 mechanical performance in this context is established by adherence to recognized industry standards (ASTM F-1717:2010), which are developed by experts in the field of materials science and medical device testing, but not in the sense of clinicians establishing a "diagnosis" or "outcome" as ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication method" relates to human interpretation of data, which is not relevant for in vitro mechanical testing against a standard. The results of the mechanical tests would be assessed directly against the pass/fail criteria of the ASTM standard.

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 spinal implant, not an AI-powered diagnostic or therapeutic system that would involve human readers or AI assistance.

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

Not applicable. This device is a physical spinal implant.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating device performance is based on engineering standards and mechanical testing specifications (ASTM F-1717:2010). This standard defines the expected mechanical properties and performance characteristics for spinal implant devices.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

The Pyrenees Cervical Plate System, Translational Plate, is a spinal fixation system consisting of cervical screws and plates made from Commercially Pure titanium alloy. It's intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and comparison to predicate devices rather than a clinical study with a test set of human subjects or data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission. The "test set" here refers to the physical devices subjected to mechanical loads.

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

This information is not applicable as the "ground truth" for mechanical testing is established by the specifications of ASTM F1717 and the performance of predicate devices, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the assessment is based on objective mechanical measurements against a standard (ASTM F1717) and direct comparison to predicate device performance. No human adjudication is mentioned or implied for this type of test.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the provided document. This submission focuses on the mechanical and functional equivalence of a spinal fixation device, not a diagnostic or interpretative AI-based system.

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

This is not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717.
• Performance of legally marketed predicate devices: The Pyrenees system's performance was compared directly to that of predicate devices in static torsion, dynamic compression, and static tension.
• Material and design specifications: Adherence to ASTM and ISO standards for materials, and equivalence in design features and sizing to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not a machine learning model that undergoes training on a dataset.

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

This is not applicable for the reasons stated in point 8.

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The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

This document is a 510(k) Summary for a medical device called the "Pyrenees Cervical Plate System, Semi-constrained Screw." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "mechanically tested," implying physical testing, but does not provide details on the number of devices or components tested.
• Data Provenance: The study is described as "mechanical testing" and "comparison to predicate systems and other currently marketed systems." This is laboratory-based testing, not human patient data. Therefore, questions of country of origin or retrospective/prospective are not applicable in this context.

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

This type of study (mechanical testing for substantial equivalence of a spinal implant) does not typically involve human "experts" establishing a clinical ground truth in the way a diagnostic AI might. The "ground truth," in this case, is defined by the objective performance standards of ASTM F1717 and the characteristics of the predicate devices. The "experts" involved would be engineering and regulatory professionals performing and analyzing the mechanical tests and comparing specifications, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication for data interpretation. The "adjudication" is based on meeting the defined mechanical test standards and comparing physical and functional characteristics to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a 510(k) submission for a physical medical device (spinal implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance is not relevant.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Mechanical Performance Standards: Specifically, ASTM F1717 for mechanical testing.
• Predicate Device Specifications: The documented design features, materials, and intended uses of previously cleared, legally marketed spinal plate systems.
• Regulatory Definitions: The FDA's criteria for substantial equivalence under 510(k).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

The provided text describes a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through material and functional comparisons, not on efficacy studies involving AI or complex statistical analysis of diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and expert evaluation is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

This type of information (specific performance metrics for AI, such as sensitivity, specificity, or AUC) is not applicable to this medical device submission. The submission is for a spinal fixation system, not a diagnostic AI tool.

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. This is a submission for a physical medical device (cervical plate system), not an AI diagnostic tool that uses datasets. The "testing" mentioned refers to mechanical and material compliance testing, not clinical studies with patient data in the context of an AI algorithm.

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. There is no "ground truth" in the AI diagnostic sense for a cervical plate system. The ground truth for this device would be established through engineering specifications, material science, and possibly in-vitro mechanical testing.

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

Not applicable. This relates to expert review of AI diagnostic outcomes, which is not relevant for this device.

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 not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

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

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

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

For this type of device, the "ground truth" is primarily engineering and material specifications, and performance against established standards (e.g., ASTM F1717 for mechanical properties). Clinical outcomes would be observed post-market but are not part of this 510(k) summary for substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the AI sense for this device.

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

Not applicable. There is no AI training set.

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable (No test set for clinical performance is described).
• Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.

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

• Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).

4. Adjudication method for the test set

• Not applicable (No adjudication method is mentioned).

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

• No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

• Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.

8. The sample size for the training set

• Not applicable (No training set is mentioned as this device is not an AI/ML product).

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

• Not applicable (No training set or associated ground truth establishment is mentioned).

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