(65 days)
Synthes (USA) LCP Proximal Femur Hook Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
The LCP Proximal Femur Hook Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates are available in a various lengths.
The provided text is a 510(k) summary for the Synthes (USA) LCP Proximal Femur Hook Plates. This document details the regulatory pathway for a medical device by demonstrating its substantial equivalence to a legally marketed predicate device.
Crucially, a 510(k) submission for this type of device (metallic bone fixation appliances) typically relies on demonstrating substantial equivalence in design, materials, and intended use to an existing predicate device, rather than on new clinical performance studies with specific accuracy metrics and ground truth evaluations like those for diagnostic AI devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this 510(k) submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
- Not applicable. This submission doesn't present performance metrics like those for diagnostic AI devices (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for a 510(k) for this type of implantable device are based on demonstrating substantial equivalence to a predicate device in terms of design, materials, and intended use, often supported by mechanical testing rather than clinical performance-based metrics. The document states: "Comparative information presented supports substantial equivalence."
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. There is no "test set" in the context of clinical performance data described. Substantial equivalence is typically demonstrated through engineering analyses, bench testing, and comparison of design specifications to the predicate device.
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 establishment by experts for a test set is not part of this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set is described.
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 device is a bone fixation plate, not an AI diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the diagnostic AI sense is not relevant for this device's 510(k) submission. The "ground truth" equivalent would be established engineering standards, material properties, and clinical performance data of the predicate device that the new device is compared against.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. Not an AI/machine learning device.
Summary relevant to this 510(k):
The Synthes (USA) LCP Proximal Femur Hook Plates gained market clearance through a 510(k) submission by demonstrating substantial equivalence to the Synthes (USA) LCP Proximal Femur Plates (predicate device). This means the FDA concluded that the new device is as safe and effective as the predicate device already on the market, based on a comparison of intended use, technological characteristics (design, materials), and performance (often mechanical testing for implants) without necessarily requiring new clinical trials or performance studies against specific accuracy metrics. The key information is the comparison to the predicate device, not new performance data against a specific acceptance criterion table.
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SEP - 4 2003
K032032
page 1 of 1
3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes (USA) LCP Proximal Femur Hook Plates |
| CLASSIFICATION: | Class II § 21 CFR 888.3030: Plate , Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) LCP Proximal Femur Plates |
| DEVICE DESCRIPTION: | The LCP Proximal Femur Hook Plates are contoured to match the anatomyof the proximal femur with a limited contact low profile design. The platehas dynamic compression holes combined with conical shaped threadedscrew holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulatedlocking & cannulated conical screws. The plates are available in a variouslengths. |
| INTENDED USE: | The LCP Proximal Femur Hook Plates are intended for fractures of thefemur including: fractures of the trochanteric region, trochanteric simple,cervicotrochanteric, trochanterodiaphyseal, multifragmentarypertrochanteric, intertrochanteric, intertrochanteric reversed, or transverseor with additional fracture of medial cortex. Fractures of the proximal endof the femur combined with ispsilateral shaft fractures, metastatic fractureof the proximal femur and osteotomies of the proximal femur. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence.The term "substantial equivalence" as used in this 510(k) notification islimited to the definition of substantial equivalence found in the FederalFood, Drug and Cosmetic Act, as amended and as applied under 21CFR807, Subpart E under which a device can be marketed without pre-marketapproval or reclassification. A determination of substantial equivalencyunder this notification is not intended to have any bearing whatsoever onthe resolution of patent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalence herein shallbe construed as an admission against interest under the US Patent Laws ortheir application by the courts. |
Confidential
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 4 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K032032
Trade/Device Name: Synthes (USA) LCP Proximal Femur Hook 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: June 30, 2003 Received: July 2, 2003
Dear Ms. Boyle:
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 10 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. Lisa M. Boyle
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours.
Mark N. Millman
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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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K032032 |
|---|---|
| Device Name: | Synthes (USA) LCP Proximal Femur Hook Plates |
Indications: Synthes (USA) LCP Proximal Femur Hook Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K032032 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
Confidential
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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.