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

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The provided text is a 510(k) clearance letter from the FDA for "Silicone Tissue Expanders" (K070303). This document confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective as a legally marketed device. It does not typically require the submission of detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) application would.

Therefore, I cannot populate the requested table or provide information on the study design, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided text.

To address your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a comprehensive premarket submission that includes performance testing and clinical data.

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The HUTCHISON Inflatable Silicone Tissue Expanders are designed for use in:

• . Scar/defect revision
• Reconstruction of the breast following subcutaneous mastectomy and other suitable . procedures or trauma
• Breast underdevelopment and combined breast and chest wall abnormalities .

The HUTCHISON Inflatable Silicone Tissue Expander is currently manufactured and marketed in Europe. The HUTCHISON Inflatable Silicone Tissue Expanders will be sold in the US, sterile for single use only and in double-peel pouches to facilitate aseptic handling during implantation in the patient. Product packaging is designed to allow sterilization gases onto the product and permit proper degassing.

The Silicone Tissue Expanders are constructed from silicone elastomer and consist of a silicone connection tube and an injection site. The injection site is a self-sealing dome valve to allow for sterile saline injections for expanding the implant. The HUTCHISON Inflatable Silicone Tissue Expanders will be manufactured and available to physicians with two surface finishes, smooth or textured.

Hutchison Silicone Tissue Expanders are available in various designs and sizes to meet the patient and surgeon's needs. A more detailed description of size and volume is provided in Section 3. The available styles are:

• . Round
• Rectangle .
• . Crescent
• Cylindrical .
• Croissant .
• U design .

The manufacturer, Biosil Ltd., uses a high-strength silicone dispersion to produce the shell. The silicone materials used in producing the shell and the valve assembly have all received full biocompatibility assessment by the raw materials supplier.

Biosil has conducted extensive tests of the mechanical properties of the silicone shell and the fused joints, including the results from pre and post sterilization studies of elongation, tensile strength, tear resistance, and valve competence.

The provided text is a 510(k) summary for the HUTCHISON Inflatable Silicone Tissue Expanders, submitted in 1998. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial acceptance criteria and performance data for a new device's accuracy or efficacy as one might find for, say, an AI diagnostic tool.

Therefore, many of the requested points regarding acceptance criteria, study design, statistical details, ground truth establishment, and expert involvement are not applicable to this type of regulatory submission concerning a physical medical device like a tissue expander.

However, I can extract information related to the device's characteristics and the validation activities that were performed to support its safety and performance.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist due to the nature of the document:

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

The document does not explicitly present a table of acceptance criteria in the way a diagnostic device would (e.g., sensitivity, specificity thresholds). Instead, for a physical implantable device like a tissue expander, "acceptance criteria" are implied by compliance with recognized standards regarding material properties, manufacturing processes, and sterilization.

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

• Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical performance data. The tests mentioned (mechanical properties, valve competence, biocompatibility) are typically performed on a representative sample of manufactured devices (e.g., batches of materials, finished products) as part of design validation and quality control, rather than on a "test set" of patients or a dataset of medical images.
• Data Provenance: The manufacturing and testing are attributed to Biosil Ltd., the manufacturer, which suggests the data originates from their internal testing processes. The device is "currently manufactured and marketed in Europe," implying European regulatory compliance and data might originate there. The 510(k) is for marketing in the US, but the data is from the European manufacturer's validation efforts. The data described is in vitro or in-process testing, not clinical "patient" data.

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)

This is not applicable to this 510(k) submission. The "ground truth" concept, in terms of expert consensus on diagnostic outcomes, is not relevant for a physical device like a tissue expander. The "truth" for this device lies in its material properties, mechanical performance, sterility, and biocompatibility, which are assessed by scientific and engineering tests, not clinical expert consensus on diagnostic findings.

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

This is not applicable. Adjudication methods are used in clinical studies with human readers / interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are laboratory/engineering tests (e.g., tensile strength, tear resistance, valve competence, biocompatibility), which would involve laboratory personnel following standardized protocols rather than a clinical adjudication process.

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 is not applicable as this is a physical medical device (tissue expander), not an AI-powered diagnostic or assistive tool.

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

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

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

As described in point 3, the concept of "ground truth" in the clinical diagnostic sense is not applicable. The "ground truth" for this device's performance is established by:

• Adherence to Material Specifications: Silicone materials meeting supplier's biocompatibility and property claims.
• Validated Mechanical Properties: Achieving specific physical properties (e.g., tensile strength, elongation, tear resistance) as measured by standardized engineering tests.
• Sterility Confirmation: Achieving a specified Sterility Assurance Level (SAL) through validated sterilization processes.
• Functional Performance: Valve competence as demonstrated by testing.

8. The sample size for the training set

This is not applicable. Since this is a physical medical device and not an AI or diagnostic algorithm, there is no "training set" in this context.

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

This is not applicable for the same reasons as point 8.

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Seare Biomedical Silicone 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.

Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.

The provided text is a 510(k) summary for a medical device called "Seare Biomedical Silicone Tissue Expanders." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary like this one generally does not include information about acceptance criteria or specific studies proving device performance beyond demonstrating substantial equivalence.

The document explicitly states:

• "Clinical Tests: None"
• "Adverse S&E Information: None" (referring to safety and effectiveness, implying no specific studies were conducted for this submission regarding these aspects for the new device as separate from its predicate.)

Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating similarity to existing devices already on the market, rather than new performance studies with acceptance criteria.

Ask a specific question about this device

Silicone 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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The provided text is a U.S. FDA 510(k) clearance letter for a "Magnetic Port Silicone Tissue Expander." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document is about regulatory approval, not a performance study report.

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