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The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Allov 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 10 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

This document describes the General Spinal System, a pedicle screw spinal system. The primary method of demonstrating acceptance criteria for this device is through non-clinical testing, specifically mechanical performance testing, and comparison to a legally marketed predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of constructs tested) for each mechanical test performed under ASTM F1717-04. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
• Data Provenance: The tests are non-clinical (laboratory tests) conducted by Tianjin Walkman Biomaterial Co., Ltd. in China. The data provenance is internal testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This information is not applicable. The "ground truth" for non-clinical performance evaluations of medical devices like spinal systems is typically established by recognized national/international standards (e.g., ASTM, ISO), which define test methodologies, acceptance criteria, and performance limits. These standards are developed and maintained by committees of experts, but specific "experts" assigned to establish "ground truth" for a particular device's test set are not mentioned or required in this context.

4. Adjudication Method for the Test Set

• This information is not applicable. The non-clinical tests involve objective measurements (e.g., load, displacement) against specified performance criteria, rather than subjective interpretation requiring adjudication among multiple parties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices where human interpretation of images is a key factor. This submission pertains to a surgical implant (pedicle screw spinal system), where performance is assessed through mechanical testing and material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance in this context is defined by established engineering and material standards. Specifically:
  • Mechanical Integrity: ASTM F1717-04 defines the "ground truth" for appropriate mechanical performance characteristics (static/dynamic bending, torsion) expected of spinal implant constructs.
  • Material Biocompatibility: ASTM F136-02a defines the "ground truth" for the material properties and biocompatibility of the titanium alloy used.
  • Sterilization: ISO 17665-1:2006 defines the "ground truth" for a validated sterilization process to achieve a specified Sterility Assurance Level.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set. The design and manufacturing process are informed by general engineering principles and material science, not a data-driven "training" process in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no "training set" for this device.

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