The II-Type Intervertebral Spacer is intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Description

II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta markers, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft.

AI/ML Overview

The provided text is for a medical device called an "II-Type Intervertebral Spacer," which is a physical implant used in spinal fusion surgery. This type of device does not typically involve AI, thus the questions regarding AI performance, human-in-the-loop, and training sets are not applicable.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for the "II-Type Intervertebral Spacer" to demonstrate its substantial equivalence to predicate devices. The acceptance criteria are implicitly defined by the chosen ASTM standards, and the reported performance indicates that the device met these standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with ASTM F2077-11 for static and dynamic axial compression, static torsion, and static compression-shear tests	"Paonan has submitted data from testing performed in compliance with ASTM F 2077-11 including static and dynamic axial compression test, static torsion test, static compression-shear test... demonstrate that the II-Type Intervertebral Spacer is substantially equivalent to legally marketed lumbar interbody fusion and is therefore appropriate for use in lumbar interbody fusion as described in the indication above." The implication is that the performance was within acceptable limits as defined by the standard and comparative data with predicate devices.
Compliance with ASTM F2267-04 for subsidence testing	"...and ASTM F 2267-04 subsidence test using samples each of a worst case construct demonstrate that the II-Type Intervertebral Spacer is substantially equivalent to legally marketed lumbar interbody fusion and is therefore appropriate for use in lumbar interbody fusion as described in the indication above." The implication is that the subsidence performance was within acceptable limits as defined by the standard and comparative data with predicate devices.
Biocompatibility	"The II-Type Intervertebral Spacer are entirely made of Poly Ether Ketone (PEEK), a biocompatible material..." This implicitly meets the acceptance criterion for biocompatibility.
Modulus characteristics similar to vertebral bone	"...a biocompatible material with modulus characteristics similar to vertebral bone." This implicitly meets the acceptance criterion for mechanical properties relevant to bone.
Radiolucency (allowing imaging follow-up)	"They are fully radiolucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses." Implied acceptance.
Radiological confirmation of cage position post-operatively	"Two metal wires at the opposite ends of the cage allow radiological confirmation of the cage position post operatively." Implied acceptance.
Substantial Equivalence to predicate devices in technical characteristics, performance, and intended use	"The II-Type Intervertebral Spacer has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use." This is the overarching conclusion of the submission.

2. Sample size used for the test set and the data provenance:

Sample size: The document states that testing was performed "using samples each of a worst case construct." It does not specify the exact number of samples for each test (e.g., 5 samples for axial compression, 3 for torsion, etc.), but it refers to "samples" in plural.
Data provenance: The data is based on non-clinical (in vitro/mechanical) testing performed by Paonan Biotech Co., Ltd. The country of origin for the testing itself isn't explicitly stated, but the company is located in Taiwan, R.O.C. This is a prospective test specifically conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a physical intervertebral spacer being evaluated through mechanical and materials testing against engineering standards, not through clinical trials or expert assessment of diagnostic images that would require "ground truth" established by human experts.

4. Adjudication method for the test set:

This question is not applicable for the same reasons as #3. Mechanical testing results are objective measurements against specified standard limits, not subjective interpretations requiring adjudication.

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:

This question is not applicable. The device is a physical implant for spinal fusion and does not involve AI or diagnostic imaging interpretation.

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

This question is not applicable. There is no algorithm associated with this device.

7. The type of ground truth used:

The "ground truth" for this device's acceptance is based on:

Engineering standards: Specifically, compliance with ASTM F2077-11 and ASTM F2267-04. These standards define the parameters and acceptable limits for mechanical performance.
Material properties: The inherent biocompatibility and mechanical properties (e.g., modulus) of PEEK.
Comparative data: Performance relative to "legally marketed lumbar interbody fusion" predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This question is not applicable as there is no AI algorithm involved that would require a training set.

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

This question is not applicable as there is no AI algorithm involved.

Summary

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Paonan Biotech Co., Ltd. Vivi Tsai Regulation Affair 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District, Taipei, 11491 Taiwan, R.O.C.

Re: K180228

Trade/Device Name: II-Type Intervertebral Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 4, 2018 Received: December 10, 2018

Dear Vivi Tsai:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

January 11, 2019

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

Katherine D. Kavlock -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180228

Device Name II-Type Intervertebral Spacer

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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K180228

510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92.

Submitter Information:	Paonan Biotech. Co., Ltd.3F, No. 50, Lane. 258, RueiguangRd., Neihu District, Taipei City, Taiwan, R.O.C.
Contact Person:	Vivi TsaiTEL: +886-2-2627-4366FAX: +886-2-2627-4399Email: vivi0921@paonan.com.tw
Date Prepared:	Nov. 15th, 2018
Trade Name:	II-Type Intervertebral Spacer
Common Name:	Intervertebral Spacer
Classification Name:	Intervertebral Fusion Device With Bone Graft(21 CFR 888.3080)
Device Class:	Class II
Panel:	Orthopedic
Product Code:	MAX
Predicate Devices:	Primary predicate device:Lumbar I/F Cage(P960025)Additional predicates:Capstone Spinal System (K073291)FORZA Spacer System (K103111)

Device Description:

Intended Use:

The II-Type Intervertebral Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or

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corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Technological Characteristics:

The II-Type Intervertebral Spacer implanted via posterior approach are intended to facilitate interbody arthrodesis. These cages allow restoration of the disc height and natural lordosis. Nerve-root decompression is also achieved by opening the neural foramen.

The II-Type Intervertebral Spacer are entirely made of Poly Ether Ketone (PEEK), a biocompatible material with modulus characteristics similar to vertebral bone. They are fully radiolucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the cage allow radiological confirmation of the cage position post operatively.

Non-Clinical Performance Data:

Paonan has submitted data from testing performed in compliance with ASTM F 2077-11 including static and dynamic axial compression test, static torsion test, static compression-shear test, and ASTM F 2267-04 subsidence test using samples each of a worst case construct demonstrate that the II-Type Intervertebral Spacer is substantially equivalent to legally marketed lumbar interbody fusion and is therefore appropriate for use in lumbar interbody fusion as described in the indication above.

Clinical Performance Data:

Clinical testing was not required for this submission.

Conclusion of Substantial Equivalence:

The II-Type Intervertebral Spacer has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.