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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.

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.

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OTC: For minor wounds, minor ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.

IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds, as a moist wound dressing. The viscous hydrogel of the device contains silver in the form of silver chloride which acts as a self preservative that inhibits the growth of broad spectrum of micro organisms in the dressing.

The product is available in a 1.5 oz (45 gm) polyethylene heat sealed tube container. The tubes will be packed in a cardboard box.

This document is a 510(k) premarket notification for a medical device called IONSIL GEL™, an unclassified wound hydrogel. The FDA determined it is substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., specific percentages for effectiveness, sensitivity, or specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility and antimicrobial testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical performance data for the device. The data mentioned relates to laboratory (in vitro) testing for biocompatibility and antimicrobial properties.

• Biocompatibility Testing: The text states "Biocompatibility testing... was conducted according to ISO Standards." This implies a set of standardized samples (e.g., material extracts, cell cultures, animal models) as prescribed by the specific ISO standards, but no sample size for a "test set" is provided in the document.
• Antimicrobial Testing: "In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test <51> and USP microbial limit test <61>." Again, the sample sizes for these in vitro tests (e.g., number of bacterial cultures, replicates) are not specified.
• Data Provenance: The studies are laboratory-based (in vitro), not involving human subjects or clinical data in the traditional sense. Therefore, country of origin of data (besides the submitting company's location in India) and retrospective/prospective categories are not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the document describes laboratory (in vitro) studies for biocompatibility and antimicrobial efficacy, not a human reader or clinical performance evaluation requiring expert ground truth in the diagnostic sense. The "ground truth" for these tests would be the standardized results and observations of the laboratory assays themselves, interpreted by qualified lab personnel.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. There is no human observer adjudication mentioned for these in vitro tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies, either standalone or assisted by AI. The device is a wound hydrogel, not an AI-powered diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical product (wound hydrogel), not a software algorithm.

7. The Type of Ground Truth Used

For the laboratory studies:

• Biocompatibility: The "ground truth" is established by the defined endpoints and criteria of the ISO standards used (e.g., cellular viability, irritation scores in validated models).
• Antimicrobial Properties: The "ground truth" reflects the measurable outcomes of the USP <51> and <61> tests and Zone of Inhibition assays, such as bacterial growth inhibition zones or reduction in microbial counts according to standardized methodologies.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" for its development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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