(29 days)
The EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations:
Distal Femoral Plate
The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and nonunions and malunions.
Proximal Lateral Tibial Plate
The Proximal Lateral Tibial Plate is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
Proximal Medial Tibial Plate
The Proximal Medial Tibial Plate is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
Distal Tibia Plate
The Distal Tibial Plate is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
The EBI Periarticular Plating System is an internal fixation device used to provide surgeons with bone plates that are capable of using locking screws for better rigidity and non-locking screws for compression. Compression slots are also available for non-locking screws to compress two bone fragments. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
The provided text is a 510(k) Summary for the EBI® Periarticular Plating System, which is an internal fixation device. This type of document is a premarket notification to the FDA for medical devices that are substantially equivalent to a legally marketed predicate device.
The document does not describe any acceptance criteria or a study that proves the device meets acceptance criteria in the context of device performance metrics often seen with AI/software-based devices (e.g., accuracy, sensitivity, specificity).
Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices based on intended use, materials, and function. This means the acceptable "performance" is that it functions safely and effectively similarly to devices already on the market, by using similar materials and having a similar intended use.
Therefore, many of the requested items in your prompt are not applicable to this type of traditional medical device submission.
Here's a breakdown based on the information provided and what is implied by a 510(k) for an internal fixation device:
1. Table of Acceptance Criteria and Reported Device Performance:
There are no specified "acceptance criteria" in terms of performance metrics (like accuracy or sensitivity) for this type of hardware device. The acceptance is based on demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence: | The EBI® Periarticular Plating System is intended for fixation of fractures and osteotomies (distal femur, proximal lateral/medial tibia, distal tibia). This matches the intended use of the predicate devices. |
| Material Equivalence: | Manufactured from titanium alloy as per ASTM F136-02. This is a commonly accepted biocompatible material for internal fixation and is substantially equivalent to materials used in predicate devices. |
| Function Equivalence: | Internal fixation device using bone plates capable of using locking and non-locking screws for rigidity and compression. Pre-contoured plates to bone shape with threaded holes for screw choice. Instruments allow minimum incision. This functional description is substantially equivalent to the predicate devices. "There are no significant differences between the EBI® Periarticular Plating System and other currently marketed internal fixation systems." |
| Safety and Effectiveness: | Implied by substantial equivalence to legally marketed predicate devices that have established safety and effectiveness profiles. No new safety concerns are raised. |
2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable. This is a mechanical device, not a diagnostic or AI device that would typically have a "test set" of data for performance evaluation in the way you're asking. The evaluation is primarily based on engineering principles, materials science, and comparison to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. No "ground truth" establishment in the context of data labeling is mentioned or expected for this type of device submission.
4. Adjudication Method for the Test Set:
Not applicable. No "test set" or adjudication method 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 is not an AI/software device, and therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical, implantable medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No "ground truth" in this sense. The closest concept is the established clinical performance and safety history of the predicate devices, which serve as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. No "training set" is mentioned or expected for this type of device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No "ground truth" for a training set.
In summary:
The provided document is a 510(k) premarket notification for a traditional, physical medical device (internal fixation system). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to already approved predicate devices, rather than establishing de novo performance metrics with clinical data sets, as would be the case for AI-based or novel diagnostic devices. The acceptance is based on the FDA's review and determination that the device is as safe and effective as a legally marketed device.
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K 04)2237
510(k) Summary
This 510(k) Summary for the EBI® Periarticular Plating System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter: EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054 | Contact Person: Peter AllanPhone: (973) 299-9300, ext. 332 |
|---|---|
| -------------------------------------------------------------------------- | ---------------------------------------------------------------- |
Date prepared: August 17, 2004
| 2. Proprietary Name: | EBI® Periarticular Plating System |
|---|---|
| Common Name: | Internal Fixation Device |
| Classification Names: | Smooth or Threaded Metallic BoneFixation Fastener, 21 CFR 888.3040Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030 |
3. Predicate or legally marketed devices that are substantially equivalent:
- ロ Synthes Locking Condylar Plate (LCP) System (K000066)
- Synthes Large Fragment LCP System T Plate (K010766) ם
- Synthes LCP Proximal Tibia Plate System (K011978) ם
- Synthes LCP Distal Tibia Plates (K013248) D
Description of the device: The EBI Periarticular Plating System is an internal 4. fixation device used to provide surgeons with bone plates that are capable of using locking screws for better rigidity and non-locking screws for compression. Compression slots are also available for non-locking screws to compress two bone fragments. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a
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choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
- Intended Use: The EBI® Periarticular Plating System is intended for fixation of 5. fractures and osteotomies. The System consists of the following plate configurations:
Distal Femoral Plate
The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone and nonunions and malunions.
Proximal Lateral Tibial Plate
The Proximal Lateral Tibial Plate is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
Proximal Medial Tibial Plate
The Proximal Medial Tibial Plate is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial spit fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
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Distal Tibia Plate
The Distal Tibal Plate is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
-
- Materials: The EBI® Periarticular Plating System is manufactured from titanium alloy as per ASTM F136-02.
Comparison of the technological characteristics of the device to predicate 7.
devices: There are no significant differences between the EBI® Periarticular Plating System and other currently marketed internal fixation systems. It is substantially equivalent* to the predicate devices in regard to intended use, materials, and function.
* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/3/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 image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
Peter Allen Regulatory Affairs Associate EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K042237
Trade/Device Name: EBI® Periarticular Plating System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: August 17, 2004 Received: August 18, 2004
Dear Mr. Allen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prox to 1125 acres in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosment Free (110) and the device, subject to the general controls provisions of the Act. The r ou mayy arons 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 If your device is exactive (controls. Existing major regulations affecting your device can may be subject to back acceral 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 that I Dr has Internations administered by other Federal agencies. You must or any I vith 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 - Mr. Peter Allen
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to ough finding of substantial equivalence of your device to a legally premarket nothcation. THC PDF milling of basification 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 advice 101 your as 1) 594-4659. Also, please note the regulation entitled, Connect the Office of Comment of notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronation 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 yours,
Miriam C. Provost
forCelia 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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STATEMENT OF INDICATIONS FOR USE
Page 1_of_2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EBI® Periarticular Plating System
Indications For Use:
The EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations:
Distal Femoral Plate
The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and nonunions and malunions.
Proximal Lateral Tibial Plate
The Proximal Lateral Tibial Plate is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
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Proximal Medial Tibial Plate
The Proximal Medial Tibial Plate is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
Distal Tibia Plate
The Distal Tibial Plate is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Miriam C Provost | |
|---|---|
| Division Sign, Office of Device Evaluation (ODE) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K042237 |
§ 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.