The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared Easy Clip' devices (K070031).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Easy Clip" device:

It is important to note that the provided documents are a 510(k) Summary and an FDA clearance letter for a Class II medical device (Staple, Fixation, Bone). For this type of device, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device) through non-clinical testing, rather than performing a clinical trial with specific performance metrics like those for AI/Software as a Medical Device (SaMD).

Therefore, many of the requested categories related to clinical studies, expert-established ground truth, and AI-specific metrics (like MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Note: For this type of device, "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) in the same way as for AI/SaMD. Instead, the acceptance criteria are implicitly that the modified device remains safe and effective, and performs comparably to the predicate device in relevant non-clinical tests. The "reported device performance" is the conclusion that these tests support substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance
Material Equivalence: Materials of the new sizes/modifications must be substantially similar to the predicate device.	Not explicitly stated in detail, but the submission supports material equivalence.
Dimensional (geometric cross section) Comparability: New sizes/modifications must meet design specifications and be consistent with the predicate device.	Dimensional (geometric cross section) analyses were conducted and support the conclusion of no adverse effects from modifications.
Engineering Strength Comparability: Mechanical strength must be maintained or improved, and comparable to the predicate device.	Engineering strength analyses were conducted and support the conclusion of no adverse effects from modifications.
Static Bending Performance: The device must demonstrate acceptable static bending characteristics comparable to the predicate.	Static bending tests were conducted and support the conclusion of no adverse effects from modifications.
Dynamic Bending Performance: The device must demonstrate acceptable dynamic bending characteristics comparable to the predicate device over time.	Dynamic bending tests were conducted and support the conclusion of no adverse effects from modifications.
Corrosion Resistance: The device must meet corrosion resistance standards to ensure biocompatibility and longevity.	Corrosion Testing as per ASTM F2129 was performed. (Result implicitly positive, as it leads to clearance).
Safety and Effectiveness: No effects of the modifications on the safety and effectiveness of the existing cleared device.	The non-clinical tests support the conclusion that there are no effects of the modifications on the safety and effectiveness of the EasyClip staples.
Substantial Equivalence: The modified device must be substantially equivalent to the predicate device (K070031).	The additional Easy Clip staples are substantially equivalent to the predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. For non-clinical testing of a medical device like a surgical staple, "sample size" refers to the number of physical units tested for mechanical properties. This specific number is not provided in the 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical laboratory testing of the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission relied on non-clinical engineering and material tests, not expert-established clinical ground truth. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM F2129) and the characteristics of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of clinical cases was performed.
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 a physical medical device (staple), not an AI/SaMD product. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission was based on established engineering and material standards (e.g., ASTM F2129 for corrosion) and the known performance and characteristics of the legally marketed predicate device (K070031). The goal was to demonstrate that modifications did not negatively impact these established benchmarks.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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510(k) Summary

Proprietary Name:	Easy Clip	MAR 1 2 2013
Common Name:	Staple, Fixation, Bone
Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories 21 CFR §888.3030
Regulatory Class:	Class II
Product Codes:	87 JDR- Single/multiple component metallic bone fixationappliances and accessories
For Information contact:	Estela Celi, Regulatory Affairs SpecialistStryker Trauma AG
	Phone: (201) 831-6461 Fax:# (201) 831-3461
Date Prepared:	July 16,2012

Description:

· This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared *Easy Clip' devices (K070031).

Intended Use:

The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Indications:

The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:

. K070031 - Memometal Memory Staples

Non-Clinical Testing:

Dimensional (geometric cross section) and engineering strength analyses as well as static and dynamic bending tests were conducted and the results support the conclusion that there are no effects of the modifications subject to this premarket notification on the safety and effectiveness of the EasyClip staples. Corrosion Testing as per ASTM F2129 was also performed.

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The additional Easy Clip staples are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: March 12, 2013

Stryker. Corporation % Ms. Estela Celi Regulatory Affairs Specialist 132 Corporate Drive Mahwah. New Jersey 07430

Re: K122113

Trade/Device Name: Memory Metal Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: February 25, 2013

Received: February 26, 2013

Dear Ms. Celi:

i i

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

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Page 2 - Ms. Estela Celi

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark NEmelkerson -S

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

Enclosure

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· Indications for Use

510(k) Number (if known): K122113

Device Name: Memory Metal Staples

Indications for Use:

The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.