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Found 3 results
510(k) Data Aggregation
(59 days)
Pre-Formed Penile Silicone Block
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 |
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(243 days)
Pre-Formed Penile Silicone Block
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.
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(134 days)
Pre-Formed Penile Silicone Block
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.
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