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510(k) Data Aggregation
(108 days)
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The purpose of this submission is to introduce an additional, larger footprint Zero-P spacer, as well as minor modifications to approved labeling.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism.
The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) summary for the Synthes Zero-P "Large Footprint" intervertebral fusion device.
This document focuses on establishing substantial equivalence to predicate devices based on design and mechanical performance, rather than clinical efficacy studies with specific acceptance criteria as you might see for novel medical diagnostics or AI/ML-driven devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to a 510(k) submission for an intervertebral fusion device like the Synthes Zero-P. These types of studies are typically conducted for different types of devices, such as diagnostic imaging software or AI algorithms, where performance is measured against a ground truth and often involves human readers.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meet or exceed the performance of predicate devices in relevant mechanical tests. | Synthes performed static and dynamic compression shear and torsion testing in accordance with ASTM F2077. The summary states, "The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate." This implies that the device met the mechanical performance requirements to be considered substantially equivalent to the predicate devices. Specific quantitative acceptance criteria (e.g., "yield strength > X N") and the exact results are not provided in this summary but would be detailed in the full submission. |
| Material Compatibility: Use materials proven safe and effective for intervertebral fusion devices. | The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). These are commonly used biocompatible materials in spinal implants, implicitly accepted through their use in predicate devices. |
| Design and Functionality: Comparable indications, fundamental scientific technology, surgical technique, screw fixation, and design to predicate devices. | "The modifications herein presented to Synthes Zero-P device are substantially equivalent to identified predicates, Synthes Zero-P System (K072981); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285) in indications, fundamental scientific technology, material, mechanical performance, surgical technique, screw fixation and design." |
| Indications for Use: Align with predicate device indications. | The indications for use are clearly stated and align with those for intervertebral fusion devices for degenerative disc disease. This is implicitly accepted by the FDA's clearance of the device as substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This device is an implantable medical device, not a diagnostic or AI/ML device that would typically have a "test set" in the sense of clinical data points for performance evaluation against a ground truth. Performance is demonstrated primarily through non-clinical (benchtop) mechanical testing and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: See point 2. Ground truth in this context would relate to the established mechanical standards (ASTM F2077) and engineering principles for implant design. The "experts" would be the engineers and biomechanical testing professionals performing and interpreting the tests.
4. Adjudication Method for the Test Set
- Not Applicable: See point 2.
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 an implantable device, not an AI-driven diagnostic tool. An MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an implantable device; there is no algorithm or standalone performance study in this context.
7. The Type of Ground Truth Used
- For the non-clinical performance data, the "ground truth" is based on established engineering standards (ASTM F2077) for static and dynamic mechanical testing of intervertebral body fusion devices, and the mechanical performance characteristics of legally marketed predicate devices.
- For material composition, the ground truth is established by ASTM standards for medical-grade PEEK Optima and titanium alloy (ASTM F2026-02, ASTM F136-2a, ASTM F1295-01).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this device. The design, materials, and mechanical properties are based on well-established engineering principles and existing predicate devices, not machine learning or AI models trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
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