Search Results

The Pre-Formed 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 to aid in the reconstruction process.

The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.

The provided text is a 510(k) Summary for a medical device (Pre-Formed Silicone Block). This document describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria through performance evaluation.

Therefore, the information required to answer the prompt (acceptance criteria, device performance results, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided text. The document states:

• "No additional testing was provided in this submission in order to demonstrate substantial equivalence."
• "Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence." (This implies that this specific submission did not include new performance studies comparing the device to acceptance criteria, but rather relied on comparisons to previously cleared devices and existing safety/biocompatibility data.)

In summary, the provided FDA 510(k) summary does not contain the information requested about performance studies, acceptance criteria, or their results. It primarily focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

The 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 to aid in the reconstruction process.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for a "Silicone Block" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The clearance letter primarily discusses:

• The FDA's decision regarding the premarket notification.
• The regulatory classification of the device.
• General controls and existing regulations applicable to the device.
• Contact information for further regulatory guidance.
• The intended use of the device, which is "in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process."

It does not include any performance data, clinical study details, acceptance criteria, or ground truth establishment methods typical for AI/ML device submissions. This is an older 510(k) from 2004 for a physical medical device (silicone block), not a software or AI medical device, which is why the requested information is absent.

Ask a specific question about this device

Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.

Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.

The provided text is a 510(k) premarket notification for a medical device called "Seare Biomedical Silicone Blocks." This document primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or AI-assisted improvements.

Therefore, many of the requested details about acceptance criteria, study methodology, and AI integration cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The primary criterion is "substantial equivalence in material, function, performance, and design" to predicate devices.
• Reported Device Performance:
  • Material: Made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer.
  • Function: For carving a finished device by the surgeon for custom use. Designed for carving flatter devices for bone onlay or curved blocks for malar and chin implants.
  • Appearance: Clear to slightly opaque. Optionally, pigments (e.g., Iron Oxide) can be added for opacity to light and radiographic exam.
  • Sterility: Will be provided sterile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• None. The document explicitly states "Clinical Tests: None." This suggests no formal test set or clinical study was conducted for this premarket notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical tests or ground truth establishment based on expert review were conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication process was described.

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

• None. There is no mention of AI assistance or MRMC studies in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a silicone block for implantation, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No ground truth was established as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices, not clinical performance data from the device itself.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

Ask a specific question about this device

The 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 to aid in the reconstruction process.

Silicone Blocks

The provided document is an FDA 510(k) clearance letter for "Silicone Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details typically found in a clinical study report.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. This document is a regulatory communication, not a performance study report.

Ask a specific question about this device

The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.

Xomed Silicone Block/Strip are sterile, implants produced from silicone elastomer molded into a squares and/or rectangular shapes of various sizes and thicknesses and durometer as specified on each product label.

This document is a 510(k) summary for a medical device (Xomed Silicone Block/Strip), not a study report on a new AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as typically found in studies for AI/ML devices.

The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and argues for its similarity to existing products.

Therefore, it is impossible to provide the requested information based on the given input.

The input only contains:

• Device Name: Xomed Silicone Block/Strip
• Intended Use: For use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.
• Device Description: Sterile implants produced from silicone elastomer molded into squares and/or rectangular shapes of various sizes, thicknesses, and durometer.
• Substantial Equivalence: Argument based on similar intended use and base material to previously marketed Xomed products and other manufacturers' silicone blocks.

Ask a specific question about this device

Ask a specific question about this device