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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 Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (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 and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7). The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes. The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.

The provided text describes a 510(k) summary for the Olsen Medical Anterior Cervical Vertebrae Plate System, which is a medical device. It is important to note that a traditional acceptance criteria table and a study proving device performance as typically understood for an AI/CADe device (e.g., sensitivity, specificity, AUC) are not applicable to this type of device submission.

This 510(k) submission is for a spinal intervertebral body fixation orthosis, which is a physical implant. The "performance data" section clearly states: "Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004." This indicates that the performance evaluation focuses on mechanical properties and biocompatibility, as per established engineering standards for orthopedic implants, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested fields related to AI/CADe device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this document.

However, I can extract the relevant information regarding the "acceptance criteria" (which in this context refers to the standards met for substantial equivalence) and the "study" (referring to the testing conducted).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of patient/case count. For mechanical testing of implants, "sample size" typically refers to the number of test articles (e.g., plates, screws) subjected to mechanical loads. This specific quantity is not detailed in the provided summary, but ASTM F1717 would define the required number of samples.
• Data Provenance: Not applicable in the context of clinical patient data. The testing is laboratory-based mechanical testing.

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

• Not applicable. Ground truth in this context is defined by objective engineering measurements (e.g., fatigue strength, pull-out force) as per ASTM standards, not expert medical consensus.

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

• Not applicable. Adjudication methods are relevant for clinical endpoints or diagnostic accuracy, not mechanical device testing.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Ground Truth: Objective mechanical properties and material specifications as defined by engineering standards (ASTM F1717, ASTM F136, ASTM F1472). These standards outline quantifiable metrics for performance (e.g., stiffness, strength, durability) and material composition.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device.

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

• Not applicable. This is not a machine learning device.

Summary of the study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a bench-top mechanical performance testing study conducted in accordance with ASTM F1717, and raw material verification against ASTM F136 or ASTM F1472. This testing demonstrates that the Olsen Medical Anterior Cervical Vertebrae Plate System possesses comparable mechanical and material properties to the predicate device (Synthes CSKP Variable Angle Cervical Plate Locking System, K031276) and is suitable for its indicated use. The specific details of the individual test results (e.g., ultimate tensile strength, fatigue life cycles) are not provided in this summary but would have been part of the full 510(k) submission to the FDA. The submission states compliance with "FDA Guidance for Spinal System 510(k)s, May 3, 2004," further solidifying the methodology used to establish substantial equivalence.

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