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The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

· degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
  · trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

The VELOX Anterior Cervical Plate is a medical device and is not subject to acceptance criteria in the same way an AI/ML diagnostic or prognostic device would be. Instead, its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Claim)

The "acceptance criteria" for a medical device like this are primarily demonstrating that its design, materials, and mechanical performance are equivalent or superior to predicate devices. The performance is reported in comparison to these predicates.

Explanation: In the context of a 510(k) submission for a traditional medical device, "acceptance criteria" are implied by the chosen predicate device's established safety and effectiveness. The manufacturer must demonstrate that the new device meets or exceeds the performance of these predicates.

Study Details (Non-Clinical)

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

   • Test Set Sample Size: Not explicitly stated in terms of the number of specific test articles. However, the study references "testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests" according to ASTM F1717-12. The ASTM standard itself would specify the number of samples required for each test.
   • Data Provenance: The testing was conducted by the manufacturer, SpineCraft, LLC, likely in a laboratory setting. The country of origin for the testing is implied to be within the USA, given the submitter's location in Westmont, IL, USA. This is a prospective non-clinical study designed for regulatory submission.

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

   • Not Applicable. This is a non-clinical mechanical performance study, not a clinical study involving human patients or expert interpretation of data. "Ground truth" in this context refers to the measured physical properties and performance characteristics determined by the mechanical tests, not expert consensus on medical conditions.

3. Adjudication method for the test set:

   • Not Applicable. As a non-clinical mechanical test, there is no expert adjudication process. The results are quantitative measurements against established engineering standards.

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:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing for regulatory approval.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical Test Results against ASTM Standards. The "ground truth" for this device's performance is derived from the objective measurements obtained through standardized mechanical testing (ASTM F1717-12). These results are then compared to the known performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. The design of the device is based on engineering principles and potentially prior experience with similar devices, but not a data-driven training set in the AI sense.

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

   • Not Applicable. No training set was used.

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The CoreLink ANODYNE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scollosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

The Anodyne™ Anterior Cervical Plate System is comprised of an assortment of cervical plates and screws that act to stabilize the spine during the intervertebral fusion process. The cervical plate has a rotatable anti-backout "lock" for each screw position to prevent back-out of the screw.

The plate is available in single and double plate configurations with multiple lengths ranging from 13 mm – 22 mm (1 level) and 26 mm – 40 mm (2 level) for the single plates. The double plates include 1 level (13 mm - 30 mm), 2 level (26 mm - 46 mm), 3 level (46 mm - 70 mm), and 4 level (60 mm -100 mm). The screws are available in various lengths from 12 mm - 20 mm, with major thread diameter options of 4.6 mm or 5.2 mm.

The Anodyne™ Anterior Cervical Plate System is a medical device intended for anterior fixation of the cervical spine. The device's acceptance criteria and the study proving it meets these criteria are outlined in the 510(k) summary.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Anodyne™ Anterior Cervical Plate System are based on the mechanical performance of the device, specifically its ability to withstand static and dynamic loads and torsion, as compared to predicate devices. The study demonstrates that the device performs equivalently to previously cleared devices.

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

• Sample Size: Not explicitly stated as a number of devices tested. Instead, the testing refers to "the ANODYNE™ Anterior Cervical Plate System" as the subject of the tests, implying a representative sample of its components (plates and screws across various sizes and configurations).
• Data Provenance: The tests are described as "Non-Clinical Test Summary" and were likely conducted in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (mechanical) tests rather than clinical studies on human subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. This device underwent non-clinical mechanical testing, not clinical studies involving human patients or expert interpretation of medical images. Therefore, no medical experts were involved in establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As described above, there was no clinical test set requiring adjudication. The assessment was based on objective mechanical testing results against industry standards.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study:

No. Since no clinical studies were performed, there was no standalone algorithm performance study (the device is a physical medical implant, not an AI or digital diagnostic tool). The "standalone performance" in this context refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during real-world use, which was indeed evaluated through the non-clinical tests.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by recognized industry standards (ASTM F1717) for mechanical testing of spinal implants. The performance of the Anodyne™ system was compared against the established mechanical properties and performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. The device is a physical medical implant, not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical implant.

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