(134 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 text pertains to a 510(k) premarket notification for a medical device called the "Pre-Formed Penile Silicone Block." The document describes the device, its intended use, and its equivalence to predicate devices, including summaries of non-clinical and clinical testing. However, it does not explicitly list acceptance criteria in a formal table or report specific performance metrics against such criteria in the way typically expected for an AI/ML device.
Here's an analysis based on the information provided, framed as closely as possible to your request, but with the understanding that this is a medical device submission, not an AI/ML algorithm submission. Therefore, many of your requested points, particularly those related to AI/ML specific studies (MRMC, standalone algorithm performance, training set details), are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as pass/fail thresholds against specific performance metrics in a numbered or tabular format. Instead, it discusses the outcomes of a clinical study demonstrating the risks of the device and comparing them to existing similar devices.
| Performance Metric | Reported Device Performance (N=100 patients) |
|---|---|
| Pain Assessment | Weighted average pain rating: 3.2 (on a 0-10 Comparative Pain Scale). Pain relief experienced on average in 7.2 days. |
| Erosion | 3 cases observed (3% incidence). Occurred on average 8 months post-procedure (min 6 months, max 10 months). 3/3 cases linked to patient non-compliance. |
| Migration | 4 cases observed (4% incidence). Occurred on average 1.5 months post-procedure (min 1 month, max 2 months). 3/4 cases linked to patient non-compliance. |
| Infection | 3 cases observed (3% incidence). Occurred on average 3.5 months post-procedure (min 2.5 months, max 4.5 months). |
| Overall Risk | "Rates of pain, erosion, migration, and infection are low compared to reports of other silicone implants on the market." (Comparative statement, no specific threshold) |
2. Sample size used for the test set and the data provenance
- Sample Size: 100 patients
- Data Provenance: Clinical evidence on 100 patients, without explicit mention of country of origin. The study is prospective, as follow-up data was collected after the surgical procedure at specified time points.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth in this context refers to the clinical outcomes and adverse events observed in patients. It's not explicitly stated how many "experts" established the ground truth in terms of retrospective review or consensus. The data appears to be collected clinically by the "clinic" observation and patient self-reporting (for pain). The "surgeon's discretion" is mentioned for contouring the device, implying a medical professional involved in the procedure itself.
4. Adjudication method for the test set
Not explicitly stated. Clinical observations and patient self-assessment (for pain) are the methods of data collection. It's not specified if multiple independent reviewers or an adjudication committee validated each reported adverse event. The document notes that a clinic observed the adverse events.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, no MRMC study, human reader improvement with/without AI, or effect size related to AI assistance would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The ground truth is based on clinical outcomes and adverse events observed in patients following the surgical implantation of the device. This includes:
- Patient-reported pain levels.
- Clinically observed events such as erosion, migration, and infection.
8. The sample size for the training set
Not applicable. This not an AI/ML algorithm requiring a training set. The clinical study of 100 patients serves as the primary evidence for the device's safety and performance in humans.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm mentioned in this document.
§ 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.