The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the Spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Device Description

The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".

AI/ML Overview

The document describes a 510(k) premarket notification for the "COMET Lumbar Interbody Fusion Cage" and references a predicate device, the "SYNTHES T-PAL SPACER" (K100089). This type of submission is for medical devices and typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or extensive AI performance studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, does not directly apply in the context of this 510(k) submission.

Instead of clinical performance, the approval hinges on demonstrating:

Identical Indications for Use.
Similar technological characteristics, materials, and operational principles.
Non-clinical testing to ensure the device meets established mechanical performance standards as outlined in relevant ASTM standards.

Here's a breakdown of the information that is available in the document, mapped against your request:

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

The document does not provide a table of acceptance criteria with specific numerical targets and the device's reported performance against them in the way clinical studies for AI algorithms might. Instead, it refers to non-clinical mechanical testing performed in accordance with specific ASTM standards. The "acceptance criteria" here are implied by compliance with these standards, meaning the device must withstand the forces outlined in the tests without failure.

The reported device "performance" is implicitly stated as having "provided in support of substantial equivalence," meaning it passed these tests.

The following non-clinical tests were performed:

Static Compression per ASTM F2077
Static Compression Shear per ASTM F2077
Subsidence per ASTM F2267
Expulsion
Dynamic Compression per ASTM F2077
Dynamic Compression Shear per ASTM F2077

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 not applicable as this is a non-clinical, mechanical device submission, not an AI or diagnostic tool clinical study. The "test set" refers to physical samples of the device used for mechanical testing. The document states "The worst-case size for the COMET Lumbar Interbody Fusion Cage was conducted" for these tests, implying specific configurations of the device were tested. No data provenance in the context of patient data is relevant here.

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)

This information is not applicable. Ground truth, in the sense of expert radiological or pathological labels, is not relevant for a mechanical device submission. The "ground truth" for mechanical testing is defined by the ASTM standard test methods and the physical properties observed during testing.

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

This information is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device submission.

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 information is not applicable. No MRMC comparative effectiveness study was conducted as this is a mechanical interbody fusion cage, not an AI or imaging diagnostic device intended to assist human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of its safety and effectiveness, is established through compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267). This demonstrates that the device has appropriate structural integrity and performance characteristics for its intended physical function.

8. The sample size for the training set

This information is not applicable. This is not an AI algorithm submission, so there is no "training set."

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

This information is not applicable. There is no "training set" or ground truth for it as this is a mechanical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 14, 2020

BAUI Biotech Co., Ltd. Jessy Lin Regulatory Affairs Specialist 6F., No.8, Sec.1, Zongxing Rd., Wugu Dist., New Taipei City, 24872 Taiwan

Re: K191353

Trade/Device Name: COMET Lumbar Interbody Fusion Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 17, 2020 Received: March 20, 2020

Dear Jessy Lin:

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. Although this letter refers to your product as a device, please be aware 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191353

Device Name COMET Lumbar Interbody Fusion Cage

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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K191353 - Page 1 of 4

510(k) SUMMARY V.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.

Submitter's Name:	BAUI BIOTECH CO., LTD.
Submitter's Address:	6F., No.8, Sec.1, Zhongxing Rd., Wugu Dist., 24872New Taipei City, Taiwan(R.O.C.)
Submitter's Telephone:	886-2-8976-9538
Contact Person:	Name: Jessy LinTitle: RA SpecialistPhone: +886-2-8976-9538 Ext.153Fax: +886-2-8976-9608Email: ra153@baui.com.tw
Date Summary was Prepared:	March. 17th, 2020
Trade or Proprietary Name :	COMET Lumbar Interbody Fusion Cage
Common or Usual Name:	Interbody fusion cage, Intervertebral cage, Spacer
Classification Name:	Intervertebral body fusion device.
Classification:	Class II per 21 CFR 888.3080
Product codes:	MAX
Predicate Device:	SYNTHES T-PAL SPACER (K100089)

Device Description:

The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in

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skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".

Indications for Use:

The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Substantial Equivalence:

The COMET Lumbar Interbody Fusion Cage is substantially equivalent to the SYNTHES T-PAL SPACER, the predicate legally marketed device (K100089). The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the listed predicate device.

Testing was performed to support the equivalence of the intervertebral body fusion device in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" The following test was performed in accordance with ASTM F2077: Test Methods For Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression with particular requests in Static Compression. Static Compression Shear, Dynamic Compression, Dynamic Compression Shear and Subsidence.

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Comparison of Technological Characteristics Equivalence:

The subject COMET Lumbar Interbody Fusion Cage has the same indications for use statements and functions as well. The dimension angle is less than the predicate device. But both design features are similar, hollow design to accommodate a bone graft and teeth serration to stable the construct.

The COMET Lumbar Interbody Fusion Cage is composed of the same PEEK material as the predicate device, however, the material of marker pin of COMET Lumbar Interbody Fusion cage used Tantalum which is different from predicate device (Ti6Al7Nb), but both Tantalum and TAN (Ti6A17Nb) are a good radiopaque solution as they offer strong radiographic opacity and excellent biocompatibility applying in medical device. No matter which material is used, both materials of marker pin allow exact determination of the position of the implant during surgery.

The COMET Lumbar Interbody Fusion Cage and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness.

510k Number	Trade or Proprietary orModel Name	Manufacturer	Predicate Type
K100089	SYNTHES T-PAL SPACER	SYNTHES SPINE	Primary

Table 5-1 Predicate Devices

Non Clinical Testing:

The worst-case size for the COMET Lumbar Interbody Fusion Cage was conducted in the following mechanical test modes:

Static Compression per ASTM F2077
Static Compression Shear per ASTM F2077
Subsidence per ASTM F2267
Expulsion
Dynamic Compression per ASTM F2077
Dynamic Compression Shear per ASTM F2077

Above non-clinical performance data was provided in support of substantial equivalence of the subject device.

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Conclusions:

The subject COMET Lumbar Interbody Fusion has identical indication for use, and similar technological characteristics, principles of operation as the predicate. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that the COMET Lumbar Interbody Fusion is substantially equivalent to legally marketed 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.