(235 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. Spine System® Evolution consists of pedicle screws (monoaxial and polyaxial), rods, linking plates, lateral connectors, and other implant components used to lock the desired construct in place. 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 acceptance criteria for the Aesculap Spine System® Evolution are not explicitly stated in terms of quantitative metrics suitable for a table format as might be seen for AI/ML device performance. Instead, the "acceptance criteria" for this traditional medical device are implicitly linked to its substantial equivalence to predicate devices and its ability to withstand specific mechanical tests, without failure, under certain conditions.
The study proving the device meets these criteria is a mechanical testing study.
Here's the information broken down based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in design, material, function, and intended use as current marketed spinal implant systems. | Device components are substantially equivalent to: Spine System® by Aesculap (K962757, K953599, K935113), CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633), Mirage™ Spinal System by Alphatec (K951846), Moss® Miami Titanium Spinal System by Depuy Motech™(K980447, K955348), Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631). |
| Device components must withstand mechanical testing according to ASTM Standard F 1717-96 without failure (implied). | "The components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model)." The text implies successful completion, as it led to 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of patients or cases. The "test set" consists of the physical device components (pedicle screws, rods, linking plates, lateral connectors) that were subjected to mechanical testing. The number of individual components tested is not specified but would be a representative sample for mechanical validation.
- Data Provenance: The device components themselves (manufactured from titanium alloy (Ti6Al4V) in accordance with ISO 5832/III) are tested. The test methodology is an internationally recognized standard (ASTM F 1717-96). This is a prospective test conducted on manufactured device units. No information on country of origin of data, as it's a mechanical test of components, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device. The "ground truth" for mechanical testing is established by recognized engineering standards (ASTM F 1717-96) and the physical properties of the materials and device design. There are no human experts "establishing ground truth" in the way clinical studies use them for diagnoses or interpretations.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined standards.
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
This is not applicable. This is a traditional spinal implant device, not an AI/ML-driven diagnostic or assistive device, and therefore no MRMC studies involving human readers or AI assistance were performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical spinal implant system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on engineering standards and material science properties. Specifically, the ability of the device components to withstand static and fatigue loads as defined by ASTM Standard F 1717-96 is the "ground truth" for its mechanical performance.
8. The Sample Size for the Training Set
This is not applicable. There is no concept of a "training set" for a traditional mechanical medical device. The design process involves engineering principles and prior knowledge of materials, but not structured data "training" in the AI/ML sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set mentioned 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.