(260 days)
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that contains sodium hypochlorite and hypochlorous acid as preservatives to prevent the growth of microorganisms within the container during shelf-life.
The provided text is a 510(k) summary for the Microdacyn Hydrogel, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria in the manner you've outlined for an AI/algorithm-based device.
The information you are asking for, such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are typically relevant for AI/ML-driven diagnostic or prognostic devices.
The Microdacyn Hydrogel is a wound dressing that relies on its physical and chemical properties for its intended use, not on complex data analysis or AI algorithms. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are addressed through a comparison with a predicate device and standard performance and biocompatibility testing.
Here's an attempt to structure the available information per your request, with the understanding that many fields will be "N/A" due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from comparison with predicate) | Reported Device Performance (from Performance Data section) |
|---|---|
| Intended Use: |
- Rx Management of wounds associated with dermal irritation, sores, injuries, ulcers of dermal tissue.
- Rx Use on first and second-degree burns, exuding wounds (leg ulcers, pressure ulcers, diabetic ulcers), and mechanically/surgically debrided wounds.
- OTC Use on minor skin irritations, lacerations, abrasions, minor burns.
- OTC Management of irritation from minor sunburn. | Determined to have the same intended use as the predicate device (Microcyn Skin and Wound HydroGel (K093585)).
The Indications for Use are almost identical, lacking only the explicit mention of "itch and pain relief" from the predicate. The FDA clearing the 510(k) indicates acceptance of this proposed use. |
| Technological Characteristics: - Where Used: RX Only; OTC
- Delivery System: Hydrogel
- Mechanism of Action: Maintaining a moist wound environment.
- Composition: Water (96.524%), Sodium Magnesium Fluorosilicate (3.000%), Sodium Phosphate (0.400%), Sodium Chloride (0.066%), Hypochlorous acid (0.008%), Sodium Hypochlorite (0.002%)
- Sterilization: Non-sterile
- Shelf Life: Acceptable shelf life
- Specification: Viscosity
- Container closure system: 50 mL, 100 mL, 200 mL PET bottles with PP Snap-top screw cap and lift 'n' peel liner. | Determined to have the same technological characteristics as the predicate device.
- Where Used: Same as predicate.
- Delivery System: Same as predicate.
- Mechanism of Action: Same as predicate.
- Composition: Same as predicate.
- Sterilization: Same as predicate.
- Shelf Life: 24 months (longer than predicate's 18 months, which is generally acceptable if proven stable).
- Specification: Viscosity: 12,000-20,000 cP (same as predicate's specification according to the table, though the predicate's value isn't explicitly stated).
- Container closure system: Expanded options (50mL, 100mL, 200mL) compared to predicate's 2oz, but within acceptable parameters for hydrogel. |
| Safety and Effectiveness: - Biocompatibility
- Antimicrobial Effectiveness | Biocompatibility Testing:
- Met ISO-10993-1 Biological Evaluation of Medical Devices.
Performance Testing: - Met USP Antimicrobial Effectiveness Testing . |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an "AI test set." The performance data is derived from standard laboratory testing for biocompatibility and antimicrobial effectiveness, not from human subject data or a diagnostic test set.
- Data Provenance: Not applicable in the context of clinical data provenance. The tests are laboratory-based, adhering to ISO and USP standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device. The "ground truth" for the performance data comes from the established scientific standards of ISO-10993-1 and USP .
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human interpretation or clinical endpoint assessments, not for laboratory performance tests of a hydrogel.
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:
- Not applicable. This device is a hydrogel wound dressing, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm to assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML context. For this device, the "ground truth" is defined by adherence to established international and pharmacopeial standards for biocompatibility (ISO-10993-1) and antimicrobial effectiveness (USP ).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
In summary: The Microdacyn Hydrogel is a non-AI/ML device. Its acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device (Microcyn Skin and Wound HydroGel) through a comparison of intended use and technological characteristics, supplemented by standard laboratory-based performance (biocompatibility and antimicrobial effectiveness) testing, rather than studies involving human data sets, expert review, or AI algorithm validation.
N/A