(202 days)
The HOURGLASSTM Vertebral Body Spacer is intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of turnor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™ device is to be used with the Medtronic Sofamor Danek ZPLATE-II® Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, and/or the GDLH® Spinal System, or their successors. Additionally, the HOURGLASS™ device is intended to be used with bone graft.
The HOURGLASS™ device is a PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The HOURGLASS™ device is fabricated and manufactured from Polyetheretherketone (PEEK OPTIMA LT) as described by ASTM F-2026. The Tantalum markers used for this product are made to the voluntary standard of ASTM F-560.
The HOURGLASS™ device must be used with additional anterior and/or posterior spinal instrumentation to augment stability
The provided text is a 510(k) premarket notification for the HOURGLASS™ Vertebral Body Spacer, primarily focusing on its substantial equivalence to previously cleared devices rather than a detailed study demonstrating performance against specific acceptance criteria. This type of document generally establishes equivalence based on design, materials, and intended use.
Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text. The document does not describe a study that proves the device meets acceptance criteria in the manner one would expect for an AI/CADe device. Instead, it relies on substantial equivalence to predicate devices.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, not on specific performance metrics or acceptance criteria for the device itself in a clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document. The document describes a premarket notification based on substantial equivalence, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the document. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the document. No test set or adjudication method is described.
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
This information is not present in the document. This is not a study of an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the document. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not present in the document. No ground truth is mentioned.
8. The sample size for the training set
This information is not present in the document. No training set is mentioned as this device is not an AI/CADe.
9. How the ground truth for the training set was established
This information is not present in the document. No training set or ground truth establishment process is described.
§ 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.