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The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.

Silimed Vaginal Stent

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Silimed Vaginal Stent) and its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot fulfill your request based on the given input.

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Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, specifics of a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is a 510(k) clearance letter from the FDA for a device called "Silimed Tissue Expander," outlining its regulatory status and intended use. It does not contain the detailed study information required to answer your request.

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The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.

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I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The text is a 510(k) clearance letter from the FDA for a Malar Implant, primarily discussing the regulatory approval process and general regulations. It does not include specific performance metrics, clinical study designs, or expert review details.

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The Silimed Chin Implants are intended for use in aesthetic, corrective or reconstructive surgery of the chin.

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This document is a 510(k) clearance letter from the FDA for Silimed Chin Implants, dated July 9, 1998. It primarily addresses the regulatory approval process and doesn't contain information about acceptance criteria or performance studies for the device. Therefore, I cannot provide the requested information.

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The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.

Silimed Silicone Carving Blocks

I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the detailed study parameters you've requested.

The document is an FDA 510(k) clearance letter for a device called "Silimed Silicone Carving Block." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

It contains:

• The FDA's decision regarding substantial equivalence.
• Regulatory information and responsibilities for the manufacturer.
• The indications for use for the "Silimed Silicone Carving Block."

It does not include:

• A table of acceptance criteria or performance data.
• Details about a study (sample sizes, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, or training set info).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

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The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.

Silimed Nasal "L" Shaped Implant

The provided text is a 510(k) premarket notification letter from the FDA to SILIMED, LLC regarding a Nasal "L" Shaped Implant. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is primarily focused on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Informing SILIMED, LLC of their ability to market the device.
• Outlining the general controls and regulations they must adhere to.
• Stating the intended use of the device: "augmentation and reconstruction of the nasal contour."

Therefore, I cannot provide the requested information based on the input text.

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The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).

The Silimed Nasal Retainer was designed for prophylaxis of stenosis and cicatricial structures. It is recommended for all age groups, and for any type of nose. It has a functional format and can be sectioned by adjusting the length according to the requirement. The Silimed Nasal Retainer is composed of chemically and mechanically resistance silicone elastomer (HCRA 35M). The elastomer is soft, smooth of surface and contains a defined volume of elastomer whose shape, density and overall consistency have been chosen to replace human tissue. It has a defined length, width and circumference for the two channels that form the opening for the right and left nostril. The advantages of the Silimed Nasal Retainer are: 1) maintains the septum in a vertical position, 2) allows for nasal breathing immediately after the operation, without blocking air flow, 3) painless and non-traumatic, 4) easy to keep clean and 5) single patient use. The Silimed Nasal Retainer is available in 13 sizes. Silimed's Nasal Retainer is sterilized by ethylene oxide. The method of sterilization is shown on the package, which is a double peel pouch. An individual confirmation of each batch is carried out, as well as a quarterly confirmation by an independent laboratory.

The provided text is a 510(k) summary for the Silimed Nasal Retainer, which is a regulatory submission to the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI or medical device might.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted or is not applicable to this document. The 510(k) process focuses on comparing a new device to an existing one, not on proving new clinical performance criteria in a traditional study.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable/Not Provided: The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance metrics from a formal study. It focuses on describing the device, its indications for use, and asserting substantial equivalence to predicate devices based on design and intended use.

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

• Not Applicable/Not Provided: There is no "test set" and no sample size mentioned because this is not a performance study that tested a device against a dataset. The 510(k) submission is a regulatory declaration, not a clinical trial report of performance metrics.

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/Not Provided: No experts were used in this context to establish ground truth for a test set, as no performance study with a test set is described.

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

• Not Applicable/Not Provided: No adjudication method is mentioned as there is no performance study or test set.

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/Not Provided: No MRMC study was done, as this device is a physical nasal retainer, not an AI-assisted diagnostic tool.

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

• Not Applicable/Not Provided: This is not an algorithm or AI device, so no standalone performance study in that context would be conducted.

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

• Not Applicable/Not Provided: The concept of "ground truth" as it pertains to performance studies is not relevant to this 510(k) submission.

8. The sample size for the training set

• Not Applicable/Not Provided: No training set is mentioned as this is not a machine learning/AI device.

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

• Not Applicable/Not Provided: No training set is mentioned, so no ground truth establishment is discussed.

Summary of Relevant Information from the K980221 Submission:

• Device Name: Silimed Nasal Retainer
• Purpose of Submission: To demonstrate substantial equivalence to predicate devices for regulatory clearance (510(k)).
• Device Description: Made of chemically and mechanically resistant silicone elastomer (HCRA 35M), designed to be soft, smooth, and to maintain the septum in a vertical position after nasal surgery. Available in 13 sizes.
• Indications for Use: After aesthetic and reconstructive rhinoplasty, rhinoseptoplasty, rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).
• Predicate Devices:
  • Boston Medical Products, Doyle Combo Nasal Airway Splint (K972151)
  • Boston Medical Products, Bivalve Nasal Splint (K972096)
• Sterilization: Ethylene oxide, confirmed for each batch and quarterly by an independent laboratory.
• Regulatory Decision: Determined substantially equivalent to legally marketed predicate devices.

This document describes a medical device and its regulatory clearance process based on its similarity to existing devices, not on specific performance metrics derived from a clinical study with acceptance criteria.

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The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.

Silicone Carving Blocks

Here's an analysis of the provided text regarding the acceptance criteria and study, focusing on the absence of such information:

The provided document is an FDA 510(k) clearance letter for a "Silicone Carving Block." This letter is an acknowledgment of substantial equivalence to a predicate device, which allows the product to be marketed. It is not a document that details acceptance criteria for performance or a study demonstrating device performance against such criteria.

Therefore, the requested information elements cannot be extracted from this specific document.

To directly answer your request based on the provided text:

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

• Acceptance Criteria: Not present in the document.
• Reported Device Performance: Not present in the document.

2. Sample size used for the test set and the data provenance:

• This information is not provided because no performance study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided because no ground truth establishment for a performance study is described.

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

• This information is not provided because no performance study is 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:

• This device is a "Silicone Carving Block," which is a physical material used in surgery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with AI assistance is not applicable, and no such study is mentioned.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable, as no performance study requiring ground truth is described.

8. The sample size for the training set:

• Not applicable, as no training set for an algorithm is relevant to this device.

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

• Not applicable, as no training set for an algorithm is relevant to this device.

Explanation:

A 510(k) clearance letter typically confirms that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness. This process usually involves comparing the new device's specifications, materials, and (if applicable) basic performance characteristics to a predicate, but does not necessarily require de novo clinical studies with acceptance criteria for device performance as would be detailed in a separate clinical study report. The intent of this letter is to permit marketing based on equivalence, not to publish an detailed performance study report.

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The Silicone Carving Block is designed to be used in acsthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.

Silicone Carving Blocks

This is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily grants market clearance and does not contain the detailed study information you're asking for regarding acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information because the provided document (K974482) is a regulatory approval letter and not a study report. It does not contain the specifics about acceptance criteria and the study that proves the device meets those criteria.

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