(45 days)
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.
Synthes LCP Modular Foot Plates consist of locking cuboid, navicular and talus plates used to treat small bone fractures. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.
The provided text describes a 510(k) premarket notification for a medical device, the Synthes (USA) LCP Modular Foot Plates. This type of regulatory submission in the United States is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance against explicit acceptance criteria with detailed statistical studies.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable (N/A) in the context of this 510(k) summary. The primary "proof" of the device's acceptability is its substantial equivalence to an existing device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to Synthes (USA) Modular Foot System. |
| Intended Use | Intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle. |
| Classification | Class II medical device, §888.3030 – Single/multiple component bone fixation appliances and accessories. |
| Material/Design | Consist of locking cuboid, navicular and talus plates. Attached to bone via 2.4 and 2.7 mm cortex and locking screws. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The 510(k) summary does not describe a clinical study with a "test set" in the traditional sense to prove device performance against specific metrics. The focus is on demonstrating substantial equivalence to a predicate device, which typically involves comparing design principles, materials, intended use, and performance claims. This usually doesn't involve new clinical data demonstrating efficacy, but rather engineering tests or comparisons to existing data for the predicate.
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)
- N/A. No "ground truth" establishment by experts for a test set is mentioned or required for this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is mentioned as there's no described test set or expert review process for performance data.
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
- N/A. This device is a bone plate, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a bone plate, it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No specific "ground truth" in the context of clinical outcomes or diagnostic accuracy is detailed. The "ground truth" for a 510(k) would be the established performance and safety of the predicate device, against which the new device is compared.
8. The sample size for the training set
- N/A. This device is a bone plate, not an AI model. Therefore, no training set is applicable.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter "S" inside of a circle. To the right of the word is a registered trademark symbol. A horizontal line is located underneath the word.
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 | |
| Device Name: | Synthes (USA) LCP Modular Foot Plates | |
| Classification: | Class II, §888.3030 – Single/multiple component bone fixationappliances and accessories | |
| Predicate Device: | Synthes (USA) Modular Foot System | |
| Device Description: | Synthes LCP Modular Foot Plates consist of locking cuboid,navicular and talus plates used to treat small bone fractures. Theplates are attached to bone via 2.4 and 2.7 mm cortex and lockingscrews. | |
| Intended Use: | The Synthes LCP Modular Foot Plates are intended for use inselective trauma, fractures, osteotomies, reconstructive proceduresand replantations of small bones including the foot and ankle. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes(USA) LCP Modular Foot Plates are substantially equivalent toother legally marketed devices.The term “substantial equivalence” as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure, represented by three curved lines, which is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.
Public Health Service
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy Anderson Regulatory Affairs Manager Synthes USA 1690 Russell Road Paoli, Pennsylvania 19301
Re: K050110 Trade/Device Name: LCP Modular Foot Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 17, 2005 Received: January 18, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve revea your your 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 connect 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 your be subject to such additional controls. Existing major regulations affecting your device r may or below 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 complics 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. Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your intial equivalence of your device to a legally prematics notification. "The PDF intently on 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 If you desire specific advise 10. 90. at 200) 276-0120 . Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of I
2.0
Indications for Use
510(k) Number (if known):
Synthes (USA) LCP Modular Foot Plates Device Name:
Indications for Use:
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, The Symnes ECF Modular Foot Rais and replantations of small bones including the foot and ankle.
Over-The-Counter Use AND/OR X Prescription Use _ (21 CFR 807 Subpart C) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Gener Restorative,
and Neurological
510(k) K05 0110
CONFIDENTIAL .
§ 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.