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Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, 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 joint spacers, and other short term uses according to the surgeon's determination.

Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.

Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are 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 607.

The provided text describes a 510(k) submission for Durasil Sheeting, which is a silicone elastomer product. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting evidence in the way a contemporary AI/Software as a Medical Device submission would.

Therefore, for aspects like "reported device performance," "sample size," "experts used," "adjudication method," "MRMC study," "standalone study," or "training set details," the information is not applicable in this context, as these are typically part of a clinical performance study for a new device's efficacy, not a substantial equivalence submission for a material.

Here's how to break down the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

• Materials meet or exceed Class VI USP Standards for biocompatibility (including Teratogenicity, Mutagenicity, Carcinogenicity, Toxicity Testing).
• Consistent with materials used in predicate device (Duralastic I and II). | - Made from HCRP-50 (Applied Silicone) and MED 4750 (Nusil Technologies), both biocompatible silicone high consistency rubbers.
• Materials meet FDA Biocompatibility Guidelines and exceed/meet Class VI USP Standards (Teratogenicity, Mutagenicity, Carcinogenicity, and Toxicity Testing). Referenced in Applied Master File - MAF 607 and Nusil Master File MAF 500.
• Chemically, Durasil II is dimethylpolysiloxane. |
  | Manufacturing Process | - Same manufacturing processes as predicate device. | - "Made from the same materials using the same processes" as predicate device. It is a "vulcanized calendared cured rubber." |
  | Physical Properties | - Consistent physical properties (hardness, elongation, tensile strength, tear strength, specific gravity) with predicate device. | - Hardness: 45-55 Durometer (Shore A).
• Elongation: 800 percent.
• Tensile Strength: 1600 psi.
• Tear Strength: 190 psi (Tear Die C).
• Elasticity: Greatly reduced in polyester reinforced sheets.
• Specific Gravity: 1.16.
• Details referenced in Masterfile MAF 607 (Applied Silicone) and MAF 500 (Nusil Technologies). |
  | Device Size and Thickness | - Same sizes and thicknesses as predicate device. | - "Made in the same sizes and thicknesses" as predicate device. Mentioned specific thicknesses in "Intended Uses" for Durasil II (e.g., .005 inch, .007 inch, .010 inch, .020 inch, .040 inch, .060 inch). |
  | Intended Use | - Same intended uses (short-term and long-term applications) as predicate device. | - Durasil I (Short Term): Nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, guided tissue regeneration between teeth and gingival margin, external ear canal, temporary joint spacers, and other short-term uses.
• Durasil II (Long Term):
  • Nonreinforced: Tympanic membrane repair, dural covering, nasal septal repair, tendon anastomosis, neural repair, correction of strabismus, orbital floor repair, galea hemodialysis shunt anchors.
  • Reinforced: Facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel, repair of orbital floor fractures. |
    | Sterilization | - Validated sterilization cycle. | - Sterilized via gamma radiation 2.5 - 4.2 Megarads.
• Validation by STI Corporation (Brea, CA) using Method 1 Testing as defined in ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization." |

Study Proving Device Meets Acceptance Criteria:

The primary "study" in a 510(k) submission for substantial equivalence is a comparison to a legally marketed predicate device.

• Substantial Equivalence Statement: The claim is that "These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses for the same intended use, it is SE to the predicate devices."

This is not a traditional scientific study with experimental results in the sense of a clinical trial. Instead, it's a demonstration that the new device (Durasil Sheeting) is as safe and effective as a device already on the market (Duralastic I and II) through direct comparison of materials, manufacturing, physical properties, dimensions, and intended uses.

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

• Not Applicable. This is a substantial equivalence submission based on material and design comparison, not a clinical performance test set. The "data" used is a direct comparison of specifications and intended use to the predicate device.

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. Ground truth, in the context of device performance studies, is not established for this type of submission. The "truth" is established by the accepted specifications and performance of the predicate device.

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

• Not Applicable. No test set or adjudication method 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

• Not Applicable. This is a physical medical device (silicone sheeting), not an AI or imaging device that would involve human readers or AI assistance.

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 an algorithm.

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

• Comparative Basis / Predicate Device Specifications: The "ground truth" for this submission is the established safety and efficacy, and the detailed specifications (material, physical properties, manufacturing process, intended use, sterilization validation) of the legally marketed predicate device (Duralastic I and II, K971480).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not Applicable. See point 8.

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