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510(k) Data Aggregation
(104 days)
Gemmed® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fision. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
This document is a 510(k) premarket notification for a medical device called the "Gemmed® pedicle screw spinal system." It is a regulatory submission to the FDA. The document focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing. Therefore, it does not contain the detailed information typically found in a clinical study report or a study evaluating AI device performance.
Based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard) | Device Performance (Test type performed) |
|---|---|
| ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard) | Static compression bending test completed |
| ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard) | Dynamic compression bending test completed |
| ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard) | Static torsion test completed |
| (Implied) Biocompatibility per ASTM F136 | Materials (Ti6Al4V ELI) meet ASTM F136 standard |
| (Implied) Sterilization efficacy (SAL of 10^-6) | Sterilization method validated per ISO 17665-1 |
Note: The document states that the proposed device "meet all design specifications as was Substantially Equivalent (SE) to the predicate device." It also says, "The test results demonstrated that proposed device complies with the following standards." However, it does not provide specific quantitative acceptance criteria or detailed numerical performance data from the conducted bench tests. It merely lists the tests performed and implies compliance with the referenced standards.
The remaining questions (2-9) are related to clinical studies and AI performance, which are not relevant to this 510(k) submission for a pedicle screw spinal system. This document describes a traditional 510(k) submission based on substantial equivalence through material properties and mechanical bench testing, not a study evaluating software or AI performance with human readers, ground truth, or training/test sets as would be applicable to an AI/ML medical device.
Therefore, for questions 2 through 9, the answer is: Not applicable or not provided in this document.
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