(129 days)
SYNTHES® Contoured SynMesh® 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 SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.
SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The SYNTHES® Contoured SynMesh® Spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy / vertebrectomy.
The provided text describes a 510(k) premarket notification for a medical device, the SYNTHES® Contoured SynMesh® Spacer. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and the study proving the device meets those criteria.
This document is a regulatory submission for a spinal implant, which typically focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, and expert adjudications as would be common for diagnostic or AI-driven devices.
Here's a breakdown of what can be extracted and what information is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- This document does not describe specific quantitative acceptance criteria or reported device performance metrics in the way you'd typically find for a diagnostic efficacy study. The "performance" demonstrated here is primarily the substantial equivalence to a predicate device based on material, design, and intended use.
- For an implant like this, "performance" would relate to mechanical testing (e.g., strength, fatigue) and biocompatibility, which are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This submission is about a physical implant, not a data-driven device that uses test sets or data provenance in the context of an algorithm's performance.
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/Not provided. Ground truth establishment with experts is relevant for diagnostic accuracy studies, not for the substantial equivalence of a spinal implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is relevant for diagnostic accuracy studies.
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/Not provided. This is relevant for diagnostic AI studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of a "test set" as understood for AI or diagnostic devices. The "ground truth" for a spinal implant's safety and effectiveness relies on established engineering principles, biocompatibility testing, pre-clinical mechanical testing, and clinical historical data of similar devices, all of which support the claim of substantial equivalence.
8. The sample size for the training set
- Not applicable/Not provided. This is relevant for AI-driven devices.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is relevant for AI-driven devices.
Summary of Available Information from the Provided Text:
The document focuses on demonstrating substantial equivalence of the SYNTHES® Contoured SynMesh® Spacer to a legally marketed predicate device (SYNTHES® SynMesh® Spacer System - K003275). This is the primary "acceptance criterion" for a 510(k) submission for this type of device.
- Device Type: Spinal intervertebral body fixation orthosis (vertebral body replacement device).
- Intended Use: 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). It provides anterior spinal column support.
- Material: Commercially pure titanium.
- Predicate Device: SYNTHES® SynMesh® Spacer System (K003275).
- Basis for Equivalence: Documentation provided demonstrates that the new device is "Substantially Equivalent" to other legally marketed SYNTHES® devices. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (e.g., mechanical properties) to the predicate device. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, for this particular document, the "study" proving the device meets acceptance criteria is the 510(k) submission itself and the FDA's determination of substantial equivalence to the predicate device, based on the comparative information submitted by the manufacturer. The details of the specific tests (e.g., mechanical, biocompatibility) that underpin this claim are not provided in this summary.
§ 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.