The General 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 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

AI/ML Overview

The provided text describes a 510(k) submission for a spinal system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about the use of AI, human readers, or clinical study data for device performance as would be relevant for acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance as typically applied to AI devices (especially those involving diagnostic accuracy) cannot be extracted from the given text:

A table of acceptance criteria and the reported device performance: Not available. The document refers to "design specifications" being met, but these are not defined in terms of specific performance metrics suitable for a table.
Sample size used for the test set and the data provenance: Not applicable, as no test set beyond bench testing materials is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert evaluation for ground truth is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as clinical ground truth establishment is not mentioned for this type of device. The studies are bench tests.
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be extracted regarding the device's "acceptance criteria" (in the context of a 510(k) submission for a physical implant) and the study that proves it meets them:

Acceptance Criteria and Device Performance for the General Spinal System (K122994)

Acceptance Criteria (Standards Met)	Reported Device Performance
ASTM F1717-04: Static compression bending test	Complied with the standard
ASTM F1717-04: Dynamic compression bending test	Complied with the standard
ASTM F1717-04: Static torsion test	Complied with the standard
Material Specification (Ti6Al4VELI)	Meets ASTM F136-02a
Sterilization Method	Validated per ISO 17665-1: 2006 (to reach a SAL of 10⁻⁶)
Device Design Specifications	Met all design specifications
Substantial Equivalence to Predicate	Determined to be Substantially Equivalent to CD HORIZON LEGACY 5.5mm Spinal System (K042790)

Study Details:

Type of Study: Non-clinical bench tests.
Sample Size for Test Set: Not explicitly stated, typical for bench testing where a representative number of samples are tested according to defined standards.
Data Provenance: Not applicable, as these are laboratory bench tests, not clinical data.
Ground Truth Establishment: For bench tests, the "ground truth" is defined by the specified performance limits and methodologies outlined in the ASTM and ISO standards used. The device's physical properties and performance are verified against these objective criteria.
Training Set: Not applicable as this is not an AI device.
Adjudication Method: Not applicable for bench testing against established engineering standards.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: The non-clinical bench tests evaluate the device's standalone physical performance parameters. The "algorithm only" concept does not apply here.

The core of the submission relies on demonstrating that the proposed device, the General Spinal System, performs similarly to a legally marketed predicate device (CD HORIZON® Spinal System, K042790) by meeting the same widely accepted industry standards for spinal implants.

Summary

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Exhibit #4 510(k) Summary

*122994 - Page 1 of 3

510(k) Summary

APR 1 2 2013

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: ...

Date of Submission: 04/03/2013 .
Sponsor

Weigao Orthopaedic Device Co., Ltd. No 26 Xiangjiang Road, Tourist Resorts, Weihai, Shandong, 264203, China

Establishment Registration Number: 3006639944

Contact Person: Han Wang Position: Quality & Technique Manager Tel: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com

Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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K122994
1. Proposed Device Identification

Proposed Device Name: General Spinal System Classification Name: Pedicle screw spinal system Product Code: MNI, MNH, KWP Regulation Number: 21 CFR part 888.3070, 21 CFR part 888.3050 Review Panel: Orthopedic

Intended Use Statement:

ડ. Predicate Device Identification
510(k) Number: K042790 Product Name: CD HORIZON ® Spinal System Predicate Device Name: CD HORIZON LEGACY 5.5mm Spinal System Manufacturer: Medtronic SofamorDanek, Inc.USA
1. Device Description
  The spinal system consists of screws, rods, crosslink plates, set screws and hooks.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave mèthod 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

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1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:

Static compression bending test; •
Dynamic compression bending test;
Static torsion test. .

8. Substantially Equivalent Conclusion

The proposed device, Spinal System, is determined to be Substantially Equivalent (SE) to the predicate device, CD HORIZON LEGACY 5.5mm Spinal System (K042790), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

Letter dated: April 12, 2013

Weigao Orthopaedic Device Co., Ltd. % MID-LINK Consulting Co., Ltd. Ms. Diana Hong General Manager P.O. Box 237-023 200237 Shanghai China

Re: K122994

Trade/Device Name: General Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: April 3, 2013 Received: April 8, 2013

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 (reporting of medical

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Page 2 - Ms. Diana Hong

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark News Regson -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: K122994 Device Name: General Spinal System

Indications for Use:

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) O OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122994

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.