(28 days)
The CarboClear® Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CarboClear® II Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CarboClear® and CarboClear® II Pedicle Screw Systems are composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The implants include pedicle screws, rods, locking elements and transverse connectors. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker.
The implants are supplied sterile, and are intended for single use.
This document is a 510(k) Premarket Notification and does not describe acceptance criteria for a device's performance based on clinical study data, nor does it detail a study proving such performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing rather than clinical outcomes or diagnostic accuracy.
Therefore, many of the requested elements (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth for training/test sets) are not applicable or findable within this document, as they relate to clinical or AI/diagnostic performance studies, which were not the basis for this specific device clearance.
The "device" in this context is a CarboClear® Pedicle Screw System and CarboClear® II Pedicle Screw System, which are medical implants. The "performance" being evaluated here is primarily mechanical performance, not diagnostic accuracy or human-in-the-loop improvement for complex medical tasks often associated with AI/diagnostic devices.
Here's an attempt to answer the questions based on the provided document, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative "acceptance criteria" in the way one might for a diagnostic device (e.g., minimum sensitivity/specificity). Instead, it states that the performance characteristics (mechanical) were evaluated against standards, and the results were comparable to predicate devices. This implies the acceptance criterion was "comparable mechanical performance" as demonstrated by meeting specified ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices and meeting relevant ASTM standards. | "The results of the tests are comparable to those of the predicate devices, as applicable, demonstrating substantially equivalent mechanical performance of the subject device." Specific quantitative results (e.g., fatigue strength, pull-out force) are not provided in this summary, only that they met the standard of comparability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify mechanical test sample sizes. Mechanical testing typically involves a set number of samples per test condition (e.g., n=6 for fatigue testing). These are in vitro tests, not patient data.
- Data Provenance: Not applicable for a mechanical performance study. The tests were performed in vitro to ASTM standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth and expert review are relevant for diagnostic or AI performance studies involving interpretation of medical data. This document describes mechanical testing of an orthopedic implant.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies. This is a mechanical performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
No. An MRMC study is relevant for diagnostic performance, evaluating how human readers perform with or without AI assistance on medical cases. This document covers mechanical testing of a pedicle screw system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based diagnostic device. The performance refers to the physical mechanical properties of the implant itself.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic "ground truth." For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F1717, F1798, F2193, F543) and demonstrable equivalence to predicate devices under these test conditions.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of why requested information is largely absent:
The provided text is a 510(k) summary for a pedicle screw system, which is an implantable medical device. The clearance is based on substantial equivalence to existing predicate devices, primarily demonstrated through mechanical performance testing (in vitro engineering tests) rather than clinical studies or diagnostic accuracy evaluations. Many of the questions posed directly relate to the methodology of AI/diagnostic device studies (e.g., human reader performance, training/test sets, expert ground truth, MRMC studies), which are not performed for this type of device clearance.
§ 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.