(243 days)
The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
The provided document is a 510(k) summary for the Pre-Formed Penile Silicone Block. It details the device, its intended use, and its substantial equivalence to a predicate device. However, this document describes a medical device (an implantable silicone block), not a software or AI/ML-based device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device performance validation (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.
The document focuses on demonstrating the safety and effectiveness of the physical implant through non-clinical testing, primarily biocompatibility testing and chemical analysis, to show substantial equivalence to a previously cleared predicate device.
Here's how the provided information relates to the typical regulatory submission for this type of device:
- Acceptance Criteria and Device Performance: For a physical implant like this, acceptance criteria would typically involve meeting specific material properties, biocompatibility standards, and demonstrating no new safety or effectiveness concerns compared to a predicate device.
- Reported Device Performance: The document states that testing (Biocompatibility Risk Assessment per ISO 10993-1, Cytotoxicity testing per ISO 10993-5, Extractable/Leachable Chemical Analysis, Toxicological Risk Assessment per ISO 10993-17) was performed and the results "indicate that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate device." This is the essential "performance" claim for this type of device in a 510(k). The detailed numerical results of these tests and their specific acceptance criteria are not provided in this public 510(k) summary but would have been part of the full submission.
In summary, none of the requested points related to AI/ML device validation (points 2-9) can be answered from this document because it pertains to a physical medical implant, not an AI/ML algorithm.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.