(126 days)
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand
The Nextremity Solutions Arcus™ Staple System is a set, consisting of:
-
- A bone staple.
-
- Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack).
The staples are fabricated from medical grade Titanium (ASTM F-136).
The provided text describes a 510(k) premarket notification for the Arcus™ Staple System, which is a metallic bone fixation device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be typical for a novel device requiring more comprehensive clinical or standalone performance studies.
Therefore, the requested information cannot be fully extracted in the format requested as the available text does not contain the specific details regarding quantitative acceptance criteria, a study that proves they are met, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, or detailed ground truth methodologies that are common for AI/imaging device submissions.
Here's a breakdown of what can be inferred and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a physical bone staple system, not an AI or imaging algorithm. Therefore, "acceptance criteria" and "device performance" are related to mechanical properties and biocompatibility, not diagnostic accuracy or standalone performance of an algorithm.
The text states:
"Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the Arcus™ Staple System as per ASTM F-564."
This indicates that mechanical tests were conducted, but the specific acceptance criteria (e.g., minimum bending strength, maximum deformation, minimum pull-out force) and the reported values for the device's performance against these criteria are not provided in the document.
2. Sample size used for the test set and the data provenance:
As this is a mechanical device, not an AI/imaging device, there isn't a "test set" in the context of diagnostic data. The "test set" would refer to the number of staples subjected to mechanical testing. This information (sample size) is not provided. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a mechanical implant, not an AI or diagnostic tool requiring expert ground truth in that sense. Mechanical testing typically follows standardized protocols and does not involve human expert adjudication of results in the same way an imaging study would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for the same reasons as point 3.
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 is not applicable as the device is a mechanical implant, not an AI-assisted diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing, the "ground truth" would be the universally accepted physical laws and engineering principles that govern material strength and performance, codified in standards like ASTM F-564. The measurements observed during these tests (e.g., actual force at failure) are compared against the requirements of the standard.
8. The sample size for the training set:
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.
Summary of what is available vs. missing:
| Category | Information from Document | Missing Information (Not in Document) |
|---|---|---|
| 1. Acceptance Criteria & Reported Device Performance Table | Mechanical testing was performed for 4-point bending (static and dynamic) and pull-out force as per ASTM F-564. The device is a bone staple system. | Specific numerical acceptance criteria (e.g., minimum ultimate tensile strength, maximum deformation, minimum pull-out force) derived from ASTM F-564. The actual quantitative "reported device performance" values for these mechanical tests. |
| 2. Sample size and Data Provenance (Test Set) | N/A (Mechanical device, not a diagnostic test set) | The number of staples tested for each mechanical test (e.g., N=X staples for 4-point bending, N=Y staples for pull-out). Data provenance does not apply. |
| 3. Number & Qualifications of Experts (Ground Truth - Test Set) | N/A (Not applicable for mechanical device testing) | Not applicable. |
| 4. Adjudication Method (Test Set) | N/A (Not applicable for mechanical device testing) | Not applicable. |
| 5. MRMC Comparative Effectiveness Study (AI improvement) | N/A (Device is a mechanical implant, not AI) | Not applicable. |
| 6. Standalone Performance (Algorithm only) | N/A (Device is a mechanical implant, not an algorithm) | Not applicable. |
| 7. Type of Ground Truth Used | Standards and principles defined by ASTM F-564 for mechanical properties of metallic surgical implants. | (Implicitly, the ground truth is the requirement of the ASTM F-564 standard, and the device is intended to meet or exceed those requirements, but specific requirements and results are not stated). |
| 8. Sample Size for Training Set | N/A (Not applicable for mechanical device) | Not applicable. |
| 9. How Ground Truth for Training Set was Established | N/A (Not applicable for mechanical device) | Not applicable. |
In conclusion, the provided FDA 510(k) document for the Arcus™ Staple System is for a mechanical device. The "study" mentioned is mechanical testing (4-point bending and pull-out force as per ASTM F-564) to demonstrate substantial equivalence to predicate devices, not a clinical trial or AI performance study with detailed ground truth establishment and expert adjudication. Therefore, most of the specific questions geared towards AI/diagnostic device performance studies cannot be answered from this text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nextremity Solutions, Incorporated Mr. Ryan Schlotterback Official Correspondent 54 Broad Street, Suite 200 Red Bank, New Jersey 07701
September 4, 2015
Re: K151160 Trade/Device Name: Arcus™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: August 11, 2015 Received: August 12, 2015
Dear Mr. Schlotterback:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
forth in the quality systems (OS) 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Statement
510(k) Number: K151160
Device Name: Arcus™ Staple System
Indications For Use:
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- ・ Fixation of bone fragments or small bones fractures
- . Fracture management in the foot and hand
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
510(k) Summary (Per 21 CFR 807.92)
| General Company Information: | Nextremity Solutions, Inc.Ryan Schlotterback210 North Buffalo StreetWarsaw, IN 46580 |
|---|---|
| Date Prepared | August 11, 2015 |
General Device Information
| Product Name: | Arcus™ Staple System |
|---|---|
| Classification: | Single/multiple component metallicbone fixation appliances andaccessories21 CFR 888.3030Product code: JDR |
Predicate Devices
| Z-Medical, GmbH | Z-Medical, Z-Guide Staple System(Marketed as Z-Staple)[510(k) K121277] |
|---|---|
| Memometal Technologies | Varisation Staple(Marketed as Varisation Staple)[510(k) K070033] |
Description
The Nextremity Solutions Arcus™ Staple System is a set, consisting of:
-
- A bone staple.
-
- Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack).
The staples are fabricated from medical grade Titanium (ASTM F-136).
{4}------------------------------------------------
Intended Use (Indications)
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand
Substantial Equivalence
The Nextremity Solutions, Arcus™ Staple System possesses the same technological characteristics as the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology.
Performance Data
Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the Arcus™ Staple System as per ASTM F-564.
§ 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.