(44 days)
When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.
When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.
Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.
The provided document is a 510(k) summary for the Aesculap Spine System® Evolution Additional Components, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to pre-existing spinal fixation systems rather than proving device performance against specific acceptance criteria through a clinical study or even extensive standalone performance testing as would be expected for an AI/ML device.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving performance are not applicable or not present in this type of regulatory submission for a medical device from that era.
Here's an attempt to answer based on the provided document, highlighting what is (and isn't) present:
Acceptance Criteria and Study to Prove Device Performance (Aesculap Spine System® Evolution Additional Components)
This submission demonstrates substantial equivalence of the Aesculap Spine System® Evolution Additional Components to previously marketed spinal implant systems. The "performance data" presented is primarily mechanical testing, typical for hardware medical devices, rather than a study proving performance against acceptance criteria as might be expected for an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established through Predicate Device Equivalence) | Reported Device Performance (from mechanical testing) |
|---|---|
| Material Composition: Titanium alloy (Ti6Al4V) in accordance with ISO 5832/III. | The implants "are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III." |
| Mechanical Performance: Performance equivalent to predicate devices when subjected to spinal implant construct testing. | Subjected to mechanical testing according to ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model). (Specific numerical results are not provided in this summary, but the implication is that it met the expected performance for such tests). |
| Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for specific conditions (degenerative spondylolisthesis, fracture, scoliosis, etc.). Also, for severe spondylolisthesis (grades 3 and 4) of L5-S1 and as a non-pedicle screw system for degenerative disc disease, kyphosis, etc. | The device is intended for these uses. The substantial equivalence argument implies it performs adequately for these indications, similar to predicate devices. |
| Design and Function: Substantially equivalent in design and function to predicate devices. | Aesculap believes the components are "substantially equivalent in design, material composition, function and intended use" to listed predicate devices. |
Note: For a traditional hardware device like this, "acceptance criteria" are often met by demonstrating adherence to recognized standards (like ISO for materials, or ASTM for mechanical testing) and by showing substantial equivalence to devices already legally on the market that have demonstrated safe and effective performance. Specific quantitative performance metrics for clinical outcomes against predefined thresholds are not typically part of a 510(k) summary for such devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML device's test set. For mechanical testing, the "sample size" would refer to the number of components or constructs tested in a lab setting. This information (specific number of samples tested for ASTM F 1717-96) is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device. The "performance data" refers to in vitro mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical spinal implant system, not a diagnostic AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process is described for this type of mechanical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for AI/ML diagnostic tools that impact human reader performance. This is a spinal implant, so such a study was not performed or described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical implant, not an algorithm. The "standalone performance" is related to its mechanical integrity, which was assessed via in vitro ASTM F 1717-96 testing. The results of this testing are not detailed in the summary, simply that it was performed.
7. Type of Ground Truth Used
Not applicable in the context of typical AI/ML ground truth.
For this device, "ground truth" would be established by:
- Adherence to material standards (ISO 5832/III).
- Results of mechanical testing (ASTM F 1717-96) demonstrating structural integrity and fatigue life, often compared against specified limits or predicate device performance.
- The established safety and effectiveness track record of the predicate devices to which it claims substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI/ML algorithm.
§ 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.