(221 days)
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 in skeletally mature patients.
The subject EXPEDIUM™ Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes.
The provided text describes a 510(k) submission for the EXPEDIUM™ Spine System, a medical device for spinal fixation. It details the device's intended use, materials, and a summary of performance data. However, it does not explicitly state acceptance criteria or a comprehensive study report with the specific details requested in your prompt regarding device performance, sample sizes, ground truth establishment, or expert involvement.
The document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a detailed clinical or standalone performance study.
Here's what can be extracted and what cannot be provided given the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." |
- Explanation: The document mentions that performance data per ASTM F 1798 was submitted, implying the device met the requirements of this standard for characterizing spinal system components. However, the specific acceptance criteria (e.g., minimum load to failure, fatigue life) from ASTM F 1798 and the actual measured performance values of the EXPEDIUM™ Spine System against those criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The performance data is stated to be "per ASTM F 1798," which is a standard for mechanical testing of spinal instrumentation, not typically involving patient data or clinical trials in the context of this 510(k) summary.
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. The "ground truth" in this context refers to mechanical performance data tested against a standard, not expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study assessing diagnostic performance or clinical outcomes requiring 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a spinal fixation system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in a sense, a "standalone" performance evaluation was done. The device components were mechanically tested "per ASTM F 1798" to characterize their performance independently. This is a standalone mechanical test, not a standalone AI algorithm performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance data would be the physical properties and mechanical behavior of the device components as measured by standardized mechanical tests outlined in ASTM F 1798. This typically involves measurements such as static and dynamic compressive strength, fatigue life, torsional strength, etc., defined by the standard.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
Summary of what the document provides regarding acceptance criteria and performance:
The document states that the EXPEDIUM™ Spine System's components were characterized by "Performance data per ASTM F 1798". This indicates that the device was subjected to the mechanical testing protocols specified by the ASTM F 1798 standard. For a 510(k) submission, meeting the requirements of such a recognized standard serves as evidence of safety and effectiveness, and by extension, fulfilling implied acceptance criteria for mechanical performance. The specific quantitative results or detailed acceptance thresholds required by DePuy Spine, Inc. for their device under ASTM F 1798 are not present in this summary.
§ 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.