(181 days)
The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).
The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.
The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.
The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated.
The previously cleared indications for use are unchanged.
This document is a 510(k) premarket notification for the GII OstaPek® Plate from COLIGNE AG. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria and reported device performance in the way typically expected for an AI/ML device.
This submission is for a medical implant (spinal fixation system), not a software/AI device that would involve performance metrics like sensitivity, specificity, or accuracy based on human interpretation or algorithm output. The "acceptance criteria" here refer to compliance with material, mechanical, and biocompatibility standards, which are physical tests rather than clinical study results comparing algorithm performance.
Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document. I will answer the applicable points based on the information provided.
1. Table of acceptance criteria and the reported device performance
For this medical implant, acceptance criteria and performance are related to physical and biological properties.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Material Standards | Compliance with material standards | Devices produced of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments. Eliminates concerns about mixing dissimilar metals or galvanic/corrosive interaction. |
| Mechanical Testing | Compliance with mechanical testing standards | Fatigue and static testing complete. Test results demonstrate new plates perform equivalently or superiorly to previously cleared GII Spinal Fixation System plates. |
| Biocompatibility | Compliance with biocompatibility standards | Biocompatibility testing complete. |
| Labeling | Specific warnings and precautions | Labeling contains required warnings and precautions. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for mechanical and biocompatibility testing. These tests typically involve a specific number of samples per test type according to the relevant standards (e.g., n=5 or n=10 per test for fatigue).
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of device performance testing. The company is based in Zurich, Switzerland, and the submission is to the US FDA. The testing would have been conducted in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. Ground truth for mechanical and biocompatibility testing is established through standardized laboratory methods and measurements, not by human expert consensus or clinical interpretation.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Standardized lab tests have defined pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No. This is not a diagnostic device or an AI/ML software; it is a physical implant. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For this device, ground truth is established through:
- Validated Physical Measurements: Mechanical properties (e.g., strength, fatigue life) are measured using calibrated testing equipment against established engineering standards (e.g., ASTM standards).
- Biocompatibility Testing: Assessed through in-vitro and in-vivo biological response tests following ISO standards.
- Material Characterization: Chemical composition and properties verified against material specifications.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. The "development" would involve engineering design and prototyping, not data training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. See point 8.
§ 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.