(147 days)
When used as a non-pedicle screw fixation system, the Aesculap Spine System® is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T, through S,.
When used as a pedicle system, the Spine System® is intended only for patients (a) having severe spondylolisthesis (Grade 3 or 4 at the L -- S, vertebral joint; (b) who are receiving fusions using autologous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (note: levels of pedicle screw fixation for this indication are from L3-S,); and (d) who are having the device removed after the development of a solid fusion mass.
The submission describes "Lateral Connectors" and "Smooth Rods" as additional components for the Aesculap Spine System®. The construct contains a lateral connector and a knurled rod, and pictures of the new smooth rods can be found in the biomechanical report.
This document is a 510(k) Summary of Safety and Effectiveness for the Aesculap Spine System® Additional Components, specifically Lateral Connectors and Smooth Rods. It is a regulatory submission to the FDA, not a study report validating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from the provided text.
The document focuses on:
- Regulatory Classification and Intended Use: Defining what the device is, its classification (Class II), and its intended applications for spinal fusion.
- Substantial Equivalence: Arguing that the new components are substantially equivalent to previously marketed devices.
- FDA's Decision and Limitations: The FDA's letter granting substantial equivalence but imposing specific limitations, especially concerning pedicle screw use (only for severe spondylolisthesis at L5-S1 and with specific conditions).
- Labeling Requirements: Mandating specific warnings and instructions for use.
There is no mention of:
- Acceptance criteria (e.g., specific performance thresholds for mechanical strength, biocompatibility, etc.).
- A formal study proving the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, ground truth establishment methods, or expert qualifications.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Training set details.
The closest relevant information is the mention of a "biomechanical report" in Appendix C which would contain pictures of the new smooth rods. This strongly suggests that biomechanical testing was performed, but the results, acceptance criteria, and details of such testing are not provided in the summary.
Therefore, I cannot populate the requested table and answer many of the questions based on the provided text, as it describes a regulatory submission, not a study report.
Information that can be inferred or directly stated from the document:
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| (Likely related to biomechanical properties, material compatibility, and similarity to predicate devices.) | (Implied to meet necessary biomechanical and safety standards for regulatory approval, but no specific data is presented.) |
Detailed breakdown of unanswerable questions and closest relevant information:
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A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The document is a 510(k) summary, not a study report with performance data against specific criteria. Biomechanical testing is implied (referred to an "Appendix C"), but the results are not in this excerpt.
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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. The document does not describe a clinical or performance study with test sets.
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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. No test set or ground truth establishment relevant to this question is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method described.
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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
- No. This device is a mechanical spinal implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies are irrelevant to this product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical spinal implant, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth definition relevant to performance data for a study is described. The "ground truth" for regulatory approval here is primarily based on equivalence to predicate devices and adherence to material and manufacturing standards.
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The sample size for the training set
- Not applicable / Not provided. There is no mention of a training set as this is not an AI/ML device.
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How the ground truth for the training set was established
- Not applicable / Not provided. There is no mention of a training set.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.