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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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