The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.

Device Description

The Entasis™ Dual-Lead Sacroiliac Implant system is composed of dual-lead sacroiliac screws manufactured from titanium (Ti-6AI-4V ELI) per ASTM F136. The screws are available in lengths of 30-70mm and diameters of 7-11.5mm.

AI/ML Overview

This document is a 510(k) summary for a medical device called the Entasis™ Dual-Lead Sacroiliac Implant. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously marketed devices. However, it does not provide information on acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

This document is for a traditional medical implant device, not an AI/ML device. Therefore, the requested information categories typically associated with AI/ML device performance (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

Here's a breakdown of the information that can be extracted from the provided text, modified to reflect the type of device:

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

The document refers to "Performance Data" from non-clinical testing but does not explicitly state numerical acceptance criteria for each test. Instead, it concludes that the "strength of the Entasis™ Dual-Lead Sacroiliac Implant is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria were met by matching or exceeding the performance of the predicate devices.

Test Mode	Reported Device Performance (Implied Acceptance)
Static torsion per ASTM F543	Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary)
Static pullout per ASTM F543	Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary)
Static driving torque per ASTM F543	Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary)
Static three-point bending per ASTM F2193	Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary)
Dynamic three-point bending per ASTM F2193	Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary)

Regarding the other information requested for an AI/ML device:

Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not an AI/ML algorithm processing data. The "test set" would refer to the physical implants tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant's mechanical performance is typically established by engineering standards and measurements, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic or interpretive device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the ground truth is established by standardized measurements according to the ASTM standards listed (F543, F2193).
The sample size for the training set: Not applicable. There is no "training set" for a physical implant device in this context.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a traditional medical device (an implant) and its mechanical performance testing for 510(k) clearance, not an AI/ML-based device. Therefore, most of the requested fields related to AI/ML device evaluation are not relevant or present in this document.

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 is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.

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

February 4, 2016

CoreLink, LLC % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K152237

Trade/Device Name: The Entasis™ Dual-Lead Sacroiliac Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: December 31, 2015 Received: January 4, 2015

Dear Mr. Maxwell:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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 Part 801), 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,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement on last page.
510(k) Number (if known)	K152237
Device Name	Entasis™ Dual-Lead Sacroiliac Implant
Indications for Use (Describe)

The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for
conditions including degenerative sacroilitis and sacroiliac joint disruptions.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5.510(K) SUMMARY

Submitter's Name:	CoreLink, LLC
Submitter's Address:	7606 Forsyth Blvd
	St. Louis, MO 63105
Submitter's Telephone:	(888) 349-7808
Contact Person:	Kenneth C. Maxwell II
	Empirical Testing Corp.
	719.291.6874
Date Summary was Prepared:	04 February 2016
Trade or Proprietary Name:	Entasis™ Dual-Lead Sacroiliac Implant
Common or Usual Name:	Smooth or threaded metallic bone fixation fastener
Classification:	Class II per 21 CFR §888.3040 Device Classification
Product Code:	OUR
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.

The indications for use for the CoreLink, LLC Entasis™ Dual-Lead Sacroiliac Implant is similar to that of the predicates listed in Table 5-1 Predicate Devices.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The following characteristics are similar between the subject and predicate devices:

Indications for Use
Materials of Manufacture ●
Principles of Operation

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K021932	6.5mm Cannulated Screw	Synthes	Primary
K140079	Silex	X-spine	Additional

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Performance Data

The Entasis™ Dual-Lead Sacroiliac Implant has been tested in the following test modes:

Static torsion per ASTM F543 ●
Static pullout per ASTM F543 ●
Static driving torque per ASTM F543 ●
Static three-point bending per ASTM F2193 ●
Dynamic three-point bending per ASTM F2193 ●

The results of this non-clinical testing show that the strength of the Entasis™ Dual-Lead Sacroiliac Implant is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Entasis™ Dual-Lead Sacroiliac Implant is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.