(168 days)
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.
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Compared to Predicate) |
|---|---|
| Performance similar to predicate device per ASTM F1717-14 (Static compression bending, Dynamic compression bending, Static torsion) | "The test results demonstrated that the mechanical performance of proposed device is similar as the predicate." |
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.
§ 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.