(86 days)
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Ankle Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
The provided document, a 510(k) summary for the "Gridlock Ankle Plating System," does not describe a study involving an algorithm or artificial intelligence (AI) for diagnostic purposes. Instead, it details the system's design, materials, and non-clinical mechanical performance tests to demonstrate substantial equivalence to existing predicate devices for bone fixation.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI performance, cannot be extracted from this document. The document focuses on the physical characteristics and mechanical properties of a surgical implant system.
Here's an analysis of what is present in the document related to "acceptance criteria" and "studies," acknowledging it's not in the context of AI performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of acceptance criteria with numerical targets and reported performance values in the way one might expect for a diagnostic AI. However, it implicitly uses a standard for equivalence to predicate devices based on mechanical testing.
| Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (from Non-clinical Test Summary) |
|---|---|
| Equivalence to predicate devices in mechanical safety and performance (specifically for Screw Torque to Failure and Plate 4-Point Bending) | "The results of these evaluations indicate that the Gridlock Ankle Plating System is equivalent to predicate devices." (Specific numerical results are not provided in this summary, but the conclusion states equivalence was met.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test (Screw Torque to Failure, Plate 4-Point Bending). These are likely conducted on a defined number of devices according to the ASTM standards.
- Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not based on patient data.
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):
- Not applicable. Ground truth in this context refers to mechanical properties measured during laboratory testing, not medical diagnoses made by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to expert review of diagnostic findings, not mechanical testing.
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 MRMC comparative effectiveness study was done. The device is a surgical implant, not a diagnostic tool where human readers would interpret results with or without AI assistance. The "Clinical Test Summary" explicitly states: "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on established mechanical standards (ASTM F543 for Screw Torque to Failure and ASTM F382 for Plate 4-Point Bending). The comparison is made against the performance of predicate devices tested under similar conditions.
8. The sample size for the training set:
- Not applicable. This refers to an AI training set, which is not relevant to this device.
9. How the ground truth for the training set was established:
- Not applicable. This refers to an AI training set, which is not relevant to this device.
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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 a stylized image of three human profiles facing to the right, with a triple helix-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Trilliant Surgical, Limited % Mr. J.D. Webb President The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: K160177
Trade/Device Name: Gridlock 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: January 23, 2016 Received: January 27, 2016
Dear Mr. Webb:
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 of medical device
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Page 2 - Mr. J.D. Webb
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Gridlock Ankle Plating System
Indications for Use (Describe)
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: Gridlock Ankle Plating System
| Date Prepared | April 19, 2016 |
|---|---|
| Submitted By | Trilliant Surgical LTD6721 Portwest Dr, Suite 160Houston, TX 770241-800-495-2919 Tele |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net |
| Trade Name | Gridlock Ankle Plating System |
| Common Name | bone plate & screws |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessoriesSmooth or threaded metallic bone fixation fastener |
| Class | II |
| Product Code | HRS / HWC |
| CFR Section | 21 CFR section 888.3030 / 888.3040 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Acumed Ankle Plating System (K143385) |
| Secondary PredicateDevices | Wright ORTHOLOC® 3Di Ankle Fracture System (K102429)Gridlock Plating System (K121452)Integra Cannulated Screw System (K040860) |
| Device Description | Gridlock Ankle Plating System consists of various shape and size plates for themanagement of orthopedic osteotomies, reconstruction, and trauma. Featuresinclude a low profile, limited contact, capability of dynamic/manual compression,and angulated-locking threaded screw holes. The system also consists of multiplelocking/standard screw lengths and diameters and the necessary instruments tofacilitate the placement of these implants. |
| Materials | CP Titanium per ASTM F67Titanium alloy (Ti-6Al-4V) per ASTM F136 |
| SubstantialEquivalence Claimedto Predicate Devices | The Gridlock Ankle Plating System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances. |
| Indications for Use | The Gridlock Ankle Plating System is intended for use in trauma and reconstructiveprocedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and otherbones appropriate for the size of the device.The plates (implant), screws (implant), washers (implant), olive wires (instrument),and guide wires (instrument) are intended for single use only. |
| Non-clinical TestSummary | The following analyses were conducted:Screw Torque to Failure (ASTM F543)Plate 4-Point Bending (ASTM F382)The results of these evaluations indicate that the Gridlock Ankle Plating System isequivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Trilliant Medical LTD considers Gridlock Ankle Plating System to be equivalent tothe predicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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§ 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.