(90 days)
Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion (Sidewinder. Python and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. The Eminent Spine Interbody Fusion System (Copperhead) 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-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement Device: The Eminent System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The Eminent Spine Interbody Fusion System will be offered in four (4) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) Copperhead, anterior cervical approach 2) Sidewinder, transforaminal lumbar approach 3) Python, posterior lumbar approach and 4) Cottonmouth, anterior lumbar approach.
Here's an analysis of the provided text regarding the Eminent Spine Interbody Fusion System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter. For interbody fusion devices (Class II medical devices), clearance is typically based on demonstration of substantial equivalence to a previously legally marketed predicate device, rather than a full clinical trial with "acceptance criteria" in the sense of a new drug or novel high-risk device. The primary "study" referred to here is generally a mechanical test study to demonstrate that the new device performs equivalently to the predicate devices in terms of biomechanical properties.
Eminent Spine Interbody Fusion System: Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
As per the nature of a 510(k) submission for this type of device, explicit "acceptance criteria" for clinical outcomes (e.g., fusion rates, pain reduction scores) and specific "reported device performance" in a clinical trial are not provided nor required. Instead, the acceptance is based on demonstrating substantial equivalence through mechanical testing.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence via Mechanical Testing) | Reported Device Performance (Summary from Text) |
|---|---|
| Biomechanical performance (e.g., strength, stiffness, fatigue resistance) of the new device is comparable to the predicate devices. | "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." |
| Material properties (e.g., biocompatibility, resistance to degradation) are comparable to predicate devices. | (Implicit, as the device is cleared based on materials commonly used in predicate devices, but specific test results are not detailed in this summary document.) |
| Device design (e.g., size, geometry) allows for similar surgical approaches and indications as predicate devices. | "The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy... The configurations are designed based on indicated spinal implant level and surgical approach..." |
| Indications for Use are consistent with those of the predicate devices. | The stated Indications for Use for both Intervertebral Body Fusion Device (lumbar L2-S1, cervical C2-T1) and Vertebral Body Replacement Device (thoracolumbar T1-L5) align with the general scope of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Mechanical Testing): The document states "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided in this summary document.
- Data Provenance: The mechanical test data would have been generated in a prospective manner, specifically for this submission, likely within a laboratory setting. The origin is implicitly the applicant (Eminent Spine). This is not human clinical data, so country of origin for patients is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For mechanical testing, the "ground truth" is established through standardized engineering test protocols (e.g., ASTM standards for spinal implants) and objective measurements. There isn't a concept of "experts" establishing ground truth in the same way as in clinical image interpretation. The testing itself, conducted by engineers or technicians in a certified lab, provides the data supporting substantial equivalence.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are relevant for clinical studies, particularly those involving subjective assessments or disagreements among readers/experts. Since the "study" referred to here is mechanical testing, no such adjudication method is applicable or mentioned. The results are based on objective physical measurements and adherence to engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance in interpreting medical images. For a spinal implant system like the Eminent Spine Interbody Fusion System, such studies are not part of the 510(k) clearance process. The device itself is a physical implant, not an imaging or diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. A "standalone" performance study refers to the isolated performance of an algorithm or AI system without human intervention. The Eminent Spine Interbody Fusion System is a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance claim is derived from objective physical measurements and engineering standards (e.g., ASTM) applied to the device and predicate devices. These standards define the expected biomechanical behavior for interbody fusion devices in terms of strength, fatigue, and other relevant properties. The comparison against predicate devices establishes the basis for substantial equivalence.
8. The Sample Size for the Training Set
- This concept is not directly applicable to a 510(k) for a physical implant based on mechanical testing. "Training set" refers to data used to train an algorithm or AI model.
- If we consider the design and manufacturing process, the "training" aspect would relate to the iterative design and engineering process, where prototypes are tested, refined, and potentially re-tested, drawing upon established engineering principles and data from similar devices. However, this isn't a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- As explained in point 8, the concept of a "training set" and associated "ground truth" in the AI/machine learning sense is not relevant for this medical device clearance based on pre-clinical mechanical testing for substantial equivalence. The "ground truth" for evaluating the design of such a device is rooted in biomechanical principles, material science, and the performance characteristics of previously cleared, safe, and effective predicate devices.
§ 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.