(140 days)
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The Cervical Spacers are provided sterile only.
This document is a 510(k) summary for the Additive Implants Cervical Spacer. It outlines the device description, indications for use, materials, predicate devices, and performance data. The device is a cervical interbody fusion device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance testing conducted for a medical device (an implant), focusing on mechanical and biological safety. The acceptance criteria for this type of device are typically based on meeting established ASTM (American Society for Testing and Materials) standards.
Here's a summary of the performance data and implied acceptance:
| Performance Criterion (Acceptance based on ASTM Standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Testing: |
- Static Compression (ASTM F2077)
- Dynamic Compression (ASTM F2077)
- Static Torsion (ASTM F2077) | "The mechanical test results demonstrate that the Cervical Spacer performance is substantially equivalent to the predicate devices." |
| Subsidence Properties (ASTM F2267) | "The subsidence properties were evaluated according to ASTM F2267." (Implies meeting the standard's requirements for substantial equivalence). |
| Expulsion Properties (ASTM draft standard) | "expulsion according to the ASTM draft standard." (Implies meeting the draft standard's requirements). |
| Manufactured Surface Evaluation (ASTM F1978) | "The manufactured surface was evaluated according to ASTM F1978." (Implies meeting the standard's requirements). |
| Bacterial Endotoxin Testing (AAMI ST72:2011) | "bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit." |
2. Sample size used for the test set and the data provenance
This document describes the regulatory clearance for a hardware medical device (a cervical spacer), not an AI/ML algorithm. Therefore, the concepts of "test set," "training set," "data provenance," "retrospective/prospective" studies do not apply in the context of AI/ML.
The "testing" refers to laboratory-based mechanical, material, and biological safety testing of the device prototypes, not a clinical study on patient data for AI model validation. The sample size for mechanical testing would refer to the number of devices tested, which is not specified in this summary but would be determined by the relevant ASTM standards for statistical significance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this clearance is for a physical medical device, not an AI/ML diagnostic or prognostic tool. Ground truth in this context relates to material properties and performance under mechanical stress, verified by engineering and laboratory testing protocols, not by expert medical image annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of human-interpreted data.
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/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective, standardized laboratory testing (e.g., mechanical load testing to failure, material composition analysis, endotoxin levels). The performance is compared to established predicate devices and known material properties as per ASTM and AAMI standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.