(185 days)
When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
- Spondylolisthesis
- Spinal Stenosis
- Fracture/dislocation
- Failed previous fusion
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- Tumors
The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.
The AIS® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occiptio-cervico-thoracic junction (occiput-T3). The AIS® S4 Cervical Occipital Plate Spinal System consists of plates, bone screws, rods, hooks, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS® S4 Cervical Occipital Plate Spinal System is manufactured from Titanium Alloy and will be provided non-sterile.
The provided text is a 510(k) summary for the Aesculap S4 Cervical Occipital Plate Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It is not a study that proves a device meets acceptance criteria in the context of AI/ML performance, diagnostic accuracy, or human factor studies.
Therefore, many of the requested fields are not applicable to the information provided in this document.
Here's an attempt to answer the questions based on the available text:
Acceptance Criteria and Device Performance Study for the Aesculap S4 Cervical Occipital Plate Spinal System
This submission is a 510(k) for a spinal implant system. The "acceptance criteria" here refers to the device's ability to meet industry standards for mechanical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Device Performance (Metric) | Reported Performance |
|---|---|---|
| Mechanical Performance (In accordance with ASTM standards) | ||
| Static Compression Strength | Passed (ASTM F1717) | "Testing results demonstrate the Aesculap Implant Systems S4 Spinal System is safe and effective." |
| Static Torsion Strength | Passed (ASTM F2067) | |
| Compression Bending Strength | Passed (ASTM F543) | |
| Torsion Fatigue Resistance | Passed | |
| Screw Pull-out Strength | Passed |
Note: The document states the device was performed in accordance with the listed ASTM standards and that results demonstrate safety and effectiveness. It does not provide specific numerical acceptance criteria or performance values beyond this qualitative statement.
2. Sample size 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 the sample size (number of implants tested) for the mechanical performance tests. The data provenance is also not specified, as these are in-vitro mechanical tests, not clinical data from patients.
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 is not applicable. "Ground truth" in the context of expert consensus is relevant for studies involving diagnostic accuracy or image interpretation. For mechanical testing of a spinal implant, the "ground truth" is defined by the physical properties and engineering specifications measured in a laboratory setting against established ASTM standards. No human experts are used to establish ground truth in this type of study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by human readers). Mechanical testing is objective.
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
Not applicable. This is a spinal implant, not an AI/ML powered diagnostic device, nor a device that involves human readers for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (spinal implant), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical performance testing would be the quantitative measurements obtained from the various tests (static compression, torsion, bending, fatigue, pull-out) and their comparison against the specifications outlined in the referenced ASTM standards (F1717, F2067, F543).
8. The sample size for the training set
Not applicable. Mechanical testing for substantial equivalence does not involve "training sets" as understood in AI/ML.
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.