(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; pseudarthrosis; and failed previous fusion.
The subject EXPEDIUM™ Spine System components are designed to accept a 4.5mm rod and are available in various geometries and sizes.
The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. This document is a premarket notification for a medical device and thus concerns the regulatory approval process rather than a study proving the device meets acceptance criteria through clinical or AI-related performance metrics.
The "Performance Data" section explicitly states: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which tests mechanical properties like static and fatigue strength. This indicates that the "acceptance criteria" here are likely related to meeting specific mechanical performance standards as defined by ASTM F1717, rather than clinical or "AI-related" performance criteria.
Therefore, many of the requested details in your prompt (such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical spinal implant system, not an AI-powered diagnostic or therapeutic device.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Mechanical Performance | "Performance data per ASTM F 1717 were submitted" to "characterize the subject EXPEDIUM™ Spine System components." |
Explanation: The document does not provide specific numerical acceptance criteria values or detailed performance results (e.g., maximum load, cycles to failure). It only states that data per the ASTM F1717 standard were submitted, implying the device met the requirements of this standard for mechanical characterization.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. ASTM F1717 outlines testing methodologies, which typically involve a specified number of samples for mechanical testing, but the exact number used for this submission is not detailed.
- Data provenance: The testing was conducted to characterize the "subject EXPEDIUM™ Spine System components," implying in-vitro mechanical testing of the device itself.
- Country of origin: Not explicitly stated, but the submission is to the U.S. FDA by DePuy Spine, Inc. (a U.S.-based company), suggesting the testing was likely conducted in the U.S. or by a lab that adheres to U.S. regulatory standards.
- Retrospective or prospective: This is mechanical (in-vitro) testing of hardware, not clinical data, so the terms "retrospective" or "prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for mechanical performance is defined by the physical properties measured according to the ASTM F1717 standard.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human judgment or adjudication.
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 device is a physical spinal implant system, not an AI-powered system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal implant system, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is the objective, measurable mechanical properties determined through standardized in-vitro testing (ASTM F1717).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.