(103 days)
The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 - T3 inclusive). The indications for use are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- . Trauma (i.e., fracture or dislocation),
- Spinal Stenosis, .
- Failed previous fusion, .
- Revision of previous cervical spine surgery,
- Spinal tumors.
The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
The Certex Spinal Implant System consists of screws, hooks, rods, and cross connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex Spinal Implant System is manufactured from Titanium alloy in accordance with ASTM F136 and will be provided non-sterile. All implants are intended for single use only and should not be reused under any circumstances.
The provided text describes a medical device, the Certex™ Spinal Implant System, and its substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/machine learning performance.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set data) cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided document:
Acceptance Criteria and Device Performance Study
The primary "acceptance criteria" discussed in this 510(k) summary pertain to demonstrating substantial equivalence to predicate devices, particularly in terms of mechanical performance and intended use. The study conducted to prove this equivalence was a biomechanical testing study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (from Biomechanical Testing) |
|---|---|
| Meets ASTM F1717 standards for spinal implant constructs | Performed "substantially equivalent to predicate device performance" |
| Static Compression Bending performance | Tested (specific results not provided, but deemed equivalent) |
| Static Torsion performance | Tested (specific results not provided, but deemed equivalent) |
| Dynamic Compression Bending performance | Tested (specific results not provided, but deemed equivalent) |
| Capable of safely and effectively performing | Demonstrated capability to perform safely and effectively |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the biomechanical tests. Biomechanical testing typically uses a certain number of samples of the device components.
- Data Provenance: The document does not specify country of origin or if the data was retrospective or prospective, as it's a materials/mechanical performance test rather than a clinical study on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to biomechanical testing where performance is measured against engineering standards (ASTM F1717) rather than human interpretation.
4. Adjudication method for the test set
- Not applicable to biomechanical 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
- No MRMC or AI-related studies were mentioned. This is a spinal implant system, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant.
7. The type of ground truth used
- The "ground truth" for the biomechanical testing was the established engineering standards outlined in ASTM F1717 and the performance of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.