(105 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 in skeletally mature patients.
Additional Component of the EXPEDIUM Spine System.
The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document is a 510(k) summary for the EXPEDIUM™ Spine System, specifically for additional components. It is a submission to the FDA for market clearance, not typically a publication of a clinical study with detailed performance metrics against acceptance criteria. Therefore, the information provided is limited to what's available in such a regulatory document.
Based on the provided text, a table of acceptance criteria and reported device performance from a clinical study cannot be constructed because the document does not describe acceptance criteria for diagnostic performance or a clinical study in the way typically seen for AI/software devices.
Instead, the document states:
"PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System."
This refers to engineering performance data for a physical medical device (spinal implants), not typically diagnostic performance as would be expected for an AI/software device. The FDA's 510(k) clearance in this context relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing, biocompatibility, and material characterization, rather than clinical efficacy studies with ground truth.
Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable or not present in this type of regulatory submission for a physical implantable device.
Here's an attempt to answer the questions based only on the provided text, noting where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for this Device in the provided text. The document describes a "Performance Data" section for "characterizing the additional components" which refers to engineering performance (mechanical, material, biocompatibility) rather than diagnostic accuracy or clinical efficacy. | Not Explicitly Stated for this Device in the provided text. The document only states "Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System." No specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds) are provided in this regulatory summary. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not provided. This document describes a physical medical device (spinal implant), not a diagnostic algorithm that would typically have a test set of data.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth establishment by experts is typically for diagnostic or AI devices, not for the performance data of a spinal implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This relates to diagnostic image interpretation or algorithm output, not the mechanical or material performance of a spinal implant.
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/Not provided. MRMC studies are for diagnostic interpretation (often with imaging and AI assistance), which is not the subject of this 510(k) summary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This document is not about an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. The "performance data" mentioned would likely be based on physical measurements, material properties, and mechanical tests, not a clinical ground truth as defined for diagnostic studies.
8. The sample size for the training set
- Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set with established ground truth.
Summary based on the provided text:
The provided document is a 510(k) summary for a physical medical device, the EXPEDIUM™ Spine System, an implantable spinal fixation device. The performance data mentioned refers to engineering tests and characterization (e.g., mechanical strength, biocompatibility, material properties) to demonstrate substantial equivalence to previously cleared predicate devices, not clinical efficacy or diagnostic performance. Therefore, the typical criteria and study design elements requested for an AI/software device or a diagnostic device are not present in this document.
§ 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.