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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Safety:
Biocompatibility (ISO 10933 for skin contact devices)	Silicone gel raw material meets all test requirements.
Hemolysis Test	Acceptable
Cytotoxicity Test (MEM Elution Method)	Acceptable
Pyrogenicity Test (Limulus Amebocyte Lysate (LAL) Test)	Acceptable
Effectiveness:
Specific performance metrics for scar treatment (e.g., reduction in scar height, color, itching)	Not specified in this document. The document asserts effectiveness based on numerous clinical studies of silicone gel sheet products in general, not a specific study on Silgel™ itself with defined acceptance criteria.
Substantial Equivalence to Predicate Devices (for intended use and characteristics)	The device is considered substantially equivalent to predicate devices for its intended use in hypertrophic and keloid scar management, prophylactic management of healed incisions, and as a splint lining insert.

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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K Number

K960254

Device Name

SILGEL TOPICAL GEL SHEET

Manufacturer

ROFIL MEDICAL USA, INC.

Date Cleared

1996-04-02

(76 days)

Product Code

MDA

Regulation Number

878.4025

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K894226

Predicate For

K991968

Intended Use

Silgel is intended for use in the management of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.

Device Description

Silgel, Topical Gel Sheet, consists of 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 desire 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 in not required for a therapeutic effect.

AI/ML Overview

This document describes a 510(k) submission for the "Silgel Topical Gel Sheet," a medical device intended for scar management. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone study with acceptance criteria in the typical sense for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of submission. The "acceptance criteria" here are defined by the product's bio-compatibility and safety tests, and its technological characteristics matching predicate devices.

Here's the breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility (Silicone Raw Material):	Meets all test requirements as defined in ISO 10933 for skin-contact devices.
Hemolysis Test (Final Product)	Acceptable
Cytotoxicity Test (MEM Elution Method) (Final Product)	Acceptable
Pyrogenicity Test (Limulus Amebocyte Lysate (LAL) Test) (Final Product)	Acceptable
Technological Characteristics:	Silgel is a thin sheet of silicone gel, contains a reinforcing mesh, is conformable, semi-occlusive, slightly adhesive, and durable. These characteristics are consistent with predicate devices.
Intended Use:	Consistent with known clinical findings for silicone gel sheeting products.
Instructions for Use:	Essentially the same as predicate devices.
Safety Information:	Product labels discuss potential skin complications consistent with predicate devices.

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 submission relies on biocompatibility and safety testing of the device materials and final product configuration, as well as comparison to existing clinical knowledge regarding the effectiveness of silicone gel sheeting. It does not present a clinical study with a "test set" of patients in the typical sense. The "data provenance" for the effectiveness claim is based on "numerous clinical studies" demonstrating the effectiveness of silicone gel sheet products in general, not a specific Silgel study.

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. No ground truth established by experts for a test set was mentioned in this submission. The effectiveness is referenced from pre-existing knowledge about the class of devices.

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

Not Applicable. No clinical test set and subsequent adjudication method are described.