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This device may be used for the management of Keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures. This device is not intended to be used on open wounds. This device is intended for over-the-counter use.

Kelocote Silicone Sheeting

This document is a 510(k) clearance letter from the FDA for the "Kelocote Silicone Sheeting" device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The letter primarily addresses the regulatory approval of the device based on substantial equivalence, but it does not detail performance metrics or studies specific to meeting acceptance criteria.

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The DuralaBtic Anatomical Chin Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery .

Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been biocompatibility, mutagenicity, thoroughly tested -for carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.

The provided text is a 510(k) premarket notification document for Duralastic Malar Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and results.

Therefore, the document does not contain the information required to answer the prompt.

Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
4. The type of ground truth used, or details about training sets.

The document primarily describes the product, its intended use, physical properties, sterilization process, and concludes that it is substantially equivalent to a previously approved device (K952707) based on using the same molds and materials.

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The Daralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for cosmetic or reconstructive surgery.

Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.

The provided text describes a 510(k) premarket notification for Duralastic Nasal Implants, focusing on their substantial equivalence to previously cleared devices. It does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, test methodologies, or statistical analyses. The document is primarily concerned with regulatory approval based on material equivalence and intended use.

Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.

Based on the available information, here's what can be extracted:

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

The document does not explicitly state acceptance criteria in the form of performance metrics for the device’s clinical efficacy or safety, nor does it report specific device performance results from a study designed to meet such criteria.

The "physical properties" listed can be considered inherent characteristics of the material used, not performance criteria from a clinical study.

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

Not applicable. The document describes a regulatory submission based on substantial equivalence, not a clinical performance study with a test set of patient data. The biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity are mentioned as "thoroughly tested" material characterizations referenced in a Master File (MAF-562), but no sample sizes or data provenance for these tests are provided in this K971481 submission.

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

Not applicable. This information pertains to studies establishing clinical performance, which is not detailed in this regulatory submission.

4. Adjudication method for the test set

Not applicable. There is no described test set requiring adjudication in this document.

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 silicone implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a silicone implant, not an algorithm.

7. The type of ground truth used

For the material properties (biocompatibility, etc.), the "ground truth" would be established through specific laboratory tests and assays designed to evaluate these characteristics, as per the standards referenced (e.g., those implicitly followed for MAF-562). For sterility, the ground truth is established through validation of the sterilization cycle according to ANSI/AAMI/ISO 1137-1994.

8. The sample size for the training set

Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.

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

Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.

Summary of what the document focuses on:

The document primarily focuses on establishing Substantial Equivalence (SE) to a predicate device (Applied Biomedical nasal implants, previously cleared under K952705). This means that instead of conducting new clinical trials to prove safety and effectiveness, the manufacturer argues that their device is as safe and effective as a legally marketed device due to similar technology, materials, and intended use.

Key arguments for SE:

• Same molds and materials: The Duralastic nasal implants use the "very same molds and materials" as the Applied Biomedical nasal implants.
• Material Characterization: The silicone elastomer (LSR 30 Implant Grade) and pigments are supported by a Master File (MAF-562) which details their biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity tests.
• Intended Use: The intended use for augmentation and reconstruction of the nasal contour is consistent.
• Sterilization: The sterilization process (gamma radiation) is validated according to recognized standards (ANSI/AAMI/ISO 1137-1994).

In essence, the "proof" the device meets acceptance criteria is primarily through its similarity to a previously approved device and the established safety of its constituent materials and sterilization process, rather than a standalone clinical study detailed within this summary.

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The Duralastic Anatomical Chin Implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.

Duralastic Chin implants are crescent shaped concave convex Bilicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Chin Implants will be provided sterile and nonsterile.

The provided text describes Duralastic Chin implants and their substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt. The document is a 510(k) summary for a medical device (chin implants), focusing on material properties, sterilization, and intended use as part of a regulatory submission.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving device performance.

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Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination.

Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.

Duralastic I and II Silicone Elastomer Sheeting is made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 704. Duralastic Sheeting is a peroxide cured rubber of a 45 - 55 Durometer hardness (Shore A). It has an elasticity of 700 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Duralastic I and II are made from HCRA-50, an Applied Silicone dimethylpolysiloxane.

The provided text is a 510(k) summary for the Duralastic I and Duralastic II Silicone Sheeting. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, study details, expert qualifications, sample sizes for test/training sets, MRMC study, standalone performance, ground truth) is not applicable to this document.

The document focuses on:

• Product Description: Material composition, available forms.
• Substantial Equivalence: Comparing Duralastic I and II to predicate devices (Applied Biomaterial Technologies Duralastic Sheeting and Dow Corning's Silastic Sheeting) based on material, size, thickness, and intended use. The core argument for SE is that it's made from Dow Corning analogs.
• Intended Uses: Extensive list of short-term and long-term medical applications.
• Physical and Chemical Properties: Durometer hardness, elasticity, tensile strength, tear strength, specific gravity, chemical composition. These are material specifications, not performance criteria in the sense of a clinical outcome study.
• Sterilization Cycle: Details on gamma radiation sterilization and its validation according to ANSI/AAMI/ISO 11137-1994.

There is no mention of an acceptance criteria table, a clinical study design, expert panel adjudication, or any data related to diagnostic performance as typically requested for AI/diagnostic devices. The approval is based on a determination of substantial equivalence, which primarily relies on comparison to existing legally marketed devices, material characterization (biocompatibility, physical properties), and manufacturing processes rather than clinical performance data from a specific study.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device