(184 days)
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual. The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
The provided document is a 510(k) summary for a "Locking compression plate system" submitted by Shanghai MicroPort Orthopedics Co., Ltd. It describes the device, its intended use, and the regulatory pathway. However, the document does not contain information related to software or AI/ML-driven medical devices. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
Here's an attempt to answer the questions based only on the provided text, recognizing that it primarily describes a physical orthopedic implant and its mechanical testing for substantial equivalence to predicate devices.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (orthopedic implant), the "acceptance criteria" and "device performance" are primarily related to meeting specific engineering standards and demonstrating mechanical equivalence to predicate devices. The document states that "bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also lists the standards used for testing.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| ASTM F382-99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone Plates | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| ASTM F897-02 (Reapproved 2007) Method for Measuring Fretting Corrosion of Osteosynthesis Plates and screws | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| Material Composition: | |
| ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) | Device made of Titanium alloy (Ti6AI4V ELI) which "meets the requirements of ASTM F136-08e1" |
| Sterilization: | |
| Achievement of a SAL of 10-6 (Sterility Assurance Level) via autoclave | "The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual." |
| Design Specifications: | |
| (Implicit: meeting pre-defined dimensional and functional specs) | "bench tests were conducted to verify that the proposed device met all design specifications" |
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 refers to "bench tests" and "mechanical testing." These typically involve testing physical samples of the device and are not directly analogous to "test sets" in an AI/ML context. The sample size (number of physical devices tested) is not specified.
Data provenance is not applicable in the typical sense for AI/ML. The "data" here refers to mechanical test results. The device sponsor is Shanghai MicroPort Orthopedics Co., Ltd., which implies the testing likely occurred in China or at a contract lab, but the specific origins of the test data (e.g., specific lab location) are not provided. These tests are inherently prospective in terms of the test execution, but they are evaluating a manufactured item, not clinical 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. Expert involvement in establishing "ground truth" (as in clinical diagnosis or image interpretation) is not relevant for the mechanical testing of a physical implant. The "ground truth" in this context is adherence to engineering standards and mechanical performance equivalence, evaluated by engineers and testing facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or adjudication of results. Mechanical testing has objective pass/fail criteria based on standards.
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 physical orthopedic implant, not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" is adherence to established international engineering standards (ASTM standards for materials, bone screws, plates, and fretting corrosion) and the demonstrated mechanical performance equivalence to legally marketed predicate devices. It is not an expert consensus on a diagnosis, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
Summary regarding AI/ML relevance:
The provided document describes a traditional, physical medical device (orthopedic implant), and its regulatory clearance process based on substantial equivalence to predicate devices through mechanical bench testing. The questions posed are highly relevant to the evaluation of AI/ML medical devices, which operate on data (images, signals, etc.) and involve algorithms. Therefore, most of the detailed information requested regarding sample sizes, expert involvement, ground truth establishment, and comparative effectiveness studies is not contained in this document because it pertains to a different type of medical device evaluation.
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| Premarket Notification 510(k) Submission | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
| (K112798) |
Exhibit #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K112798
-
- Date of Submission: March 12, 2012.
-
- Sponsor
Shanghai MicroPort Orthopedics Co., Ltd.
Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, Pudong new area, Shanghai 201318, P.R. China
Contact Person: Jason Ma
Position: Regulatory Affairs Manager
+86-21-38954600-631 Tel:
+86-21-38019063 Fax:
ypma@microport.com Email:
-
- Proposed Device Identification
Proposed Device Name: Locking compression plate system
- Proposed Device Identification
Classification name: Plate, Fixation, Bone
Classification: II
Product Code: HRS, HWC
Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040
Review Panel: Orthopedic
Intended Use Statement:
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
| Shanghai MicroPort Orthopedics Co., Ltd. | ||
|---|---|---|
| Rev.: C | Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, | |
| Pudong new area, Shanghai 201318, P.R.China |
113
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| Premarket Notification 510(k) Submission(K112798) | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
| ------------------------------------------------------- | --------------------------- | ---------------------- |
-
- Predicate Device Identification
510(k) Number: K101400.
- Predicate Device Identification
Product Name: Locking Compression Plate.
510(k) Number: K100721.
Product Name: Locking Bone Screw.
5. Device Description
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual.
The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
| Component name | Specification |
|---|---|
| Locking compression plate | Holes number: 2 |
| Locking screw | Diameter: 3.5, 5.0mm;Length: 14~120mm. |
6. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F543-07 Standard Specification and Test Methods for Metallic Medical A Bone Screws
- A ASTM F 382–99 (Reapproved 2008) Standard Specification and Test Method for
| Shanghai MicroPort Orthopedics Co., Ltd. | ||
|---|---|---|
| Rev.: C | Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, | 2/3 |
| Pudong new area, Shanghai 201318, P.R.China |
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| Premarket Notification 510(k) Submission(K112798) | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
Metallic Bone Plates
- Standard Test A ASTM F897-02 (Reapproved 2007) Method for Measuring Fretting Corrosion of Osteosynthesis Plates and screws
-
- Substantially Equivalent Conclusion
Both the proposed and predicate devices have same classification, intended use and materials. The main differences between the proposed and predicate devices are dimension specifications. Mechanical testing were performed on both devices, test results demonstrated that they have similar performances. Therefore the proposed device, Locking Compression Plate System, is determined to be Substantially Equivalent (SE) to the predicate device, Locking Compression Plate as cleared under K101400 and Locking Bone Screw as cleared under K100721, in respect to safety and effectiveness.
Rev.: C
Shanghai MicroPort Orthopedics Co., Ltd. Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, Pudong new area, Shanghai 201318, P.R.China
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shanghai Microport Orthopedics Co., LTD % Mr. Jason Ma Building 23, No. 588 Tianxiong Road SIMZ Bio Business Park Shanghai, P.R. China, 201318
MAR 2 9 2012
Re: K112798
Trade/Device Name: Locking compression plate 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 7, 2012 Received: March 22, 2012
Dear Mr. Ma:
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
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Page 2 - Mr. Jason Ma
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/CDRH/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,
Mark A. Millenson
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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Exhibit #3 Indications for Use Project #: 510k-G11Z Premarket Notification 510(k) Submission (K112798)
Exhibit #3 Indications for Use
510(k) Number: K112798
Device Name: Locking compression plate system
Indications for Use:
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
&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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Douglas
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112798
Rev.: B
§ 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.