Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.

Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.

The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

Device Description

The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.

Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as effect size of AI assistance, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.

The acceptance criteria and studies described in this document relate to the safety and performance of the Acumed Acutrak System and Acumed Acutrak 2 System, which are metallic bone fixation fasteners.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily by proving that the subject devices meet established mechanical and MR safety standards. The "acceptance criteria" are the thresholds or performance requirements defined by these standards, and "reported device performance" indicates that the devices met these criteria.

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
MR Conditional Safety	Magnetically induced displacement force	Per ASTM F2052 (within safe limits)	Devices are not adversely affected; meet criteria.
	Magnetically induced torque	Per ASTM F2213 (within safe limits)	Devices are not adversely affected; meet criteria.
	Radiofrequency (RF) induced heating	Per ASTM F2182 (within safe limits)	Devices are not adversely affected; meet criteria.
	MR image artifact	Per ASTM F2119 (acceptable artifact levels for diagnostic utility)	Acceptable image artifacts; meet criteria.
	Marking for MR Safety	Per ASTM F2503	Device is appropriately marked for MR environment.
Mechanical Performance	Torsional Yield Strength	Per ASTM F543-17	Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws.
	Insertion Torque	Per ASTM F543-17	Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws.
	Axial Pullout Force	Per ASTM F543-17	Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws.

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

The document does not explicitly state the exact sample sizes used for each physical and mechanical test (e.g., number of screws tested for torsional yield strength). However, the testing was conducted on samples of the Acutrak and Acutrak 2 screws, comparing them to relevant predicate screws.

Test Set: Acutrak and Acutrak 2 Screw Systems.
Data Provenance: The tests are non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM standards). The origin of individual samples is not specified beyond being manufacturing products of Acumed LLC. The data is prospective, generated specifically for this 510(k) submission.

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

Not applicable. This is a submission for a physical medical device, and its performance is evaluated against engineering and safety standards (e.g., MR safety, mechanical strength), not against expert interpretations of a test set in the way an AI/ML device would be evaluated (e.g., image interpretation).

4. Adjudication Method for the Test Set

Not applicable. The tests are objective, laboratory-based measurements against defined physical/engineering standards, not subjective assessments requiring adjudication.

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

No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

For this device, "ground truth" is established by:

Established Engineering Standards: Compliance with ASTM standards (e.g., F2052, F2213, F2182, F2119, F2503 for MR safety; F543-17 for mechanical performance). These standards define acceptable performance metrics based on engineering principles and industry consensus.
Predicate Device Performance: The mechanical performance of the subject devices was compared to existing legally marketed predicate devices to demonstrate substantial equivalence, implying that the performance of the predicate devices serves as a benchmark for "ground truth" in terms of acceptable and safe mechanical characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set."

Summary

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December 29, 2022

Acumed LLC Saleh Amirriyazi Regulatory Affairs Specialist 5885 NE Cornelius Pass Rd. Hillsboro, Oregon 97124

Re: K221333

Trade/Device Name: Acumed Acutrak System, Acumed Acturak 2 System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 5, 2022 Received: May 9, 2022

Dear Saleh Amirriyazi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K221333

Device Name

Acumed Acutrak System Acumed Acturak 2 System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

he-Counter Use (21 CFR 801 Subpart C)

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K221333 (Page 1 of 2)	510(k) Summary			Prepared on: 2022-12-28
Contact Details				21 CFR 807.92(a)(1)
Applicant Name		Acumed LLC
Applicant Address		5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States
Applicant Contact Telephone		925-353-7073
Applicant Contact		Mr. Saleh Amirriyazi
Applicant Contact Email		saleh.Amirriyazi@acumed.net
Device Name				21 CFR 807.92(a)(2)
Device Trade Name		Acumed Acutrak SystemAcumed Acturak 2 System
Common Name		Smooth or threaded metallic bone fixation fastener
Classification Name		Screw, Fixation, Bone
Regulation Number		888.3040
Product Code		HWC
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)			Product Code
K930834	Acutrak Fixation System			HWC
K944330	Acutrak Plus Fixation System			HWC
K110658	APTUS Cannulated Compression Screws			HWC
K123890	Acumed Cannulated Screw System			HWC
K163303	OsteoMed ExtremiFix Mid and Large Screw System			HWC
K202680	OsteoMed ExtremiFix Mini & Small Cannulated Screw System			HWC
Device Description Summary21 CFR 807.92(a)(4)

Device Description Summary

The purpose of this Traditional 510(k) is to add the MR conditional safety information to the labeling and provide performance data for Acutrak and Acutrak 2 Screw Systems. The intended use, technological characteristics, function and operating principles and anatomical site for implantation of the devices remain unchanged. No modification has been made to the ilization, packaging, and the manufacturing processes of the currently marketed devices.

The Acutrak and Acutrak 2 Screw Systems - MR Conditional (subject devices) are being compared to the existing on market Acutrak and Acutrak 2 Screw Systems (predicate devices). Mechanical performance of Acutrak 2 screws were compared to other comparable on market screws (other predicates).

The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These

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K221333 (Page 2 of 2)

systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.

Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.

Intended Use/Indications for Use

Acutrak Fusion, Standard and Mini, Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not interference or soft tissue fixation.

Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, or osteotomies of the clavice, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.

The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

Indications for Use Comparison

The subject devices, Acutrak and Acutrak 2 Screw Systems, have the same indications for use as their corresponding predicate devices. The basis of substantial equivalence for the similarities in intended use, material, technology, operating principle, anatomical site for implantation, performance and design.

Technological Comparison

The technological characteristics, operating principles and anatomical site for implantation of the subject devices remain unchanged. Both subject and predicate devices are bone screws intended for fracture fixation of bones appropriate for their sizes. The subject and predicate screws achieve their intended use through a variety of diameters and lengths of screw size offerings.

No modification has been made to the device material, sterilization, packaging, and the manufacturing processes of the currently marketed devices.

While some differences exist in the basic shape, design and technology; however, the performance evaluation demonstrates that the subject screws are equivalent to their predicate screws.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical testing to support MR Conditional labeling was conducted per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014, and the standards listed below:

· Magnetically induced displacement force (ASTM F2052)
· Magnetically induced torque (ASTM F2213)
· Radiofrequency (RF) induced heating (ASTM F2182)
MR image artifact (ASTM F2119) include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment (ASTM F2503)

Performance data demonstrate that the Acutrak and Acutrak 2 screws, when used in the MR environment using specified MR parameters and instructions, are not adversely affected by magnetically induced displacement force and frequency (RF) heating, and image artifacts.

Mechanical performance testing (Torsional Yield Strength, Insertion Torque, and Axial Pullout Force) was conducted on the subject screws per ASTM F543-17 (Standard Specification and Testing Methods for Metallic Medical Bone Screws passed acceptance criteria and demonstrated substantially equivalent mechanical performance to their corresponding predicate screws.

Clinical testing was not necessary.

Based on the results of the nonclinical testing described above, it was concluded that the subject and predicate devices are substantially equivalent in performance specifically for the intended use, hence the subject devices were proven to be safe and effective for the indications.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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.