(36 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 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification
The provided text is a 510(k) summary for a medical device called the EXPEDIUM™ Spine System. This document focuses on the regulatory submission process and the substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria and results as typically seen in an AI/ML device submission.
Therefore, many of the requested details about acceptance criteria, study design, and AI-specific metrics (like sample size for test/training sets, ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not present in the provided text.
Here's an attempt to extract the information that is available and note what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the format of a clinical or performance target. The submission focuses on substantial equivalence to predicate devices. | "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." |
Note: The document implies that the device's performance, as characterized by ASTM F 1798 standards, was sufficient to demonstrate substantial equivalence to the predicate devices. The specific thresholds or performance metrics from ASTM F 1798 are not detailed here, only that the data was submitted.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not provided. This is a spinal implant, not an AI/ML diagnostic device with a "test set" in the context of image analysis. The "performance data" likely refers to mechanical testing of the implant components.
- Data Provenance: Not applicable/Not provided in the context of clinical data for an AI/ML device. The performance data is for the physical device components.
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 with experts is generally for diagnostic or AI/ML evaluations.
4. Adjudication method for the test set
- Not applicable/Not provided.
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 is a spinal implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
- Not applicable in the context of AI/ML. For mechanical implants, the "ground truth" would be established by the physical testing results against specified engineering standards (e.g., strength, fatigue life according to ASTM F 1798).
8. The sample size for the training set
- Not applicable/Not provided. The device does not involve machine learning.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of what the document focuses on:
The K063156 submission is a "Special 510(k) Submission" for additions to an existing spinal implant system (EXPEDIUM™ Spine System). The key information provided relates to:
- Device Description: The new components accept a 6.35mm rod and come in various geometries and sizes.
- Materials: ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.
- Intended Use: Non-cervical pedicle and non-pedicle fixation for various spinal conditions in skeletally mature patients (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
- Performance Data: "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components..."
- Substantial Equivalence: The FDA determined the device is substantially equivalent to predicate devices (EXPEDIUM™ 5.5mm Spine System (K051024) and EXPEDIUM™ 6.35mm Spine System (K062174)).
This is a traditional medical device submission for a physical implant, not a software as a medical device (SaMD) or AI/ML-driven device, which is why the detailed questions about acceptance criteria specific to AI/ML performance are largely unanswerable from the provided text. The "acceptance criteria" here are implicitly linked to meeting the performance requirements of ASTM F 1798 to demonstrate substantial equivalence, rather than clinical performance targets for accuracy, sensitivity, or specificity of a diagnostic algorithm.
§ 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.