Acumed Wrist Plating System is a set of plates, 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 Congruent Bone Plate Systems, per K012655, K120903 and K102998.

Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile.

The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only.

Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-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 Acumed Wrist Plating System is a medical device designed to provide fixation for fractures, fusions, or osteotomies of the distal radius and ulna. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated table with specific pass/fail values. Instead, it refers to FDA guidance documents and international standards, implying that the device's performance met the requirements outlined in these documents.

Acceptance Criteria (Implied from referenced standards)	Reported Device Performance
Mechanical Strength (e.g., bending, torsion) for plates (ASTM F382-17)	"Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements)
Torsional Yield Strength for screws (ASTM F543 Annex A1)	"Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements)
Driving Torque for screws (ASTM F543 Annex 2)	"Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements)
Axial Pullout Force for screws (ASTM F543 Annex 3)	"Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements)
Self-Tapping Performance for screws (ASTM F543-17 Annex 4)	"Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements)
Sterilization effectiveness (ISO 17665-1, ISO 11137-1)	"Sterilization (ISO 17665-1)", "Sterilization (ISO 11137-1)" (Implicitly passed by meeting standard requirements)
Packaging integrity (ISO 11607-1)	"Packaging (ISO 11607-1)" (Implicitly passed by meeting standard requirements)
Biocompatibility (ISO 10993-1)	"Biocompatibility (ISO 10993-1)" (Implicitly passed by meeting standard requirements)
Screw Lifetime Verification	"Screw Lifetime Verification Testing" (Implicitly passed by meeting internal and/or standard requirements)
Self-Drilling Verification	"Self-Drilling Verification Testing" (Implicitly passed by meeting internal and/or standard requirements)
MRI Compatibility (Magnetically Induced Displacement Force - ASTM F2052, Magnetically Induced Torque - ASTM F2213, MR Image Artifact - ASTM F2119, MRI Safety Labelling - ASTM F2503)	"Magnetically Induced Displacement Force (ASTM F2052)", "Magnetically Induced Torque (ASTM F2213)", "MR Image Artifact (ASTM F2119)", "MRI Safety Labelling (ASTM F2503)" (Implicitly passed by meeting standard requirements and allowing for appropriate labeling)

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

The document does not explicitly state the sample sizes used for each specific non-clinical test. The testing was non-clinical, indicating that it involved laboratory-based evaluations of the device's physical and mechanical properties, not human or animal subjects. Therefore, the concept of "country of origin of the data" or "retrospective or prospective" is not directly applicable in the same way it would be for a clinical study involving patients. The data provenance is from laboratory testing conducted by or for Acumed LLC.

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

This information is not applicable as the study was non-clinical testing of the device's physical and mechanical properties. "Ground truth" in the context of expert review typically refers to clinical diagnosis or evaluation, which was not the nature of these tests. Standards like ASTM and ISO set the "ground truth" or performance benchmarks through established methodologies and consensus from experts in materials science, engineering, and medical device safety.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions, which is not relevant for objective laboratory measurements defined by standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The FDA 510(k) summary explicitly states: "Clinical testing was not necessary." This indicates that the regulatory pathway for this device did not require human-in-the-loop performance studies or AI assistance.

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

A standalone performance study for an algorithm was not performed. This device is a physical implant (plates and screws), not a software or AI-driven diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by recognized industry standards (ASTM and ISO), along with internal engineering specifications. These standards define the methodologies for testing, acceptable limits, and performance requirements for medical devices like bone fixation systems. The device's performance was compared against the requirements and specifications outlined in these standards and FDA guidance for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device design would refer to engineering principles and prior device iterations, but not data sets used to train a model.

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

This information is not applicable as there is no "training set" in the context of machine learning for this physical device. The design and manufacturing processes are guided by established engineering principles, biocompatibility requirements, and material science, all based on widely accepted scientific and regulatory standards.

Summary

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April 22, 2024

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Acumed LLC Anusha Gedala Regulatory Affairs Specialist 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124

Re: K233311

Trade/Device Name: Acumed Wrist Plating 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 Dated: March 19, 2024 Received: March 20, 2024

Dear Anusha Gedala:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, MPH 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

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Indications for Use

510(k) Number (if known)

Device Name Acumed Wrist Plating System

Indications for Use (Describe)

Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.

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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Image /page/3/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in black on the right. The plus sign is made up of two intersecting rectangles. The word "acumed" is in a sans-serif font. There is a registered trademark symbol to the upper right of the word "acumed".

510(k) Summary

Date prepared: April 15, 2024

l. Contact Details

Applicant Name: Acumed LLC Applicant Address: 5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States Applicant Contact Name: Ms. Anusha Gedala Applicant Telephone: 503-207-1638 Applicant Contact Email: anusha.gedala@acumed.net

II. Device Name

Device Trade Name: Acumed Wrist Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3030 21 CFR 888.3040

Product Code: HRS, HWC

III. Legally Marketed Primary Predicate Devices

Primary Predicate Device: Congruent Bone Plate System, K012655 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HRS

Predicate Device: Congruent Bone Plate System - Acu-Loc 2 Plate, K120903 / K102998 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3030 21 CFR 888.3040

Product Code: HRS, HWC

Reference Device: Acumed Hand Plating System, K132769 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030

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Image /page/4/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in dark gray on the right. The plus sign is made up of two intersecting rectangles. There is a registered trademark symbol next to the "d" in "acumed".

Product Code: HRS, HWC

Reference Device: Frag-Loc System, K130986 Common Name: Washer, Bolt, Nut Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HTN, HWC

IV. Device Description Summary

V. Intended Use/ Indications for Use

The Acumed Wrist Plating System provides fixation for fractures, fusions, of the distal radius and ulna.

VI. Indications for Use Comparison

The subject device system, Acumed Wrist Plating System includications for use of the primary predicate device, Congruent Bone Plate System (K012665).

VII. Technological Comparison

The operating principles and anatomical site for implantation of the subject device are identical to the predicate devices. Both subject and predicate devices are bone plates and screws intended to provide fixation for fractures, fusions and osteotomies. There are some differences in basic shape, design, and size between the subject and predicate.

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Image /page/5/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in black on the right. There is a registered trademark symbol next to the "d" in "acumed."

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

Non-Clinical testing to support performance was conducted per FDA's Guidance:

Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, April 11, 2022

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

Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment- Guidance for Industry and Food and Drug Administration Staff, May 20, 2021.

Safety and Performance evaluation conducted for the subject devices:

Safety and Performance evaluation conducted for the subject devices (ASTM F382-17) ●
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 demonstrates that the Acumed Wrist Plating System plates and 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.

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.