(145 days)
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
| 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.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.