(24 days)
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm (occept 10), components of the Synthes CerviFix™ System are indicating for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- spinal stenosis
- fracture/dislocation
- atlantoaxial fracture with instability
- occipitocervical dislocation
- revision of previous cervical spine surgery
- tumors
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.
Synthes CerviFix System consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of the titanium alloy Ti6Al7Nb (ASTM F1295) or commercially pure grade 4 Titanium (ASTM F67).
The provided text is a 510(k) Summary for the Synthes CerviFix System, a medical device. This document describes the device, its indications for use, classification, and the basis for its substantial equivalence to previously cleared devices.
Crucially, this document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It is not a clinical study report or a direct description of acceptance criteria and performance data from a specific study designed to "prove the device meets acceptance criteria" in terms of clinical outcomes or diagnostic accuracy.
Therefore, many of the requested elements for describing a study and acceptance criteria (like sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not typically found in a 510(k) Summary for a spinal fixation system.
The "study" mentioned in the document refers to pre-clinical biomechanical testing, which is used to demonstrate that the device's performance is similar to already cleared predicate devices. It does not involve human subjects or diagnostic performance metrics described in the prompt.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document states, "Pre-clinical testing shows the biomechanical performance of the CerviFix System is similar to the performance of previously cleared spinal systems with similar indications."
Reported Device Performance:
The document implies that the pre-clinical biomechanical testing confirmed this "similarity" to predicate devices. However, no specific quantitative performance metrics, test results (e.g., fatigue strength, pull-out strength values), or detailed acceptance limits are provided in this summary. The acceptance criterion is qualitative: "biomechanical performance... similar to... previously cleared spinal systems."
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/stated) | Reported Device Performance (as implied/stated) |
|---|---|---|
| Biomechanical Performance | Similar to previously cleared spinal systems with similar indications. | Pre-clinical testing demonstrated similarity to previously cleared spinal systems. (No specific quantitative data provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not specified. The "test set" here refers to the components of the device undergoing pre-clinical biomechanical testing, not a dataset of patient images or clinical cases. The number of implants or test specimens used in the biomechanical testing is not provided.
- Data Provenance: Not applicable/Not specified. This refers to pre-clinical laboratory testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the context of diagnostic accuracy or clinical outcomes is not relevant here. The "ground truth" for biomechanical testing would be established by standardized testing methods and engineering principles, not expert clinicians.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (e.g., 2+1) are used for resolving discrepancies in expert interpretations, which is not relevant to pre-clinical biomechanical testing.
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
- Not applicable. This is a spinal fixation system, not an AI-powered diagnostic device. No MRMC study or AI assistance is mentioned or relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical implant, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the pre-clinical testing, the "ground truth" implicitly would be established engineering standards, material properties, and comparative biomechanical data from predicate devices. It is not clinical "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI algorithm for this device. If interpreted very broadly as the data informing the design, it would be engineering specifications and prior device performance data, but no explicit "sample size" is mentioned.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the AI sense. For the design and comparative testing, the "ground truth" (i.e., expected performance benchmarks) would be established by engineering principles, regulatory standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the known performance characteristics of the predicate devices.
§ 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.