(29 days)
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The subject EXPEDIUM Spine System components consist of implants that are available in various geometries and sizes.
The provided document describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System, which is a medical device for spinal stabilization. The submission is primarily focused on demonstrating the substantial equivalence of the modified device to existing predicate devices.
Here's an analysis of the acceptance criteria and study information contained in the document, based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | The device's mechanical performance was characterized by testing according to recognized ASTM standards. |
| Biocompatibility | Implied through the use of implant grade materials (ASTM F 138 and ASTM F 2229 stainless steel, ASTM F 136 titanium alloy), which are known to be biocompatible for medical implants. |
| Substantial Equivalence to Predicate Devices | The FDA determined the device to be substantially equivalent to legally marketed predicate devices, indicating it meets existing safety and effectiveness standards. |
Study that Proves the Device Meets Acceptance Criteria:
The document states: "Performance data per ASTM F 1717 and ASTM 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification."
- ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model. This standard evaluates the static and fatigue properties of spinal implant constructs used in corpectomy procedures.
- ASTM F 1798: Standard Guide for Evaluating the Fatigue Properties of Spinal Implants – refers to the evaluation of fatigue properties specifically (though the provided excerpt only mentions "ASTM 1798" without "F" and full title, this is the most likely relevant standard).
These tests evaluate the mechanical strength, durability, and stability of the spinal implant components under simulated physiological loading conditions. Successful completion of these tests with results comparable to, or better than, predicate devices demonstrates that the device meets the necessary mechanical performance acceptance criteria. The use of implant-grade materials (ASTM F 138, ASTM F 2229, ASTM F 136) inherently addresses biocompatibility criteria as these materials are well-established for implant use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the number of implants or constructs tested for the performance data (ASTM F 1717 and ASTM F 1798). Test standards typically provide guidance on sample sizes, but the exact numbers used are not detailed here.
- Data Provenance: The studies are laboratory-based mechanical tests performed on the device components. The data provenance is internal to DePuy Spine, Inc. (the manufacturer) and is not clinical data from patients (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for mechanical performance tests is defined by the objective physical and material properties measured against established engineering standards (ASTM F 1717, ASTM F 1798), not by expert human interpretation or consensus.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical tests rely on instrumental measurements and defined pass/fail criteria from engineered standards, not on human adjudication of results.
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 submission is for a physical medical implant (spinal fixation system), not an AI-powered diagnostic or assistive device where MRMC studies would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This is not applicable. This is not an algorithmic device.
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 physical measurements. Specifically:
- Compliance with ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) to evaluate static and fatigue properties.
- Compliance with ASTM F 1798 (Standard Guide for Evaluating the Fatigue Properties of Spinal Implants).
- Use of implant-grade materials (ASTM F 138, ASTM F 2229, ASTM F 136) with documented acceptance criteria for their physical and chemical properties and biocompatibility.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. The testing is for verification and validation against specified performance requirements.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
§ 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.