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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

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.

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