(71 days)
The COALITION® Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) 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 nonoperative treatment. The COALITION® Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.
The COALITION® Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The COALITION® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
The provided text describes a 510(k) summary for the COALITION® Spacer, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance against expert ground truth.
Therefore, many of the requested categories for AI/clinical performance studies cannot be addressed from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (How determined to be "met") |
|---|---|
| Static compression | Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems. |
| Dynamic compression | Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems. |
| Static compression-shear | Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems. |
| Dynamic compression-shear | Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems. |
| Expulsion | Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems. |
Note: The document states that these tests were conducted and that they demonstrated substantial equivalence, but it does not provide the specific numerical acceptance criteria or the quantitative results from these tests.
Regarding the study that proves the device meets acceptance criteria:
The study described is a mechanical performance study.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards, but the specific number of units tested for each criterion is not provided in this summary.
- Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical data sets from patients or countries.
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 mechanical testing is based on engineered specifications and standardized test methods, not expert human interpretation.
4. Adjudication method for the test set:
- Not applicable. This refers to consensus among human experts for clinical data, not mechanical testing results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This study is focused on the mechanical performance of a physical implant, not the diagnostic performance or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithms, which are not mentioned in this device description. The device itself is a physical implant.
7. The type of ground truth used:
- For mechanical testing, the "ground truth" is defined by the specifications and acceptable ranges outlined in the relevant ASTM standards (F2077) and the FDA's "Class II Special Controls Guidance Document: Intervertebral Fusion Device."
8. The sample size for the training set:
- Not applicable for a physical medical device and mechanical testing. There is no "training set" in the context of algorithm development mentioned here.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm mentioned.
§ 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.