(380 days)
For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1st degree burns.
For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
CELVER® is a sterile silver moist wound dressing. CELVER® is composed of sodium carboxymethylcellulose, sodium lactate and ionic silver imbedded into a non-woven 100% cotton substrate.
In contact with wound exudate, the highly adsorbent dressing creates a soft cohesive gel that forms an intimate contact with the wound surface and maintains a moist wound-healing environment.
The construction of the bandage provides for easy removal with minimal residue left on the wound.
The bandage dimensions are 4" x 4" and is further perforated into 15 equal sections appropriately ¾" x 1 ½" for flexibility and ease of use.
This document describes the 510(k) submission for the medical device CELVER®, an absorbent antimicrobial wound dressing, and its substantial equivalence to a predicate device. The information provided focuses on the regulatory submission process and not on a clinical trial with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information, such as sample size, expert ground truth, adjudication methods, and MRMC studies, is not applicable or available in this document.
Here's an attempt to address the points based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass/Fail per ISO 10993-10:2002 and ISO10993-5:2009 | The device passed all of the tests based on pre-determined Pass/Fail criteria. |
| Performance/Functionality | (Not explicitly detailed, but implied suitability for wound care) | Verification, validation, and testing activities were conducted to establish performance, functionality, and reliability characteristics with respect to the predicate device. |
| Reliability | (Not explicitly detailed) | Verification, validation, and testing activities were conducted to establish reliability characteristics with respect to the predicate device. |
| Substantial Equivalence | As safe and effective as the legally marketed predicate device. | The data from the biocompatibility and non-clinical tests show that the CELVER® is as safe and effective as the legally marketed predicate device, thus demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any testing. The document refers to "testing activities" and "third-party testing" but does not quantify the number of units or samples tested for biocompatibility or other performance aspects.
- Data Provenance: Not specified. The testing activities are described as "third-party testing," but the country of origin of the data or whether it was retrospective or prospective is not mentioned. Given the nature of a 510(k) for a physical device, this would likely involve laboratory testing rather than clinical data from human subjects in the way AI/software studies do.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided in the document. The "ground truth" for a physical device's characteristics (like biocompatibility) is typically established by laboratory standards and protocols, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers and interpretations, which is not the type of study described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and therefore, no effect size of human readers improving with or without AI assistance is mentioned. This type of study is relevant for AI/software devices that assist human interpretation, not for a physical wound dressing in a 510(k) submission focused on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This is not an AI/software device. The performance evaluation was for the physical properties and safety of the wound dressing itself.
7. The Type of Ground Truth Used
- For biocompatibility, the ground truth was established by pre-determined Pass/Fail criteria based on international standards (ISO 10993-10:2002 and ISO10993-5:2009).
- For other performance and functionality aspects, the ground truth was implicitly related to the characteristics of the predicate device which CELVER® aimed to be substantially equivalent to.
8. The Sample Size for the Training Set
- Not applicable/Not provided. There is no concept of a "training set" for this type of device and submission. This is relevant for machine learning models, not for a physical wound dressing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided, as there is no training set for this device.
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