(60 days)
Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
Synthes LCP Ankle Arthrodesis Plates are minimally contoured metal plates that utilize locking screw technology to promote fusion or "arthrodesis" of the ankle. The plates will be offered in stainless steel and commercially pure titanium and will be available in sterile and non-sterile versions.
The provided document is a 510(k) summary for the Synthes LCP Ankle Arthrodesis Plate. This type of regulatory submission is for medical devices that are substantially equivalent to a surgically marketed predicate device. This document does not describe a study involving device performance against acceptance criteria in the way typically associated with AI/ML-based medical devices or complex diagnostic tools requiring clinical validation.
Instead, the document focuses on demonstrating that the new Synthes LCP Ankle Arthrodesis Plate is substantially equivalent to a previously marketed device (Synthes Ankle Arthrodesis Plates). The "acceptance criteria" here is not about diagnostic accuracy (like sensitivity, specificity, or AUC) but rather about meeting regulatory standards for safety and effectiveness by being comparable to an already approved device.
Therefore, most of the requested information (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) is not applicable to this type of medical device submission.
Here's an attempt to answer the questions based on the provided text, highlighting what is and isn't applicable:
1. A table of acceptance criteria and the reported device performance
For this type of device (a metallic bone fixation appliance), "acceptance criteria" and "reported device performance" are not typically presented as diagnostic metrics with specific thresholds. Instead, the acceptance criterion is substantial equivalence to a predicate, meaning the device's technological characteristics and intended use do not raise different questions of safety and effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k) Submission) |
|---|---|
| Intended Use | Intended for arthrodesis of the ankle joint and distal tibia. (Matches predicate's general use for ankle arthrodesis) |
| Technological Characteristics (Material, Design) | Minimally contoured metal plates, utilizing locking screw technology. Offered in stainless steel and commercially pure titanium in sterile and non-sterile versions. (Assumed to be comparable or an improvement not raising new safety/effectiveness questions compared to predicate). |
| Performance (e.g., mechanical properties) | Not explicitly detailed in this summary, but would have been demonstrated in the full 510(k) submission to be equivalent or superior without new risks. This would typically involve bench testing (fatigue, strength, etc.) rather than clinical outcomes studies for substantial equivalence. |
| Safety & Effectiveness | "Information presented supports substantial equivalence." (Meaning the device is deemed as safe and effective as the predicate.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a mechanical implantable device, not a diagnostic algorithm. There is no "test set" of patient data for performance evaluation in the context of diagnostic accuracy. Clinical studies with patient data are generally not required for 510(k) substantial equivalence for devices like this, unless the proposed device introduces new technology or raises new safety/effectiveness questions.
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 for diagnostic purposes is not relevant for this device. The "truth" for this device relates to its mechanical integrity, biocompatibility, and ability to achieve arthrodesis, which are evaluated through engineering tests, material science, and comparison to predicate devices, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of diagnostic performance that would require adjudication.
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 not an AI/ML device, nor is it a diagnostic tool where human reader performance would be assessed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the diagnostic sense. The "ground truth" for this device relies on engineering principles, material science, bench testing results, and regulatory comparison to an existing predicate device deemed safe and effective. For the 510(k) process, the "ground truth" is that the predicate device is legally marketed and generally safe and effective, and the new device performs comparably in its intended use.
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 or associated ground truth for this medical device submission.
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold black letters with a registered trademark symbol. To the right of the word is the code "Ko61940 (fg 1 of i)" in handwritten-style font. A black line is present underneath the word "SYNTHES".
3.0 510(k) Summary
Page _________ of __1
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 |
|---|---|
| Device Name: | Synthes LCP Ankle Arthrodesis Plate |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories. |
| Predicate Device: | Synthes Ankle Arthrodesis Plates |
| Device Description: | Synthes LCP Ankle Arthrodesis Plates are minimally contouredmetal plates that utilize locking screw technology to promotefusion or "arthrodesis" of the ankle. The plates will be offered instainless steel and commercially pure titanium and will be availablein sterile and non-sterile versions. |
| Intended Use: | Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesisof the ankle joint and distal tibia. |
| Substantial Equivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2006
Synthes (USA) % Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K061940 Trade/Device Name: Synthes LCP Ankle Arthrodesis Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 7, 2006 Received: July 10, 2006
Dear Ms. Musgnung:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchup
Mark N. Melkerson Division of General, Restorative and Neurological 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): | K061940 |
| Device Name: | Synthes LCP Ankle Arthrodesis Plates |
| Indications for Use: | |
| Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia. | |
| Prescription Use | X |
| (Per 21 CFR 801.109) | 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) | |
| Barbara Buchholz |
Sources Such (Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(1) Number_Kloke 1940______________________________________________________________________________________________________________________________________________________
090004
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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.