(283 days)
OTC: DONASORB™ is intended for use in management of minor cuts, minor abrasions, minor lacerations and minor burns.
Rx: DONASORB™ is intended for use by prescription for the management of partial and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, abrasions, surgical wounds, graft sites, skin tears, and first and second degree burns. DONASORB™ is not indicated for use on third degree burns.
DONASORB™ is a moist hydrogel sheet containing the antimicrobial ionic silver in the form of silver chloride which is intended to be a primary wound contact dressing to manage wound moisture. The base matrix of the subject device is composed of crosslinked polyacrylate sheet incorporating antimicrobial ionic silver in a silver chloride reservoir. Ionic silver in the form of silver chloride in the sheet inhibits the growth of broad spectrum microbes on or within the dressing. The Device is a sterile single use dressing supplied on PVC (Poly Vinyl Chloride) transparent carrier sheet, packed in a medical grade heat sealed aluminum foil pouch. Five single piece pouches are packed in a Mono-carton along with a package insert. Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. It is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first. It is available in sterile sheets of 2x2 cm, 2x4 cm, 4x8 cm, 8x8 cm and 10x10 cm sizes.
This document describes the DONASORB™ Silver Wound Dressing, a medical device, and the testing conducted to demonstrate its performance and safety. It's important to note that this is a 510(k) premarket notification, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study" described are primarily focused on equivalence and bench testing, not necessarily a comparative effectiveness study against a gold standard for treatment outcomes.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail sense with numerical thresholds typically seen for AI device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (AcryDerm Silver Antimicrobial Barrier Wound Dressing) and conformity to established testing standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bacterial Barrier Property (Prevent bacterial penetration) | DONASORB™ was evaluated for its effective barrier property. |
| Antimicrobial Efficiency (Inhibit microbial growth on/within dressing) | DONASORB™ was evaluated for its antimicrobial efficiency to inhibit the growth of microorganisms. Tests used 3 Gram positive, 3 Gram negative, and 2 fungi organisms with repeated inoculation over 24 hours. |
| Duration of Effectiveness | Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. Recommended use is up to 2 days or until saturated. |
| Biocompatibility/Safety (ISO 10993 compliance) | Demonstrated to be substantially similar to its predicate (AcryDerm) in: In Vitro Cytotoxicity Study, Acute Toxicity Test, Intracutaneous Irritation/Reactivity Study, Skin Sensitization testing, and Sub chronic toxicity test. |
| Sterility | Provided as a sterile single use device. |
| Manufacturing Standards | Will be manufactured according to product specifications under good manufacturing practices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of dressings or units tested for the bacterial barrier, antimicrobial efficacy, and biocompatibility studies. These were bench tests, not clinical studies on patient samples. For the antimicrobial efficacy, the "sample" refers to the types of microorganisms tested (3 Gram positive, 3 Gram negative, and 2 fungi organisms).
- Data Provenance: The document does not specify country of origin for the test data directly, but the submitter (Virchow Biotech PVT LTD) is located in India. The tests performed are described as "bench testing," meaning they were conducted in a laboratory setting. These were prospective bench tests specifically designed to evaluate the DONASORB™ device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the "test set" does not involve human interpretation or subjective assessment that would require expert consensus for ground truth. The tests are laboratory-based, objective measurements (e.g., microbial growth inhibition, penetration rates, cytotoxicity).
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective laboratory tests, and thus no adjudication method like 2+1 or 3+1 is required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human readers interpret results, and the study would compare human performance with and without AI assistance on a set of cases. The DONASORB™ is a wound dressing, and its performance is evaluated through bench testing and biocompatibility assessments, not through human reader interpretation of output.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a "standalone" performance evaluation in the context of an algorithm or AI device was not done. The term "standalone" performance typically applies to AI algorithms operating independently of human intervention. DONASORB™ is a physical medical device (wound dressing), not an algorithm or AI. Its performance (e.g., antimicrobial efficacy, barrier property) is inherent to the dressing itself.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through objective laboratory measurements and established scientific testing standards.
- Bacterial Barrier Property: Likely determined by measuring the passage of bacteria through the dressing material under controlled conditions, with the "ground truth" being the measured presence or absence and quantity of bacteria on the "wound" side of the dressing.
- Antimicrobial Efficacy: Determined by measuring the inhibition or reduction of microbial growth on or within the dressing compared to controls, with the "ground truth" being the observed microbial counts.
- Biocompatibility/Safety (ISO 10993): "Ground truth" established by compliance with the well-defined methodologies and acceptance criteria outlined in the ISO 10993 series of standards for biological evaluation of medical devices. This includes observing cellular responses (cytotoxicity), tissue reactions (irritation, sensitization), and systemic effects (acute and subchronic toxicity).
8. The Sample Size for the Training Set
Not applicable. The DONASORB™ is a physical medical device (wound dressing), not an AI/ML algorithm or system that requires a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the DONASORB™ device.
N/A