Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.

Device Description

Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.

Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides 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.

The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.

Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Acumed Acutrak 3 Headless Compression Screw System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing.

Crucially, this document does not describe a study involving an AI/Machine Learning (AI/ML) powered device that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.

The "device" in this context is a physical medical implant (a bone screw system), not a software or AI-powered diagnostic/analytic tool. Therefore, the questions related to AI/ML device performance metrics (such as acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and material performance of the physical screw system, through non-clinical bench testing.

However, to directly answer your request based on the provided text, and to clarify that the nature of the device means many of your specific questions are not relevant, here's what can be extracted:

Device: Acumed Acutrak 3 Headless Compression Screw System

Type of Device: Physical medical implant (bone screw system)

Study Focus: Non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices and ensure safety and performance of the physical screw system.

1. A table of acceptance criteria and the reported device performance:

The document lists the non-clinical tests performed, implying that the device "passed" or "met" the performance requirements for these tests to be deemed substantially equivalent. The specific acceptance criteria values (e.g., minimum torsional yield strength in Nm) and reported performance values for each test are not explicitly provided in this summary. They would typically be in the full submission, but not in the public 510(k) summary.

Acceptance Criteria (Implied by Test Type)	Reported Device Performance (Implied Result)
Meet Torsional Yield Strength per ASTM F543 Annex A1	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Driving Torque per ASTM F543 Annex 2	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Axial Pullout Force per ASTM F543 Annex 3	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Self-Tapping Performance per ASTM F543-17 Annex 4	Performance data demonstrate equivalence to predicate; safe and effective.
Sterilization per ISO 17665-1	Performance data demonstrate equivalence to predicate; safe and effective.
Sterilization per ISO 11137-1	Performance data demonstrate equivalence to predicate; safe and effective.
Packaging integrity per ISO 11607-1	Performance data demonstrate equivalence to predicate; safe and effective.
Biocompatibility per ISO 10993-1	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Screw Lifetime Verification Testing	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Self-Drilling Verification Testing	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Magnetically Induced Displacement Force per ASTM F2052	Performance data demonstrate equivalence to predicate; safe and effective.
Meet Magnetically Induced Torque per ASTM F2213	Performance data demonstrate equivalence to predicate; safe and effective.
Meet MR Image Artifact per ASTM F2119	Performance data demonstrate equivalence to predicate; safe and effective.
Allow MRI Safety Labeling per ASTM F2503	Performance data demonstrate equivalence to predicate; safe and effective.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified in the summary. For mechanical tests like these, sample sizes are typically determined by the relevant ASTM standards or internal validation protocols.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing related to the manufacturer (Acumed LLC, based in Hillsboro, Oregon, United States). These are laboratory bench tests, not clinical data from patients. The terms "retrospective" or "prospective" are not applicable to this type of device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not established for this type of non-clinical, mechanical device testing. The "ground truth" for these tests are the objective measurements against
established engineering and material science standards (e.g., precise force measurements, torque values, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are relevant for cases where human experts interpret data (e.g., medical images) to establish a ground truth. For mechanical testing of a medical implant, the results are measured directly against predefined engineering and material standards.

5. 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:

This question is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic aids where human readers are involved in interpreting medical cases. This device is a surgical implant, not an AI diagnostic tool. The document explicitly states: "Clinical testing was not necessary."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This device is a physical screw, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this type of device testing relies on adherence to international and national engineering standards (e.g., ASTM, ISO) for material properties and mechanical performance. The device's performance is measured directly against the specifications and requirements outlined in these standards, and in comparison to predicate devices.

8. The sample size for the training set:

This question is not applicable. This device is a physical product, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:

This question is not applicable. As above, there is no "training set" for a physical medical implant.

Summary

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June 9, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Acumed LLC Phillip Saddik Regulatory Affairs Specialist 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124

Re: K230744

Trade/Device Name: Acumed Acutrak 3 Headless Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 15, 2023 Received: March 17, 2023

Dear Mr. Phillip Saddik:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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

510(k) Number (if known) K230744

Device Name Acutrak 3 Headless Compression Screws

Indications for Use (Describe)

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 K230744

Date prepared: May 16th 2023

l. Contact Details

Applicant Name: Acumed LLC Applicant Address: 5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States Applicant Contact Name: Mr. Philip Saddik Applicant Telephone: 917-586-5641 Applicant Contact Email: Philip.saddik@acumed.net

II. Device Name

Device Trade Name: Acumed Acutrak 3 Headless Compression Screw System Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Requlation Number: 21 CFR 888.3040 Product Code: HWC

lll. Leqally Marketed Primary Predicate Devices

Primary Predicate Device: OsteoMed ExtremiFix Mini & Small Cannulated Screws Screw System K202680 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040

Product Code: HWC

Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K163303 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC

Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K063298 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC

Predicate Device: Medartis Aptus SpeedTip Cannulated Compression Screw System, K110658 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC

Reference Device: Acumed Acutrak/Acutrak 2 System, K221333 Common Name: Screw. Fixation. Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC

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IV. Device Description Summary

V. Intended Use/ Indications for Use

Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screws are not intended for interference or soft tissue fixation.

VI. Indications for Use Comparison

The subject devices, Acutrak 3 Headless Compression Screws, have the same indications for use as the predicate devices.

Technological Comparison VII.

The technological characteristics, operating principles and anatomical site for implantation of the subject device is identical to the predicates.

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 the use of variety of sizes, in terms of diameters and lengths.

While some differences exist in the basic shape and design of the performance evaluation demonstrates that the subject devices are equivalent to the predicate devices.

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VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions

Non-Clinical testing to support performance was conducted per FDA's Guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, December 11, 2020, and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment- Guidance for Industry and Food and Drug Administration Staff, May 20, 2021.

Safety and Performance evaluation conducted for the subject devices:

Torsional Yield Strength (ASTM F543 Annex A1) ●
. Driving Torque (ASTM F543 Annex 2)
Axial Pullout Force (ASTM F543 Annex 3) ●
Self-Tapping Performance (ASTM F543-17 Annex 4) .
Sterilization (ISO 17665-1)
Sterilization (ISO 11137-1) ●
. Packaging (ISO 11607-1)
. Biocompatibility (ISO 10993-1)
. Screw Lifetime Verification Testing
Self-Drilling Verification Testing
Magnetically Induced Displacement Force (ASTM F2052) ●
Magnetically Induced Torque (ASTM F2213)
. MR Image Artifact (ASTM F2119)
MRI Safety Labelling (ASTM F2503) ●

Performance data demonstrate that the Acutrak 3 Headless Compression Screws are equivalent to the designated predicate devices when used as intended.

Clinical testing was not necessary.

Based on the results of the non-clinical testing described above, it was concluded that the subject and predicate devices are substantially equivalent when used as intended. Therefore, the subject devices were proven to be safe and effective for the indications.

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.