(256 days)
The SynFix-LR is a stand-alone vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues. The interior of the spacer component of the SynFix-LR can be packed with bone (autograft or allograft). The SynFix-LR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device that provides structural stability in skeletally mature individuals following corpectomy. The SynfixTM-LR may be used to accommodate the anatomical requirements of the space created by the corpectomy. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The SynfixTM-LR is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
This is a 510(k) summary for a medical device (SynFixTM-LR, a vertebral body replacement device) and not a study proving the device meets acceptance criteria. The document explicitly states it is a "510(k) Summary" and a "Response to Request for Additional Information," which are regulatory submissions for market clearance based on substantial equivalence, not typically a detailed report of a study designed to prove acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and a study to prove adherence to them is not present in the provided text. The traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood in the context of performance metrics for, for example, an AI/diagnostic device, are not detailed here.
However, I can extract information related to the device description, intended use, and the regulatory process, which are foundational to understanding what criteria would be relevant if a performance study were being discussed.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
The provided document describes a submission for 510(k) clearance for a vertebral body replacement device, the SynFixTM-LR. This process is about demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance acceptance criteria in the way a diagnostic algorithm might.
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A table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on regulatory classification, device description, and intended use for a 510(k) submission. There are no quantifiable performance metrics or acceptance criteria listed (e.g., in terms of strength, biocompatibility, etc.), nor are there reported performance values against such criteria. The "performance" in this context is implicitly that it functions as a vertebral body replacement device, similar to its predicates.
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Sample size used for the test set and the data provenance:
- Not provided. This document does not describe a clinical or in-vitro performance study with a "test set" in the context of AI or diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. Ground truth establishment by experts is not described, as this is not a diagnostic device study.
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Adjudication method for the test set:
- Not provided. Adjudication methods are not discussed.
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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 and Not provided. This is a surgical implant, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable and Not provided. This is an implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. The concept of "ground truth" as it applies to assessing performance of diagnostic or AI systems is not relevant to this type of device submission.
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The sample size for the training set:
- Not applicable and Not provided. No training set is mentioned as this is not an algorithm or AI device.
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How the ground truth for the training set was established:
- Not applicable and Not provided.
Summary of what is available in the provided text:
- Device Name: SynFixTM-LR
- Device Type: Vertebral Body Replacement
- Intended Use/Indications for Use: Stand-alone vertebral body replacement device for use in the thoracolumbar spine (T1-L5) following partial vertebrectomy for tumor or trauma (fracture) to achieve anterior decompression. It restores biomechanical integrity even without fusion for a prolonged period.
- Regulatory Pathway: 510(k) Premarket Notification
- Predicate Devices: K011037 – Synthes Vertebral Spacer, K010530 – Interpore Cross GeoTM Structure
- Reason for Submission: Demonstrating substantial equivalence to these predicates.
- Date of Clearance Letter: April 3, 2007 (for K062083)
To answer your request based only on the provided text, the specific information about "acceptance criteria" and a "study proving the device meets the acceptance criteria" in the format you described is not present because this document is a regulatory filing for market clearance based on substantial equivalence to predicate devices, rather than a performance study report for a diagnostic or AI device.
§ 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.