The Wiltrom Spinal Fixation System is intended to provide immobilization 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; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Wiltrom Spinal Fixation System. It focuses on establishing substantial equivalence to a predicate device, the Fortex Pedicle Screw System (K090224). The information provided is primarily related to mechanical testing for safety and effectiveness, rather than a clinical study evaluating diagnostic or prognostic performance based on specific acceptance criteria for AI or algorithmic output. Therefore, many of the requested sections about AI/algorithm performance and ground truth establishment cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document discusses mechanical testing criteria for the physical device, not for an AI or algorithm.

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Static Torsion Testing (ASTM F1717-15)	Conducted
Static Axial Compression Bending Testing (ASTM F1717-15)	Conducted
Dynamic Axial Compression Bending Testing (ASTM F1717-15)	Conducted
Overall Goal: Evaluate safety and effectiveness, demonstrate performance in stabilizing the operative site, and mechanical safety.	Overall Outcome: "The performance of Wiltrom spinal implants in stabilizing the operative site and the mechanical safety was demonstrated."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is for mechanical testing of the physical device, not an AI test set. The sample size would refer to the number of implants/constructs tested. The document states "mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted," but does not specify the number of samples for each test or the provenance of the data in the context of clinical or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in this context, would relate to the physical integrity and performance of the device under stress, measured through engineering standards, not expert evaluation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for clinical or imaging studies where expert consensus is needed. The testing here is mechanical.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This document does not describe an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" would be established by the engineering standards themselves (e.g., ASTM F1717-15) and the objective measurements of force, deformation, and failure points taken during the tests.

8. The sample size for the training set

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

Summary

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January 12, 2018

Wiltrom Corporation Limited Yi-Chun Su Director 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City, Hsinchu County 30261 Taiwan

Re: K172548

Trade/Device Name: Wiltrom Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: December 29, 2017 Received: January 2, 2018

Dear Yi-Chun Su:

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S for

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) K172548

Device Name Wiltrom Spinal Fixation 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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Image /page/3/Picture/0 description: The image shows the logo for Wittrom, a health partner. The word "wittrom" is written in a bold, sans-serif font. Below the word "wittrom" is the phrase "Your Health Partner" in a smaller, sans-serif font. The logo is simple and modern, and it conveys a sense of trust and reliability.

510(k) Summary

I. Submitter	Wiltrom Corporation Limited
	No. 221, Sec. 1, Chung Hsing Rd.Chutung, Hsinchu County 31053Taiwan
Contact Information	Yi-Chun Su. Director
	1F, No. 26, Sec. 2, Shengyi Rd.Zhubei City, Hsinchu County 30261Taiwan
	TEL: +886-3-6107168FAX: +886-3-6580006
Date Prepared	Aug 21, 2017
II. Subject Device	Wiltrom Spinal Fixation System
Common Name	Pedicle Screw System
Classification Name	Thoracolumbosacral Pedicle Screw System
Regulation Number	21 CFR §888.3070
Product Code / Device Class	NKB / Class II
510(k) Review Panel	Orthopedic
III. Primary Predicate Device	Fortex Pedicle Screw System (K090224)

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Image /page/4/Picture/0 description: The image shows the logo for Wittrom. The logo is black and consists of the word "wittrom" in a bold, sans-serif font. Below the word "wittrom" is the phrase "Your Health Partner" in a smaller, sans-serif font. The logo is simple and modern.

Device Description

Indication for Use

The Wiltrom Spinal Fixation System is 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).

Comparison of Technological Characteristics

Both of the Wiltrom Spinal Fixation System and Fortex Pedicle Screw System contain screws, rods, cross-link connector and surgical instruments. The implants of these devices are made of identical titanium alloy material, Ti-6Al-4V ELI. The Wiltrom Spinal Fixation System and Fortex Pedicle Screw System have similar principle of operation.

Discussion of Nonclinical Tests

In accordance with ASTM F1717-15, mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted to evaluate the safety and effectiveness of the Wiltrom Spinal Fixation System. The performance of Wiltrom spinal implants in stabilizing the operative site and the mechanical safety was demonstrated.

Conclusion

Wiltrom Spinal Fixation System has identical intended use, target population, anatomical site and indications for use to the predicate device, Fortex Pedicle Screw System (K090224). Furthermore, based on the technological characteristics, materials, and mechanical testing, the Wiltrom Spinal Fixation System is substantially equivalent to the predicate device.

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.