(56 days)
The ESL® PEEK-OPTIMA® is 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.
This 510(k) summary focuses on the EBI® ESL® PEEK-OPTIMA® Spine System, a vertebral body replacement device. The document states that the primary purpose of this submission is to add PEEK spacers to an existing system and demonstrate substantial equivalence to predicate devices through mechanical testing.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria or detailed results of device performance in a table format. It broadly mentions "Mechanical testing demonstrated comparable mechanical properties to the predicate components."
Therefore, a table cannot be constructed from the given text.
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Sample size used for the test set and the data provenance:
The document mentions "Mechanical testing," but does not specify the sample size used for these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study described is mechanical testing of a medical device, not a study involving human interpretation of data where "ground truth" would be established by experts.
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Adjudication method for the test set:
This information is not applicable as the study described is mechanical testing, not a study requiring adjudication of expert opinions.
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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:
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI systems where human interpretation is involved. This submission is for a spinal implant, and the supporting data is mechanical testing, not a clinical study involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a physical implant, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable in the context of mechanical testing. The "ground truth" for mechanical testing would be established by engineering standards and validated testing methodologies, not by expert consensus, pathology, or outcomes data in the traditional sense. The standard for evaluation is "comparable mechanical properties to the predicate components."
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The sample size for the training set:
This information is not applicable. There is no mention of a "training set" in the context of the mechanical testing conducted for this device. Training sets are relevant for AI algorithms.
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How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 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.