(28 days)
The Rods from the Osteonics® Spinal System and Opus Spinal System are intended to be used with the components of the Xia Spinal System.
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the XIA Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The submission involves no change to the components themselves. This submission covers use of predicate OSS and Opus 6 mm diameter Rods with the predicate Xia Spinal System.
This 510(k) submission (K013688) focuses on allowing the use of previously cleared Osteonics® Spinal System (OSS) and Opus Spinal System rods with the Xia Spinal System. It does not describe a study involving an "AI device" or "algorithm" in the conventional sense of machine learning or diagnostic imaging. Instead, the "device" in question is a medical implant (spinal fixation system components). Therefore, acceptance criteria and study details related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of human readers with/without AI) are not applicable here.
However, I can extract the relevant information regarding the mechanical performance study conducted to demonstrate the safety and effectiveness of using these combined components, which serves as the "study that proves the device meets the acceptance criteria" in this context.
Here's the information structured to best fit your request, adapting the columns where necessary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Objective) | Reported Device Performance (Conclusion) |
|---|---|
| Comparable mechanical properties | Construct fatigue testing demonstrates comparable mechanical properties of the subject Xia Spinal System with Ti-6A1-4V alloy (Opus or OSS) Rods to other predicate constructs. |
Study Details (Mechanical Testing)
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Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The description refers to "Construct fatigue testing," implying multiple test specimens were subjected to fatigue loads. Data provenance is not applicable in the human subject or imaging sense; this is a laboratory-based mechanical test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized testing protocols (e.g., ASTM standards for fatigue testing of medical implants) and measured physical properties by engineers. No human expert "ground truth" establishment in the diagnostic sense is mentioned.
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Adjudication method for the test set: Not applicable. This is mechanical testing, not a clinical review of images or data requiring adjudication among experts.
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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 submission for a physical medical device (spinal implant components), not an AI diagnostic or assistance tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm involved. "Standalone" performance here refers to the mechanical integrity of the device itself.
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The type of ground truth used: For mechanical properties, the "ground truth" is typically defined by established engineering standards and material specifications that define acceptable performance limits (e.g., fatigue life, stiffness, strength) for spinal implants. The comparison is against predicate constructs (existing, legally marketed spinal systems). The phrase "comparable mechanical properties" indicates the tested construct's performance met or exceeded the performance of the predicate devices.
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The sample size for the training set: Not applicable. This is a mechanical test for a physical device, not an AI or machine learning model that requires a training set.
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How the ground truth for the training set was established: Not applicable, as no training set exists for this type of submission.
§ 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.