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510(k) Data Aggregation
(63 days)
The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The KeYi Spinal Fixation System implant consists of a variety of shapes and sizes of rods, screws and cross-connectors which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The proposed device is made of Titanium Alloy (Ti6Al4V) which meets ASTM F136-13 and CoCrMo which meets ASTM F1537-11. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The provided text is a 510(k) summary for the "KeYi Spinal Fixation System," a medical device. This document details the process and data used to demonstrate the device's substantial equivalence to predicate devices, focusing on non-clinical testing.
Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. The performance is assessed against established ASTM standards for spinal implants.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Compliance with ASTM F 1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including: | "The test results demonstrated that the proposed device complies with the following standards: ASTM F 1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items: A Static compression bending test; Dynamic compression bending test; A Static torsion test;" |
| - Static compression bending test parameters | Passed |
| - Dynamic compression bending test parameters | Passed |
| - Static torsion test parameters | Passed |
| Performance of proposed device not inferior to that of predicate devices, even with minor differences (e.g., additional screw types). | "the performance of proposed device has been tested per ASTM F1717 and the test results shows the performance of proposed device is not inferior to that of predicate." |
| Sterilization validation (S.A.L. of 10-6 via autoclave) per ISO 17665-1:2006. | "The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of constructs or tests performed) for the non-clinical tests (ASTM F1717). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: The data comes from non-clinical testing, specifically mechanical bench testing performed to established ASTM standards. The location of the testing is not explicitly stated, but the company is based in Beijing, China. This data is part of a premarket notification (510(k)) submission to the U.S. FDA, indicating it's intended for regulatory review in the US. The timeframe is from April 2019. It is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For this type of mechanical device, "ground truth" is established through engineering specifications and standardized test methods (like ASTM F1717). There are no human experts in the traditional sense involved in establishing "ground truth" for the performance of the non-clinical tests themselves, beyond the engineers and technicians conducting and analyzing the tests according to the standard protocols.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is non-clinical mechanical testing against a standard, there is no "adjudication method" in the sense of reconciling divergent human expert opinions. The determination of whether a test result meets the standard is objective based on the protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not performed as part of this particular submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study:
- Not Applicable. This is a physical spinal fixation system, not a software algorithm or AI-based device. Performance is assessed through mechanical testing and comparison to predicate physical devices.
7. The Type of Ground Truth Used:
- The "ground truth" for the non-clinical testing is based on established engineering standards and material specifications (e.g., ASTM F1717-15 for mechanical performance, ASTM F136-13 for Titanium Alloy, ASTM F1537-11 for CoCrMo, and ISO 17665-1:2006 for sterilization). The performance of the device is assessed against these quantifiable, objective criteria.
8. The Sample Size for the Training Set:
- Not Applicable. This is a traditional medical device (spinal implant), not an AI/ML-based device that requires a training set. The performance is based on the inherent properties of the manufactured components and their assembly.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
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