(258 days)
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:
- Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
Occipital Plates / Occipital Bone Screws / Hooks:
The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and rods:
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Polyaxial screws/Connectors:
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.
The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.
Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|
| Multi-axial screws & Rods Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Occipital Plates, Occipital Screws & Dual Diameter Rod Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
Study Details
- Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
- Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
- 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 device is a physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
- The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.
§ 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.