ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.

Device Description

The Exsomed Small Screw system are stainless steel compression bone screws contained in sterile procedure kits. The ArcPhix screws are offered in two lengths, 28mm or 36mm by 3.2mm with an 18-degree bend. The ArrowPhix is a straight screw 26mm by 2.5mm. Implantation is facilitated by use of accessories provided in a sterile kit: • Implant • K-wire used as a guide Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw

AI/ML Overview

The provided text is a 510(k) summary for the ExsoMed ArcPhix and ExsoMed ArrowPhix small bone screw system. It details the device's intended use, indications for use, and a comparison to a predicate device. However, it does not contain information related to a study that uses a machine learning algorithm or AI, nor does it discuss acceptance criteria and device performance in the context of AI/ML or a clinical study with human readers.

The "Non-Clinical Performance Testing" section describes bench testing studies, which are standard for orthopedic implants, to demonstrate the performance of the devices against the predicate. These tests evaluate mechanical properties like torsional properties, driving torque, pullout strength, and self-tapping performance, as well as an engineering analysis comparing torsional and bending strength.

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI, or standalone algorithm performance, as these elements are not present in the provided document.

Here's a breakdown of what is available regarding testing and comparison, tailored to the table format as much as possible, acknowledging the lack of AI/ML-specific details:

Acceptance Criteria and Device Performance (Non-AI/ML Product)

Device Name: ExsoMed ArcPhix and ExsoMed ArrowPhix

Acceptance Criteria Category (for Mechanical Performance)	Reported Device Performance
Torsional Properties (per ASTM F543-13 Annex 1)	Bench testing conducted. (Specific metric values for torsional strength are not provided in the summary, but the conclusion states "demonstrated that the ArcPhix and ArrowPhix perform in a substantially equivalent manner to the predicate device" and that "engineering analysis has been conducted demonstrating that the subject devices outperform the SBI Autofix screws in torsional and bending strength.")
Driving Torque Testing (per ASTM F543-13 Annex 2)	Bench testing conducted. (Specific metric values are not provided.)
Pullout (per ASTM F543-13 Annex 3)	Bench testing conducted. (Specific metric values are not provided.)
Self-Tapping Performance (per ASTM F543-13 Annex 4)	Bench testing conducted (for SpikeScrew only, though the document refers to ArcPhix and ArrowPhix). (Specific metric values are not provided.)
Bending Strength (Engineering Analysis)	Engineering analysis demonstrated the subject devices outperform the predicate (SBI Autofix screws) in bending strength. (Specific metric values are not provided.)
Endotoxin Testing	Testing completed. (Results not specified but implicitly met required standards for sterile implants.)

Additional Study Details (Not applicable to AI/ML or comparative effectiveness with human readers)

The provided document describes non-clinical performance testing for the ExsoMed ArcPhix and ExsoMed ArrowPhix small bone screw system, an orthopedic implant. It does not involve a study with a machine learning algorithm, AI, or human readers.

Sample size used for the test set and the data provenance: Not applicable. The "test set" described refers to physical devices undergoing bench testing. The document does not specify the number of devices tested for each mechanical performance criterion. Data provenance is implied to be from laboratory bench testing.
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 standardized test methods (ASTM standards) and engineering analysis, not by human expert interpretation in this context.
Adjudication method for the test set: Not applicable. Performance is measured against engineering standards and compared to a predicate device, not adjudicated by experts in the context of diagnostic interpretation.
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 document does not describe an AI/ML device or a study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an AI/ML algorithm.
The type of ground truth used: For mechanical performance, the "ground truth" is derived from established engineering principles and ASTM standards for medical device testing.
The sample size for the training set: Not applicable. No AI/ML training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. No AI/ML training set is mentioned.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

ExsoMed Holding Company, LLC Richard L. Kovach Chief Executive Officer 7227 N. 16th Street. Suite 245 Phoenix, Arizona 85020

August 18, 2017

Re: K171407

Trade/Device Name: ExsoMed ArcPhix and ExsoMed ArrowPhix Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 25, 2017 Received: July 25, 2017

Dear Richard Kovach:

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,

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) K171407

Device Name

ExsoMed ArcPhix and ExsoMed ArrowPhix

Indications for Use (Describe)

ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.

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)

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510(k) Summary

This 510(k) Summary is presented in compliance with 21 CFR 807.92

DEVICE NAME	EXSOMED™ SMALL BONE SCREW SYSTEM
OWNER/SUBMITTERINFORMATION	ExsoMed Holding Company, LLC7227 N. 16th Street, Suite 245Phoenix, Arizona 85020
DATE OFPREPARATION	May 12, 2017
CONTACT	Richard L. KovachChief Executive OfficerTel: (602) 466-3186Email: rkovach@ExsoMed.com
DEVICE NAME ANDCLASSIFICATION	Trade Name: ExsoMed ArcPhix and ExsoMedArrowPhixCommon Name: Screw, Fixation, BoneClassification: 21 CFR 888.3040, IIProduct Code: HWC
INTENDED USE	The ArcPhix and ArrowPhix are intended forpermanent fixation of small bones and small bonejoints.
INDICATIONS FORUSE	ExsoMed ArcPhix and ArrowPhix are indicated foruse in the surgical fixation of small bones, bonefragments, and osteotomies. The devices are notindicated for soft tissue fixation.
DEVICEDESCRIPTION	The Exsomed Small Screw system are stainlesssteel compression bone screws contained in sterileprocedure kits.The ArcPhix screws are offered in two lengths,28mm or 36mm by 3.2mm with an 18-degree bend.The ArrowPhix is a straight screw 26mm by 2.5mm.Implantation is facilitated by use of accessoriesprovided in a sterile kit:• Implant• K-wire used as a guide
	Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw
PREDICATEDEVICE(S)	Primary Predicate:Name of Device: SBI AutoFix systemManufacturer: Small Bone InnovationsInternational S.A.K Number: K052576Approval Date: 11/07/2005
PREDICATEPRINCIPALS OFOPERATION	Small bone screws, delivered in a sterile kitincluding implantation instrumentation
COMPARISON OFTECHNOLOGICALCHARACTERISTICS	The ExsoMed Small Screws have the same intended use as the predicate device. are manufactured from the same materials as the predicate devices. range of sizes of the subject screws are is similar to the predicate device. Both the subject devices and the predicates are inserted into bone with the assistance of the driver for compression of the fracture and stabilization of the bone.
NON-CLINICALPERFORMANCETESTING	Bench testing studies were conducted to demonstrate the performance of the subject devices. The following tests were conducted: Torsional Properties Per ASTM F543-13 Annex 1 Driving Torque Testing Per ASTM F543-13 Annex 2 Pullout per ASTM F543-13 Annex 3 Self-Tapping Performance per ASTM F543-13 Annex 4 (SpikeScrew only) Engineering analysis has been conducted demonstrating that the subject devices outperform the SBI Autofix screws in torsional and bending strength.
CONCLUSION	Additionally, endotoxin testing has been completed on the subject device.The results from these evaluations demonstrated that the ArcPhix and ArrowPhix perform in a substantially equivalent manner to the predicate device.
	The Exsomed Small Bone screws and the predicate devices have the same technological characteristics, method of use, and materials.
	The performance testing, engineering analysis and comparison of technological characteristics of the predicate and the subject devices demonstrate the subject devices are substantially equivalent.

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.