The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.

AI/ML Overview

The provided text is a 510(k) summary for the MedShape FastForward device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparative testing of mechanical properties, rather than clinical performance studies typically associated with AI/software-based devices. Therefore, much of the requested information regarding clinical acceptance criteria, human reader studies, and AI-specific ground truth will not be present.

Based on the provided text, here's the information that can be extracted:

Acceptance Criteria and Device Performance

The 510(k) summary indicates that the device's performance was evaluated through pullout/fracture strength testing, monotonic and cyclic tension, and shear testing. The overall acceptance criterion for these tests was substantial equivalence to the predicate device (Arthrex Mini Tightrope, K061925).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Strength	Substantial equivalence in pullout/fracture strength	"Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device."
Monotonic Tension Strength	Substantial equivalence	"Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device."
Cyclic Tension Strength	Substantial equivalence	"Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device."
Shear Strength	Substantial equivalence	"Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device."
Overall Comparison	Differences "do not raise safety or efficacy concerns"	"Any differences between the proposed and predicate devices do not raise safety or efficacy concerns."
Intended Use Equivalence	Equivalent indications for use	The FastForward "is substantially equivalent in design, function and intended use to the following predicate device: Arthrex Mini Tightrope, K061925"

Study Details

Given the nature of a 510(k) for a metallic bone fixation appliance, the "study" referred to is primarily benchtop mechanical testing.

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (i.e., number of FastForward devices or predicate devices) used for the pullout, fracture, tension, and shear testing.
- The data provenance is not explicitly stated as country of origin, but it is implied to be from MedShape's internal testing or a contract lab. The test data is retrospective in the sense that it was conducted as part of the device development and submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" was established purely through objective mechanical testing measurements (e.g., force at failure, displacement under load) rather than expert interpretation of medical images or clinical outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are relevant for subjective assessments (e.g., reading medical images) where human agreement is required to establish ground truth. As this was mechanical testing, objective measurements were taken.
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 is not mentioned. This type of study is relevant for AI-powered diagnostic or interpretive devices, not for a mechanical bone fixation device like the FastForward. There is no AI component mentioned for this device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation was based on quantitative mechanical measurements (e.g., force, displacement) obtained during pullout/fracture strength, monotonic and cyclic tension, and shear testing. The performance was then compared to a predicate device's performance using these objective measurements.
The sample size for the training set:
- This is not applicable. There is no "training set" as this device is a mechanical implant and does not involve machine learning or AI.
How the ground truth for the training set was established:
- This is not applicable. There is no training set for a mechanical device.

Summary

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

December 18, 2014

MedShape, Incorporated Mr. Jeremy Blair Project Manager 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318

Re: K141420 Trade/Device Name: FastForward Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: November 14, 2014 Received: November 17, 2014

Dear Mr. Blair:

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

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Page 2 - Mr. Jeremy Blair

device-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/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.

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: _ K141420

Device Name: FastForward

Indications for Use:

The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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Image /page/3/Picture/0 description: The image shows the logo for MedShape. The logo consists of a stylized blue shape resembling a figure eight with a square at the top. To the right of the shape is the word "MEDSHAPE" in gray, with the letters in a bold, sans-serif font. A trademark symbol is present after the word "MEDSHAPE".

510(k) Summary

510(k) Number: K141420

Date Prepared: November 10, 2014

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter:
MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
B. Company Contact:
Jeremy Blair Project Manager (678) 235-3319(direct) (404) 249-9158 (fax) Jeremy.Blair@MedShape.com
C. Device Information:
Trade Name: FastForward Common Name: Button
D. Classification Name: Washer, Bolt Nut HTN: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030
E. Predicate Device(s):

Arthrex Mini Tightrope, K061925

ட். Physical Description:
The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.

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G. Indications for Use:

The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.

H. Comparison of Technological Characteristics:

The FastForward is substantially equivalent in design, function and intended use to the following predicate device:

Arthrex Mini Tightrope, K061925

Any differences between the proposed and predicate devices do not raise safety or efficacy concerns. Pullout/fracture strength testing of the predicate and proposed devices was conducted. The proposed device was evaluated in conjunction with various suture sizes and materials. Monotonic and cyclic tension and shear testing was completed on full constructs which included 185 metatarsal fixation. Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device.

Image /page/4/Picture/6 description: The image contains the MedShape logo. The logo features a stylized letter "M" in teal, with a square on top and a circle on the bottom. The word "MEDSHAPE" is written in gray, block letters to the right of the stylized "M". The logo appears to be for a medical or healthcare-related company.

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.