(530 days)
The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.
This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.
This document is a 510(k) premarket notification for the Eminent Spine 3D Cervical Interbody Fusion System. It aims to prove the substantial equivalence of the new device to existing predicate devices.
Here's the breakdown of the acceptance criteria and the study information as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression Bending (per ASTM F2077) | Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document) | "Results support that the subject device performs as well as or better than the chosen acceptance criteria." |
| Static and Dynamic Torsion (per ASTM F2077) | Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document) | "Results support that the subject device performs as well as or better than the chosen acceptance criteria." |
| Expulsion | Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document) | "Results support that the subject device performs as well as or better than the chosen acceptance criteria." |
| Subsidence (per ASTM F2267) | Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document) | "Results support that the subject device performs as well as or better than the chosen acceptance criteria." |
2. Sample size used for the test set and the data provenance
The document refers to "mechanical testing" and "results," but does not specify the sample size for the test set used in the mechanical tests.
The data provenance is from mechanical testing of the device, likely conducted in a laboratory setting. The country of origin and whether it was retrospective or prospective is not mentioned for the mechanical testing data.
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 as the study presented is a mechanical performance study, not a clinical study involving expert interpretation for ground truth.
4. Adjudication method for the test set
This information is not applicable for a mechanical testing study.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical substantial equivalence of a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" is established by the specified ASTM standards (F2077 and F2267) and potentially by comparing the performance to the predicate devices. These standards define the acceptable mechanical properties for such devices.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" for AI or other data-driven modeling in this device submission. The device is a physical implant, and the testing described is mechanical.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned or implied in the provided document.
§ 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.