When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the surgeon with proper placement of the device.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "The Integrity Spine Core System." This submission is for an intervertebral body fusion device and is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of analytical or clinical performance of an AI/ML algorithm. Instead, it describes non-clinical engineering tests conducted to ensure the physical and mechanical properties of the implant device meet established standards.

Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission as it is not an AI/ML product.

Here's the relevant information based on the provided text:

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

The document lists non-clinical mechanical tests to ensure the device's structural integrity and performance in vitro. It states these tests were "conducted in accordance with" specific ASTM standards, implying that the device successfully met the requirements of these standards. The acceptance criteria are implicitly those defined by the ASTM standards, but specific numerical thresholds and results are not provided in this summary.

Test Type	Standard / Method	Reported Performance (Qualitative)
Static and Dynamic Compression	ASTM F2077-11	Conducted in accordance; implies met standard
Static and Dynamic Torsion	ASTM F2077-11	Conducted in accordance; implies met standard
Subsidence	ASTM F2267-04	Conducted in accordance; implies met standard
Expulsion	ASTM Draft Standard F-04.25.02.02	Conducted in accordance; implies met standard

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This is not applicable to the non-clinical mechanical testing described. The "test set" here refers to the physical devices subjected to mechanical loads, not a dataset for an AI/ML algorithm. No information on data provenance is provided or expected for this type of testing.

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 is not applicable. The "ground truth" for mechanical testing is defined by the physical properties and performance against established engineering standards (ASTM). No human experts are involved in establishing this "ground truth."

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

This is not applicable. No adjudication method is relevant for objective mechanical testing.

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 is not applicable. This is a medical implant, not an AI/ML diagnostic or assistive device.

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

This is not applicable. This is a medical implant, not an AI/ML algorithm.

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

The "ground truth" for the mechanical testing is based on objective measurements against the performance criteria specified in the referenced ASTM (American Society for Testing and Materials) standards. These standards define the acceptable mechanical properties and failure modes for intervertebral body fusion devices.

8. The sample size for the training set

This is not applicable. This is a medical implant undergoing mechanical testing, not an AI/ML algorithm.

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

This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this device.

Summary

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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2023

Integrity Spine % Jennifer Palinchik President JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145

Re: K223043

Trade/Device Name: The Integrity Spine Core System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 22, 2023 Received: February 23, 2023

Dear Jennifer Palinchik:

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.

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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 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 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 -S

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)

K223043

Device Name The Integrity Spine Core 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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Image /page/3/Picture/0 description: The image is a logo for Integrity Spine. The logo features the letters "I" and "S" in a stylized font, with the word "Integrity" in red above the word "Spine" in black. To the left of the letters is a spine graphic. The logo is clean and professional, and it conveys a sense of trust and expertise.

510(k) Summary

Submitted By:	Integrity Spine414 W Sunset Rd Ste 205Dallas, TX 75206
Date:	03/16/2023
Contact Person:	Jennifer Palinchik, PresidentJALEX Medical
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Device Trade Name:	Integrity Spine Core System
Device Classification Name:	Intervertebral Body Fusion Device with Bone Graft, Cervical
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	ODP
Predicate Device:	K132718 Integrity Spine Core System
Additional Predicate:	K133967 Aurora Spine Interbody Fusion System
	The predicate devices have not been subject to any design relatedrecalls

Device Description:

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.

Intended Use:

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Image /page/4/Picture/0 description: The image is a logo for Integrity Spine. The logo features the letters "I" and "S" in a stylized font, with a spine graphic incorporated into the "I". The word "Integrity" is written in red above the word "Spine", which is written in black. The logo is clean and professional, and it effectively communicates the company's focus on spinal health.

Summary of Technological Characteristics:

The Integrity Spine Core System and the primary predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use ●
Materials
Dimensions .
. Function

Feature	Integrity Spine Core System (Subject)	Integrity Spine Core System (K132718)	Aurora Spine Interbody Fusion System (K133967)	Comparison
Classification Name	Intervertebral Body Fusion Device with Integrated Fixation, Cervical	Intervertebral Body Fusion Device with Integrated Fixation, Cervical	Intervertebral Body Fusion Device with Integrated Fixation, Cervical	Equivalent
Regulation	888.3080	888.3080	888.3080	Equivalent
Product Code	ODP	ODP	ODP	Equivalent
Device Description	The Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray	The Integrity Spine Core System is a cervical interbody fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the	The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed	Equivalent
Feature	Integrity SpineCore System(Subject)	Integrity Spine CoreSystem (K132718)	Aurora SpineInterbody FusionSystem (K133967)	Comparison
	coated withtitanium thatconforms to ASTMF1580.Additionally, thedevices containtantalum markersthat conform toASTM F560 toassist the surgeonwith properplacement of thedevice.	surgeon with properplacement of thedevice.The Integrity SpineCore System isimplanted using acombination of devicespecific and universalclass I instrumentsmanufactured fromstainless steel thatconforms to ASTMF899.	commercially puretitanium coating onthe superior andinferior surfaces.
Intended Use	When used as acervicalintervertebral bodyfusion device, theIntegrity SpineCore System isindicated forintervertebral bodyfusion in skeletallymature patientswith degenerativedisc disease (DDD)of the cervicalspine withaccompanyingradicular symptomsat one disc levelfrom the C2-C3disc to the C7-T1disc. DDD isdefined as	When used as acervical intervertebralbody fusion device,the Integrity SpineCore System isindicated forintervertebral bodyfusion in skeletallymature patients withdegenerative discdisease (DDD) of thecervical spine withaccompanyingradicular symptoms atone disc level from theC2-C3 disc to the C7-T1 disc. DDD isdefined as discogenicpain with degenerationof the disc confirmedby history and	The Aurora SpineInterbody FusionSystem is indicatedfor use as anintervertebral bodyfusion device inskeletally maturepatients withdegenerative discdisease (defined asdiscogenic back painwith degeneration ofthe disc confirmedby patient historyand radiographicstudies) at one levelof the cervical spinewith accompanyingradicular symptoms.Patients should havesix weeks of non-	Equivalent
Feature	Integrity Spine Core System (Subject)	Integrity Spine Core System (K132718)	Aurora Spine Interbody Fusion System (K133967)	Comparison
	discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.	radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.	operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
Interbody Heights	5-11 mm	5-11 mm	5-12 mm	Equivalent
Interbody Footprints	14x11 mm, 17x13 mm	14x11 mm, 17x13 mm	14x12 mm, 16x14 mm	Equivalent
Lordosis	6°	0° and 6°	5°	Equivalent
Implant Materials	PEEK Zeniva ZA-500 Per ASTM F2026, Titanium coating Per ASTM F1580, Tantalum markers Per ASTM F560	PEEK Zeniva ZA-500 Per ASTM F2026, Tantalum markers Per ASTM F560	PEEK Optima Per ASTM F2026, Titanium coating per ASTM F67, Tantalum markers Per ASTM F560	Equivalent

Table 1, Technological Characteristics Comparison

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Image /page/5/Picture/0 description: The image is a logo for Integrity Spine. The logo features a stylized spine graphic integrated into the letters "I" and "S". The word "Integrity" is in red above the word "Spine" which is in black.

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Image /page/6/Picture/0 description: The image contains a logo for "Integrity Spine". The logo features a stylized spine graphic integrated into the letters "I" and "S". The word "Integrity" is in red, and the word "Spine" is in black.

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Image /page/7/Picture/0 description: The image is a logo for Integrity Spine. The logo features the words "Integrity Spine" in a bold, sans-serif font. The word "Integrity" is in red, while the word "Spine" is in black. To the left of the words is a stylized image of a spine in black and white, with a red square behind it. The logo is simple and professional, and it conveys the message that Integrity Spine is a reliable and trustworthy provider of spinal care.

Non-clinical Testing:

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-11 ●
Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11 ●
Subsidence testing, conducted in accordance with ASTM F2267-04
Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 ●

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

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.