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510(k) Data Aggregation
(261 days)
BEIERSDORF, INC.
The Anti-Embolism Stockings: Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Over-the-Counter (OTC) Use
The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes. The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design. The Anti-Embolism Stockings are not made with natural rubber latex.
The provided text is a 510(k) Summary for medical support stockings and contains no information regarding studies conducted, acceptance criteria, or performance data for a device in the context of AI or diagnostic accuracy studies. Therefore, I cannot generate the requested table or study details based on this input.
The document is a submission to the FDA for market clearance for "Anti-Embolism Stockings." It outlines the general information, predicate devices, indications for use, and a description of the device (compression stockings made of nylon and spandex). The FDA letter confirms the substantial equivalence determination.
To answer your request, I would need a different type of document, such as a clinical study report or a 510(k) summary that includes performance data and acceptance criteria for a device that has undergone such testing.
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(191 days)
BEIERSDORF, INC.
Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.
Curad® Scar Therapy is a semi-occlusive, flexible pad for the management of hypertrophic scars resulting from burns, surgery, or injuries, after complete healing. The device is also intended for management of keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring. It is intended for over-the-counter use.
Curad® Scar Therapy consists of an adhesive aliphatic polyurethane matrix. Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a waterproof polyurethane film that is permeable to oxygen and water vapor.
The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Curad® Scar Therapy device, structured according to your request:
Device: Curad® Scar Therapy
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Biocompatibility, application to compromised/intact skin) | "The safety of this polyurethane pad for application to both compromised and intact skin has been demonstrated with biocompatibility studies and long-term use. Thus, Curad Scar Therapy, which is applied only to intact skin, does not raise new issues of safety." (Section VI - Summary of Substantial Equivalence) |
| Efficacy (Management and reduction of hypertrophic and keloid scars) | "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars. Therefore, Curad Scar Therapy does not raise new issues of efficacy." (Section VI - Summary of Substantial Equivalence) |
| Substantial Equivalence to Predicate Devices (Composition/Technology) | "In terms of its composition or technological characteristics, Curad®Scar Therapy is identical, and therefore substantially equivalent, to Beiersdorf's Cutinova®thin Wound Dressing, cleared for marketing under 510(k) number K94-4581." and "Curad® Scar Therapy has the same intended use and principle of operation as, and is therefore also substantially equivalent to, the Mepiform product." (Section VI - Summary of Substantial Equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the efficacy clinical studies or the data provenance (country of origin, retrospective/prospective). It only makes a general statement about "Clinical studies".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical studies. Given the nature of scar assessment, it is likely that clinicians (e.g., dermatologists, plastic surgeons) would have been involved, but this is not specified.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This device is a topical medical device, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical scar therapy pad and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
Based on "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," the ground truth for efficacy would likely be based on clinical assessment of scar appearance and characteristics by medical professionals. This could involve subjective ratings (e.g., Vancouver Scar Scale, patient satisfaction) or objective measurements (though not specified). It is not pathology or direct outcomes data in the sense of mortality or disease progression, but rather clinical improvement in a visible condition.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical scar therapy pad and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
Summary of Study Information Provided in the 510(k):
The 510(k) summary for Curad® Scar Therapy relies on demonstrating substantial equivalence to predicate devices (Cutinova®thin Wound Dressing and Mepiform Adherent Silicone Dressing).
- Safety: Demonstrated through "biocompatibility studies and long-term use" of the device's polyurethane pad, claiming it "does not raise new issues of safety" since it's applied only to intact skin.
- Efficacy: Stated that "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," implying a comparative clinical study against the Mepiform predicate. However, specific details about these clinical studies (e.g., sample size, methodology, endpoints, blinding) are not provided in this summary document. The submission is primarily focused on asserting equivalence rather than detailing the full clinical study report.
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