(69 days)
The Synthes Posterior Universal Spinal System devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Synthes Posterior Universal Spinal System consists of stainless steel or titanium components and consists of rods, hooks, side-opening screws with collar and nut (including he subject 9mm diameter side opening screw), variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transverse bars, parallel connectors. Schanz screws, clamp with posterior nut and associated manual surgical instruments.
The provided text is a summary of safety and effectiveness information for the Synthes Posterior Universal Spinal System and the FDA's response to its 510(k) premarket notification. It describes the device, its intended use, and the FDA's determination of substantial equivalence.
However, a critical review of the provided text reveals that it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document states: "This system is substantially equivalent to previously cleared Synthes spinal systems and is supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation." This implies that testing was performed, but the details of that testing, including acceptance criteria and results, are not present in the provided excerpts.
Without a detailed study report, it's impossible to completely fill out the requested table and answer all questions. Based solely on the information provided, here's what can be inferred or stated about the lack of information:
Acceptance Criteria and Device Performance
The provided text does not explicitly state acceptance criteria or report specific device performance metrics in a quantifiable manner. It broadly states that the system is "supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation" and is "substantially equivalent to previously cleared Synthes spinal systems."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., specific thresholds for strength, durability, biocompatibility) | Reported Device Performance (e.g., numerical results from mechanical tests, clinical outcomes) |
|---|---|
| [Not specified in the provided text] | [Not specified in the provided text] The document only generally states that testing "satisfies the requirements" for its intended use and that the device is "substantially equivalent" to predicate devices. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "testing," but provides no details on the sample size of any test sets. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.
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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 specified. The document does not describe any studies involving human experts establishing ground truth for a test set. The evaluation seems to be based on engineering tests and comparison to predicate devices, rather than clinical efficacy studies in the format often seen for AI/diagnostic devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. No information is provided about adjudications for a test set.
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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 is a medical device (spinal implant system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described for this type of product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical spinal implant system, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided text. For a spinal implant, "ground truth" would typically relate to biomechanical performance (e.g., stiffness, fatigue life, pull-out strength based on industry standards) or an assessment of successful fusion in a clinical setting (outcomes data). The document refers to "testing which satisfies the requirements," implying a comparison against established standards or predicate device performance.
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The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. If "training set" refers to data used to inform the design, it's not detailed in the provided text.
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How the ground truth for the training set was established:
- Not applicable/Not specified. As above, the concept of a "training set" is not relevant in the context of this physical medical device.
Conclusion:
The provided document (K983530) is a 510(k) summary for a spinal implant system. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to detail a comprehensive study with acceptance criteria, performance metrics, and rigorous statistical analysis in the way one might expect for a novel diagnostic or AI device. The text indicates that testing was done to satisfy requirements for posterior thoracolumbar and sacral fixation, but the specifics of that testing (methodology, acceptance criteria, results, sample sizes, etc.) are not included in this summary.
§ 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.