(72 days)
The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.
The provided text describes a Special 510(k) Summary for a medical device called the VERTEBRON PSS™ Pedicle Screw System, specifically for the addition of 4.5mm Standard and MA Screws. The document asserts the substantial equivalence of these new components to previously cleared devices.
Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Vertebron PSS™ Pedicle Screw System 4.5mm Standard and MA Screws demonstrated substantial equivalence to the Vertebron PSS™ Pedicle Screw System (K033352 & K043152) and Optima Spinal Fixation System; U&I America (K024096). |
| Mechanical Performance (ASTM F1717) | "Testing in accordance with ASTM F1717 was performed..." (Specific performance results or thresholds are NOT provided in this document) |
| Material Conformity (ASTM F136) | "The material used is medical grade titanium material that conforms to ASTM F136." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or patient samples. The testing referred to is mechanical testing according to ASTM F1717. The sample size for this mechanical testing is not explicitly stated. The data provenance is not mentioned, as it is a laboratory-based mechanical test, not clinical data from a specific country or patient population.
3. 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)
This section is not applicable to the provided document. The "ground truth" for the device's acceptance is established through the demonstration of substantial equivalence to predicate devices, which is primarily based on mechanical testing and material conformity, not expert evaluation of a clinical "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to the provided document for the same reasons as #3. There is no mention of a human-reviewed "test set" or adjudication process.
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
This section is not applicable to the provided document. The device is a pedicle screw system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable to the provided document. The device is a mechanical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance of this device relies on demonstrated substantial equivalence to predicate devices. This is established through:
- Mechanical performance data (conformance to ASTM F1717).
- Material composition (conformance to ASTM F136).
- Design similarities to previously cleared devices.
- Intended use and indications being comparable to predicate devices.
8. The sample size for the training set
This section is not applicable to the provided document, as it concerns a mechanical medical device and not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 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.