The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

bi-laterally in pairs via a posterior (PLIF) approach;
as a single device via an oblique (OLIF) approach: a
as a single device via a transforaminal (TLIF) approach: or -
as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

AI/ML Overview

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Equivalent static and dynamic performance to predicate devices (ASTM F2077-11)	Met: Substantially equivalent results for static and dynamic compression and torsion testing.
Subsidence Performance: Equivalent subsidence resistance to predicate devices (ASTM F2267-04)	Met: Substantially equivalent results for subsidence testing.
Expulsion Performance: Equivalent expulsion resistance to predicate devices (ASTM Draft Standard F-04.25.02.02)	Met: Substantially equivalent results for expulsion testing.
Material Equivalence: Use of materials compliant with recognized standards and similar to predicates	Met: Implant components made of PEEK Zeniva ZA-500 (ASTM F2026) and tantalum markers (ASTM F560), similar to predicate materials.
Intended Use Equivalence: Same indications for use as predicate devices	Met: Intended for intervertebral body fusion of the lumbar spine (L2-S1) in skeletally mature patients for DDD with up to Grade I spondylolisthesis, similar to predicates.

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

The document describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device 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

There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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 spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 0 2017

Mr. Robert Kelly C Change Surgical, LLC 101 N. Chestnut Street, Suite 301 Winston-Salem, NC 27101

Re: K051819

Trade/Device Name: C Change Solution Warmer Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: July 1, 2005 Received: July 7, 2005

Dear Mr. Kelly:

This letter corrects our substantially equivalent letter of August 15, 2005.

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2 - Mr. Robert Kelly

as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

. .

510(k) Number (if known): _ KOSIBIS -

C Change Solution Warmer Device Name: _

Indications for Use:

The C Change Solution Warmer is designed to warm and maintain the temperature of surgical solutions prior to their use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Haubara Buchep for Mellekerson

Division of General, Restorative, and Neurological Devices

Page _ 1_ of _1

510(k) Number K051819.

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510(k) Summary Integrity Spine Lumbar Interbody Fusion System Premarket Notification

SUBMITTED BY	Integrity Spine2800 NE Loop 410 Suite 203San Antonio, TX 78218
ESTABLISHMENTREGISTRATION NUMBER	3010763958
OWNER/OPERATORNUMBER	10046086
CONTACT PERSON	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746Fax: 512-266-3364Ipeterson@kaedonconsulting.com
DATE PREPARED	October 12, 2015
CLASSIFICATION NAME	Intervertebral Body Fusion Device
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080 (Product Code MAX)
COMMON NAME	Intervertebral Fusion Device with Bone Graft, Lumbar
PROPRIETARY NAME	Integrity Spine Lumbar Interbody Fusion System

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IDENTIFICATION OF PREDICATE DEVICE(S)

Predicate devices include various cleared interbody fusion systems:

Primary

DiFusion: Xiphos Interbody Fusion System (K100042)

Secondary

Additional Predicate
DePuy Acromed: Lumbar I/F Cage (P960025)

Reference Devices

Eminent Spine: Eminent Spine Interbody Fusion System ı (K090064)
Medtronic: InterFix System (P970015) ,
SeaSpine: SeaSpine Spacer System (K082310) .
Tyber Medical: Tyber Medical Interbody System ﺎ (K130573)
Spinal USA: Spinal USA Interbody Fusion Device -(K092193)

DEVICE DESCRIPTION

bi-laterally in pairs via a posterior (PLIF) approach;
as a single device via an oblique (OLIF) approach: a
as a single device via a transforaminal (TLIF) approach: or -
as as a single device via an anterior or anterolateral (ALIF) approach.

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

INDICATIONS

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Integrity Spine Lumbar Interbody Fusion System. The Integrity Spine System is comprised of various device configurations based on surgical approach and patient anatomy. The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

. Intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
. Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-11 ), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

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

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Integrity Spine Lumbar Interbody Fusion System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5950 Powered heating unit.

(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.