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Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Specific indications (SynPOR HD Ocular Spheres):
• Ocular reconstruction
• Socket preservation
Specific indications (SynPOR HD Facial Shapes):
• Enhancement of the malar and chin
• Correction of deficiencies of the malar and chin

SynPOR HD Porous Polyethylene Three Dimensional Implants are devices intended for ocular reconstruction and socket preservation, enhancement of the midface and mandibular skeleton, and correction of deficiencies of the midface and mandible. The porous structure of the HDPE material allows for fibrovascular ingrowth.
The implants include facial shapes (chin and malar implants for aesthetic and reconstructive surgery to augment the contours of the craniofacial skeleton) and ocular spheres (for restoring the volume of an eviscerated or enucleated eye globe).
SynPOR HD Porous Polyethylene Implants are delivered sterile for single patient use and should not be resterilized.

The requested information about the acceptance criteria and the study proving the device meets them is not available in the provided text. The document is a 510(k) summary for a medical device (Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants), and it primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria or a study designed to meet them.

The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. The type of ground truth used or the sample size for a training set.

The document states that the new device is "substantially equivalent" to predicate devices based on "indications, materials, principles of operation, dimensions, and device design," and that "none of the modifications impact safety and effectiveness." This indicates a regulatory clearance pathway that relies on comparison to existing legally marketed devices, rather than a new study with explicit acceptance criteria for novel performance claims.

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