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510(k) Data Aggregation
(161 days)
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
The CORNERSTONE® PSR Cervical device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach. The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.
This document is a 510(k) summary for the CORNERSTONE® PSR Cervical Fusion System, which is an intervertebral body fusion device. It describes the product, its indications for use, and how it demonstrates substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Study | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Compression | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. |
| Dynamic Compression | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Static Torsion | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Dynamic Torsion | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Static Compression Shear (ASTM F2077-03) | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Dynamic Compression Shear (ASTM F2077-03) | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Subsidence (ASTM F2267-04) | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Expulsion | Substantially equivalent to legally marketed devices | Results found to be substantially equivalent to legally marketed devices. | |
| Biocompatibility/Material | (Implicit via material choice) | Medical grade PEEK and Tantalum/Titanium alloy | Manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136. |
| Indications for Use | (Comparison to predicates) | Equivalent indications for use | "determined that the subject device is substantially equivalent in design, materials, function, indications for use, and scientific technology to the predicate devices presented." |
Study Proving Acceptance Criteria:
The document states: "The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices."
The study described is a series of pre-clinical mechanical and physical performance tests designed to demonstrate that the CORNERSTONE® PSR system performs similarly to existing, legally marketed predicate devices. The basis of acceptance in a 510(k) submission is showing "substantial equivalence" to a predicate device, meaning it is as safe and effective.
The remaining information requested is not available in the provided text, as this is a 510(k) summary for a medical device (an intervertebral fusion device), not an AI/software device. The questions are specifically tailored for AI/ML performance evaluations and thus do not apply to this type of regulatory submission.
Therefore, for questions 2 through 9, the answer is: This information is not applicable or not provided in the context of a 510(k) summary for this type of medical device. The document focuses on demonstrating substantial equivalence through pre-clinical mechanical testing and material compatibility, not on human-AI interaction or algorithm performance on a test set.
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