(231 days)
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGXTM Plate acting as the supplemental fixation.
The COALITION AGX™ Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The screws for use with the COALITION AGX™ Plates are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
COALITION AGX™ Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer. with titanium alloy or tantalum markers, as specified in ASTM. F2026, F136. F1295, F1472, and F560.
This document describes the COALITION AGX™ Plate and COALITION AGX™ Spacer, which are devices intended for anterior screw fixation to the cervical spine and as an interbody fusion device, respectively. The document focuses on regulatory clearance and substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, much of the requested information regarding AI device evaluation is not available.
Here's an analysis based on the provided text, highlighting the information that is present and noting what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| COALITION AGX™ Plate: | |
| Static Compression Bend | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Dynamic Compression Bend | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Static Torsion | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| COALITION AGX™ Spacer: | |
| Static Compression | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Dynamic Compression | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Static Compression-Shear | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Dynamic Compression-Shear | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Static Torsion | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Dynamic Torsion | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Subsidence | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| COALITION AGX™ Plate and Spacer (Assembly): | |
| Static Compression | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Compression-Shear | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Torsion | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Expulsion | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Subsidence | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Plate Pull-Off | Conducted; performance deemed acceptable and substantially equivalent to predicates. |
| Design Validation/Cadaver Testing | Conducted; ensured performance is acceptable and substantially equivalent to predicates. |
| Biomechanical Cadaveric Testing | Conducted; demonstrated substantial equivalence to predicate device(s). |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the mechanical tests, but refers to testing "in accordance with the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s (May 3, 2004) and ASTM F1717, F2077 and F2267, as applicable." These standards would define typical numbers of samples.
The "design validation/cadaver testing" and "biomechanical cadaveric testing" imply the use of cadaveric specimens, which would likely be prospective data. The country of origin of this cadaveric data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of device and study described. Mechanical and biomechanical tests typically rely on standardized measurement techniques and established engineering principles, rather than expert interpretation for "ground truth."
4. Adjudication method for the test set
Not applicable. Mechanical and biomechanical tests involve objective measurements rather than expert adjudication.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device's performance is standalone in the sense that it performs its physical function without human-in-the-loop "performance" in the analytical sense.
7. The type of ground truth used
For the mechanical and biomechanical tests, the "ground truth" would be established by:
- Standardized Test Methods and Specifications: Adherence to ASTM standards (F1717, F2077, F2267) and FDA guidance for spinal systems, which define acceptable performance ranges and methodologies.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed predicate devices (SUSTAIN® Radiolucent Medium, VIP® Anterior Cervical Plate System, InterPlateTM C, IN:C2TM Spinal Fixation System, PEEK Prevail® Cervical Interbody Device, PATRIOT® Colonial® ACDF Spacer, COALITION® Spacer). The new device's performance is compared against these benchmarks.
- Cadaveric Data: For the design validation and biomechanical cadaveric testing, the "ground truth" would be the actual physical responses observed in the cadaveric specimens under specific loading conditions, measured against established biomechanical principles and potentially compared to existing literature or predicate device behavior.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device, so there is no "training set" or corresponding ground truth establishment in this context.
§ 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.