The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Device Description

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system 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 10th 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 document provided is a 510(k) premarket notification for the WASTON General Spinal System, identifying it as a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Trauson General Spinal System, K082617) through non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM F1717-14: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including:	The non-clinical tests demonstrated that the proposed device met "all design specifications" and complied with the ASTM F1717-14 standard. Specific quantitative results (e.g., maximum load, displacement, cycles to failure) are not provided in this summary. The summary states that the tests included:
- Static compression bending test	(Implied compliance, no specific numeric results provided)
- Dynamic compression bending test	(Implied compliance, no specific numeric results provided)
- Static torsion test	(Implied compliance, no specific numeric results provided)
Sterilization validation per ISO 17665-1: 2006	The recommended sterilization method (autoclave) was validated per ISO 17665-1: 2006 to achieve a Sterility Assurance Level (SAL) of 10^-6, ensuring the devices are sterile prior to use.
Biocompatibility (Material)	The device is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, and is noted for its "well-known biocompatibility" for surgical implant applications.
Substantial Equivalence to predicate (K082617) through comparison of technological characteristics and intended use.	Based on the comparison of product code, regulation number, intended use (with minor differences noted but deemed equivalent for SE), configurations (with minor differences), material, sterilization, and single-use status, the proposed device was determined to be "Substantially Equivalent (SE)" to the predicate.

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

Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests conducted per ASTM F1717-14. It only states that "Non clinical tests were conducted." Typically, these tests involve multiple samples for each component or construct configuration, but the precise numbers are not disclosed in this summary.
Data Provenance: The device manufacturer is Changzhou Waston Medical Appliance Company, Limited, located in China. Therefore, the non-clinical test data was likely generated in China, associated with the manufacturer or a contracted testing facility. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

This information is not applicable to this submission. The "test set" in this context refers to non-clinical, mechanical performance testing of a spinal implant system. The "ground truth" is established by adherence to a recognized standard (ASTM F1717-14) and the physical properties of the materials and device design, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting human-read data or clinical endpoints. For mechanical testing against a standard, the results are objectively measured and compared to the standard's pass/fail criteria, often requiring a pass for all tested samples.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for AI-powered diagnostic or interpretive devices, which is not the case for a spinal implant system.

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

No, a standalone algorithm performance study was not done. This device is a physical spinal implant system, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study would not be relevant.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is typically defined by established engineering standards and material specifications. The device's performance is compared against the requirements and methodologies outlined in:
- ASTM F1717-14 for mechanical performance (static compression bending, dynamic compression bending, static torsion).
- ASTM F136-02a for material composition and properties.
- ISO 17665-1: 2006 for sterilization validation.

8. The Sample Size for the Training Set

This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. As this device is a physical spinal implant system and does not involve AI or algorithms, there is no training set in this context.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for this type of device.

Summary

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November 18, 2015

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

Changzhou Waston Medical Appliance Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K150684

Trade/Device Name: WASTON General Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: October 21, 2015 Received: October 23, 2015

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 Parts 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) K150684

Device Name WASTON General Spinal System

Indications for Use (Describe)

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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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K150684

1. Date of Preparation: 08/27/2014
1. Sponsor Identification

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD 9 Xihu Road, Wujin Hi-tech Industry Zone, Changzhou, Jiangsu, 213164, China

Establishment Registration Number: Not yet registered

Contact Person: Mr. Jack Lu Position: International Department Director Tel: +86-519-8652226 Fax: +86-519-86221108 Email: Waston18@gmail.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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: WASTON General Spinal System Common Name: General Spinal System

Regulatory Information

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

Intended Use Statement:

The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Device Description

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th 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.

ર : Identification of Predicate Device(s)
510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Model Name: GSS-II

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6. Non-Clinical Test Conclusion

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

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

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device(s)	Predicate Device(s)
		K082617
Product Code	MNHMNI	MNHMNI
Regulation Number	21 CFR 888.3070	21 CFR 888.3070
Intended Use	The WSTON General Spinal System isintended for posterior pedicle screwfixation of the non-cervical posteriorspine in skeletally mature patients. Itprovides stabilization andimmobilization of spinal segments as anadjunct to fusion in the treatment of thefollowing acute and chronic instabilitiesdeformities: (1) trauma (i.e. fracture ordislocation), (2) curvatures (scoliosis,kyphosis, and/or lordosis), (3) spinaltumor, (4) failed previous fusion, (5)pseudarthrosis, (6) spinal stenosis. It isnot intended for pedicle screw fixationabove T8.	Trauson General Spinal System (GSS) isintended for posterior pedicle screwfixation (GSS-VII can be applied foranterior or anterolateral fixation) of thenon-cervical posterior spine in skeletallymature patients. It provides stabilizationand immobilization of spinal segments asan adjunct to fusion in the treatment of thefollowing acute and chronic instabilitiesdeformities.When used as a posterior spinethoracic/lumbar system, TrausonGeneral Spinal System (GSS) is indicatedfor one or more of the following: (1)trauma (i.e. fracture or dislocation), (2)curvatures (scoliosis, kyphosis, and/orlordosis), (3) spinal tumor, (4) failedprevious fusion, (5) pseudarthrosis, (6)spinal stenosis.Trauson General Spinal (GSS) is notintended for pedicle screw fixation aboveT8.
Configurations	RodFixed-Angle ScrewFixed-Angle Reduction ScrewsSet Screws	RodN.A.Fixed-Angle Reduction ScrewsSet Screws
Material	Titanium alloy	Titanium alloy
Sterile	Subject to steam sterilized prior to use.	Subject to steam sterilized prior to use.
Single Use	Yes	Yes
Performance	ASTM F 1717 Standard Test Methodsfor Spinal Implant Constructs in aVertebrectomy Model	ASTM F 1717 Standard Test Methods forSpinal Implant Constructs in aVertebrectomy Model

Table 1 Comparison of Technology Characteristics (Scalpel System)

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1. Substantially Equivalent (SE) Conclusion
  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.