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The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools. Instead, it is an FDA 510(k) clearance letter for a physical medical device, the "Augmenta Penile Implant," which is a silicone implant for cosmetic correction of soft tissue deformities.

The document focuses on demonstrating substantial equivalence to a predicate device (Pre-Formed Penile Silicone Block, K181387) rather than proving performance against specific acceptance criteria for an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device and clearance described in the provided text.

The closest analogue to "acceptance criteria" in this document are the non-clinical performance data listed on page 5, which are primarily related to biocompatibility, material integrity, and sterilization for an implantable device, usually demonstrated through adherence to recognized standards like ISO 10993 and ASTM standards.

Non-Clinical Performance Data (related to material and sterilization safety, not algorithmic performance):

• Biocompatibility Assessments (in accordance with ISO 10993-1):
  • Cytotoxicity
  • Sensitization
  • Irritation/intracutaneous reactivity
  • Acute Systemic Toxicity
  • Material-Mediated Pyrogenicity
  • Implantation
  • Genotoxicity
  • Extractables and Leachables
  • Toxicology Risk Assessment
• Product and Packaging Integrity Assessments (in accordance with recognized standards):
  • Visual integrity
  • Seal strength
  • Shipping
  • Burst test
  • Sterilization validation (ISO 111135: 2014)
  • EO residual (ISO 10993-7: 2008)
  • Image artifact evaluations (F2119-07 (2013))
  • ASTM D4169-16
  • ASTM F88/F88M-15
  • ASTM F1140/F1140M-13
• Conclusion: The claim is that these assessments provide evidence that the Augmenta Penile Implant "performs comparable to the legally marketed predicate device."

In summary, none of the requested information regarding AI/ML device performance and validation can be provided from this document.

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