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510(k) Data Aggregation
(59 days)
The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.
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 visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
The device in question is the Pre-Formed Penile Silicone Block.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative format for the clinical study. Instead, it describes observed outcomes and improvements. Based on the "Clinical effectiveness" section, we can infer the measures of performance.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (Achieved) |
|---|---|
| Penile Circumference Increase | Increased from 8.5 ± 1.2 cm to 13.4 ± 1.9 cm (56.7% increase, P<.001) |
| Self-confidence and Self-esteem Improvement | 83% of patients noted a 2-category improvement 6-8 weeks postoperatively |
| APPSSI Score Improvement (Long-term) | 72% patients maintained a 2-category improvement upon long-term follow-up (2-6 years, mean 4 years) |
| Patient Satisfaction | 81% of subjects reported "high" or "very high" levels of satisfaction |
| Adverse Events requiring device removal | 3% of patients |
| Impact on Sexual Function | No reports of any changes to sexual function, erections, or ejaculations |
| Most Frequent Postoperative Complications | Seroma (4.8%), Scar formation (4.5%), Infection (3.3%) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Test Set):
- Initial retrospective study included 526 patients.
- 400 patients responded to the request for consent and were included in the analysis.
- Data Provenance: Retrospective study. The country of origin is not explicitly stated, but the submission is from "International Medical Devices, Inc." in Beverly Hills, CA, USA, suggesting the study likely took place in the USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the clinical outcomes. The clinical effectiveness was evaluated via patient-reported outcomes (APPSSI, self-confidence/self-esteem, satisfaction) and objective measurements (penile circumference) taken by clinical staff, and complication rates observed by the surgeons.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the study relies on patient-reported outcomes, objective measurements, and observed complications rather than expert consensus on interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical effectiveness study of the device itself, not an evaluation of an AI system with or without human assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) study was not done. The device is a physical implant, and the study evaluates its clinical performance in human patients. This document does not describe an AI medical device.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's clinical effectiveness was a combination of:
- Objective Measurements: Penile circumference measurements taken before, immediately after, and 30-90 days after surgery.
- Patient-Reported Outcomes: Changes in the Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in patient self-confidence and self-esteem, and patient-reported satisfaction levels.
- Clinical Observations: Incidence of adverse events (seroma, scar formation, infection) and events necessitating device removal, as well as absence of changes to sexual function.
8. Sample Size for the Training Set
The document describes a clinical study evaluating the performance of the device; it does not mention a training set in the context of machine learning or AI. This is a study of a physical medical device.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set or an AI algorithm, this question is not applicable to the provided document.
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