(506 days)
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
The provided text describes a 510(k) summary for the Pioneer Posterior Cable Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and standalone performance evaluations as would be expected for novel devices or software.
Therefore, much of the requested information regarding acceptance criteria, specific study details (sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document, as it falls outside the scope of a typical 510(k) summary focused on hardware equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Comprised of implant grade stainless steel (ASTM F138 and ISO 5832-1) | Implied to meet this, as the material is stated to be "Implant grade stainless steel (ASTM F138 and ISO 5832-1.)" |
| Mechanical Performance: Equivalent mechanical properties to predicate device. | "Mechanical information was presented to support a determination of PERFORMANCE SE [Substantial Equivalence]." (Specific metrics or thresholds not detailed). |
| Intended Use Equivalence: Similar intended use as predicate device. | "The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures." (Matches or is similar to predicate). |
| Design Equivalence: Similar to components of a previously cleared device. | "The Pioneer Posterior Cable Screw system is similar to the components of a previously cleared device." (Specific design details not provided). |
2. Sample Size used for the test set and the data provenance
- Not Applicable/Not Provided. The submission is for a mechanical spinal implant and focuses on substantial equivalence based on material and mechanical properties, not a clinical study on a test set of data (e.g., images for an AI device).
- Data Provenance: Not applicable. Performance is based on material standards and mechanical testing, not a dataset from a specific country or retrospective/prospective study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. This information is relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.
4. Adjudication method for the test set
- Not Applicable/Not Provided. No test set requiring expert adjudication is described.
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
- No. This is a hardware device (spinal implant), not a software/AI device. Therefore, an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device. "Standalone performance" in the context of AI algorithms is not relevant here. The "standalone" performance would be its mechanical integrity, which is assessed through testing that is not detailed in terms of its specific methodology or standalone vs. human-in-the-loop comparison.
7. The type of ground truth used
- Not Applicable/Not Provided in the typical AI/clinical study sense. For this device, "ground truth" relates to:
- Material composition: Confirmed by adherence to ASTM F138 and ISO 5832-1 standards.
- Mechanical performance: Confirmed through testing (implied by "Mechanical information was presented") against accepted engineering criteria, likely benchmarking against the predicate device.
- Clinical Efficacy/Safety: Not directly proven in this 510(k) summary; rather, it is inferred by substantial equivalence to a device with an established safety and efficacy profile.
8. The sample size for the training set
- Not Applicable/Not Provided. This pertains to AI/machine learning models, which is not the subject of this 510(k). For mechanical testing, the number of samples tested for mechanical properties is not specified.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. As there's no AI "training set" described, this question is not relevant. The "ground truth" for the device's material and mechanical properties would be established through accredited laboratory testing and adherence to recognized material and performance standards.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.