(28 days)
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The Titanium Elastic Nail End Cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation. The threads are self-tapping with reverse cutting flutes to facilitate end cap removal. The back end of the cap is blunt to minimize soft tissue irritation.
This document is a 510(k) summary for the Synthes Elastic Intramedullary Nail (EIN) End Cap. It contains information about the device, its intended use, and its substantial equivalence to predicate devices. However, it does not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any performance data in the way a clinical study would.
Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.
Here is a summary of what is available in the document, demonstrating why the requested information cannot be extracted:
-
A table of acceptance criteria and the reported device performance: This information is completely absent. No acceptance criteria are stated, and no performance metrics (e.g., accuracy, sensitivity, specificity, or any other quantifiable measure) are reported for the device.
-
Sample size used for the test set and the data provenance: This information is completely absent. There is no mention of a test set, sample size, or data provenance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent. There is no mention of experts or ground truth establishment.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is completely absent.
-
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: This information is completely absent. The device described is a physical medical implant (an end cap for an intramedullary nail), not an AI-assisted diagnostic or decision support tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is completely absent. As mentioned, this is a physical implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is completely absent.
-
The sample size for the training set: This information is completely absent.
-
How the ground truth for the training set was established: This information is completely absent.
Conclusion:
The provided document is a regulatory submission for a medical device (Synthes Elastic Intramedullary Nail (EIN) End Cap) seeking 510(k) clearance. The purpose of a 510(k) summary is to demonstrate "substantial equivalence" to a predicate device, which primarily involves comparing design, materials, and intended use, rather than presenting detailed clinical performance data from a prospective study with acceptance criteria.
Therefore, the specific information you requested regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement for performance evaluation is not available in this document. Such details would typically be found in a separate clinical or non-clinical performance study report, which is not part of this 510(k) summary.
{0}------------------------------------------------
DEC 2 2005
. . . . . . . . . . . . . . . . . . . .
and the contract and the consisted to the consisted to the contract
A SYNTHES ...
the control control control concession in the consideration
Andrew and the count
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '053105'. The numbers are written in a cursive style, and the overall appearance suggests that it is a code or identifier. The handwriting is clear and legible, with a consistent stroke weight.
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 | |
| Device Name: | Synthes Elastic Intramedullary Nail (EIN) End Cap | |
| Classification: | 21 CFR 888.3020: Intramedullary fixation rod (HSB) | |
| Predicate Devices: | Encore Orthopedics (formerly Applied Osteo Systems):True/Flex® Intramedullary Rod EndcapsTrue/Flex® Humerus Cap | |
| Device Description: | The Synthes Elastic Intramedullary Nail (EIN) End Cap is usedwith the Synthes Elastic Intramedullary Nail (EIN) System. TheTitanium Elastic Nail End Cap is inserted over the external portionof the nail and threaded into the cancellous bone in an obliqueorientation. The threads are self-tapping with reverse cutting flutesto facilitate end cap removal. The back end of the cap is blunt tominimize soft tissue irritation. | |
| Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicatedfor fixation of diaphyseal fractures where the canal is narrow orflexibility of the implant is paramount. This includes upperextremity fractures in all patients and lower extremity fractures inpediatric or small-stature patients. This system is also intended totreat metaphyseal and epiphyseal fractures, such as radial neckfractures and is intended for fixation of small long bones, such ascarpal and tarsal bones. In pediatric applications, the flexibility ofthe EIN allows it to be inserted at a point which avoids disruptionto the bone growth plate. | |
| SubstantialEquivalence: | Comparative information presented supports substantialequivalence. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2005
Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K053105
K053105
Trade/Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) End Cup
Trade/Device Name: Synthes 200 2000 Trauc/Device incher: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 2, 2005 Received: November 4, 2005
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 5 IU(K) premaince in the mindent (for the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed previce Amendments, for use stated in the enclosure) to legally market production in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the ensectived the provision of the Fede commerce prior to May 28, 1976, the enactinent une of the Federal Food, Drug, devices that have been reclassified in accordance when oversions of the more of the Act.
and Cosmetic Act (Act) that do not require approval of a proval application of the Ac and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general vonmul registration, listing of
general controls provisions of the Act the lines and recisibitions and general controls provisions of the Act Include requirements as and more of the stations and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mile entirer cass if opedial som alleoting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional controis: Listing iniger togato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add be found in the Code of Federal Regulations, This 24, 2017, 11:45, 11, 1991, 1991, 1991, 1991, 1991, 1991, 199
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance on the requirements of the Act
that FDA has made a determination that your device complies with other requirements. You that FDA has made a determination intributions administered by other Federal agencies. You must
or any Federal statutes and regulations and regulation registration and list or any Federal statutes and regulations administed to registration and listing (21
comply with all the Act's requirements, including, but not ice reguirements as set comply with all the Act s requirements, including to the chiming practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and 120); and 120); and if annicable, CFR Part 807); labeling (21 CFR Part 801); god manufacture, platfielde, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (QS) regulation (21 CFR Part of Schools) =
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submit and one of exhatential equivalence of your device to a legal This letter will allow you to begin market it equivalence of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantal equivalence of 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
r (1) (1) (1) (1) (1) (1) (110) (110) (140) 276 (110) . Also, please note If you desire specific advice for your device on our laborating the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please not 91). You may contact the Office of Compliance at (240) 276-01-20. Proved 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtai "Misbranding by reference to prematical international " (2) Cr Cr Cr Are Division of Small
other general information on your responsibilities under (800) 638-204 other general information on your responsionities uncer and except and one of 2001 of 2001 of 2001 of 2001 of 2001 of 2001 Manufacturers, International and Consumer Assistance at los of the March (1) 10 million (1) 10 mil.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/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 inside of a circle. A horizontal line is present underneath the word "SYNTHES".
Page 1 of 1
| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K053105 |
|---|---|
| Device Name: | Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap |
| Indications for Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. |
X Prescription Use __ (Per 21 CFR 801.109)
ﻳ
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Gff) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 3 |05
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.