(148 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is intended for:
-Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-Spondylolisthesis
-Spinal Stenosis
-Fracture/ Dislocation
-Atlanto/axial fracture with instability
-Occipito-cervical dislocation
-Deformities or Curvature
-Tumors
-Pseudoarthrosis
-Revision of previous cervical and upper thoracic spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.
The hooks, connectors, 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.
The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) using connectors.
The Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to introduce occipital plate and connecting components to the previously cleared Pioneer Posterior CT System to expand the indications for the system as a whole and to build an OCT spinal construct.
The Pioneer Posterior OCT System components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F1537 cobalt chromium. Medical grade titanium alloy and cobalt chromium may be used together.
Below is an analysis of the provided text regarding the Pioneer Posterior Occipito-Cervico-Thoracic System. It focuses on acceptance criteria and the supporting study, where information is available.
Acceptance Criteria and Device Performance
The provided text focuses on the substantial equivalence of the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System to existing legally marketed predicate devices rather than defining specific acceptance criteria in terms of numerical performance metrics. The study conducted aimed to demonstrate that the device functions as intended and performs in a manner substantially equivalent to predicate systems.
The general acceptance criteria for spinal systems, as outlined by the FDA's "Guidance for Performance Data: Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004," involve mechanical testing. The device's performance was reported to meet these general criteria.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Dynamic Axial Compression | System functioned as intended and performed substantially equivalent to predicate systems. |
| Static Axial Compression | System functioned as intended and performed substantially equivalent to predicate systems. |
| Dynamic Torsion | System functioned as intended and performed substantially equivalent to predicate systems. |
| Static Torsion | System functioned as intended and performed substantially equivalent to predicate systems. |
| Biocompatibility | Components manufactured from medical grade ASTM F136 titanium alloy and ASTM F1537 cobalt chromium, implying biocompatibility consistent with predicate devices. |
Study Details
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Sample sizes used for the test set and the data provenance:
- The provided text does not specify numerical sample sizes for mechanical testing. It mentions "Testing was conducted in accordance with ASTM F2706 and ASTM F1798." These standards typically define testing methodologies including sample numbers.
- Data Provenance: The nature of the testing (mechanical, cadaver studies, computer modeling) indicates the data would be generated from laboratory settings and in vitro studies, rather than retrospective or prospective human clinical trials with specific country of origin. Cadaver studies would typically involve human anatomical specimens.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for the performance of a spinal implant system in this context would be its mechanical integrity and functional equivalence to predicate devices, established through engineering and biomechanical testing, not expert consensus on diagnostic images or clinical outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable to the type of mechanical and cadaver studies described. Adjudication methods are typically used in clinical studies or imaging studies where expert interpretation or consensus is required.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images with or without AI assistance). The device in question is a surgical implant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical spinal implant, not an algorithm or AI system. The testing described (mechanical, cadaver, computer modeling) is inherently "standalone" in the sense that it evaluates the device's physical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineered specifications, biomechanical properties, and established performance benchmarks for predicate devices. This is assessed through:
- Mechanical Testing Results: Adherence to ASTM F2706 and ASTM F1798 standards.
- Cadaver Studies: Likely assessing surgical feasibility, implant fit, and potentially initial stability in anatomical models.
- Computer Modeling: Predicting mechanical behavior and stress distribution.
- Dimensional Analysis: Confirming manufacturing tolerances.
- The "ground truth" for this device's performance is based on engineered specifications, biomechanical properties, and established performance benchmarks for predicate devices. This is assessed through:
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The sample size for the training set:
- This concept is not applicable here. A "training set" refers to data used to train machine learning models. This submission describes mechanical and in vitro testing of a physical medical device.
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How the ground truth for the training set was established:
- This concept is not applicable, as there is no training set for 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.