(168 days)
The SynEx™ Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynEx™ Spacer System can be packed with bone. The SynEx™ Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The SynEx device is a cylindrically-shaped titanium vertebral implant with a hollow core; the walls and endplates have a plurality of holes. Each implant consists of two telescoping end pieces and a locking ring. The plurality of holes and hollow core allow for the use of grafting materials to help achieve solid fusion. To resist expulsion, the implant endplates have teeth and small spikes to grip the endplates of the adjacent vertebrae. The implant can be expanded vertically using the self-locking ratchet mechanism. A shoulder on the inner telescoping piece will not pass through the locking ring, preventing over-expansion of the implant. The SynEx device is available in a variety of geometries and sizes. This enables the surgeon to choose the configuration suited to the individual pathology and anatomical condition. Only one SynEx device is to be implanted per spinal level. The interior of the spacer is open and can be packed with bone graft material. The Synex Spacer implant is intended only for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Synex™ Spacer implant include SYNTHES plate and rod systems (e.g., ATLP, VentroFix, USS).
The document provided is a 510(k) Premarket Notification for the Synthes SynEx™ Spacer, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving device performance through clinical studies with specific acceptance criteria as you would typically find for a novel device or in a clinical trial setting.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given document. This document focuses on demonstrating substantial equivalence through a comparison to existing devices and mechanical testing.
Here's an analysis based on the provided text, highlighting what is available and what is not:
Synthes SynEx™ Spacer 510(k) Premarket Notification Analysis
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Material Composition | Titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11 | Meets standard for implantable materials. |
| Mechanical Performance | Mechanical testing in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented. | The specific results and acceptance values are not detailed in this summary document. It only states that testing was performed according to a recognized guidance. |
| Substantial Equivalence to Predicate Devices | Similar to components of previously cleared spinal systems (K990148 & K001340) with respect to certain technical characteristics. | This is the primary "acceptance criterion" for a 510(k). The FDA concurred with the substantial equivalence. |
| Intended Use | Thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture), used with supplemental internal fixation, and can be packed with bone. Provide anterior spinal column support even in absence of fusion for prolonged period. | The device's intended use aligns with the predicate devices and is deemed acceptable by the FDA. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes a premarket notification based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients or data in the typical sense. Data provenance would refer to the origin of the mechanical test data, which is implied to be from the manufacturer's internal 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. Ground truth in the context of clinical expert review is not relevant for this 510(k) submission, which relies on mechanical testing and comparison to predicate devices, not diagnostic or image-based assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 device is a physical spinal implant, not an AI or image analysis device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) involves adherence to recognized material standards (ASTM, ISO) and mechanical testing guidance (FDA Guidance for Spinal System 510(k)s). For substantial equivalence, the "ground truth" is the performance and design characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this 510(k); it's not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of what the document does provide regarding "proof" of meeting criteria:
The "study" that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. This testing would have specific benchmarks for strength, durability, and other biomechanical properties. The summary states that this testing was presented to the FDA, and the FDA determined the device to be substantially equivalent. This substantial equivalence is the primary basis for market clearance for this type of device under a 510(k). The document also highlights the use of standardized materials (titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11) as a key characteristic satisfying material requirements.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.