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The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.

The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.

The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.

Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.

The provided document is a 510(k) summary for the Axis Chena Cervical PEEK Spacer System and focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing rather than clinical studies or reader studies. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and clinical efficacy will not be directly applicable or available in this specific document.

However, I can extract and infer information relevant to its acceptance criteria and the engineering performance testing showing it meets those criteria.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to predicate devices through mechanical performance testing according to established ASTM standards. The reported performance is that the device met these standards.

Study Details (as inferable from the document)

Because this is a 510(k) submission primarily relying on mechanical testing for substantial equivalence, clinical study details (like MRMC, human-in-the-loop, etc.) are not part of this submission and are therefore not available in the provided text.

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

   • Sample Size: Not explicitly stated for each test, but standard engineering protocols for ASTM testing would involve a sufficient number of samples (e.g., typically N=5-6 per test condition).
   • Data Provenance: The testing was performed by the manufacturer, Axis Orthopaedics, or a contracted lab. The document does not specify the country of origin for the testing or whether it was retrospective or prospective in a clinical sense. It's prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

   • Not Applicable. For mechanical performance testing of an implant, "ground truth" is established by the well-defined parameters and methods outlined in the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would. The device's performance is objectively measured against the standard's specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data. For mechanical testing, the results are quantitative and objective measurements against established criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is a type of clinical study involving human readers evaluating images or data. This 510(k) is based on mechanical testing, not a clinical MRMC study.

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

   • Not Applicable. This device is a passive mechanical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

6. The Type of Ground Truth Used:

   • Mechanical Test Standards and Predicate Performance: The "ground truth" for this submission is adherence to recognized industry standards (ASTM F2077-14 and F2267-11) for intervertebral body fusion devices, and demonstrating that the device performs equivalently to its legally marketed predicate devices under these conditions.

7. The Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical implant; therefore, no training set was used.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. See point 7.

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The AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The AXIS 5.5 LUMBAR PEDICLE SCEW System consists of a variety of shapes and sizes of rods, screws, Crosslink plates, which can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.

The AXIS 5.5 LUMBAR PEDICLE SCEW System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2.

This document is a 510(k) premarket notification for the AXIS 5.5 Lumbar Pedicle Screw System. It describes the device, its intended use, and provides evidence of substantial equivalence to predicate devices. However, it does not contain information about an AI/ML-driven medical device or studies related to its acceptance criteria and performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-driven device based on the provided text. The document pertains to a mechanical orthopedic implant.

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The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.

This document is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. The information provided is not about an AI/ML powered device, but a physical medical implant. Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML validation studies, are not applicable here.

However, I can extract the information relevant to the performance assessment of this physical device as presented in the document itself.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are related to its mechanical performance, demonstrating equivalence to a predicate device based on specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

A performance assessment was conducted through mechanical testing.

• Study Type: Mechanical performance testing.
• Standards Used: ASTM F1717-15 and ASTM F543-13e1.
• Objective: To demonstrate that the Axis Anterior Cervical Plate System is equivalent to a predicate device with respect to the testing recommended in these ASTM standards.

The following sections are not applicable as this is not an AI/ML device:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to physical testing of the device components, not data analysis.
• 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 a physical device is established through engineering and material science specifications and testing.
• 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.
• 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): The ground truth here is the established mechanical performance standards as outlined in ASTM F1717-15 and ASTM F543-13e1, and the performance of the predicate devices.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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