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SILGEL™ STC-S is intended for use in the management of Keloid and Hypertrophic scars and associated erythema.

Silgel™ STC-S consists of a high purity, medical grade silicone gel. The device will be sold non-sterile and supplied in aluminum tubes packaged into single unit cartons. Once applied to the skin according to the Instruction for Use the device does not need to be covered or held in place. Please note that the product is a device and not a pharmaceutical cream. It is not absorbed by the skin and functions as a membrane which retains moisture whilst permitting air to penetrate to the affected area.

Here's an analysis of the provided text regarding the acceptance criteria and study for Silgel™ STC-S:

This 510(k) premarket notification describes a device called Silgel™ STC-S, a silicone gel. The core of this submission is to demonstrate substantial equivalence to already legally marketed predicate devices. This means the manufacturer is not trying to prove the device is effective from scratch through new clinical trials, but rather that it is as safe and effective as existing, similar products.

Therefore, the type of "acceptance criteria" and "study" are interpreted in the context of a 510(k) submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set: No specific "test set" in the traditional sense of a clinical trial with patient data is mentioned for Silgel™ STC-S itself. The submission relies on establishing equivalence rather than new clinical data.
• Data Provenance: The biocompatibility testing likely involved laboratory samples of the Silgel™ STC-S material. The "numerous clinical studies" referenced are general literature on silicone gels, not specific to this device. Therefore, no specific country of origin or retrospective/prospective status for a dedicated test set for Silgel™ STC-S is applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This submission does not involve external experts establishing ground truth for a clinical test set specific to Silgel™ STC-S. The "ground truth" for the effectiveness of silicone gels in general is established through the existing scientific literature and clinical experience, which is then referenced to support substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not conducted. This type of study is typically used for diagnostic devices (e.g., imaging AI) to compare reader performance with and without AI assistance. This device is a topical silicone gel, not a diagnostic tool requiring human interpretation of data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not applicable. This device is a physical product (silicone gel) applied topically, not an AI algorithm. Therefore, "standalone performance" in the context of AI is not relevant.

7. The Type of Ground Truth Used

• General Scientific Consensus/Literature: The "ground truth" concerning the effectiveness of silicone gels for scar management is based on a broad body of existing scientific literature and clinical practice, rather than specific pathology or outcomes data from a study directly evaluating Silgel™ STC-S. The application claims that "The effectiveness of silicone gel products in the management and of hypertrophic and keloid scars has been demonstrated by numerous clinical studies."

8. The Sample Size for the Training Set

• Not applicable. This product is not an AI algorithm and does not have a "training set" in that context. The "training" for the device's design implicitly comes from the established knowledge and manufacturing processes for medical-grade silicone gels.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set for an AI algorithm is involved. The "ground truth" for developing this type of medical device is based on established chemical, material science, and biocompatibility principles for medical-grade silicone, as well as the observed clinical efficacy of similar products over time.

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Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars. Silger™ helps relieve friction on newly healed scars when used as a splint lining insert.

Silgel™. Topical Gel Sheet, consists of a durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desired shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure is not required for a therapeutic effect.

The provided document is a 510(k) premarket notification for the Silgel™ Topical Gel Sheet. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the information required to populate most of the sections regarding acceptance criteria and a study proving device performance is not present in the provided text. The document describes component and final product testing for safety, but not for effectiveness against defined performance metrics for scar treatment.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not specified for effectiveness testing of Silgel™. The safety tests (biocompatibility, hemolysis, cytotoxicity, pyrogenicity) would have involved specific sample sizes, but these are not detailed in the summary.
• Data Provenance: Not applicable/not specified for effectiveness testing of Silgel™.

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. The document relies on existing clinical literature to support the general effectiveness of silicone gel sheets for scar management, rather than a de novo study with expert-established ground truth for Silgel™.

4. Adjudication method for the test set

• Not applicable, as no specific clinical effectiveness study for Silgel™ with expert ground truth establishment 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 medical device for topical application, 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 is a medical device for topical application.

7. The type of ground truth used

• For the asserted effectiveness, the document references "numerous clinical studies" that have "demonstrated" the effectiveness of silicone gel sheet products in general. This implies ground truth established through clinical outcomes data from those external studies, but not specific to Silgel™'s own novel clinical trial with pre-defined ground truth.
• For safety, the ground truth is based on standardized in vitro and in vivo biocompatibility and general safety tests.

8. The sample size for the training set

• Not applicable, as this is not a machine learning device.

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

• Not applicable, as this is not a machine learning device.

Summary of what the document does provide regarding acceptance and proof:

The document primarily focuses on demonstrating that Silgel™ is substantially equivalent to legally marketed predicate silicone gel sheets. The "acceptance criteria" here largely pertain to:

• Safety: Meeting ISO 10933 biocompatibility standards and passing specific in-vitro tests (Hemolysis, Cytotoxicity, Pyrogenicity). The document states "All test were acceptable demonstrating that the product is safe for its intended use."
• Technological Characteristics: Being a thin sheet of silicone gel, having a reinforcing mesh (similar to some predicates), being comfortable, semiocclusive, slightly adhesive, and durable.
• Intended Use: Consistent with predicate devices and supported by existing clinical evidence for silicone gel sheets as a class.
• Instructions for Use: Essentially the same as predicate devices.

The "study that proves the device meets the acceptance criteria" refers to the biocompatibility and final product safety testing mentioned in section 7. For effectiveness, the proof is indirect: it relies on the established efficacy of the device type (silicone gel sheets) in clinical literature, coupled with the argument that Silgel™ is technologically equivalent to devices already proven effective.

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