(239 days)
Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
The Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are low-profile plates with a pre-contoured shape designed to conform to the distal tibia. The plates are available in stainless steel and feature specific versions for the right and left tibia.
The provided document is a 510(k) summary for the Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates. It states that the device's substantial equivalence is supported by preclinical bench testing and analyses, as well as a published clinical literature review, rather than a study involving human subjects or AI performance.
Therefore, the requested information regarding acceptance criteria, device performance from clinical studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable in this context, as the provided document focuses on mechanical and design equivalence to predicate devices.
However, based on the provided text, I can infer the acceptance criteria were related to mechanical performance and design specifications to demonstrate substantial equivalence to existing predicate devices.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | Information presented supports the substantial equivalence of the Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates to the predicate devices. The proposed plate has the same indications for use, incorporates the same fundamental product technology and is composed of the same material. |
| Mechanical Performance (Geometric Bending Strength): | Geometrical bending strength analysis was conducted. |
| Mechanical Performance (Static Bend Testing): | Static bend testing was conducted. |
| Mechanical Performance (Dynamic Fatigue Testing): | Dynamic fatigue testing was conducted. |
| Clinical Literature Review for Safety/Effectiveness: | Published clinical literature review was conducted. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The number of plates tested is not specified.
- Data Provenance: Not applicable for a human data test set. The data provenance would be from the engineering lab where the mechanical tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not clinical experts.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are objective measurements, not subject to adjudication in the clinical sense.
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, an MRMC comparative effectiveness study was not done. This device is a bone fixation appliance, not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- Engineering specifications and measurements from mechanical testing (e.g., force, displacement, cycles to failure) consistent with industry standards for medical implants.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for the evaluation of this device, as it is not an AI/machine learning product.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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MAY 1 1 2010
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K092812_
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Date Prepared: | May 5, 2010 | |
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 | |
| Device Name: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal TibiaPlates | |
| Classification: | Class II, §888.3030 - Single / multiple component metallic bonefixation appliance and accessories. | |
| Predicate Device: | Synthes 3.5mm LCP Distal Tibia T Plates (K080522)Synthes LCP Distal Tibia Plates (K013248)Synthes Pilon Plate (K020602)Depuy Orthopaedics, Inc. Anterolateral and Medial Locking PlatingSystem (K072832) | |
| Device Description: | The Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Platesare low-profile plates with a pre-contoured shape designed toconform to the distal tibia. The plates are available in stainless steeland feature specific versions for the right and left tibia. | |
| Indications forUse: | Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates areindicated for fractures, osteotomies, and non-unions of the distaltibia, especially in osteopenic bone. | |
| SubstantialEquivalence: | Information presented supports the substantial equivalence of theSynthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates tothe predicate devices. The proposed plate has the same indicationsfor use, incorporates the same fundamental product technology andis composed of the same material.Preclinical bench testing and analyses were conducted in support ofa determination of substantial equivalence including: | |
| • Geometrical bending strength analysis. | ||
| • Static bend testing. | ||
| • Dynamic fatigue testing. | ||
| • Published clinical literature review |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Karl Nittinger Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAY 1 1 2010
Re: K092812
Trade/Device Name: Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS Dated: April 15, 2010 Received: April 29, 2010
Dear Mr. Nittinger:
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
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Page 2 - Mr. Karl Nittinger
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/CentersOflices/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,
Ckalbay Buelmp
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K092812 |
|---|---|
| Device Name: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates |
Indications for Use:
Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
| Prescription Use(Per 21 CFR 801.109) | X AND/OR Over-The-Counter Use(21 CFR 807 Subpart C) |
|---|---|
| ------------------------------------------ | --------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonitu for mxm
(Division Sign-off)
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092812
§ 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.