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The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.

The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.

The provided text is a 510(k) Premarket Notification from the FDA regarding an ePTFE-Coated Auricular Implant. This document is a regulatory approval for a physical medical device (an implant for ear reconstruction), not a software or AI-based medical device.

Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, AUC) are not applicable to this document. The document describes:

1. Device Description: A silicone elastomer core with an ePTFE outer layer, shaped for external ear reconstruction.
2. Intended Use: Reconstruction of the external ear.
3. Predicate Devices: Other ear prostheses and facial implants, primarily based on material and design similarities, and identical indications for use.
4. Non-Clinical Testing:
   • Biocompatibility testing: In compliance with ISO 10993-1, covering cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, implantation, and chemical characterization.
   • Bond strength testing: To confirm the integrity of the silicone/ePTFE bond despite aging, repetitive sterilization, and pigment.
5. Conclusion: The device is substantially equivalent to predicate devices based on identical indications for use and similar technological characteristics, and material testing indicates it does not raise new issues of safety or efficacy.

There is no mention of a "study that proves the device meets the acceptance criteria" in terms of an AI/ML algorithm's performance on a test set, nor are there any acceptance criteria related to diagnostic accuracy, statistical metrics, or human reader performance. The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices through material testing and design comparison to ensure safety and effectiveness.

In summary, none of the requested information regarding AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies can be extracted from this document, as it pertains to a traditional physical medical implant, not an AI/ML diagnostic or assistive device.

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Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.

This document is a 510(k) submission for Porous HDPE Surgical Implants (K022665). It establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this document describes a traditional medical device (surgical implants) and not an AI/ML powered device.

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