(65 days)
Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
Synthes LCP System is a plate and screw system. The primary feature of the plate and screw system is that the locking screws engage with the head and shaft of the plate to form a locked, fixed angle construct. The system features a limited-contact profile, dynamic compression unit (DCU) and locking screw holes. The plate accepts 7.3 mm locking screws, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mm cannulated screws, and 4.5 mm cortex screws. A screw nut is also utilized with this system.
This document is a 510(k) summary for the Synthes Locking Condylar Plate (LCP) System, indicating it's a medical device submission to the FDA. The information provided is primarily for regulatory clearance and focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria and detailed study results demonstrating performance against those criteria.
Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, expert qualifications, and study designs (like MRMC or standalone) are not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document describes the device, its intended use, and indicates that it has been found "substantially equivalent" to a predicate device. This regulatory determination does not typically involve explicit, publically stated acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that would be presented in a table alongside reported device performance. Instead, substantial equivalence implies that the device performs as safely and effectively as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe any specific clinical or performance studies for the LCP system that would involve a "test set" in the context of AI/software performance. The 510(k) process for hardware like this generally relies on bench testing, mechanical testing, and comparison to existing devices, rather than data-driven performance metrics against a test set.
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)
- Cannot be answered from the provided text. As there is no mention of a "test set" or data-driven performance evaluation requiring expert ground truth, this information is not applicable or available in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. Similar to points 2 and 3, this information is not applicable as no test set requiring adjudication 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
- Cannot be answered from the provided text. This device is a medical implant (plate and screw system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. This is a physical medical device, not an algorithm. Standalone performance as described (algorithm only) is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. Given that this is a hardware device submission, "ground truth" in the context of data analysis or diagnosis is not applicable. For a physical implant, "performance" would likely be assessed through mechanical testing (e.g., fatigue, strength), biocompatibility, and manufacturing quality. The "ground truth" for its function would be its demonstrated mechanical properties and ability to stabilize fractures as intended. These details are not elaborated in this summary.
8. The sample size for the training set
- Cannot be answered from the provided text. This is not a data-driven or AI device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. As there is no training set, this question is not applicable.
Summary of available information:
- Device Name: Synthes Locking Condylar Plate (LCP) System
- Submitted by: Synthes (USA)
- Date of Submission: Received January 10, 2000
- FDA Clearance Date: March 15, 2000
- Regulatory Status: Class II medical device, 510(k) cleared based on substantial equivalence.
- Predicate Device: Synthes Distal Femur Plate (DFP) System, (K982222)
- Device Description: A plate and screw system where locking screws engage with the plate to form a locked, fixed-angle construct. Features limited-contact profile, dynamic compression unit (DCU), and locking screw holes. Accepts various screw sizes (7.3 mm locking, 7.3 mm conical, 5.0 mm locking, 5.0 mm cannulated, and 4.5 mm cortex screws) and utilizes a screw nut.
- Intended Use: Buttressing multifragmentary distal femur fractures, including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
- Material: Stainless Steel.
The document states "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...". This implies that the device meets the regulatory requirements for safety and effectiveness by demonstrating equivalence to a legally marketed predicate device. The performance is inferred to be similar to the predicate device, which would have undergone its own rigorous testing. However, the specific "acceptance criteria" and detailed "study" results that directly quantify the LCP system's performance against numerical targets are not provided in this 510(k) summary.
{0}------------------------------------------------
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 representation of a person. A small circle with a dot inside is located to the right of the word.
· Mar 1 5 2000
K00066
| Attachment VI: | Summary of Safety and Effectiveness Information[510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
| Contact: Sheri L. Musgnung | |
| DEVICE NAME: | Synthes Locking Condylar Plate (LCP) System |
| COMMON OR USUALNAME | Appliance, Fixation, Nail/Blade/Plate Combination, SingleComponent;Screw, Fixation, Bone |
| DEVICECLASSIFICATION: | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes Distal Femur Plate (DFP) System, (K982222) |
| DESCRIPTION: | Synthes LCP System is a plate and screw system. The primary feature ofthe plate and screw system is that the locking screws engage with thehead and shaft of the plate to form a locked, fixed angle construct. Thesystem features a limited-contact profile, dynamic compression unit(DCU) and locking screw holes. The plate accepts 7.3 mm lockingscrews, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mmcannulated screws, and 4.5 mm cortex screws. A screw nut is alsoutilized with this system. |
| INTENDED USE: | Synthes LCP System is intended for buttressingmultifragmentary distal femur fractures including:supracondylar, intra-articular and extra-articular condylarfractures, fractures in normal or osteopenic bone, and non-unions and malunions. |
| MATERIAL: | Stainless Steel |
Synthes Locking Condylar Plate System 510(k) Synthes (USA)
.
CONFIDENTIAL
:
0000000
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K000066
Trade Name: Synthes Locking Condylar Plate (LCP) System Regulatory Class: Class II Product Codes: HRS, HWC, HTY, and JDW Dated: January 7, 2000 Received: January 10, 2000
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
{2}------------------------------------------------
Page 2 -- Ms. Sheri L. Musgnung
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 009110 for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Neil R.P. Ogden
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Synthes (USA) Locking Condylar Plate (LCP) System Device Name:
Indications For Use:
Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
NPO for Faria
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K000066
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.