(97 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,
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trauma (i.e., fracture or dislocation),
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spinal stenosis,
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deformities or curvatures (i.e., scoliosis, and/or lordosis),
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tumor.
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pseudoarthrosis, and
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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, and fixed and adjustable rod to 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 a spinal implant system (Aesculap® Implant Systems S4 Spinal System), not a device that relies on algorithms or image analysis. Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment methods) are not applicable to this type of medical device submission.
The acceptance criteria for this device are based on mechanical performance and material characteristics, and its substantial equivalence to previously cleared devices.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Static and dynamic compression bending testing in accordance with ASTM F1717 | Results were found to be similar to other legally marketed predicate devices. | This indicates the device meets the mechanical strength and durability standards expected for spinal fixation systems. |
| Material Composition | Manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2 | All components are manufactured from Titanium and Titanium Alloy. | Confirms the materials used meet the specified biocompatibility and mechanical standards for medical implants. |
| Design Characteristics | Similar shapes and sizes to predicate devices; top loading and top tightening components. | Components are offered in similar shapes and sizes as the predicate devices. All implant components are top loading and top tightening. | Demonstrates consistency in design principles and functional aspects with established devices. |
| Indications for Use | Intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for specific conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities/curvatures, tumor, pseudoarthrosis, failed previous fusion). | The system is indicated for the listed conditions in skeletally mature patients, as an adjunct to fusion. | The proposed indications align with those of predicate devices and are deemed appropriate for the device's design and materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A). This submission pertains to a spinal implant system, not a data-driven diagnostic or AI device. The "test set" here refers to physical components undergoing mechanical testing, not a dataset of patient information. The document does not specify the number of samples used for ASTM F1717 testing, nor the data provenance in the context of clinical data.
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)
- Not applicable (N/A). "Ground truth" in this context would typically refer to clinical outcomes or diagnoses. For mechanical testing, the "ground truth" is established by adherence to a standardized test method (ASTM F1717). Experts are involved in developing and interpreting such standards, but not in establishing ground truth for individual test sets in the way it's done for AI models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A). Adjudication methods like 2+1 are used for resolving disagreements among multiple human readers for diagnostic tasks. Since this is a mechanical device, such methods are not relevant.
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 (N/A). MRMC studies are for evaluating diagnostic accuracy, especially with AI systems. This is a physical implant, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable (N/A) for clinical "ground truth." For the mechanical performance, the "ground truth" is defined by the ASTM F1717 standard and the performance of legally marketed predicate devices. The material composition "ground truth" is established by adherence to ISO 5832/3 and ISO 5832/2 standards.
8. The sample size for the training set
- Not applicable (N/A). This is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable (N/A). As above, this is not an AI model.
Summary of the Study:
The study that proves the device meets the acceptance criteria is a mechanical performance study adhering to the ASTM F1717 standard for static and dynamic compression bending testing. The results of this testing were compared against the performance of predicate devices, and the S4 Spinal System was found to exhibit similar performance characteristics.
Additionally, the device's adherence to material standards (ISO 5832/3 and ISO 5832/2 for Titanium and Titanium alloy) and its similar design characteristics and indications for use to previously cleared predicate devices (S4 Spinal System, Blackstone Pedicle Screw System, Stryker XIA 3 Spinal System, and Depuy Expedium Spine System) form the basis of its acceptance and clearance via the 510(k) pathway for substantial equivalence. No clinical studies are referenced as part of this premarket notification.
§ 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.