Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Device Description

The Pinit™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options and two thickness options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture loop intended to provide a traction force required to achieve compression between bone seaments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.

The only modification made in this submission was the addition of bone plates having the same design profile with a different thickness. Also, the Trade/Proprietary Name was changed from CheckMate™ to Pinit™.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Pinit™ Small Bone Fusion System." This submission is a "Special 510(k): Device Modification," meaning the device is largely the same as a previously cleared device, with minor modifications.

The evaluation for this submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through extensive clinical studies. Therefore, the details requested in your prompt (like specific acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and large training sets with detailed ground truth methods) are not typically present or required in this type of 510(k) submission for a device modification.

The provided document does not contain information regarding specific quantitative acceptance criteria for device performance, a study proving the device meets these criteria in the way you've outlined, or detailed clinical study results involving human readers or large datasets.

However, based on the information provided, I can infer and summarize what was done to demonstrate substantial equivalence:

Summary of Acceptance Criteria and the Study Demonstrating Conformance for the Pinit™ Small Bone Fusion System (K140617)

The Pinit™ Small Bone Fusion System is a modification of a previously cleared device (CheckMate™ Small Bone Fusion System, K122334). The primary modification was the addition of bone plates with the same design profile but a different thickness and a change in the trade/proprietary name.

The "acceptance criteria" in this context are not quantitative performance metrics in a clinical trial, but rather a demonstration that the modified device remains substantially equivalent to its predicate device(s) in terms of safety and effectiveness, despite the changes. This is achieved by showing that the fundamental scientific technology, indications for use, operating principles, design profile, materials, shelf life, packaging, and sterilization processes are either unchanged or the changes do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated by non-clinical testing and analysis)
Indications for Use: Must be identical to or substantially similar to predicate.	Same Indications for Use as the predicate device (CheckMate™ Small Bone Fusion System K122334): "Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities."
Operating Principle: Must be the same as predicate.	Same operating principle as the predicate device.
Design Profile: Must maintain a similar design profile, especially for the modified components.	Same design profile for the new bone plates, with a different thickness. The design integrity was supported by engineering analyses.
Materials: Must use the same implant grade materials.	Same manufactured using the same material (implant grade stainless steel).
Shelf Life: Must maintain the same shelf life.	Same shelf life as the predicate device.
Packaging & Sterilization: Must use the same methods.	Packaged and sterilized using the same materials and processes as the predicate device.
Mechanical Performance (for modified components): Mechanical properties of the new thickness plate must be adequate and comparable to predicate.	Passed Bending Moment/Flexural Strength Testing for the modified plates. Engineering Analyses/Calculations using Bending Theory were performed. The results "demonstrated that the Arthrosurface Pinit™ Implants are substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

No "test set" in the traditional sense of a clinical or imaging study was used. The evaluation was based on non-clinical bench testing and engineering analyses.
The data provenance for bench testing would be from laboratory testing performed by or for Arthrosurface, Inc., on samples of the modified device. This is a controlled, prospective testing environment, not dependent on country of origin of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

No external experts (e.g., radiologists) were used to establish ground truth for this type of non-clinical evaluation. The "ground truth" for mechanical properties is established by the engineering specifications and validated testing methods (e.g., ASTM standards for mechanical testing). The interpretation and validation of these results would be done by qualified engineers and regulatory specialists within the company and at the FDA.

4. Adjudication Method for the Test Set

Not applicable. There was no human "test set" requiring adjudication. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices or algorithms that interpret images, and is not applicable to an orthopedic implant like the Pinit™ Small Bone Fusion System, especially for a device modification submission focused on substantial equivalence.

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

Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on engineering and mechanical specifications, validated material properties, and established test methods for orthopedic implants. The performance targets are derived from the predicate devices and general standards for such implants.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/algorithm. For the physical device, manufacturing and process controls ensure consistency across production runs, but this isn't a "training set" in the data science sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was used, no ground truth needed to be established for one. The "truth" for this device revolves around its physical and mechanical properties meeting established engineering principles and performance comparable to its predicate through bench testing.

Summary

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K140617

Page 1 of 3

Section 5 510(k) Summary

Pinit™ Small Bone Fusion System Special 510(k): Device Modification

510(k) Owner:

Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 Tel: 508.520.3003 Fax: 508.528.4604

Contact:

Dawn Wilson VP, Quality & Regulatory 508.520.3003 Tel: 508.528.4604 Fax: dwilson@arthrosurface.com

Establishment RegistrationNumber:	3004154314
Date of Preparation:	March 25, 2014
Confidentiality:	Reference Section 3
Proprietary Name:	Pinit TM Small Bone Fusion System
Common Name:	Bone Plates and Screws
Regulation Description:	Single/multiple component metallic bonefixation appliances and accessories.Smooth or threaded metallic bone fixationfastener
Regulation Number:	888.3030888.3040

Device Class:

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Review Panel:

Orthopedic

Product Code:

HRS: HWC

Intended Use

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Device Description

Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Pinit™ Small Bone Fusion System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

CheckMate™ Small Bone Fusion System (K122334, Cleared on 11/28/2012) Aptus® 1.5 TriLock (K102537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907, Cleared on 07/01/2004)

The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K122334).

Have the same Indications for Use, .

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Use the same operating principle, .
Have the same design profile, .
Manufactured using the same material, .
Have the same shelf life, .
Are packaged and sterilized using the same materials and processes. .

In support of this submission, the following non-clinical tests and analysis have been performed for the Subject Device:

Bending Moment/Flexural Strength Testing .
. Engineering Analyses/Calculations using Bending Theory

The results have demonstrated that the Arthrosurface Pinit™ Implants are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes.

Public Health Service

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

April 25, 2014

Arthrosurface. Incorporated Ms. Dawn J. Wilson Vice President, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K140617

Trade/Device Name: Pinit™ Small Bone Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation appliances and accessories Regulatory Class: Class 11 Product Code: HRS, HWC Dated: March 25, 2014 Received: March 26, 2014

Dear Ms. Wilson:

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

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Page 2 - Ms. Dawn J. Wilson

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 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.

Ronald P. Jean -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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Section 4 Indications for Use Statement 1 - 1 - 1 - 1 - 1 -

510(k) Number (if known): _ K140617

Device Name: Pinit™ Small Bone Fusion System

Indications for Use:

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Prescription Use V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Limin Sun-S 2014.04.25 14:45:31 -04'00'

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140617

Page 1 of 1

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.