(67 days)
The CarboClear® Pedicle Screw System is intended to provide rigid immobilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level 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® Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone graff.
The CarboClear® 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 CarboClear® implants include pedicle screws, rods and locking elements. 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. The implants include tantalum markers. The implants are supplied sterile, and are intended for single use.
The provided text describes the CarboClear® Pedicle Screw System, a medical device for spinal stabilization, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as might be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and study methodology for proving device performance through such studies is not available in this document.
However, based on the provided text, here's what can be extracted regarding performance and substantiation:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices in static and dynamic tests. | Performance testing (per ASTM F1717, F1798, F2193, F543, fatigue lateral bending-axial rotation, rod creep tests): "The test results were found to be comparable to those of predicate devices, as applicable, demonstrating substantially equivalent mechanical performance of the subject system." |
| Clinical performance comparable to predicate devices for the specified indications for use. | Clinical data: "Clinical data for the CarboClear® Pedicle Screw System was presented for the target population specified in the indications for use statement, and supports the substantially equivalent performance of the subject system." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Instead, it refers to "Performance data" and "Clinical data."
- Performance Data (Mechanical Testing): The sample size for mechanical tests (e.g., number of screws, rods tested) is not provided. The data provenance is laboratory testing conducted according to ASTM standards. Country of origin not specified, but the applicant is based in Israel.
- Clinical Data: The sample size for clinical data (e.g., number of patients) is not provided. The provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of submission described. The document does not describe a study involving expert-established ground truth for a test set, as would be relevant for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of an adjudication method as it relates to expert review of a test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a physical pedicle screw system, not an AI/ML-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" is established by adherence to recognized ASTM standards and comparison to predicate device performance. For clinical performance, the "ground truth" would likely be patient outcomes, but the specific type of clinical ground truth (e.g., imaging follow-up, functional scores, fusion rates) is not detailed.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML model that requires a training set with established ground truth.
§ 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.