(247 days)
The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® X Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The CarboClear® X Pedicle Screw System is 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, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available.
The implants are supplied sterile, and are intended for single use.
The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
The provided text describes the 510(k) premarket notification for the CarboClear® X Pedicle Screw System. This document is a regulatory submission for a medical device, specifically spinal implants. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices already on the market.
Crucially, this document does not describe studies proving device meets acceptance criteria related to AI/software performance or diagnostic accuracy. It primarily discusses the mechanical performance and material equivalence of a physical implant system (pedicle screws) to predicate devices, and an expansion of its indications for use.
Therefore, many of the requested items related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained within this regulatory submission.
However, I can extract information relevant to the device's performance as understood in the context of this specific regulatory submission for a physical medical device:
Acceptance Criteria and Device Performance (Mechanical/Physical)
For this type of medical device (pedicle screws), "acceptance criteria" and "performance" relate to mechanical and material characteristics rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test Standard | Performance/Result | Notes |
|---|---|---|---|
| Mechanical Stability | ASTM F1717 | Results comparable to predicate devices. | Includes static and dynamic tests for spinal implant constructs. |
| Axial Gripping Capacity | ASTM F1798 | Results comparable to predicate devices. | Relates to the ability of the screws to grip the bone. |
| Torsional Gripping Capacity | ASTM F1798 | Results comparable to predicate devices. | Relates to the rotational stability of the screws in the bone. |
| Static Flexion-Extension | ASTM F1798 | Results comparable to predicate devices. | Simulates spinal movement. |
| Material Equivalence | Not explicit standard, but inferred | Components (pedicle screws, rods, locking elements) made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). Threaded portion of screws encased in thin titanium shell. Tantalum markers may be included. Titanium alloy rod also available. | Compared to predicate devices, especially the primary predicate, the subject device's implant components are "the same." |
| Geometric Equivalence | Not explicit standard, but inferred | Subject device includes "longer rods" compared to primary predicate. Otherwise, implant components are "the same." | This is the basis for the "expansion of indications for use." |
2. Sample size used for the test set and data provenance:
- The document mentions "Performance Data" from mechanical tests (ASTM F1717, ASTM F1798). It does not specify the sample size for these tests (e.g., number of constructs tested, number of screws).
- The data provenance is not explicitly stated beyond being part of this 510(k) submission by CarboFix Orthopedics Ltd. (Israel-based company). It's scientific laboratory data gathered for regulatory purposes, typically conducted in a controlled lab environment. It is prospective testing for the submission, not retrospective data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM standards) and the physical measurements obtained from those tests, not by expert human interpretation.
4. Adjudication method for the test set:
- Not applicable for mechanical testing.
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 as this is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/software device.
7. The type of ground truth used:
- The "ground truth" for this device's performance relies on objective physical measurements derived from standardized mechanical testing (e.g., load-displacement curves, fatigue life) compared against established performance benchmarks within the specific ASTM standards for spinal implants and demonstrating comparability to predicate devices.
8. The sample size for the training set:
- Not applicable as this is not an AI/software device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/software device.
Summary regarding the provided document:
The provided document (a 510(k) clearance letter and summary) is for a physical medical device (pedicle screw system), not an AI/software device. As such, the "acceptance criteria" and "performance studies" described are entirely focused on the mechanical and material properties of the implant, demonstrating its substantial equivalence to already cleared devices. The detailed questions about AI, ground truth, experts, and MRMC studies are not relevant to the content of this specific regulatory submission.
§ 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.