(138 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic 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, and 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 Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.
The Streamline OCT Occipito-Cervico-Thoracic 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 add components to the system.
This is a medical device submission (K133374) for the Streamline OCT Occipito-Cervico-Thoracic System, which is a spinal fixation system. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through various comparisons, including pre-clinical testing.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Benchmarking against predicates) | Reported Device Performance and Comparisons |
|---|---|
| Mechanical Performance: |
- Static and Dynamic Compression Bending and Torsion Testing (per ASTM F1717)
- Interconnection mechanisms and subassemblies testing (per ASTM F1798) | Pre-Clinical Performance Data:
- Subject system evaluated per ASTM F1717.
- Subject system evaluated per ASTM F1798.
- Conclusion: "Testing demonstrated that the device is as safe, as effective and performs as well as or better than predicate systems." |
| Technological Characteristics: - Intended use
- Basic design (rod-based with screw/hook/plate anchors and connecting components)
- Materials (Titanium alloy and cobalt chromium alloy)
- Sizes (dimensions comparable to predicates)
- Sterilization and cleaning methods
- Performance (equivalent mechanical test results) | Technological Characteristics:
- "The subject and predicate systems are overall similar in: Intended use, Basic design, Materials, Sizes, Sterilization and cleaning methods, Performance (equivalent mechanical test results)."
- "The fundamental scientific technology of the subject system is the same as predicate devices." |
| Material Equivalence: - Medical grade ASTM F136 titanium alloy
- Medical grade ASTM F71537 cobalt chromium alloy | Materials:
- "The system components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F71537 cobalt chromium alloy."
- "Medical grade titanium alloy and cobalt chromium alloy may be used together." |
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Sample size used for the test set and the data provenance:
The provided text describes pre-clinical performance data which typically refers to laboratory or bench testing, not human subject testing. Therefore, there is no "test set" in the sense of patient data. The "samples" would be the spinal implant components themselves, tested in a lab setting. The provenance is the testing conducted by Pioneer Surgical Technology, Inc. There is no information regarding the number of components tested in the provided summary. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable as the "testing" described is mechanical bench testing, not expert review of clinical data to establish ground truth. The "ground truth" here is the specific mechanical properties and failure points determined by the standardized ASTM tests. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used for clinical studies involving interpretation of data by multiple experts. This submission focuses on engineering and mechanical testing. -
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 spinal implant, not an AI-powered diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a spinal implant. Performance is evaluated through mechanical testing and comparison to predicate devices, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is defined by the objective, quantitative criteria established in the ASTM standards (ASTM F1717 and ASTM F1798). These standards define acceptable levels of performance for spinal fixation devices related to static and dynamic compression, bending, torsion, and connector integrity. -
The sample size for the training set:
Not applicable. This is a medical device submission for a physical implant, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable (no training set for an AI 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.