The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.

Device Description

The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervical interbody device consisting of a titanium alloy (Ti-6Al-4V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al-4V ELI) anchors per ASTM F136, and a titanium alloy (Ti-6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and are offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal bladed anchors that lock on deployment and provide additional fixation.

The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., an anterior plate, posterior pedicle screws) may be needed.

AI/ML Overview

This document describes the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. Therefore, the "acceptance criteria" and "device performance" are primarily related to biomechanical testing and material properties, rather than diagnostic accuracy as would be found in an AI/ML device submission.

Here's the information as requested, interpreted in the context of this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Purpose	Device Performance
Static Subsidence (ASTM F2267-04)	Evaluates how much the implant sinks into the bone under static load.	Results demonstrate equivalence to predicate devices.
Expulsion (Standard N/A)	Assesses the resistance of the implant to being dislodged from the intervertebral space.	Results demonstrate equivalence to predicate devices.
Dynamic Axial Compression (ASTM F2077-18)	Measures the fatigue strength of the implant under cyclic compressive loads.	Results demonstrate equivalence to predicate devices.
Dynamic Compression-Shear (ASTM F2077-18)	Measures the fatigue strength of the implant under combined compressive and shear loads.	Results demonstrate equivalence to predicate devices.
Dynamic Torsion (ASTM F2077-18)	Measures the fatigue strength of the implant under twisting loads.	Results demonstrate equivalence to predicate devices.
ROM Cadaveric Testing	Compares the range of motion provided by the subject device versus a previously cleared standalone device in a cadaveric model.	The results demonstrate the subject device is substantially equivalent to the predicate devices in stabilization performance.
Sterilization Assurance Level (SAL)	Confirms sterile processing reaches a SAL of 10^-6.	Minimum radiation dose of 25kGy was sufficient to meet a SAL of 10^-6.
Package System Integrity	Ensures packaging remains intact and maintains a hermetic barrier after sterilization and distribution.	Package system remained intact while also maintaining the hermetic barrier.

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

Sample Size for Biomechanical Testing (Implants): Not explicitly stated how many individual implants were tested for each biomechanical test (Static Subsidence, Dynamic Axial Compression, etc.). However, these tests are generally conducted on a sufficient number of samples (e.g., 5-10 per test condition) to establish statistical significance according to the ASTM standards.
Sample Size for Cadaveric Testing: Not explicitly stated how many cadaveric spines were used.
Data Provenance: The tests are non-clinical (laboratory and cadaveric studies). This is retrospective data collected for the purpose of this submission.
- Country of Origin: Not specified, but generally, such testing is conducted in accredited labs, often within the US or by international labs recognized by the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable in the context of an orthopedic implant biomechanical study. "Ground truth" in this scenario is established by the standardized methods outlined in ASTM specifications and accepted engineering principles, rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" (i.e., test results meeting predefined criteria) is determined directly by the physical measurements from standardized biomechanical tests, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/ML diagnostic devices to assess how the AI assists human readers. This submission is for an orthopedic implant.

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

This question is not applicable. The device is a physical implant, not an algorithm. The "standalone" performance here refers to the biomechanical performance of the implant itself, which is what the non-clinical testing evaluates (without human intervention in the device's function).

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Standardized Biomechanical Test Results: Adherence to established ASTM standards (F2267-04, F2077-18) defines the "ground truth" for mechanical properties (e.g., strength, fatigue resistance).
Cadaveric Biomechanical Measurements: Measurements of range of motion and stability in a cadaveric model serve as "ground truth" for the device's functional performance in a relevant anatomical context.
Sterilization Validation: Meeting a pre-defined Sterility Assurance Level (SAL) of 10^-6 is the "ground truth" for sterility.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device. The device's design and materials are based on established engineering principles and prior predicate device data, not machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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September 14, 2023

ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K223869

Trade/Device Name: ChoiceSpine Blackhawk Ti Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: August 17, 2023 Received: August 18, 2023

Dear Kim Finch:

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

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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) 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 (QS) 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 medical devices and radiation-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,

Katherine D. Kavlock -S

for

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) K223869

Device Name

ChoiceSpine Blackhawk Ti Cervical Spacer 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

Date:Sponsor:	September 11, 2023ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919
Phone:Fax:Contact Person:	865-246-3333865-246-3334Kim Finch, Director of Regulatory Affairs
ProposedProprietary TradeName:	ChoiceSpine Blackhawk™ Ti Cervical Spacer System
Product Class:	Class II
ClassificationName:	ChoiceSpine Blackhawk™ Ti Cervical Spacer System888.3080 - Intervertebral Fusion Device with Integrated Fixation, Cervical
Device ProductCode:	ChoiceSpine Blackhawk™ Ti Cervical Spacer SystemOVE
Purpose of Submission:	The purpose is to modify our existing ChoiceSpine Blackhawk™ Ti Cervical SpacerSystem (K203311). Modifying the intended use to include stand-alone indicationand updating the labeling.
Device Description:	The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervicalinterbody device consisting of a titanium alloy (Ti-6Al-4V ELI) implant cage perASTM F3001, nitinol internal locking components per ASTM F2063, two internaltitanium alloy (Ti-6Al-4V ELI) anchors per ASTM F136, and a titanium alloy (Ti-6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbodyfusion devices and are offered in a variety of heights, footprints, and lordoticangles to accommodate varying anatomical conditions. The device features achamber intended to be filled with autogenous bone and/or allogenic bonegraft material. The Blackhawk™ Ti Cervical Spacer System is used with twointernal bladed anchors that lock on deployment and provide additionalfixation.
	The integrated fixation anchors may not provide adequate stability for allsituations. The surgeon should consider the appropriate fixation required foreach patient and determine if additional supplemental fixation (e.g., an anteriorplate, posterior pedicle screws) may be needed.
Indications for Use:	The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervicalinterbody fusion device indicated for use in a skeletally mature patient withdegenerative disc disease (DDD) with accompanying radicular symptoms at onelevel from C2-T1. DDD is defined as discogenic pain with degeneration of the
	disc conformed by history and radiographic studies. These patients should havehad six weeks of non-operative treatment. The Blackhawk™ Ti Cervical SpacerSystem is to be used with autogenous bone and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.
Materials:	The Blackhawk™ Ti Cervical Spacer System implants are composed of a titaniumalloy (Ti-6Al- 4V ELI per ASTM F3001, Class C) implant spacer, nitinol (per ASTMF2063) internal locking clips, titanium alloy (Ti-6Al-4V ELI per ASTM F136)anchors, and a titanium alloy (Ti-6Al-4V ELI per ASTM F136) locking cam. Theimplant body, cam, and anchors are composed of Titanium alloy Ti-6Al-4V perASTM F136/F3001, which has a long history of safe and effective use inorthopedic implants. The locking clips are composed of nitinol per ASTM F2063,which has a long history of safe and effective use in orthopedic implants. TheBlackhawk™ Ti Cervical Spacer System implants will be provided sterile.Instruments will be provided non-sterile but will be steam sterilized before use.The instrumentation is made from 17-4 Stainless Steel (ASTM F899/A693), 465Stainless Steel (ASTM F899), titanium alloy (Ti-6Al-4V ELI Grade 5 per ASTMF136), and polyphenylsulfone (Radel R5000 Series).
Predicate Devices:	Primary Predicate:ChoiceSpine Tomcat™ Cervical Spacer System (K170953)Additional Predicates:ChoiceSpine Blackhawk™ Cervical Spacer System (K203311)
Non-clinical Testing:	Static subsidence per ASTM F2267-04Expulsion (standard N/A)Dynamic axial compression per ASTM F2077-18Dynamic compression-shear per ASTM F2077-18Dynamic torsion per ASTM F2077-18ROM Cadaveric testing of the Tomcat & Blackhawk Ti Implants
TechnologicalCharacteristics:	The implants proposed in this submission are similar to the predicate devices inthe principle of operation, indications for use, stabilization method, anatomiclocation and approach, product code and classification, and biocompatibility.
	The subject device has similar geometry and identical footprints as the primarypredicate (Tomcat Cervical Spacer System). The subject device's spacercomponent is made out of titanium alloy whereas the primary predicate'sspacer component is made out of PEEK. The anchor components of the subjectdevices are made out of the same titanium alloy. The primary predicate Tomcatis secured by two screws with an internal locking mechanism, whereas theBlackhawk Ti has two bladed anchors secured with a titanium cam lock andlocking clips that are deployed in an equivalent fashion.
	The Blackhawk Ti Cervical Spacer is a 3D printed device and manufacturingprocess remains unchanged since initially cleared under K203311.

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Substantial Equivalence Conclusion:

Cadaveric range of motion testing was performed comparing the design to a previously cleared standalone device. The results demonstrate the subject device is substantially equivalent to the predicate devices in safety, effectiveness, and performance. While the designs are different, the mechanical strength and stabilization performance are equivalent as demonstrated through ASTM F2077 and ASTM F2267 testing and cadaveric testing.

The subject device is provided sterile and are processed at the same supplier as previously cleared Blackhawk Ti K203311. ChoiceSpine's sterilization process has been validated through gamma validation and distribution testing and the results demonstrate that the predetermined acceptance criteria were met. The minimum radiation dose of 25kGy was sufficient to meet a sterilization assurance level (SAL) of 106 and the package system remained intact while also maintaining the hermetic barrier.

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.