(79 days)
The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Lattice Locking Plates consist of a plate and locking and non-locking screws with surgical site preparation and insertion instruments. It is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The locking lattice plate and screws come in multiple sizes.
The provided text is a 510(k) premarket notification for a medical device (Additive Orthopaedics Locking Lattice Plate). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical evidence. However, this document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/algorithm-based diagnostic or assistive device.
The document describes a mechanical device, specifically a surgical plate, and the assessment of its physical properties for substantial equivalence to existing similar devices. It does not involve any AI algorithms, human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity, specificity, or AUC, which are typically found in studies for AI-powered medical devices.
Therefore, I cannot provide the requested information based on the provided text, as the context is entirely different.
Here's why and what the document does discuss regarding evaluation:
- Device Type: The "Additive Orthopaedics Locking Lattice Plate" is a physical implant used for bone fixation.
- Evaluation Method: The document relies on "Substantial Equivalence - Non-Clinical Evidence" which includes mechanical testing (e.g., 4-point bending, static torsion, static axial pullout) per ASTM standards (F382, F543) and bacterial endotoxin testing (LAL pyrogen testing).
- "Acceptance Criteria" in this context: The "acceptance criteria" are implied by meeting the performance demonstrated by the predicate devices through the specified ASTM standards and pyrogen limits (e.g., "Pyrogen levels for the device system were below the 20 EU/device limit"). The study demonstrating this is the mechanical and biological testing itself.
- No AI/Algorithm: The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," or "standalone algorithm performance" are not applicable because this is not an AI-driven device.
To reiterate, the requested information cannot be extracted from the provided text because it pertains to an entirely different type of medical device evaluation (mechanical implant vs. AI/diagnostic software).
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Public Health Service
April 13, 2017
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Additive Orthopaedics, LLC Greg Kowalczyk President 83 Amelia Circle Little Silver. New Jersey 07739
Re: K170214
Trade/Device Name: Additive Orthopaedics Locking Lattice Plate 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: January 23, 2017 Received: March 23, 2017
Dear Greg Kowalczyk:
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
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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 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/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) K170214
Device Name
Additive Orthopaedics Locking Lattice Plate
Indications for Use (Describe)
The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
| 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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510K Summary (Per 21 CFR 807.92)
| General Company Information: | Additive Orthopaedics, LLC.Gregory KowalczykPresident83 Amelia CircleLittle Silver, NJ 07739Phone: (732) 882-6633greg@additiveorthopaedics.com |
|---|---|
| Date Prepared: | March 29, 2017 |
| General Device Information: | |
| Proprietary Name: | Additive Orthopaedics Locking Lattice Plate |
| System Classification: | Common Name: Plate, Fixation, Bone |
| Regulation Name: Single/multiple component metallibone fixation appliances and accessories;Product Code: HRS- Class IIClassification Name and Reference: 21 CFR 888.3030 | |
| Regulation Name: Smooth or Threaded metallic bonefixation fastener and accessories;Product Code: HWC- Class IIClassification Name and Reference: 21 CFR 888.3040 |
Predicate Devices:
| Company | Product Name | 510K Number |
|---|---|---|
| Primary: Nextremity Solutions, Inc. | Restore Fixation System | K131061 |
| Additional: Paragon 28, Inc. | Paralock Plating System | K140397 |
| Reference: Additive Orthopaedics, LLC | Hammertoe Correction System | K153207 |
| Reference: Additive Orthopaedics, LLC | Bone Wedge System | K160264 |
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Description
The Additive Orthopaedics Lattice Locking Plates consist of a plate and locking and non-locking screws with surgical site preparation and insertion instruments. It is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The locking lattice plate and screws come in multiple sizes.
Intended Use (Indications)
The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
(a) (6) Technological Characteristics Comparison
The Additive Orthopaedics Locking Lattice Plate and the legally marketed predicated devices have similar indications, dimensions, geometry, materials and manufacturing process. The Additive Orthopaedics Locking Lattice Plate is technologically substantially equivalent to the predicate devices.
(b) (1) Substantial Equivalence- Non-Clinical Evidence
Mechanical testing including 4 point bending (static and dynamic) per ASTM F382 as well as static torsion, static driving torque and removal torque, and static axial pullout per F543 for the proposed device. Bacterial endotoxin levels on the device were also evaluated by LAL pyrogen testing. Pyrogen levels for the device system were below the 20 EU/device limit. The results of these verification activities demonstrate that the Additive Orthopaedics Locking Lattice Plate is substantially equivalent to the predicate device identified.
(b) (3) Substantial Equivalence - Conclusions
The Additive Orthopaedics Locking Lattice Plate possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, manufacturing process, size and fundamental technology. The design characteristics of the subject system raises no new safety and effectiveness questions. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as 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.