The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The Integrity Implants FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the FlareHawk Interbody Fusion System, which is an expandable lumbar intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study proving those criteria are met for a new AI/ML-driven device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training data, how ground truth for training data was established) are not applicable to this document because it is not about an AI/ML device that generates diagnostic or prognostic outputs requiring such evaluations.

However, I can extract the closest analogous information regarding acceptance criteria and the study performed, focusing on the bench performance testing mentioned.

Here's a breakdown of the information that can be extracted or noted as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in precise numerical terms with corresponding reported performance for comparison in a table format as might be expected for AI/ML device metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to industry standards for mechanical testing.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ASTM F2077 for Static Axial Compression	Confirmatory bench performance testing conducted to demonstrate compliance.
Compliance with ASTM F2077 for Dynamic Axial Compression	Confirmatory bench performance testing conducted to demonstrate compliance.
Compliance with ASTM F2077 for Static Compression Shear	Confirmatory bench performance testing conducted to demonstrate compliance.
Compliance with ASTM F2077 for Dynamic Compression Shear	Confirmatory bench performance testing conducted to demonstrate compliance.
No new risks introduced by device modifications	Risk analysis completed; engineering rationales demonstrated no new risks.
Device does not create a new worst case for the overall system	Risk analysis completed; engineering rationales demonstrated no new worst case.
Substantial Equivalence to predicate devices	Demonstrated through engineering rationales, confirmatory bench testing, and supporting documentation.

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

Sample Size for Test Set: Not explicitly stated as this is mechanical testing of physical implants, not a data-driven AI/based test. The "test set" would be the number of physical devices subjected to the bench tests.
Data Provenance: Not applicable in the context of digital data; this refers to results from physical bench testing performed by Integrity Implants Inc.

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

Not applicable. Ground truth for mechanical testing is typically established by physical measurement against engineering specifications and industry standards, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. This is mechanical testing against standards.

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 device is an interbody fusion system, not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This device is a physical implant.

7. The type of ground truth used

Ground Truth: Engineering specifications and compliance with established ASTM standards (specifically ASTM F2077) for mechanical properties (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes confirmatory bench performance testing as the study method. This testing was conducted in support of the premarket notification submission to demonstrate that the modified FlareHawk Interbody Fusion System maintains performance characteristics comparable to its predicate devices and adheres to relevant industry standards.

The specific tests performed were:

Static Axial Compression in accordance with ASTM F2077
Dynamic Axial Compression in accordance with ASTM F2077
Static Compression Shear in accordance with ASTM F2077
Dynamic Compression Shear in accordance with ASTM F2077

Additionally, a risk analysis was completed, demonstrating that no new risks were introduced and that the device modifications did not create a new worst-case scenario.

The conclusion stated is that, based on engineering rationales, confirmatory bench performance testing, and other supporting documentation, the subject FlareHawk® Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices. This indicates that the device's performance met the implicit acceptance criteria of conforming to the established mechanical standards and not introducing new risks compared to its predicates.

Summary

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March 24, 2022

Integrity Implants Inc. Anne Mulvihill Senior Regulatory Affairs Specialist 354 Hiatt Drive Palm Beach Gardens, Florida 33418

Re: K220453

Trade/Device Name: FlareHawk Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 18, 2022 Received: March 21, 2022

Dear Anne Mulvihill:

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 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

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Indications for Use

510(k) Number (if known) K220453

Device Name FlareHawk® Interbody Fusion 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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510(k) SUMMARY

FlareHawk® Interbody Fusion System

February 15, 2022

I. Company:	Integrity Implants Inc.354 Hiatt DrivePalm Beach Gardens, FL 33418Telephone: 561-529-3861
II. Contact:	Anne MulvihillSenior Regulatory Affairs Specialist
III. Proprietary Trade Name:	FlareHawk® Interbody Fusion System
IV. Common Name:	Intervertebral Body Fusion Devicewith Bone Graft, Lumbar
V. Classification Name:	Intervertebral Body Fusion Device (21 CFR 888.3080)
Class:	II
Product Code:	MAX

VI. Product Description

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shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion.

The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine.

The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

VII. Indications for Use

Summary of Technological Characteristics VIII.

The subject FlareHawk Interbody Fusion System has substantially similar fundamental scientific technology as the predicate FlareHawk Interbody Fusion System. Like the predicate FlareHawk Interbody Fusion System, the shell component of the subject FlareHawk Interbody Fusion System implants is a rectangular frame that is inserted into the disc space in a non-expanded form, with subsequent in-situ expansion resulting from the insertion of the shim component. The shim locks to both the shell core and the posterior of the shell when the implant is deployed.

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Like the predicate FlareHawk Interbody Fusion System, the subject shell component is manufactured from PEEK per ASTM F2026, and incorporates an integrated core manufactured from titanium alloy per ASTM F136, and tantalum markers per ASTM F560 for imaging purposes. The subject shell components are offered in both non-coated and coated with CP titanium (Grade 2 commercially pure titanium that meets the chemical composition requirements of ASTM F67) versions. The shell component features a bulleted nose designed to facilitate ease of insertion, as well as directional teeth on its superior and inferior surfaces to resist expulsion.

Like the predicate FlareHawk Interbody Fusion System, the shim component of the subject FlareHawk Interbody Fusion System implants has a tapered front end that inserts into and expands the shell component to the desired height and lordosis. The shim is manufactured from titanium alloy per ASTM F136 and are color anodized for differentiation.

Like the predicate FlareHawk Interbody Fusion System, the subject shells and shims are offered in both non-sterile (and intended to be steam sterilized by the user) and gamma sterilized versions.

IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

To demonstrate the substantial equivalence of the subject FlareHawk Interbody Fusion System to legally marketed predicate devices, FlareHawk Interbody Fusion System, K202198 (SE 11/03/2020), is used as the primary predicate device. Integrity Implants' FlareHawk Interbody Fusion System, K182114 (SE 01/07/2019) and K183184 (SE 04/03/2019) are also used as predicates for this submission.

Additionally, Amplify Surgical's DualX™ Dual Expanding Interbody Fusion System, K181397 (SE 09/27/2018) is used as a predicate for this submission.

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X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted

A risk analysis of the device modifications was completed in accordance with Integrity Implants design control procedures. Verification and validation activities, including engineering rationales, demonstrated that no new risks have been introduced to FlareHawk Interbody Fusion System by the addition of the subject devices, and that the addition of the subject devices does not create a new worst case for the overall FlareHawk Interbody Fusion System.

Confirmatory bench performance testing conducted in support of this premarket notification submission included:

Static Axial Compression in accordance with ASTM F2077 .
. Dynamic Axial Compression in accordance with ASTM F2077
Static Compression Shear in accordance with ASTM F2077
. Dynamic Compression Shear in accordance with ASTM F2077

Conclusions Drawn for the Non-Clinical and Clinical Tests XI.

Based on the engineering rationales, confirmatory bench performance testing, and other supporting documentation provided in this premarket notification, the subject FlareHawk® Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices, including the previously cleared FlareHawk® Interbody Fusion System.

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.