(146 days)
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput - T3) for the following indications:
- Degenerative disease of the cervical vertebrae (neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis of the cervical vertebrac ●
- Spinal stenosis of the cervical vertebrae .
- Atlanto-axial fracture with instability ●
- Occipital-cervical dislocation D
- Revision of cervical spine fusion surgeries .
- Tumors .
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System consists of plate/rod. hooks, set screws The plate/rods, hooks, and set screws are and bone screws for the occipital region of the skull. manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are manufactured from commercially pure titanium Grade 4 (ASTM F67). The Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the occipital-cervical junction (occiput-T3) for the following indications:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondvlolisthesis of the cervical vertebrae
- Spinal stenosis of the cervical vertebrae ●
- Atlanto-axial fracture with instability ●
- Occipital-cervical dislocation .
- Revision of cervical spine fusion surgeries .
- Tumors ●
The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. The plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
Manual surgical instruments that will be marketed with this system include Bending Pliers for 3.5 rods, a 2.5mm Hex screwdriver and holding forceps.
The provided document describes a medical device, the Synthes Spine Occipital-Cervical Plate/Rod and Hook System, and its approval process, specifically a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria in the way a new drug or diagnostic algorithm would.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document because it outlines a regulatory pathway based on equivalence to an existing, cleared device, not an effectiveness study with predefined performance metrics.
However, I can extract the information that is present in the document relevant to its "effectiveness" and "acceptance criteria" in the context of a 510(k) by interpreting "acceptance criteria" as the criteria for regulatory clearance.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for 510(k) Equivalence) | Reported Device Performance/Characteristics |
|---|---|
| Material Composition | Identical to numerous other cleared Synthes Spinal products (TiAlNb (ASTM F1295) for plate/rods, hooks, set screws; commercially pure titanium Grade 4 (ASTM F67) for bone screws). |
| Indication/Intended Use | Same as the Ransford Cervical Fixation System (K965221) and listed indications (degenerative disc disease, spondylolisthesis, spinal stenosis, atlanto-axial fracture with instability, occipital-cervical dislocation, revision of cervical spine fusion, tumors). |
| Mechanical Performance (Static & Fatigue) | Documented in accordance with ASTM standard F1717. Clearly demonstrated performance characteristics satisfy requirements of posterior cervical and upper thoracic (T1-T3) fixation. |
| Surgical Technique & Instrumentation | Same as that of the Synthes USS Hook/Rod systems. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test" mentioned here refers to mechanical bench testing, not a clinical study involving patients. The document does not specify the number of samples (e.g., number of implants) used for the mechanical testing.
- Data Provenance: Not applicable in the context of clinical patient data. The "testing" refers to mechanical testing performed in accordance with ASTM standards, presumably by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device's clearance is based on substantial equivalence and mechanical testing, not on adjudicated expert-reviewed clinical outcomes.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication in this regulatory submission.
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 surgical implant, not an AI-powered diagnostic device, and no MRMC study was conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a surgical implant, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the regulatory acceptance of this device relies on:
- Mechanical Testing Standards: Adherence to ASTM standard F1717 for static and fatigue performance.
- Predicate Device Characteristics: Direct comparison of material composition, indications for use, and surgical technique to a legally marketed predicate device (Ransford Cervical Fixation System, K965221).
8. The sample size for the training set
- Not applicable. This is a hardware implant, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware implant, not a machine learning model.
§ 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.