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AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC Porous Polyethylene Implants are provided sterile by irradiation and must not be resterilized.

The provided text describes a 510(k) submission for the Ceremed, Inc. AOC Porous Polyethylene surgical implants. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about a study to prove the device meets acceptance criteria (as this is not required for a 510(k) submission in the same way it would be for a PMA).
• Sample size used for a test set or its data provenance.
• Number and qualifications of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: AOC™ Porous Polyethylene Surgical Implants are made of porous high-density polyethylene (HDPE), used for craniofacial reconstruction. They can be coated with an alkylene oxide copolymer blend and/or have embedded titanium mesh. They are provided sterile by irradiation.
• Intended Use: Augmentation or reconstruction of the craniomaxillofacial skeleton.
• Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (Ceremed, Inc. AOC™ Porous Polyethylene Surgical Implants K043133 and Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364) based on:
  • Same intended use and indications for use.
  • Biocompatibility of the alkylene oxide copolymer blend in accordance with ISO-10993.
  • Mechanical properties being substantially equivalent to predicate devices, with minor differences raising no new issues of safety and efficacy.

Conclusion:

This document is a 510(k) summary, which inherently focuses on demonstrating "substantial equivalence" to existing predicate devices rather than establishing de novo performance against acceptance criteria in the manner of a clinical trial. As such, the information requested in your prompt (specific acceptance criteria, study details, expert involvement for ground truth, AI performance metrics, etc.) is not applicable to or present in this type of regulatory submission.

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AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. The implants are provided with a coating of a water-soluble alkylene oxide copolymer blend. AOC Porous Polyethylene Implants are provided sterile by irradiation and must not be resterilized.

The provided document is a 510(k) summary for the Ceremed, Inc. AOC Porous Polyethylene surgical implant. It focuses on establishing substantial equivalence to predicate devices and describes the device, its intended use, and regulatory classification.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory submission for premarket notification, not a detailed technical performance study report.

Ask a specific question about this device