Compressive osteosynthesis staples are single-use bone fixation appliances intended to be permanently implanted. ARCAD osteosynthesis staples are bipodal compression staples made of shape memory nickel titanium alloy.

AI/ML Overview

The provided text describes a 510(k) summary for the ARCAD and EXPRESS Compressive Osteosynthesis Staples. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device's performance against specific acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of a new, AI-driven diagnostic or therapeutic device is not directly available in this submission.

This 510(k) submission primarily relies on comparisons of material, design, and mechanical characteristics to a legally marketed predicate device.

Here's an analysis based on the information provided, highlighting what is and is not present concerning the acceptance criteria and study proving device performance:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Implicit): For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence (SE) to a predicate device. This involves showing that the new device has similar technological characteristics (material, design, mechanical properties) and intended use, and that any differences do not raise new questions of safety or effectiveness.
Reported Device Performance (Implicit): The performance is demonstrated by showing compliance with relevant industry standards and successful mechanical testing that mirrors the predicate.

Criteria Category (Implied for 510(k) SE)	Reported Device Performance (from text)
Material Compatibility	The ARCAD/EXPRESS staples are made of shape memory nickel-titanium alloy, complying with ASTM F2063-12 (Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants).
Mechanical Characteristics	Similar technological characteristics in terms of design and mechanical characteristics (static bending, dynamic bending and pull-out resistance). Compliance with ASTM F564-10 Sections A1, A2, and A4 (Standard Specification and Test Methods for Metallic Bone Staples) is implicitly met through comparison with the predicate.
Biocompatibility	Conducted in accordance with Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
Intended Use	Same as predicate: Hand and foot bone fragments osteotomy fixation and joint arthrodesis.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The submission does not describe a "test set" in the context of clinical or diagnostic performance. Instead, it refers to mechanical testing of the staple devices themselves. The specific number of devices tested for static bending, dynamic bending, and pull-out resistance is not detailed.
The provenance of data would be from laboratory mechanical testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the sense of expert medical review for diagnostic accuracy or outcomes is not relevant for this type of device and submission. The "ground truth" for mechanical performance is established by the specifications of the ASTM standards and the measurements taken during mechanical testing.

4. Adjudication method for the test set:

Not applicable. There is no adjudication method described as there isn't a "test set" requiring expert consensus.

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:

Not applicable. This device is a surgical implant (staple) and does not involve AI, human readers, or diagnostic interpretation.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

For this 510(k) submission, the "ground truth" for device performance is primarily based on engineering standards and mechanical testing results, demonstrating that the device meets the specifications outlined in ASTM F2063-12 (material) and ASTM F564-10 Sections A1, A2, A4 (mechanical properties). The biocompatibility "ground truth" is established by compliance with ISO 10993-1.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. This device does not involve machine learning or a "training set."

In summary: The provided document is a 510(k) premarket notification for a medical device (surgical staples). The regulatory pathway for this type of device typically involves demonstrating substantial equivalence to a predicate device through engineering and performance testing against recognized standards, rather than clinical trials with specific acceptance criteria as you might see for a novel diagnostic or therapeutic product seeking its own performance claims. Therefore, many of the questions related to AI/algorithm performance and clinical study designs are not applicable to this submission.

Summary

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December 19, 2014

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

Novatsep % Mr. Gilles Audic QA/RA Director Espace Performance Alphasis-Batiment C1-C2 Saint Gregoire, 35769 France

Re: K142111 Trade/Device Name: ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: November 17, 2014 Received: November 21, 2014

Dear Mr. Audic:

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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,

Mark N. Melkerson -S

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) K142111

Device Name

ARCAD Compressive osteosynthesis staple EXPRESS Compressive osteosynthesis staple

Indications for Use (Describe)

The compressive osteosynthesis staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

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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"510(k) Summary" as required by section 807.92(c)

Submitter	NOVASTEP
	Espace performance Alphasis
	Bâtiment C1-C2
	35769 SAINT GREGOIRE
	France
	Phone : + 33 (0)2 99 33 86 50
	Fax :+ 33 (0)9 70 29 18 95
Contact person	Mister Gilles AUDIC
	QA / RA Director
	Cell phone:+33 (0)6 30 93 96 08
	e-mail: gilles.audic@novastep-ortho.com
Preparation date	17th November, 2014

Trade name	ARCAD compressive osteosynthesis stapleEXPRESS compressive osteosynthesis staple
Common Name	Staple, Fixation, Bone
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030, product code JDR)
Regulatory class	II

Legally marketedpredicate devices	510(k) number: K122113Device name: memory metal staples, EasyclipOriginal applicant: STRYKER corp.
Description	Compressive osteosynthesis staples are single-use bone fixationappliances intended to be permanently implanted. ARCAD osteosynthesisstaples are bipodal compression staples made of shape memory nickeltitanium alloy.

Intended use	The compressive osteosynthesis staples are intended for hand and footbone fragments osteotomy fixation and joint arthrodesis.
Comparison of thetechnologicalcharacteristics with thepredicate device	The new devices compressive osteosynthesis staples have similartechnological characteristics in terms of material (ASTM F2063-12Standard Specification for Wrought Nickel-Titanium Shape MemoryAlloys for Medical Devices and Surgical Implants) and mechanicalcharacteristics (ASTM F564-10 Sections A1, A2 and A4 StandardSpecification and Test Methods for Metallic Bone Staples) and thus arebelieved to be substantially equivalent to the predicate STRYKER corp.
Performance data	The biocompatibility evaluation for new devices compressiveosteosynthesis staples was conducted in accordance with Blue BookMemorandum #G95-1 (Use of International Standard ISO-10993,Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)and International Standard ISO 10993-1 (Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testing Within a Risk ManagementProcess) as recognized by FDA.The new devices compressive osteosynthesis staples have similartechnological characteristics in terms of design and mechanicalcharacteristics (static bending, dynamic bending and pull-out resistance)and thus are believed to be substantially equivalent to the predicateSTRYKER corp. memory metal staples, Easyclip (K122113).
Indication for use	The compressive osteosynthesis staples are indicated for hand and footbone fragments osteotomy fixation and joint arthrodesis.
Clinical studies	Clinical studies were not required for this submission.
Animal studies	Animal studies were not required for this submission.
Conclusion	The compressive osteosynthesis staples are substantially equivalent totheir predicate devices STRYKER corp. memory metal staples, Easyclip(K122113) in terms of intended use and indications for use, material,design and function. Any minor differences between these two devicesdo not raise new questions of safety and effectiveness.

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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.