(17 days)
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia Stainless Steel System is also 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, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes 4.5 mm diameter Polyaxial Screws and longer length rods.
The provided document is a 510(k) Premarket Notification for a line extension to the Xia Stainless Steel System, a spinal fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it is not a clinical study report.
Here's why the requested information is absent and what the document does provide:
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A table of acceptance criteria and the reported device performance:
- Absent. This document doesn't define specific clinical acceptance criteria (e.g., a certain reduction in pain, a specific fusion rate, or a particular performance statistic like sensitivity/specificity for a diagnostic device).
- What is present: The document states that "Mechanical testing demonstrated comparable mechanical properties to the predicate device." This is the basis for demonstrating substantial equivalence for this type of device modification (a line extension with different screw diameters and rod lengths). The acceptance criteria for this would be defined by the mechanical testing standards used (e.g., ASTM standards for spinal implants) comparing the new components to the predicate, demonstrating that they perform similarly or better under defined load conditions. However, the specific results or table of these criteria/performance are not included in this summary.
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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):
- Absent. There is no clinical test set in the context of a prospective or retrospective study for a diagnostic or therapeutic effect. The "test set" here would refer to the samples of the new device components used for mechanical testing. The document does not specify the number of samples used for these mechanical tests.
- What is present: The device itself is manufactured by Howmedica Osteonics Corp based in Allendale, NJ, USA.
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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):
- Absent. Ground truth establishment by experts is relevant for diagnostic devices or those with subjective outcome measures. For spinal fixation hardware, the "ground truth" is typically defined by engineering standards for mechanical performance, biocompatibility, and material properties, not by expert medical evaluation of a patient test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Absent. Adjudication methods are used for resolving disagreements in expert ground truth establishment for clinical or diagnostic studies. This is not applicable here.
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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:
- Absent. This is a hardware device (spinal implant), not a diagnostic algorithm or AI-assisted system. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Absent. This is a hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- What is present: For a spinal implant, the "ground truth" for demonstrating safety and effectiveness in a 510(k) submission is typically established through:
- Mechanical Integrity/Performance: Compliance with recognized ASTM or ISO standards for spinal implants, demonstrating equivalent or superior strength, fatigue life, and other mechanical properties compared to the predicate device.
- Biocompatibility: Confirmation that the materials (stainless steel) are appropriate for implant use and have known biocompatibility profiles (often addressed by referencing predicate devices or established material standards).
- Intended Use Compatibility: The new components fit within the intended use of the existing system and predicate.
- The document implies that mechanical testing was the primary evidence for this line extension.
- What is present: For a spinal implant, the "ground truth" for demonstrating safety and effectiveness in a 510(k) submission is typically established through:
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The sample size for the training set:
- Absent. Spinal implants do not have a "training set" in the sense of machine learning algorithms or clinical trials.
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How the ground truth for the training set was established:
- Absent. Not applicable.
In summary, the provided document is a regulatory submission for a device modification (line extension) that demonstrates substantial equivalence to a legally marketed predicate device. It primarily relies on design comparison and mechanical testing to establish comparable safety and effectiveness, rather than a clinical study with specific acceptance criteria and detailed performance metrics as would be found for a novel therapeutic or a diagnostic device.
§ 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.