Suture wires and wire loops are indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.

Device Description

Suture wires and wire loops are used for bone fracture fixation during the healing process. These wires are available in multiple diameters and lengths.

AI/ML Overview

The document provided is a 510(k) premarket notification for "Suture Wires and Wire Loops". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of diagnostics or AI-driven systems.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's an breakdown based on the information available:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 and 21 CFR § 58 standards.	"All testing passed."
Performance Evaluation (Bending Strength): Substantially equivalent to predicate devices.	"The engineering analysis shows the bending strength of the subject devices is substantially equivalent to the predicate devices."

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

Not Applicable. The performance evaluation was based on an "engineering analysis" and biocompatibility testing, not a clinical test set in the traditional sense. Therefore, there's no data provenance or sample size for a test set in relation to patient data.

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)

Not Applicable. No human experts were involved in establishing a ground truth for a test set, as this was not a diagnostic or AI-driven device evaluation.

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

Not Applicable. No adjudication method was used as there was no test set requiring human review.

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 study was not conducted. This device is not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device (suture wires and loops), not an algorithm or AI.

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

Not Applicable. For the biocompatibility testing, the "ground truth" would be regulatory standards (ISO 10993-1 and 21 CFR § 58). For the performance evaluation, the "ground truth" or reference was the performance of the predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. No training set was used.

Summary

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

July 1, 2015

Zimmer, Incorporated Dorothy Snyder Associate Director, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K150889

Trade/Device Name: Suture Wires and Wire Loops Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 26, 2015 Received: May 28, 2015

Dear Ms. Snyder:

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 Part 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/Resourcesfor You/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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Indications for Use

510(k) Number (if known)

K150889

Device Name Suture Wires and Wire Loops

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 shows the logo for Zimmer Biomet. The logo features a large, stylized letter "Z" in a blue circle. Below the circle, the word "zimmer" is written in lowercase letters, also in blue. The font used for "zimmer" is sans-serif and appears to be a custom design.

510(k) Summary

Sponsor:	Zimmer. Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dorothy A. SnyderAssociate Director, Regulatory AffairsTelephone: (574) 372-4092Fax: (574) 371-8760
Date:	March 23, 2015
Trade Name:	Suture Wires and Wire Loops
Common Name:	Suture Wires and Wire Loops
Classification Namesand References:	Cerclage, fixation (JDQ) per 21 § CFR 888.3010, Bonefixation cerclage
Classification Panel:	Orthopedics/87
Predicate Device(s):	Ortho Solutions Limited, Ortho Solutions TraumaImplants for Osteosynthesis, Cerclage Wires (K110895 -cleared 12/19/2011)
Purpose and Device Description:	Suture wires and wire loops are used for bone fracturefixation during the healing process. These wires areavailable in multiple diameters and lengths.
Intended Use:	Suture wires and wire loops are indicated for use for bonefracture fixation, osteotomy, arthrodesis, correction ofdeformity, revision procedures where other treatments ordevices have been unsuccessful, and bone reconstructionprocedures.
Comparison to Predicate Device:	The Zimmer suture wires and wire loops are identical inintended use and similar in materials, basic shape andperformance characteristics to the predicate devices.

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

. Biocompatibility – Biocompatibility testing on the suture wire and wire loop materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Performance Evaluation The engineering analysis . shows the bending strength of the subject devices is substantially equivalent to the predicate devices. The evaluation shows the differences in materials, diameter and length between the subject devices and the predicate devices do not affect the clinical strength of the subject suture wires and wire loops.

Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for . these devices.

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.