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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.

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