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The SynFixTM-LR is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFixTM-LR can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Synthes SynFixTM-LR is a combination radiolucent and radiopaque intervertebral body fusion device. 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 Synthes SynFixTM-LR is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.

The provided text describes a 510(k) premarket notification for the Synthes SynFixTM-LR intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study with acceptance criteria and performance metrics in the same way an AI/ML device would.

Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable. The information provided focuses on non-clinical (bench) testing to demonstrate mechanical equivalence.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:
   Not applicable (N/A). The submission is for an intervertebral body fusion device, not an AI/ML device. The "Performance Date (Nonclinical and/or Clinical)" section states: "Bench testing results demonstrate that the Synthes SynFix™-LR is substantially equivalent to the predicate devices." No specific numerical acceptance criteria or performance metrics are provided in the summary.

2. Sample size used for the test set and the data provenance:
   N/A. No test set for an AI/ML algorithm is mentioned. The testing was "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   N/A. Ground truth establishment by experts is not relevant for bench testing of a physical medical device.

4. Adjudication method for the test set:
   N/A. Not relevant for bench testing of a physical medical device.

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:
   N/A. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   N/A. The "ground truth" for this device would be its mechanical and material properties meeting established standards or being equivalent to the predicate device's properties as determined through bench testing.

8. The sample size for the training set:
   N/A. There is no training set for a physical medical device.

9. How the ground truth for the training set was established:
   N/A. There is no training set for a physical medical device.

Summary of available information:

• Acceptance Criteria/Performance: The device met the "substantial equivalence" criteria through bench testing. No specific numerical values or acceptance ranges are provided in the summary.
• Study Type: Non-clinical bench testing.
• Clinical Data: "Clinical data and conclusions were not needed for this device." This statement clarifies that no human clinical trials were required for this 510(k) submission.

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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.

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set:

   • Not provided. Adjudication methods are not discussed.

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 and Not provided. This is a surgical implant, not an AI-assisted diagnostic tool for human readers.

6. 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.

7. 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.

8. 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.

9. 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.

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The SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTM-LR can be packed with bone (autograft or allograft). SynFixTM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device to provide 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 neighboring vertebral bodies and lock securely to the plate using a tapered thread locking mechanism. The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer has openings that can be packed with bone (autograft or allograft). The SynfixTM-LR is available as assembled components in various heights and geometrics to suit the individual pathology and anatomical conditions.

This document is a 510(k) summary for the SynFixTM-LR, a spinal intervertebral body fixation orthosis. As such, it does not contain any information about acceptance criteria or specific studies proving device performance against such criteria.

The document states that substantial equivalence was demonstrated based on comparison to a previously cleared vertebral replacement device (K011037). This typically means that the new device has similar technological characteristics and comparable performance to the predicate device, but specific performance metrics and acceptance thresholds are not provided in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, MRMC studies, or standalone performance for the SynFixTM-LR based on the provided text.

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