(83 days)
The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.
This document is a 510(k) premarket notification for a medical device called DIMISIL Scar Gel. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.
Here's why and what information can be extracted:
This document describes a traditional medical device (a scar gel), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML performance metrics (like sensitivity, specificity, F1 score, etc.) are not applicable here.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on design, materials, function, and intended use.
However, I can extract information relevant to the device and its regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, traditional performance metrics and acceptance criteria for an AI/ML device are not present. The "performance" for this device relates to its equivalence to predicate devices for scar management.
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance (as claimed by applicant) |
|---|---|
| Function: Topical management of keloid or hypertrophic scars secondary to trauma. | Substantially equivalent to Kelocote and Kelocote Scar Gel. |
| Design: Medical grade silicone gel, amorphous paste, minimal to no elasticity/strength. Supplied in 0.34 fl. oz. (10ml) tubes. | Substantially equivalent to Kelocote and Kelocote Scar Gel in design. |
| Performance: Effectively manages scars as intended. (Performance is directly linked to the function and material composition, which is claimed to be equivalent). | Substantially equivalent to Kelocote and Kelocote Scar Gel in performance. |
| Materials: Manufactured from medical grade silicone gel. | Substantially equivalent to Kelocote and Kelocote Scar Gel in materials. |
| Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds. | Identical intended use as predicate devices. |
The following numbered points are specific to AI/ML device studies and are therefore not applicable to this document:
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what this document does provide:
- Device Name: DIMISIL Scar Gel
- Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
- Predicate Devices: Kelocote (marketed by Allied Biomedical Corporation) and Kelocote Scar Gel (marketed by Hanson Medical, Inc.).
- Basis for Equivalence: Substantial equivalence in function, design, performance, and materials to the predicate devices.
- K Number: K023678
- Date of Submission: Received November 1, 2003 (Dated October 28, 2002)
- Date of FDA Decision: January 23, 2003 (as per the stamp)
§ 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.