When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

Device Description

The Pantheon IBFD is oval in shape with one or more openings through the structure. Pyramidal teeth are incorporated on the inferior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes to accommodate differing anatomic requirements. The device is manufactured from medical grade PEEK in accordance with ASTM F2026 and Ti6Al4V titanium alloy with tantalum markers conforming to ASTM F136. The subject device introduces the 20 degree hyperlordotic sizes in a variety of lengths, widths and heights.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Pantheon IBFD, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in a clinical or performance study involving human subjects or complex AI algorithms.

Therefore, many of the requested information points (like sample size for test sets, expert qualifications, MRMC studies, standalone AI performance, training set details) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance testing that was done to validate changes to the device:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (or Study Type)
Mechanical Performance	New ASTM F2077 static and dynamic compression tests were performed.
Structural Integrity	An FEA (Finite Element Analysis) was created.

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

This information is not provided in the document. The performance testing mentioned (ASTM F2077 and FEA) are bench-top engineering tests, not clinical studies with human participants. Therefore, concepts like sample size for a "test set" in the context of clinical data or data provenance (country of origin, retrospective/prospective) are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided because the performance testing described are engineering tests, not studies requiring expert clinical assessment for ground truth establishment.

4. Adjudication Method:

Not applicable as this was not a study requiring adjudication of clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. The device is a physical intervertebral fusion device, not a diagnostic or prognostic system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

For the ASTM F2077 tests, the ground truth would be established by the standardized methods and thresholds defined in the ASTM F2077 standard itself.
For the FEA, the ground truth would be based on the principles of mechanical engineering and material science used to develop the model and interpret its results.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the reasons stated above.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria involved:

New ASTM F2077 static and dynamic compression tests: These standard tests are used to evaluate the mechanical performance of intervertebral body fusion devices under various loading conditions. The purpose was to "validate changes to the device," implying that the device was tested against the established mechanical performance requirements and limits of the ASTM F2077 standard. The specific acceptance criteria (e.g., maximum deflection, fatigue cycles without failure) are inherent to the standard but not explicitly stated in this document.
Finite Element Analysis (FEA): An FEA was created "to verify that a new worse case was not created with the new size additions." This computational analysis helps predict how the device will behave under different stresses and strains, especially with new geometric variations. The "acceptance criteria" here would be that the FEA results demonstrate the new sizes maintain sufficient structural integrity and do not introduce new failure modes or decrease safety margins below acceptable engineering limits.

The conclusion states: "Based on information contained in this submission, and the similarities of the subject and predicate devices, the subject IBFD Interbody Fusion System is substantially equivalent to the predicate devices." This substantial equivalence determination, supported by the performance testing, indicates that the device is considered safe and effective for its indicated uses, similar to the predicate device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 7, 2021

Pantheon Spinal Dave Lamb Ouality and Regulatory Affairs 40132 Industrial Park Circle Suite 101 Georgetown, Texas 78626

Re: K203003

Trade/Device Name: Pantheon IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 9, 2021 Received: June 10, 2021

Dear Mr. Lamb:

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

{1}------------------------------------------------

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 DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203003

Device Name Pantheon IBFD

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summarv

Date:	July 6, 2021
Sponsor:	Pantheon Spinal
	40132 Industrial Park Circle Suite
	101 Georgetown, TX 78626
	512-308-3488
Establishment Registration	3010665091
Sponsor Contact:	Dave Lamb
Proposed Trade Name:	Pantheon IBFD
Common Name:	Interbody Fusion System
Device Classification:	Class II
Regulation Name	Intervertebral fusion device
Product Code	MAX
Regulation Number	888.3080
Primary Predicate:	Pantheon Spinal Interbody Fusion Device K181548, K113781
Additional Predicates	Titan Spine Endoskeleton TL Hyperlordotic Interbody Fusion DeviceK191581

Device Description: The Pantheon IBFD is oval in shape with one or more openings through the structure. Pyramidal teeth are incorporated on the inferior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes to accommodate differing anatomic requirements. The device is manufactured from medical grade PEEK in accordance with ASTM F2026 and Ti6Al4V titanium alloy with tantalum markers conforming to ASTM F136. The subject device introduces the 20 degree hyperlordotic sizes in a variety of lengths, widths and heights.

Indications for use: When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc

{4}------------------------------------------------

disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non- operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

Substantial Equivalence: The Pantheon IBFD is substantially equivalent to the primary predicate Pantheon Spinal Interbody Fusion Device (K181548) with respect to design, function, intended use, and materials with the exception of the proposed additional sizes.

Pantheon Spinal Interbody Fusion Device K181548 and additional (secondary) predicate Titan Spine Endoskeleton TL Hyperlordotic Interbody Fusion Device K191581 are similar in design,materials, and indications. The new Pantheon IBFD does not raise new questions about safety and effectiveness.

Performance Testing: New ASTM F2077 static and dynamic compression tests were performed to validate changes to the device. An FEA was created to verify that a new worse case was not created with the new size additions.

Conclusion: Based on information contained in this submission, and the similarities of the subject and predicate devices, the subject IBFD Interbody Fusion System is substantially equivalent to the predicate devices.

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.