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The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form. Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing. The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.

The provided text is a 510(k) Summary for the MEDPOR® CONTAIN™ CAN Implant. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

This document describes a medical device clearance process based on substantial equivalence, not a study designed to prove the device meets specific acceptance criteria through measured performance.

Therefore, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text. The text focuses on comparing the new device's characteristics to a predicate device to establish substantial equivalence, rather than detailing performance studies with specific metrics.

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 does not describe specific acceptance criteria (e.g., a target accuracy or sensitivity) for the "MEDPOR® CONTAIN™ CAN Implant" nor does it report performance data against such criteria. The submission is for substantial equivalence to a predicate device. The "Safety & Effectiveness" row in the Substantial Equivalence Matrix states "No changes in function and intended use," implying that its safety and effectiveness are considered equivalent to the predicate without needing new performance metrics to be proven.

2. Sample sized 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. There is no mention of a "test set," "sample size," or data provenance, as a performance study of the device against specific metrics was not presented in this 510(k) summary.

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. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. There is no mention of adjudication or a test set.

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 an implantable medical device, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be answered from the provided text. This device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be answered from the provided text. There is no mention of a "ground truth" as it pertains to a performance study for this device. The "ground truth" in this context would likely refer to the established safety and efficacy of the predicate device.

8. The sample size for the training set

• Cannot be answered from the provided text. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such a device would refer to its manufacturing and design process.

9. How the ground truth for the training set was established

• Cannot be answered from the provided text. As above, there is no mention of a "training set" or "ground truth" in the context of typical AI/ML studies.

Summary of what can be extracted from the text, relevant to the inquiry's spirit of evaluating the device:

The "study" presented here is a substantial equivalence comparison to a predicate device, as required for a 510(k) submission.

Predicate Device: MEDPOR CONTAIN Implant (K091120)

Basis of Equivalence: The MEDPOR CONTAIN CAN Implant is deemed substantially equivalent based on:

• Intended Use: Identical - to stabilize, support, and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma.
• Material: Identical - Linear high-density polyethylene biomaterial.
• Function and Design Principles: Substantially equivalent. The new "CAN" configuration (cylinder) is designed to minimize the need for the surgeon to shape the implant, compared to the predicate's "Sheet" configuration.
• Manufacturing and Sterilization: Manufactured, packaged, labeled, and sterilized the same as other MEDPOR CONTAIN Implants.

Key Differences and Why They Don't Jeopardize Equivalence (as implied by clearance):

• Shape: New device is Cylinder (Can), predicate is Flat (Sheet).
• Diameter: New device has specified diameters (8, 9, 10 mm), predicate is not applicable for this dimension.
• Thickness: New device is 0.40 mm, predicate devices were 0.25, 0.35, 0.45 mm. The new thickness is within the range of the predicate, and the change is considered minor in this context.

Conclusion from the document: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the information provided regarding the device's characteristics and comparison to the predicate, not on new performance data demonstrating specific acceptance criteria.

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