(129 days)
The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System 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 ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.
The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 720-760μm and major axis length of 1030-1060μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
The provided document is a 510(k) summary for the ZSFab Cervical Interbody System, a medical device intended for anterior interbody fusion in the cervical spine. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The information primarily focuses on the physical and mechanical performance of the device in comparison to a predicate device, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, ground truth methodology for AI, MRMC studies, and standalone algorithm performance, are not applicable to this device and the type of performance data presented.
Below is the information that can be extracted from the provided text, primarily focusing on the mechanical testing performance of the device, which is the "study" demonstrating it meets acceptance criteria for substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Device Performance (ZSFab Cervical Interbody System) |
|---|---|
| ASTM F2077: Static Axial Compression | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
| ASTM F2077: Dynamic Axial Compression | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
| ASTM F2077: Static Torsion | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
| ASTM F2077: Dynamic Torsion | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
| ASTM F2267: Subsidence | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
| Expulsion Tests | Met acceptance criteria (demonstrated substantial equivalence to predicate) |
Note: The document states that "The mechanical test results demonstrate that the ZSFab Cervical Interbody System performance is substantially equivalent to the predicate devices." This implies that the performance of the ZSFab device met or exceeded the performance of the predicate device under these specified test conditions, thus fulfilling the acceptance criteria for substantial equivalence. Specific quantitative values for the acceptance criteria and the device's exact performance against those criteria are not detailed in this summary.
Study Details (Focusing on the Mechanical Testing)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the summary. For mechanical testing, samples typically refer to individual devices tested.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). These are laboratory bench tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Mechanical testing relies on standardized test methods (ASTM standards) and engineering principles, not expert interpretation of outputs.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing results are objective measurements directly compared against predefined specifications within the ASTM standards.
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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 a spinal implant, not an AI diagnostic or assistance device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a spinal implant, not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" is defined by the objective pass/fail criteria established within the referenced ASTM international standards (F2077 and F2267) for intervertebral body fusion devices, and potentially internal specifications derived from the predicate device's performance.
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The sample size for the training set:
- Not applicable. There is no AI algorithm being trained for this device. The "training set" would not be relevant in a mechanical testing context. If interpreted very broadly, it might refer to samples used during design and development iterations, but this is not reported here.
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How the ground truth for the training set was established:
- Not applicable, as there is no AI training set.
§ 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.