(113 days)
When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.
When used as an intervertebral body fusion device, the X-spine Calix PC System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks non-operative treatment prior to treatment with the Calix intervertebral body fusion device.
For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The X-spine Calix PC System is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device is made from polyetheretherketone (Invibio PEEK-Optima LT1). The devices contain radiographic markers made from tantalum per ASTM F560. The technological difference between this system and the current Calix Spinal Implant System is the addition of a commercially pure titanium (CP Ti) coating per ASTM F1580 applied to the superior and inferior surfaces of each device.
The provided text describes a medical device, the Calix™ PC Spinal Implant System, and non-clinical testing performed to establish its substantial equivalence to predicate devices. However, the document does not contain information regarding a study involving acceptance criteria, device performance, or human-in-the-loop performance using AI.
Therefore, I cannot fulfill the request to provide information based on the provided input for acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document focuses on non-clinical biomechanical and coating characterization testing to demonstrate substantial equivalence to previously approved predicate devices, which is a common pathway for 510(k) clearances. It is not an efficacy or diagnostic performance study in the context of AI or human interpretation.
Summary of what the document does provide regarding testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present acceptance criteria in a quantitative table with specific performance metrics and their corresponding values. It lists the types of tests conducted:
| Test Type | Description |
|---|---|
| Biomechanical Testing (Full Device Constructs) | |
| ASTM F2077 – Test Methods for Intervertebral Body Fusion Devices | - Static and dynamic axial compression |
| - Static torsion | |
| Expulsion testing (FDA Guidance) | - As suggested by FDA Guidance for Intervertebral Body Fusion Devices |
| Coating Characterization (Test Coupons) | |
| ASTM F1044 - Standard Test Method for Shear Testing | - Static and dynamic shear |
| ASTM F1147 - Standard Test Method for Tension Testing | - Static tension |
| Abrasion testing (FDA Guidance) | - As suggested by FDA Guidance for Modified Metallic Surfaces Apposing Bone or Bone Cement |
The "reported device performance" is not quantified in the document beyond stating that "biomechanical testing results indicate that the Calix PC Spinal Implant System is substantially equivalent to predicate device performance and is as effective, and performs at least as safely and effectively as the cited predicate devices." Specific numerical results or pass/fail criteria are not detailed.
Further information regarding your specific questions, as it relates to the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. The tests are non-clinical (biomechanical and material characterization) performed on device constructs and test coupons, not on human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical engineering tests is based on established ASTM standards and FDA guidance, not expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 document describes a medical device for spinal implant, not an AI-powered diagnostic or interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the parameters and acceptance criteria set forth in the ASTM standards and FDA guidance documents cited for each test (e.g., specific load endurance, displacement limits, or bond strength thresholds).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.