(29 days)
The Sure-Lok C Extended Tab PSS System is 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Sure-Lok C Extended Tab Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
The Sure-Lok C Extended Tab PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws. All components are available in a variety of sizes to match more closely the patient's anatomy. The Sure-Lok C Extended Tab PSS System is suitable for the following procedures: open, mini-open, percutaneous MIS approach, or a combination of any during the same procedure. All components are made from medical grade stainless steel, titanium or titanium alloy which comply with such standards as ASTM F-138, ASTM F-136, ISO5832-1 or ISO5832-3. All components are supplied clean and "NON STERILE."
The provided text is a 510(k) summary for a medical device (Sure-Lok C Extended Tab Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding clinical study performance, sample sizes, expert ground truth, and comparative effectiveness is not applicable or not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found for an AI/algorithm-based device. Instead, it focuses on compliance with established engineering standards for mechanical and material properties.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ASTM F-138 (Medical Grade Stainless Steel) | Complies with standard |
| ASTM F-136 (Medical Grade Titanium/Titanium Alloy for Long Arm Cannulated Screw) | Complies with standard (specifically Ti-6AI-4V ELI) |
| ISO5832-1 (Implants for surgery - Metallic materials - Part 1: Wrought stainless steel) | Complies with standard |
| ISO5832-3 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy) | Complies with standard |
| ASTM F1717-12 (Spinal Implant Constructs in a Corpectomy Model) | Complies with standard (for mechanical performance overall) |
The justification for meeting these criteria is a statement of compliance with these recognized standards, rather than presenting detailed test reports. The document states: "Consistent with FDA's guidance document entitled "Use of Standards in Substantial Equivalence Determinations" (...) Precision Spine is including this statement that the Sure-Lok C Extended Tab Pedicle Screw System complies with the following recognized standards instead of providing the test reports demonstrating compliance with these standards."
2. Sample size used for the test set and the data provenance
Not applicable/Not available. No clinical test set or data provenance from patients is mentioned. The "study" here is demonstrating compliance with engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not available. No expert review or ground truth establishment relevant to an AI/algorithm is described. The ground truth for this type of device is compliance with material and mechanical standards.
4. Adjudication method for the test set
Not applicable/Not available. There is no test set in the context of an algorithm's performance review.
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/Not available. This device is a pedicle screw system, a physical implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant to its approval.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not available. This device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's approval is based on:
- Compliance with recognized engineering and material standards: ASTM F-138, ASTM F-136, ISO5832-1, ISO5832-3, and ASTM F1717-12. This establishes the physical and mechanical properties.
- Substantial Equivalence to predicate devices: The modifications (slightly increased length of extended tab screw, changed rod edges) are deemed not to raise new questions of safety or effectiveness because "The Sure-Lok C Extended Tab Pedicle Screw System has the same intended use and fundamental scientific technology as our previously cleared Pedicle Screw System devices."
8. The sample size for the training set
Not applicable/Not available. There is no "training set" in the context of a pedicle screw system as it is not an AI or learning algorithm.
9. How the ground truth for the training set was established
Not applicable/Not available. As there is no training set for an AI, this question is not relevant.
§ 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.