(228 days)
The Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.
The provided 510(k) summary for the "Small Stature Spacers" does not include acceptance criteria or a study that proves the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing.
Here's a breakdown based on the information provided:
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Table of Acceptance Criteria and Reported Device Performance: This information is not available in the provided text. The submission states, "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use." This is a general statement and does not present specific quantitative acceptance criteria or performance metrics.
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Sample size used for the test set and the data provenance: Not applicable, as no clinical or specific non-clinical test set with a sample size is described beyond a general statement about "non-clinical laboratory testing."
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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, as no ground truth establishment by experts is mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.
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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 device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed ground truth is not discussed for non-clinical testing. The "ground truth" for substantial equivalence of a physical implant is typically established by demonstrating that its material properties, mechanical performance, and design characteristics are comparable to a predicate device, as confirmed through laboratory testing.
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The sample size for the training set: Not applicable, as no training set (in the context of AI/machine learning) is mentioned for this physical device.
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How the ground truth for the training set was established: Not applicable, as no training set is discussed.
Summary of the 510(k) Approach:
The submission for the "Small Stature Spacers" follows a traditional 510(k) pathway for medical devices that are substantially equivalent to existing, legally marketed devices. The "study" proving the device meets criteria is primarily non-clinical laboratory testing aimed at demonstrating that its technological characteristics, materials (PEEK), and design are similar to the predicate device (ESL® PEEK-OPTIMA® Spine System K061016) and that it is "functional within its intended use."
The key phrase is: "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."
And specifically: "Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing."
This means the acceptance criteria were likely based on established engineering standards and performance benchmarks for spinal implants, and the non-clinical tests (e.g., mechanical strength, fatigue, material characterization) confirmed the device met these standards, thereby demonstrating substantial equivalence to the predicate. Specific numerical criteria and results are not detailed in this summary.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.