(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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.