(305 days)
The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture. dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The KAPSS® Spinal System consists of longitudinal members (rods), anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
The KAPSS® Spinal System is a medical device designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. This response summarizes the acceptance criteria and the study proving the device meets these criteria as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static compression bending tests per ASTM F1717. Dynamic compression bending tests per ASTM F1717. Static torsion tests per ASTM F1717. | "The mechanical test results demonstrated that KAPSS® Spinal System performs as well as or better than the predicate devices." |
| Technological Equivalence | Intended Use (as described). Basic design (rod-based fixation system having monoaxial and polyaxial pedicle screws and various hook shapes and sizes). Material (titanium alloy). Sizes (rod and screw sizes encompassed by predicate systems). | "The KAPSS® Spinal System possesses the same technological characteristics as the predicate devices. The fundamental scientific technology of the KAPSS® Spinal System is the same as previously cleared devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical performance testing rather than a clinical study involving human subjects or medical image data. Therefore, the concept of a "test set" for data provenance in the traditional sense (e.g., country of origin of data, retrospective/prospective) is not applicable here.
For the mechanical tests conducted:
- Sample Size (Test Set): The document does not specify the exact number of constructs tested for each type of mechanical test (static compression bending, dynamic compression bending, static torsion). It refers to "KAPSS® Spinal System constructs" generally.
- Data Provenance: The tests were performed "according to ASTM F1717," which is an international standard from ASTM International (originally American Society for Testing and Materials). This implies a controlled laboratory setting, testing physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study involved mechanical performance testing of physical devices against engineering standards (ASTM F1717), not clinical data requiring expert review for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as this was mechanical testing against a standard and not a clinical study requiring adjudicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study described is mechanical testing of medical device components.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical spinal system, not an algorithm or AI software, so the concept of "standalone performance" in that context does not apply. The performance evaluated was the standalone mechanical performance of the device constructs themselves.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by engineering standards and predicate device performance comparison through mechanical testing. Specifically:
- Adherence to ASTM F1717 standards for various mechanical tests.
- Performance "as well as or better than the predicate devices" in those mechanical tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.