(131 days)
The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.
This document describes a 510(k) premarket notification for the Acumed Ankle Plating System, a metallic bone fixation appliance. The information provided outlines the device, its intended use, and a non-clinical study conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific details required to answer your request about acceptance criteria and study proving device meets acceptance criteria, as those terms are typically used for AI/ML device performance evaluations.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- This is a medical device approval, not an AI/ML device approval. The document pertains to an ankle plating system, which is a physical implant, not a software-based or AI device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC study," "human improvement with AI assistance," or "standalone algorithm performance" are not applicable in this context.
- The "study" described is non-clinical comparative testing. It's a mechanical test to show physical equivalence, not a clinical trial or performance study against specific diagnostic or treatment criteria.
Therefore, many parts of your request are not relevant to this document.
However, I can extract the closest analogous information based on the provided text, focusing on the non-clinical testing performed to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like an ankle plating system, "acceptance criteria" in this context usually refer to meeting established mechanical performance standards. The document mentions compliance with ASTM F382-99.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in static 4-point bend per ASTM F382-99 | Acumed Ankle Plating System was substantially equivalent to the predicate device in static four-point bend. |
| Substantial equivalence to predicate device in bending fatigue per ASTM F382-99 | Acumed Ankle Plating System was substantially equivalent to the predicate device in bending fatigue tests. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the document. ASTM F382-99 outlines standards for material mechanical testing, which typically involves a small number of samples per test condition.
- Data provenance: Non-clinical (laboratory testing)
- Country of origin: Not specified, but generally performed in a certified testing lab.
- Retrospective or prospective: N/A for mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is non-clinical mechanical testing, not a study requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" is adherence to mechanical standards.
4. Adjudication method for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for clinical judgment of images or outcomes, which is not applicable here. Mechanical tests yield objective measurements.
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
- No. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used
- Mechanical performance standards: The "ground truth" for this device's non-clinical testing is its ability to meet specified mechanical properties (e.g., strength, fatigue resistance) as defined by established ASTM standards (ASTM F382-99) and to be substantially equivalent to the predicate device's performance under those standards.
8. The sample size for the training set
- N/A. This is not an AI/ML device, and there is no "training set."
9. How the ground truth for the training set was established
- N/A. There is no training set for this type of device.
In summary, the provided text describes the regulatory clearance of a physical medical device (ankle plating system) based on a non-clinical comparative mechanical study. The questions posed in your request are primarily tailored for AI/ML-based diagnostic or assistive devices, which are not relevant to this specific document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Acumed, LLC Mr. Nathan Wolf Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
Re: K143385
Trade/Device Name: Acumed Ankle 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 4, 2015 Received: March 6, 2015
Dear Mr. Wolf:
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
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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Acumed Ankle Plating System
Indications for Use (Describe)
The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
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)
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510(k) Summary
Contact Details
| Applicant Name: | Acumed LLC5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|---|---|
| Nathan Wolf, Regulatory Specialist503-726-6622 (Cell)503-207-1502 (Desk)503-520-9618 (Fax) | |
| Date Prepared: | 24 November 2014 |
Device Name
- Trade Name: Acumed Ankle Plating System
Common Name: Ankle Plating System
21 CFR 888.3030 Single/multiple component metallic bone fixation Classification: appliances and accessories
Class: Class II
HRS. HWC Product Code:
Legally Marketed Predicate Device(s)
The Synthes Third Tubular Plate (pre-amendment per K011335), Synthes VA LCP Ankle Trauma System cleared in 2012 (K120854), and the Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates cleared in 2008 (K083213) serve as the predicate devices.
Device Description
The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.
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Intended Use/Indications for Use
The Acumed Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
Substantial Equivalence Comparison
In consideration of the comparisons given herein, the Acumed Ankle Plating System has been determined to be substantially equivalent to its predicate devices, the Synthes Third Tubular Plates (pre-amendment), Synthes VA LCP Ankle Trauma System (K120854), and Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates (K083213). Substantial equivalence was determined due to similarities in materials, technology, function, and dimensions.
Non-clinical Testing
Comparative testing between the Acumed Ankle Plating System and a predicate device was conducted per ASTM F382-99. The test data showed the Acumed Ankle Plating System was substantially equivalent to the predicate device in both static four-point bend and bending fatigue tests as described herein.
§ 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.