(86 days)
Synthes Porous Polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
Synthes porous polyethylene implants are made from ultra-high molecular weight polyethylene (UHMWPE) or a combination of UHMWPE and titanium for use in anatomical reconstruction of the craniofacial skeleton. These implants are available, with and without embedded titanium, in porous and porous/smooth sheets of various shapes and dimensions. The interconnected, open pore structure of Synthes porous polyethylene implants allows for tissue ingrowth. Synthes porous polyethylene implants are intended for single-patient use only. Synthes porous polyethylene implants are intended for use in non- load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The provided 510(k) summary and associated FDA letter for the Synthes Porous Polyethylene Implants (K051879) do not describe acceptance criteria or a study proving that the device meets such criteria.
This document details the regulatory pathway for a Class II medical device seeking substantial equivalence to existing predicate devices. In such cases, the primary focus is often on demonstrating that the new device has the same intended use and similar technological characteristics to legally marketed devices, and does not raise new questions of safety or effectiveness.
Therefore, many of the requested items related to performance studies and ground truth establishment are not typically found in these types of submissions, as the device is not undergoing a novel performance evaluation against predefined criteria.
Here's an explanation based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided in the document.
- The 510(k) submission for the Synthes Porous Polyethylene Implants focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing performance against specific acceptance criteria for a new clinical or diagnostic capability. The device is a physical implant made from UHMWPE, and its "performance" is implicitly tied to its material properties and intended anatomical reconstruction, which are compared to existing devices.
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 / Not provided in the document.
- There is no mention of a "test set" in the context of a performance study for this device. The submission relies on a comparison to predicate devices, implying that any data presented would relate to the characteristics of the materials or designs, rather than a clinical performance study with a specific sample size.
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 / Not provided in the document.
- Since no test set or performance study is detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided in the document.
- No details on a test set or adjudication are provided.
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 / Not provided in the document.
- This device is a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided in the document.
- This device is a physical implant. The concept of "standalone performance" for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided in the document.
- No ground truth in the context of a performance study is mentioned. The "ground truth" for this type of device is usually its material composition, biocompatibility, and mechanical properties, which are assessed through laboratory testing and comparison to predicate devices, not clinical outcomes data in a study context described here.
8. The sample size for the training set
- Not applicable / Not provided in the document.
- There is no mention of a "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 provided in the document.
- As there is no training set, this question is not applicable.
Summary of the Document's Content:
The K051879 submission for Synthes Porous Polyethylene Implants is a 510(k) premarket notification. It focuses on establishing "substantial equivalence" to already FDA-approved predicate devices (MedPor Craniofacial Implants with Embedded Titanium Mesh, MedPor Barrier Surgical Implant Biomaterials, Medpor Surgical Implants, Porous HDPE Surgical Implants).
This means the manufacturer provided documentation to the FDA demonstrating that their device has:
- Same intended use: non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
- Similar technological characteristics: made from UHMWPE or a combination of UHMWPE and titanium, with porous structures for tissue ingrowth, available in various shapes and dimensions.
The FDA reviewed this documentation and determined that the Synthes Porous Polyethylene Implants are substantially equivalent to the predicate devices, allowing them to be marketed. This regulatory pathway does not typically require the conduct or reporting of new clinical performance studies with acceptance criteria, test sets, or ground truth establishment in the way these questions imply for a novel device or diagnostic algorithm.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. There is a line underneath the word "SYNTHES". A registered trademark symbol is located to the right of the word.
OCT 5 - 2005
| 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 Porous Polyethylene Implants | |
| Classification: | Class II, § 882.5320 Preformed Alterable Cranioplasty Plate | |
| Predicate Device: | Porex Surgical, Inc.: MedPor Craniofacial Implants with EmbeddedTitanium MeshPorex Surgical, Inc.: MedPor Barrier Surgical Implant BiomaterialsPorex Medical: Medpor Surgical ImplantsePor Inc.: Porous HDPE Surgical Implants | |
| Device Description: | Synthes porous polyethylene implants are made from ultra-highmolecular weight polyethylene (UHMWPE) or a combination ofUHMWPE and titanium for use in anatomical reconstruction of thecraniofacial skeleton. These implants are available, with andwithout embedded titanium, in porous and porous/smooth sheets ofvarious shapes and dimensions. The interconnected, open porestructure of Synthes porous polyethylene implants allows for tissueingrowth. Synthes porous polyethylene implants are intended forsingle-patient use only.Synthes porous polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmeticsurgery, and repair of craniofacial trauma. | |
| SubstantialEquivalence: | Documentation was provided which demonstrated the SynthesPorous Polyethylene Implants are substantially equivalent to otherlegally 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 amended andas applied under 21CFR 807, Subpart E under which a device canbe 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 equivalence hereinshall be construed as an admission against interest under the USPatent Laws or their application by the courts. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
OCT 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380
Re: K051879
Trade/Device Name: Synthes Porous Polyethylene Implants Regulation Number: CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: II Product Code: GWO, FTM, FTL Dated: July 8, 2005 Received: July 11, 2005
Dear Ms. Anderson:
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 introtate 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, Dr to 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, RDArou 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 not 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 100-1000.
{2}------------------------------------------------
Page 2- Ms. Patricia Sandborn Beres
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 (240) 276-0210. 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 yours,
Signature
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 circular logo with a design inside. A horizontal line runs underneath the word and logo. There is a period after the word "SYNTHES".
:
:
| 2.0 | Indications for Use | Page | 1 | of | 1 | |
|---|---|---|---|---|---|---|
| 510(k) Number (if known): | K051879 | |||||
| Device Name: | Synthes (USA) Porous Polyethylene Implants | |||||
| Indications for Use: | Synthes Porous Polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma. | |||||
| Prescription Use | X | AND/OR | Over-The-Counter Use | |||
| (Per 21 CFR 801.109) | (21 CFR 807 Subpart C) | |||||
| (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 General, Restorative, | ||||||
| and Neurological Devices | ||||||
| 510(k) Number | K051879 |
.
·
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.