(164 days)
MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness™ is effective in the management of hypertrophic and keloid scars. .
- Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring. .
PREVENTION OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of . hypertrophic and keloid scarring.
- If used following surgical procedures, ReJuveness™ may prevent hypertrophic and . keloid scarring.
- ReJuveness™ can be used as soon as the wound is closed, dry and the sutures have . been removed.
- ReJuveness™ may prevent scarring disorders. .
REJUVENESS IS A SOFT, DURABLE REUSABLE SILICONE OCCLUSIVE SHEETING. IT IS A MEDICAL-GRADE, PURE SILICONE SHEETING THAT IS MANUFACTURED IN THE USA.
REJUVENESS IS A NON-INVASIVE MEDICAL DEVICE THAT REDUCES HYPERTROPHIC AND KELOID SCARS RESULTING FROM BURNS, SURGICAL PROCEDURES AND TRAUMATIC EVENTS. IT SOFTENS, SMOOTHES AND FLATTENS SCARS AND RESTORES THEM TO A MORE NORMAL TEXTURE AND COLOR. WHEN USED DAILY AS DIRECTED, REJUVENESS HAS THE POTENTIAL TO DRAMATICALLY IMPROVE THE APPEARANCE OF BOTH OLD AND REJUVENESS HAS BEEN CIJNICALLY PROVEN EFFECTIVE IN THE NEW SCARS. MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS AND MAY RELIEVE THE BURNING AND ITCHING THAT IS CHARACTERISTIC OF SCARRING DISORDERS. REJUVENESS HAS ALSO SHOWN SUCCESS IN THE PREVENTION OF HYPERTROPHIC AND KELOID SCARS WHEN APPLIED FOLLOWING SURGICAL PROCEDURES.
The provided text describes the 510(k) clearance for "Rejuveness Silicone Sheeting" (K974380), a device intended for the management and prevention of hypertrophic and keloid scars. However, it does not include a study that proves the device meets specific acceptance criteria with quantitative performance metrics.
The document primarily focuses on:
- Introducing the device and its intended use.
- The FDA's determination of substantial equivalence to a predicate device.
- The indications for use for which the device was cleared.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Rejuveness "clinically proven effective in the management of hypertrophic and keloid scars." |
| "Has the potential to dramatically improve the appearance of both old and new scars." | |
| "May relieve the burning and itching." | |
| "Has also shown success in the prevention of hypertrophic and keloid scars." |
Explanation: The document states that Rejuveness is "clinically proven effective." However, it does not provide specific, quantifiable acceptance criteria (e.g., "reduce scar elevation by X% in Y% of patients") or the detailed performance against such criteria. The statements provided are general claims of efficacy rather than specific performance metrics from a study.
2. Sample size used for the test set and the data provenance:
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided in the document. The document refers to "clinically proven effective" but does not detail how this clinical proof was established, nor the role or qualifications of any experts involved in a ground truth assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not provided in the document.
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 device is a silicone sheeting, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a silicone sheeting, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states "clinically proven effective," implying that the ground truth would likely be based on clinical outcomes data related to scar appearance, texture, color, and potentially subjective patient reports of burning/itching. However, the specific methodology for establishing this ground truth (e.g., blinded assessments, objective measurements, patient-reported outcomes) is not detailed.
8. The sample size for the training set:
Not applicable. This device is a silicone sheeting; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no "training set" for an algorithm.
§ 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.