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.

Device Description

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.

AI/ML Overview

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.

Summary

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February 1, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Beijing Weigao Yahua Artificial Joint Development Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai 200120 CHINA

Re: K152324

Trade/Device Name: YAHUA Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: January 6, 2016 Received: January 11, 2016

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152324

Device Name YAHUA Spinal System

Indications for Use (Describe)

The Y AHUA 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.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

1. Date of Preparation: 06/20/2015
1. Sponsor Identification

Beijing Weigao Yahua Artificial Joint Development Co. Ltd. No.7, NiuHui Street, NiuLanShan Town ,ShunYi District ,Beijing, 101301, China

Establishment Registration Number: Not yet registered

Contact Person: Xinjian Lv Position: R&D Manager Tel: +86-10-69416956 Fax: +86-10-69416956 Email: lxj@wegojoint.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: YAHUA Spinal System

Regulatory Information

Classification Name: Pedicle screw spinal system Classification: Class II Product Code: MNI, MNH, KWP Regulation Number: 21 CFR part 888.3070, 21 CFR part 888.3050 Review Panel: Orthopedic

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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, 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.

Device Description

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.

Primary Predicate న్.

510(k) Number: K122994 Product Name: General Spinal System Manufacturer: Weigao Orthopaedic Device Co., Ltd

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Non-Clinical Test Conclusion 6.

The proposed device and predicate device are tested together per the following standard, to evaluate the performance of the proposed device and the predicate device. The test results demonstrated that the mechanical performance of proposed device is similar as the predicate.

ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:

A Static compression bending test;
≫ Dynamic compression bending test;
Static torsion test.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate Device
	YAHUA Spinal System	General Spinal System
Product Code	MNI, MNH, KWP	MNI, MNH, KWP
RegulationNumber	888.3070 and 888.3050	888.3070 and 888.3050
Intended Use	The YAHUA Spinal System is intended forposterior, non-cervical, pedicle fixation for thefollowing indications:	The General Spinal System is intended forposterior, non-cervical, pedicle fixation for thefollowing indications:
	Severe spondylolisthesis (grade 3 or 4) of the L5-S1vertebrae	Severe spondylolisthesis (grade 3 or 4) of theL5-S1 vertebrae
	Trauma (i.e. fracture or dislocation)	Trauma (i.e. fracture or dislocation)
	Spinal stenosis	Spinal stenosis
	Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);	Curvatures (i.e., scoliosis, kyphosis and/orlordosis);
	Tumor	Tumor
	Pseudoarthrosis;	Pseudoarthrosis;
	Failed previous fusion.	Failed previous fusion
	The device is to be used in skeletally maturepatients, and for stabilization and immobilization ofthe spine as an adjunct to fusion with bone graft.The levels of fixation are T8 – S1.	The device is to be used in skeletally maturepatients, and forstabilization and immobilization of the spine as anadjunct tofusion with bone graft. The levels of fixation areT8 – S1
Configuration	Rods	Rods
	Multi Axial Screws	Multi Axial Screws
	Multi-Axial Reduction Screws	Multi-Axial Reduction Screws
	Fixed Angle Screw	Fixed Angle Screw
	Fixed Angle Reduction Screws	Fixed Angle Reduction Screws
	Crosslink Plate	Crosslink Plate
	Set Screws (Non Break-off, Break-off)	Set Screws (Non Break-off, Break-off)
Sterile	Provided Non-Sterile, required to be sterilized priorto operation.	Provided Non-Sterile, required to be sterilizedprior to operation.
	Method: Steam	Method: Steam
	SAL: 10-6	SAL: 10-6

Single Use	Yes	Yes
Material	Titanium Alloy (Ti-6Al-4V ELI)Conforms to ASTM F136	Titanium Alloy (Ti-6Al-4V ELI)Conforms to ASTM F136
	Implant

Table 1 Comparison of Technology Characteristics

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	instruments	Stainless SteelConforms to ASTM F138	Stainless SteelConforms to ASTM F138
--	-------------	------------------------------------------	------------------------------------------

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 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.