(30 days)
Synthes VECTRA System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes VECTRA System is indicated for the following:
• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fractures or dislocations)
• Spinal Stenosis
• Tumors (primary and metastatic)
• Failed previous fusions
• Pseudoarthrosis
• Deformity (i.e., scoliosis, kyphosis, and/or lordosis)
The Synthes Vectra System consists of one-level to four-level plates with cancellous and cortical fixed-angle and variable-angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate is 2.5 mm thick, has bigger graft visibility windows (as compared to the predicate device), bend grooves, and fixed-angle screw DTS Guide orientation holes.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb), the same as the predicate device. The plate clip is manufactured from Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo), the same as the predicate device.
This document is a 510(k) summary for the Synthes Vectra System, a medical device for cervical spine fixation. It establishes substantial equivalence by referencing a predicate device (Synthes ACCS - K033844) and detailing the device's description, materials, and indications for use.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not present a table of acceptance criteria nor reported device performance data in the way you might expect for a diagnostic AI device. Instead, it describes a device for spinal intervertebral body fixation, which is a physical implant.
For such a device, "acceptance criteria" and "performance" are typically related to:
- Biocompatibility: The materials being non-toxic and compatible with the body.
- Mechanical Strength: The device's ability to withstand physiological loads without failure (fatigue, ultimate strength, bending, torsion).
- Sterility: The device being free of microorganisms.
- Design Specifications: Adherence to defined dimensions and features.
- Substantial Equivalence: Demonstrated similarity in safety and effectiveness to a legally marketed predicate device.
The document implicitly "reports performance" by stating that the device is "substantially equivalent" to the predicate device (Synthes ACCS - K033844). This implies that its safety and effectiveness, based on its design, materials, and intended use, are comparable to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a physical medical implant, not a diagnostic AI device that would utilize a "test set" of data. Therefore, the concepts of sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable to the information provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
As this is a physical medical implant, the concept of "ground truth" established by experts for a diagnostic test set is not relevant. The safety and efficacy are primarily assessed through engineering principles, material science, and comparison to predicate devices, rather than expert interpretation of data samples.
4. Adjudication Method
The concept of an "adjudication method" (like 2+1 or 3+1) is used in the context of expert review for diagnostic test sets. It is not applicable to the type of medical device described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned in this document. Such studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the focus is on how AI assistance impacts their performance. This document concerns a physical implant.
6. If a Standalone Study Was Done
The concept of a "standalone" study (algorithm-only performance) is for diagnostic algorithms. For this physical implant, performance is assessed through bench testing (mechanical testing), biocompatibility testing, sterility testing, and comparison to the predicate device, not through an algorithm-only standalone study. The document does not explicitly detail these tests but relies on the demonstration of substantial equivalence.
7. The Type of Ground Truth Used
For a physical implant like the Synthes Vectra System, "ground truth" is established through:
- Engineering specifications and standards: Confirming the device meets design and material strength requirements.
- Biocompatibility test results: Demonstrating the materials are safe for human implantation.
- Clinical experience with similar predicate devices: The safety and effectiveness of the existing predicate device (Synthes ACCS) serve as a de facto "ground truth" reference against which the new device is compared.
The document explicitly states the new device uses the "same as the predicate device" materials, which points to relying on the established safety of those materials.
8. The Sample Size for the Training Set
Similar to the test set, the concept of a "training set" is for diagnostic AI devices. This document describes a physical implant, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
In summary, the provided 510(k) document is for a physical medical implant, not a diagnostic AI device. Therefore, many of your questions regarding acceptance criteria, study design, and ground truth for AI/diagnostic contexts are not directly addressed in this type of submission. The primary method of demonstrating acceptance and performance for such a device is through substantial equivalence to a legally marketed predicate device, along with underlying engineering and material science evidence (which are not detailed in this specific summary but are implied to have been performed).
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.