The Aesculap SternumFix Sternal Closure System is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

Device Description

The Aesculap Sternal Closure System consists of an implantable single use clamp made of titanium alloy (TiAl6V4) and a specially designed applicator instrument.

AI/ML Overview

The provided text describes a medical device called the "SternumFix Sternal Closure System" and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

Here's an analysis based on the available information and a breakdown of why some requested fields cannot be filled:

The document (K063017) is a 510(k) summary, which typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a comprehensive clinical trial with explicit acceptance criteria and detailed performance metrics against those criteria.

However, based on the text provided:

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

Acceptance Criteria (Inferred)	Reported Device Performance
Efficacy	"proved the efficacy of the new device"
Material compatibility	Same as CranioFix implant (TiAl4V6)
Design	Based on proven CranioFix clamp and applier design
Packaging	Same as CranioFix
Sterilization	Same as CranioFix
Indicated Use	Similar to Synthes Sternal Fixation System

Note: The document states, "Mechanical testing of the SternumFix and the predicate Ethicon Stainless Steel proved the efficacy of the new device." This implies that the acceptance criteria for efficacy were met through this comparative mechanical testing. However, the specific numerical thresholds or performance targets for "efficacy" are not provided.

Regarding the other requested information:

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 does not specify the sample size for the mechanical testing or any other test set.
- It does not specify the data provenance (country of origin, retrospective/prospective). As it's mechanical testing, it's likely laboratory-based rather than patient-based.
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 information is not applicable or provided. The "ground truth" for mechanical testing would typically be based on established engineering standards and measurements, not expert human assessment in the way clinical studies requiring image interpretation or diagnosis would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or provided as the primary evidence cited is mechanical testing, not a clinical study involving human judgment that would require adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical implant for sternal closure, not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "efficacy" claim, the ground truth was established through mechanical testing against a predicate device. This would involve objective physical measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
- This information is not applicable. The device is a physical implant, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence primarily through a comparison of technological characteristics and mechanical testing against a predicate device. It does not detail specific acceptance criteria in a quantitative manner or describe a clinical study with elements like human experts, adjudication, or AI performance, as these are generally not required for this type of device and regulatory submission.

Summary

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Image /page/0/Picture/2 description: The image shows the text "K063017" in a bold, handwritten font. Below this, the text "Page 1 of 2" is printed in a smaller, standard font. The text suggests that the image is part of a document, possibly a multi-page report or a set of instructions.

510(k) SUMMARY (as required by 21 CFR 807.92) B.

Device Name 26 September 2006

DEC 2 7 2006

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714	DEC 27
CONTACT:	Matthew M. Hull610-984-9072 (phone)610-791-6882 (fax)
TRADE NAME:	SternumFix Sternal Closure System
COMMON NAME:	Metallic Cerclage Fixation System
CLASSIFICATION NAME:	Bone fixation cerclage
REGULATION NUMBER:	888.3010
PRODUCT CODE:	JDQ

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the SternumFix Sternal Closure System is substantially equivalent to:

1. Ethicon Stainless Steel Suture Wire (K931271/ K946173)
1. Aesculap CranioFix Titanium Clamp System (K040864)
1. Synthes Sternal Fixation System (K010943)

DEVICE DESCRIPTION

The Aesculap Sternal Closure System consists of an implantable single use clamp made of titanium alloy (TiAl6V4) and a specially designed applicator instrument.

INDICATIONS FOR USE

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एक प्रतिक्रियों को प्रति किया था। इस बार की मानी की में बाद में दिल्ली की में हो गया है।
एक बार की में दिल्ली की में हो गई है। होगी की है और किसी है और किसी है और किसी है

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K063017
Page 2 of 2

TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The design of the clamp and the applier are based upon the proven design features of the Aesculap CranioFix clamp and applier. The implant material (TiAl4V6) is the same as that used in the CranioFix implant. The packaging and sterilization are the same as that used for CranioFix as well. The efficacy of the SternumFix was compared to that of the current standard of care: wire cerclage fixation (Ethicon SS Suture). The indicated use for this device is similar to that of the Synthes Sternal Fixation System.

PERFORMANCE DATA

Mechanical testing of the SternumFix and the predicate Ethicon Stainless Steel proved the efficacy of the new device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

DEC 2 7 2006

Re: K063017

Trade/Device Name: SternumFix Sternal Closure System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 29, 2006 Received: October 2, 2006

Dear Mr. Hull:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Matthew M. Hull

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Bouchind

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number: K063017

Device Name:

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bridum

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K063017 510(k) Number

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.