The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

Device Description

The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.

AI/ML Overview

The provided text describes the regulatory clearance for the "In2Bones Fracture and Correction System," a medical device consisting of plates, screws, and washers used for bone fixation. However, the document does not contain information about acceptance criteria, device performance metrics, or study design details in the way requested by the prompt (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment, or training set details).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through performance data confirming the mechanical properties of the device rather than clinical or AI algorithm performance.

Here's what can be extracted from the document regarding "performance data," albeit not in the format of AI algorithm acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, the device underwent various mechanical tests to demonstrate its substantial equivalence to predicate devices. The specific acceptance criteria (e.g., minimum torque values, maximum displacement under load) are not explicitly stated in this summary but are implied by the statement that the testing "demonstrate[s] that the device is substantially equivalent to the predicate devices identified."

Acceptance Criteria (Implied)	Reported Device Performance
(Not explicitly stated, but expected to meet or exceed predicate performance for mechanical properties)	* Pyrogenicity testing performed and successful
	* Static driving torque testing performed and successful
	* Static pullout testing performed and successful
	* Static torsion testing performed and successful
	* Static bending testing performed and successful
	* Fatigue bending testing performed and successful
Overall: Substantially equivalent to predicate devices based on these tests	Overall: Device demonstrated substantial equivalence to predicate devices K123241, K983495, K131920, and K160174

Missing Information (Regarding the original prompt's questions):

The document does not provide details for the following requested items as they are not relevant to a 510(k) submission for a mechanical bone fixation system:

Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. "Test set" here refers to physical device samples, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by engineering standards and measurements, not medical expert consensus.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, but a surgical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
The type of ground truth used: For mechanical tests, the ground truth is derived from engineering measurements and established standards.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary from the provided text:

The In2Bones Fracture and Correction System demonstrated "substantial equivalence" to identified predicate devices (K123241, K983495, K131920, K160174) by undergoing mechanical performance testing, including pyrogenicity, static driving torque, static pullout, static torsion, static bending, and fatigue bending tests. The results of these tests (namely, that the device performed adequately to be deemed substantially equivalent) are reported, but the specific numerical acceptance criteria or detailed outcomes of each test are not provided in this 510(k) summary. The device's "acceptance criteria" were met by establishing that its technological characteristics and performance were comparable to legally marketed predicate devices, ensuring its safety and effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002.

In2bones USA, LLC % Christine Scifert Managing Partner MRC-X. LLC 6075 Poplar Avenue, Suite 500 Memphis. Tennessee 38119

July 14, 2017

Re: K170518 Trade/Device Name: In2bones Fracture and Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: June 2, 2017 Received: June 6, 2017

Dear Christine Scifert:

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

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170518

Device Name

In2Bones Fracture and Correction System

Indications for Use (Describe)

The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.

Type of Use (Select one or both, as applicable)

X 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)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Pg.1/2 K170518

510(k) Summary of Safety and Effectiveness

Summary of 510(k) safety and effectiveness information upon which the substantial equivalence determination is based:

I. Submitter Date Prepared: July 11, 2017 Device Submitter: In2Bones USA, LLC 6060 Poplar Avenue, Suite 380 Memphis, TN 38119 Phone: 901-260-7931 Contact Person: Christine Scifert II. Device Proprietary Name: In2Bones Fracture and Correction System Common Name: Plate, Fixation, Bone Screw, Fixation, Bone Regulation Number/ 21 CFR 888.3030: Single/multiple component metallic Name: bone fixation appliances and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II HRS, HWC, HTN Product Code: Review Panel: Orthopedic III. Predicate Device

Predicate Device:	K123241 Arthrex Fracture Plates
	K983495 Syntec Taichung Non-Sterile Bone Plate and ScrewImplants
	K131920 In2Bones SAS I.B.S. Osteosynthesis Screw
	K160174 In2Bones SAS I.B.S. 2.0 Osteosynthesis Screw

IV. Device Description

The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.

{5}------------------------------------------------

V. Intended Use and Indications for Use
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

VI. Comparison of technological characteristics with the predicate devices
The In2Bones USA Fracture and Correction System and the legally marketed predicate devices have the same intended use and similar indications for use, similar dimensions, geometry and materials. The In2Bones device and the predicates are available in multiple sizes and various shapes. The plates are attached to bone using various diameter and length screws. The In2Bones USA Fracture and Correction System implants are made from titanium alloy.

VII. Performance Data

Testing including pyrogenicity, static driving torque, static pullout, static torsion, static bending and fatigue bending were performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate devices identified.

VIII. Conclusions

The In2Bones USA Fracture and Correction System when compared to the predicates have similar intended use and indications for use, technological characteristics, and principals of operation as the predicate devices. Thus, the In2Bones USA Fracture and Correction System design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate 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.