(78 days)
SKAR-KARE™ is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
SKAR-KARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.
This document appears to be a 510(k) Premarket Notification for a medical device called SKAR-KARE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics typically seen in clinical trials for new technologies.
As such, the information requested for a comprehensive study description, including detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, and specific performance metrics like effect sizes, is largely not present in the provided text.
Here's an analysis of what can and cannot be extracted from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) submission are generally "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., reduction in scar size, improvement in appearance, patient satisfaction scores) are reported in this document. The document confirms that the device is "intended for use in the topical management of hypertrophic and keloid scars" and that the FDA found it substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned. (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned.
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
- MRMC Study: Not mentioned. This type of study is more common for diagnostic imaging AI devices, which is not the case here.
- Effect Size: Not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. SKAR-KARE™ is a physical medical device (topical dressing), not an algorithm or AI.
7. The Type of Ground Truth Used
- Ground Truth: Not explicitly defined or used in the context of a "test set" as this is not a study reporting on diagnostic accuracy or AI performance. The basis for substantial equivalence is comparison to a predicate device, REJUVENESS™ (K953420), regarding intended use and technological characteristics.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/not mentioned. There's no "training set" in the context of this device being a physical topical dressing.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable/not mentioned.
Summary of what is available from the provided text:
- Device Name: SKAR-KARE™
- Intended Use: Topical management of hypertrophic and keloid scars (do not use on open wounds).
- Predicate Device: REJUVENESS™ (K953420) by RichMark International Corporation.
- Device Description: An outer shell of medical grade silicone sheets with a sealed internal component filled with medical grade silicone oil; a soft, semi-transparent rubbery device.
- Regulatory Outcome: FDA found the device substantially equivalent (K973271) to the predicate device.
- Over-The-Counter Use: Permitted.
- No detailed clinical study data, performance metrics, or information on specific acceptance criteria beyond "substantial equivalence" is provided in this 510(k) summary.
§ 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.