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Ideal® 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-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization 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, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), 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 10-6 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.

This document is a 510(k) premarket notification for a medical device called the "Ideal® Pedicle Screw Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, etc.) is not applicable or present in this document.

Here's why and what information is available:

• No acceptance criteria or device performance report: This document focuses on demonstrating that the new device (Ideal® Pedicle Screw Spinal System) is "substantially equivalent" to an existing, legally marketed device (Kangli® pedicle screw spinal system). This is typically achieved through design comparisons, material specifications, and bench testing rather than clinical studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.
• No clinical study: The document explicitly states: "Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device." This means the evaluation was limited to non-clinical, laboratory-based tests.
• No test set, training set, or ground truth information: These concepts relate to clinical studies involving AI/ML algorithms or human interpretation of data, which are not part of this 510(k) submission.

Information that is available from the document:

• Device Name: Ideal® Pedicle Screw Spinal System
• Predicate Device: K140053 Kangli® pedicle screw spinal system
• Non-Clinical Testing Standards:
  • ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including:
    • Static compression bending test
    • Dynamic compression bending test
    • Static torsion test
• Materials: Titanium alloy (Ti6Al4V ELI) meeting ASTM F136.
• Sterilization: Non-sterile, required to be sterilized by autoclave to a SAL of 10^-6, validated per ISO 17665-1.
• Intended Use/Indications: Posterior, non-cervical, pedicle fixation for severe spondylolisthesis (grade 3 or 4) of L5-S1; trauma; spinal stenosis; curvatures (scoliosis, kyphosis, lordosis); tumor; pseudoarthrosis; and failed previous fusion. Used in skeletally mature patients as an adjunct to fusion with bone graft at levels T8-S1.

In summary, this 510(k) premarket notification describes a device that showed substantial equivalence to a predicate device through bench testing, not through a clinical study with performance acceptance criteria, test/training sets, or expert ground truth adjudication.

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