(168 days)
KangLi® 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 fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization 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, nuts and rods etc. It is made of titanium alloy (Ti6AI4V ELJ), 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 106 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.
The provided document describes a 510(k) premarket notification for the KangLi® Pedicle Screw Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical utility through extensive clinical trials. Therefore, the information provided primarily addresses bench testing to meet design specifications and demonstrate equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Properties | Biocompatibility | Made of titanium alloy (Ti6AI4V ELJ) meeting ASTM F136; "widely used for surgical implants with well-known biocompatibility." |
| Sterilization | Sterility Assurance Level (SAL) | Validated to reach a SAL of 10⁻⁶ via autoclave method, per ISO 17665-1. |
| Mechanical Performance | Static Compression Bending | Complies with ASTM F1717-13. (Specific numerical results not provided, but compliance is stated). |
| Dynamic Compression Bending | Complies with ASTM F1717-13. (Specific numerical results not provided, but compliance is stated). | |
| Static Torsion | Complies with ASTM F1717-13. (Specific numerical results not provided, but compliance is stated). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of devices or constructs) used for the bench tests. It only states that "Bench tests were conducted."
- Data Provenance: The tests were conducted internally by the manufacturer (Suzhou Kangli Orthopaedics Instrument Co., Ltd.) to verify design specifications and substantial equivalence to the predicate device. This is a form of retrospective data analysis in the sense that the tests are performed on manufactured devices. The country of origin of the manufacturer is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. For a 510(k) submission based on substantial equivalence and bench testing, expert review to establish "ground truth" in the clinical sense (e.g., diagnosis, outcome) is not typically required. The "ground truth" here is adherence to recognized industry standards (ASTM F1717-13) and successful completion of the specified mechanical tests, which are objective measurements.
4. Adjudication Method for the Test Set
- None. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's subjective interpretation involved, such as reading medical images. This document describes bench testing, which involves objective, quantifiable measurements against established standards.
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
- No. An MRMC study is relevant for AI/radiology systems involving human readers. This document is for a physical medical implant (pedicle screw spinal system) and does not involve AI or human image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This question is also relevant for AI-powered devices. The subject device is a hardware implant, not a software algorithm.
7. The Type of Ground Truth Used
- Objective Measurements Against Industry Standards: The "ground truth" for the performance evaluation in this submission is compliance with the mechanical performance requirements defined in the ASTM F1717-13 standard. For material properties, it's meeting ASTM F136 for titanium alloy composition and for sterilization, it's meeting ISO 17665-1.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of device approval through bench testing for substantial equivalence. This concept applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
§ 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.