(64 days)
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:
1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2) spondylolisthesis,
3) trauma (i.e., fracture or dislocation),
4) spinal stenosis,
5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6) tumor,
7) pseudoarthrosis, and
8) failed previous fusion.
The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.
The provided document describes the Aesculap® Implant Systems (AIS) S4 Spinal System Modification Lateral Offset Connectors and its premarket notification (K130291). The study proving the device meets acceptance criteria is a non-clinical performance study comparing the modified device to predicate devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Static Axial Compression Bending (per ASTM F1717-12) | "meet or exceed the performance of the predicate devices" |
| Dynamic Axial Compression Bending (per ASTM F1717-12) | "meet or exceed the performance of the predicate devices" |
| Static Torsion (per ASTM F1717-12) | "meet or exceed the performance of the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "non-clinical testing" was performed, which typically suggests a laboratory-based test with a specific number of samples for each test type, but the exact count is not provided.
- Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This was a non-clinical, mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance data itself, measured according to industry standards.
4. Adjudication Method for the Test Set
- Not applicable. This was a non-clinical, mechanical performance study. Adjudication methods are typically associated with clinical studies involving interpretation of data or images by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document describes a non-clinical mechanical performance study, not a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical spinal implant component, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Mechanical performance data a per ASTM standards: The ground truth for this study was the quantifiable mechanical performance (e.g., strength, stiffness, fatigue resistance) measured according to the specified ASTM F1717-12 standards.
8. The Sample Size for the Training Set
- Not applicable. This was a mechanical performance study, not a machine learning or AI study that would typically involve a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this was a mechanical performance study, not an AI study.
Summary of the Study:
The study conducted was a non-clinical performance study on the S4 Lateral Offset Rod Connectors. It involved standardized mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) as recommended by FDA Guidance for Spinal System 510(k)s and according to ASTM F1717-12. The acceptance criterion was that the modified device "meet or exceed the performance of the predicate devices" in these tests. The results demonstrated that the device successfully met this criterion, leading to a determination of substantial equivalence.
§ 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.