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The YAHUA 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); tumor; 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 screws, rods, crosslink plates, set screws and hooks. 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) 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: 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 document is a 510(k) summary for the YAHUA Spinal System. It describes the device's technical characteristics and compares it to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

Here's why and what information is available:

• Device Type: The YAHUA Spinal System is a medical implant (pedicle screw spinal system), not an AI or algorithm-based diagnostic/therapeutic device. Its approval relies on mechanical integrity, material biocompatibility, and substantial equivalence to existing devices.
• Approval Process: A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications, materials, manufacturing processes, and performance (e.g., mechanical testing for implants) to show it's as safe and effective as the predicate.
• Lack of AI/Algorithm Information: Consequently, the document does not contain any of the requested information related to AI or algorithm performance, such as:
  • Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
  • Test set details (sample size, data provenance)
  • Ground truth establishment (experts, pathology)
  • Adjudication methods
  • MRMC studies
  • Standalone algorithm performance
  • Training set details

Based on the provided document, I cannot fulfill your request for information regarding acceptance criteria and studies proving an AI device's performance.

However, I can extract the relevant information regarding the mechanical performance study conducted for this implant device, which is an analogous concept to an acceptance study for an AI device.

Acceptance Criteria and Study for YAHUA Spinal System (Mechanical Performance)

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

For an implantable device like the YAHUA Spinal System, the "acceptance criteria" for mechanical performance are implicitly met by demonstrating that its performance is "similar" to a legally marketed predicate device when tested under specific industry standards. The comparison is the critical part of the substantial equivalence determination.

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

• Test Set Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples to ensure statistical validity, but the exact number for each test item is not provided.
• Data Provenance: The tests were conducted by the manufacturer (or a testing facility on their behalf) as part of the 510(k) submission. The document implies these were prospective tests performed specifically for this submission, comparing the proposed device against the predicate.
• Country of Origin of the Data: Not explicitly stated, but the manufacturer is based in China: Beijing Weigao Yahua Artificial Joint Development Co. Ltd., China.

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

• This question is not applicable to this type of device and study. "Ground truth" in the context of an implant's mechanical testing refers to objective measurements against established technical standards (like ASTM F1717-14) and direct comparison to a predicate device's performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

• This question is not applicable to this type of study. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or clinical outcomes, not for objective mechanical performance testing.

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, this was not an MRMC study. This is a mechanical performance study for an implant, not a diagnostic imaging study involving human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, this was not an algorithm performance study. It was a standalone mechanical test of the physical implant device.

7. The type of ground truth used

• Objective Mechanical Measurements and Comparison to Predicate Device Performance. The "ground truth" for demonstrating device safety and effectiveness in this context is adherence to recognized industry standards (ASTM F1717-14) and direct, quantifiable comparison of mechanical properties (static compression bending, dynamic compression bending, static torsion) between the proposed device and its established predicate.

8. The sample size for the training set

• This question is not applicable as there is no "training set" for a physical implant device's mechanical performance testing.

9. How the ground truth for the training set was established

• This question is not applicable as there is no "ground truth for a training set" for this type of device and study.

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