(329 days)
The Arzzt 3.5/4.5 Small & Large Fragment Systems is indicated for fixation of fractures, and nonunions of the humerus, radius, ulna, femur, and tibia.
The Arzzt 3.5/4.5 Small & Large Fragments System consist of a variety of plates designed for specific bone areas, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded and cannulated or not, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either stainless steel or titanium.
This document describes the Arzzt 3.5 / 4.5 Small & Large Fragments System, a bone fixation system. The provided information is from a 510(k) Premarket Notification, which is a process to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria through clinical trials or extensive standalone performance studies in the context of AI software.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a table with quantitative performance metrics for a specific function like an AI algorithm. Instead, it refers to equivalence to a predicate device and compliance with industry standards for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Strength (Static Bending Yield) | "Arzzt blocking plates... proving to be as strong as the predicate devices." (No specific numerical value provided, but claims equivalence to Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System). |
| Mechanical Strength (Static Torsional Yield) | "Arzzt blocking plates... proving to be as strong as the predicate devices." (No specific numerical value provided, but claims equivalence to Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System). |
| Mechanical Strength (Maximum Shear Stress of Screws) | "Arzzt blocking and cortical screws... [compared] to the predicate device." (No specific numerical value provided, but claims equivalence). |
| Mechanical Strength (Thread of Screws) | "Arzzt blocking and cortical screws... [compared] to the predicate device." (No specific numerical value provided, but claims equivalence). |
| Compliance with ASTM F-983-86 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for permanent marking.) |
| Compliance with ASTM F543-07 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for metallic medical bone screws.) |
| Compliance with ISO 5832-1:2007 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for wrought stainless steel.) |
| Compliance with ISO 5832-3:1996 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for wrought titanium 6-aluminium 4-vanadium alloy.) |
| Substantial Equivalence (Intended Use, Target Population, etc.) | "The Arzzt 3.5 / 4.5 Small & Large Fragments System has an equivalent intended use, target population, anatomical sites, materials, biocompatibility, as well performance and properties as Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications and other predicates devices for fixation of bone fractures." "the engineering analyses performed on the product demonstrate that the performance and properties are of Arzzt Plates & Screw System are substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "engineering analyses" for mechanical testing, but it does not specify sample sizes for these tests (e.g., number of plates or screws tested). There is no mention of clinical data or studies involving human subjects with associated data provenance. This is a premarket notification for a physical medical device, not an AI software.
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 information is not applicable. The "ground truth" for this device would be its mechanical properties, established through physical testing and measurement, not expert review of AI output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not mechanical testing for physical devices.
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 such study was conducted or is mentioned, as this is a physical medical device and not an AI-based diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as there is no algorithm or AI component in the described device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the mechanical properties as measured through standardized engineering tests (e.g., static bending, torsional yield, shear stress) and comparison to established predicate devices and industry standards.
8. The sample size for the training set
This is not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
This is not applicable as there is no AI model or training set.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Truemed Group LLC % Ms. Lara Luzak Senior Regulatory Specialist Registrar Corp. 144 Research Drive Hampton, Virginia 23666
Re: K162507 Trade/Device Name: Arzzt 3.5 / 4.5 Small & Large Fragments 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: July 5, 2017 Received: July 6. 2017
Dear Ms. Luzak:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
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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Indications for Use
510(k) Number (if known) K162507
Device Name
Arzzt 3.5 / 4.5 Small & Large Fragments System
Indications for Use (Describe)
The Arzzt 3.5/4.5 Small & Large Fragment Systems is indicated for fixation of fractures, and nonunions of the humerus, radius, ulna, femur, and tibia.
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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Image /page/3/Picture/2 description: The image contains the logo for TrueMed Group. The logo consists of a teal-colored abstract symbol on the left, resembling a stylized person within a circle. To the right of the symbol, the word "TRUEMED" is written in a bold, dark gray font. Below "TRUEMED", the word "GROUP" is written in a smaller, teal font, with a horizontal line extending from the right side of the word.
Premarket Notification 510(k) Summary
| 1. | Submitter's Name: | Truemed Group LLC |
|---|---|---|
| 2. | Contact Person: | Jorge Trujillo Zavala2002 Timberloch Place Suite 200The Woodlands, TX 77380Telephone: 832 442 2310 |
| 3. | Date Prepared: | April 21, 2016 |
| 4. | Device Name: | Arzzt 3.5 / 4.5 Small & Large Fragments System |
| 5. | Common Name: | Osteosynthesis plates and screws |
| 6. | Classification Name: | • Plate, Fixation, Bone and accessories per 21 CFRsection 888.3030• Screw, Fixation, Bone and accessories per 21 CFR section888.3040 |
| 7. | Product Codes: | HRS, HWC |
| 8. | Devices Classification: | Class II |
| 9. | Regulation Numbers: | 21 CFR 888.3030 21 CFR 888.3040 |
| 10. | Predicate Device (Primary): | - Synthes (USA) 3.5 mm and 4.5 mm Locking CompressionPlate (LCP) System with Expanded Indications K082807 |
| 11. | Device Description: | The Arzzt 3.5/4.5 Small & Large Fragments System consistof a variety of plates designed for specific bone areas,with orifices to receive either locking or non-lockingscrews. The screws are can be total or partially threadedand cannulated or not, some are self-tapping and they canbe with or without locking features. All plates and screwsmay be manufactured in either stainless steel or titanium. |
| 12. | Intended Use: | The Arzzt 3.5/4.5 Small & Large Fragment System isindicated for fixation of fractures, osteotomies, and non-unions of the humerus, radius, ulna, femur, and tibia. |
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Image /page/4/Picture/1 description: The image shows the logo for TrueMed Group. The logo consists of a teal-colored abstract symbol on the left, resembling a person with arms raised inside a circle. To the right of the symbol, the word "TRUEMED" is written in dark gray, with "GROUP" in teal below it. A horizontal line extends from the word "GROUP".
13. Test Performed:
We performed engineering analyses comparing the static bending and static torsional yield strengths of the Arzzt blocking plates to the predicate devices proving to be as strong as the predicate devices. For the screws, we performed engineering analyses comparing the maximum shear stress and thread of the Arzzt blocking and cortical screws to the predicate device.
14. Standards:
• ASTM F-983-86 Standard Practice for Permanent Marking of Orthopedic Implant Components • ASTM F543-07 Standard Specifications And Test Methods For Metallic Medical Bone Screws • ISO 5832-1:2007 Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel • ISO 5832-3:1996. Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4vanadium allov The Arzzt Plates & Screw System met the requirements of the above standards.
- Substantial Equivalence: The Arzzt 3.5 / 4.5 Small & Large Fragments System has an equivalent intended use, target population, anatomical sites, materials, biocompatibility, as well performance and properties as Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications and other predicates devices for fixation of bone fractures.
In considering the technological characteristics of the device compared to the predicate device, the Arzzt 3.5 / 4.5 Small & Large Fragments System has a solid design and the engineering analyses performed on the product demonstrate that the performance and properties are of Arzzt Plates & Screw System are substantially equivalent to the predicate device.
§ 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.