(238 days)
Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.
Zuma-C is a stand-alone interbody fusion device composed of PEEK and titanium alloy with radiopaque markers, titanium screws and a locking cover. The screws are inserted through the device into adjacent vertebral bodies and the locking cover mates with the device, covering the screws. The device has an open central area for receiving bone graft material and is offered pre-assembled in a variety of heights and geometries to accommodate variations patient anatomy.
This document is a 510(k) summary for the Zuma-C™ interbody fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and pre-clinical testing for mechanical performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, ground truth establishment, and expert involvement are not applicable or not detailed in this submission.
Here's the information extracted and categorized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as criteria, but implied and "worst case Performance Data" were used) | Reported Device Performance (Results were found to be substantially equivalent to legally marketed devices) |
|---|---|---|
| Mechanical Performance | Static and Dynamic Axial Compression (per ASTM F2077) | Substantially equivalent to predicate devices. |
| Static and Dynamic Compression Shear (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Static and Dynamic Torsion (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Subsidence (per ASTM F2267) | Substantially equivalent to predicate devices. | |
| Wear Testing (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Wear Debris Characterization (per ASTM F1714 and ASTM F1877) | Substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The studies performed were pre-clinical (benchtop) tests on device constructs, not data from a patient test set.
- Data Provenance: The data provenance is pre-clinical testing conducted by the manufacturer, SeaSpine, Inc. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for diagnostic or prognostic devices with expert review is not relevant for this type of pre-clinical mechanical performance assessment. The "ground truth" here is adherence to established ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication is not relevant for pre-clinical mechanical performance testing.
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
- No. This is a medical device for spinal fusion, not an AI-powered diagnostic or decision support tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these pre-clinical studies is defined by the performance requirements and testing methodologies outlined in the referenced ASTM standards (ASTM F2077, ASTM F2267, ASTM F1714, ASTM F1877). The goal was to show "substantial equivalence" to legally marketed predicate devices under these conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The "samples" would be the physical device constructs tested in the pre-clinical studies, but the concept of a "training set" doesn't apply.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model was used.
§ 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.