(106 days)
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
The AERO®-C Cervical Cage is a hollow, ring-shaped PEEK Optima (per ASTM F2026) cage surrounded by a titanium alloy (per ASTM F136 and ISO 5832-3) jacket. It is intended for use as an interbody fusion device and is offered in a variety of heights, widths, depths, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used with the internal supplemental fixation provided (AERO®-C Fixation Anchors). The AERO®-C Fixation Anchors are constructed from titanium alloy and possess rails that mate with dovetail channels located within the AERO®-C Cervical Cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.
This document is a 510(k) premarket notification for the Stryker Spine AERO®-C Cervical Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices through design features, indications for use, technological characteristics, material use, and mechanical performance. It does NOT contain information about a clinical study involving human patients, human readers, or ground truth established by experts for classification performance.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria through clinical performance metrics is largely absent because this document pertains to a premarket notification based on substantial equivalence and non-clinical (mechanical) testing, not clinical outcome studies measuring performance like sensitivity, specificity, or accuracy compared to a ground truth.
However, I can extract information related to the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance
The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AERO-C® implant system and demonstrated substantially equivalent performance to the identified predicate device systems."
While explicit numerical acceptance criteria are not detailed in this summary, the criteria are implicitly derived from the FDA's guidance document and the performance of the predicate devices. The reported performance is that the device demonstrated "substantially equivalent performance" to the predicates across the listed mechanical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007) and performance substantially equivalent to predicate devices for: | Demonstrated "substantially equivalent performance" to the identified predicate device systems for all listed mechanical tests. |
| Static Compression (per ASTM F2077) | Performance comparable to predicate devices. |
| Dynamic Compression (per ASTM F2077) | Performance comparable to predicate devices. |
| Static Compression Shear (per ASTM F2077) | Performance comparable to predicate devices. |
| Dynamic Compression Shear (per ASTM F2077) | Performance comparable to predicate devices. |
| Static Torsion (per ASTM F2077) | Performance comparable to predicate devices. |
| Dynamic Torsion (per ASTM F2077) | Performance comparable to predicate devices. |
| Expulsion (per ASTM F04-25-02-02 Draft) | Performance comparable to predicate devices. |
| Subsidence (per ASTM F2267) | Performance comparable to predicate devices. |
| Wear Debris Assessment | Performance comparable to predicate devices. |
| Fixation Anchor Engagement Evaluation | Performance comparable to predicate devices. |
| Dynamic Cadaveric Testing (fatigue performance under multiple loading modes) | Performance comparable to predicate devices; involved implantation into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical mechanical testing, primarily involving physical samples of the device and biological (cadaveric) material for a specific test. It does not refer to a "test set" in the context of clinical data for AI/algorithm performance.
- Mechanical Tests (e.g., Static Compression, Dynamic Compression, etc.): The specific number of physical samples (devices) tested for each mechanical test is not provided in this summary but would typically be specified within the full test reports referenced by the ASTM standards.
- Dynamic Cadaveric Testing: The summary mentions "the implantation of the AERO®-C device into multiple functional spinal units." The exact "multiple" number is not specified.
- Data Provenance: Not applicable in the context of country of origin of patient data or clinical retrospective/prospective studies, as this is purely mechanical and cadaveric testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes non-clinical mechanical testing for an implantable device, not an AI or diagnostic device that requires expert-established ground truth for its performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving adjudication of clinical outcomes or decisions.
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 document describes non-clinical mechanical testing for a spinal implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes non-clinical mechanical testing for a spinal implant, not an AI or algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the acceptance criteria established by national and international standards (e.g., ASTM F2077, ASTM F2267) and FDA guidance documents, which quantify acceptable mechanical properties and behaviors of intervertebral body fusion devices. The performance of the predicate devices also serves as a benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This document describes non-clinical mechanical testing, not an AI/machine learning model where a "training set" would be relevant.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML model is described.
§ 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.