(83 days)
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The submission is a modification to the Mini MaxLock Extreme® Plating System to add Mini MTP Plates. This submission also includes the ISO plate that was previously cleared through internal documentation. No modifications were made to the existing plates or screws. The OrthoHelix Mini MTP Plates are designed for 18 MTP joint fusions.
This document describes a 510(k) submission for a medical device called the Mini MaxLock Extreme® Plating System. The submission is for a modification to an existing system, specifically the addition of Mini MTP Plates for MTP joint fusions.
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for a diagnostic AI/ML device.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. For mechanical devices like bone plates, this usually involves showing that the new device has similar:
- Indications for use
- Design
- Materials
- Performance (often through mechanical testing and/or finite element analysis)
Therefore, the requested information elements related to AI/ML device performance (like accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available in this specific regulatory filing.
Based on the provided text, here’s an analysis of what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength and performance comparable to predicate devices | Calculations, mechanical testing, and finite element analysis comparing the strength of the subject and predicate devices were performed. The results support substantial equivalence. |
| Similar indications for use to predicate devices | The Mini MaxLock Extreme® Plating System's intended use is to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments, which is consistent with the predicate devices. |
| Similar design and materials to predicate devices | The device uses Titanium Alloy and PEEK, consistent with existing systems. The design modification (Mini MTP Plates) is evaluated for substantial equivalence. |
| No new issues of safety and effectiveness | Stated that "No new issues of safety and effectiveness have been raised." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, not an AI/ML diagnostic. The "test set" would refer to mechanical test samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device.
4. Adjudication method for the test set
Not applicable. This is a mechanical device.
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
Not applicable. This is a mechanical device, not an AI/ML system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used
Not applicable in the context of diagnostic performance. For a mechanical device, "ground truth" would relate to material properties, mechanical limits, and biomechanical performance data, which are typically established through engineering standards, material science, and physical testing.
8. The sample size for the training set
Not applicable. This is a mechanical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth establishment" in the AI/ML sense for this mechanical device.
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510(k) SUMMARY
Submitter Information
Submitter's Name: Address:
Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:
Device Information
Trade Name:
Common Name:
Classification Name:
Device Classification:
Material Composition:
Device Description:
Intended Use:
Substantial Equivalence:
OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Medina, Ohio 44256 330-869-9562 330-247-1598 Brian Hockett, Liz Altenau Derek Lewis 12/28/11
Mini MaxLock Extreme® Plating System
Fixation Plates and Screws
Plate, Fixation, Bone
Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS Smooth or threaded metallic bone fixation fastener (Class II per 21 CFR 888.3040)
Panel: Orthopedic, Product Code: HWC ·
Titanium Alloy, PEEK
The submission is a modification to the Mini MaxLock Extreme® Plating System to add Mini MTP Plates. This submission also includes the ISO plate that was previously cleared through internal documentation. No modifications were made to the existing plates or screws. The OrthoHelix Mini MTP Plates are designed for 18 MTP joint fusions.
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The new Mini MaxLock Extreme® Plating System is substantially equivalent to the existing OrthoHelix Mini MaxLock Extreme® Plating System (K101962) and the Mini Variable System (K111041). Calculations, mechanical testing and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.
APR 1 0 2012
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 0 2012
OrthoHelix Surgical Designs, Inc. % Mr. Derek Lewis VP of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K120157
Trade/Device Name: Mini MaxLock Extreme® 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 23, 2012 Received: March 26, 2012
Dear Mr. Lewis:
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
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Page 2 - Mr. Derek Lewis
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Erin d. Keith
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Mini MaxLock Extreme® Plating System
Indications for Use:
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use
(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David
Division Sign-Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K120157
§ 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.