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The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.

The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are cleansing solutions intended for the external cleansing of skin and wounds. The mechanical action of the fluid moving across the skin or wound surface provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are identical devices. The only difference is that the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is for prescription use and the AGX Wound Wash Skin and Wound Cleanser is for Over-the-Counter Use.

The solution consists of deionized water containing 10ppm silver. The silver is from American Biotech Labs and is the same silver used in ABL Medical's Wound Dressing hydrogel devices cleared in K140483, K092826 and K082333. The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which was established through testing in accordance with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae. MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.

This document pertains to the 510(k) premarket notification for a medical device (AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and AGX Wound Wash Skin and Wound Cleanser), which is a wound cleansing solution, not an AI or imaging device. Therefore, the questions about acceptance criteria for AI models, such as sample size for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this document.

The document discusses the substantial equivalence of the proposed wound wash devices to a predicate device (Silvaklenz Antibacterial Silver Skin & Wound Cleanser, K063069).

Here's an analysis of the "acceptance criteria" and "study" as they apply to this medical device submission:

Acceptance Criteria and Reported Device Performance (as inferred from the document)

For this type of device (wound wash), "acceptance criteria" are not framed in terms of precision, recall, or AUC like they would be for an AI model. Instead, they are related to safety, functionality, and equivalence to a legally marketed predicate device. The "study" mentioned here is primarily through verification, comparative, biocompatibility, antimicrobial effectiveness, and stability testing.

Table of Acceptance Criteria and Reported Device Performance (as relevant for a wound wash)

• Indications for Use: Nearly identical for OTC and Prescription uses, aiding in removal of oils, dirt, debris, and cleansing various wounds/irritations.
• Packaging: Identical (2oz, 4oz, 8oz, 16oz spray/squeeze bottles).
• Sterile when used: Both "No."
• Mechanism of Action: Stated as "mechanical action of the fluid moving across the skin or wound surface."
• Differences Addressed: The primary difference is the "Ingredients" (10ppm silver in deionized water vs. surfactant, cocamidopropyl betaine, silver). The document argues this difference "does not affect the safety of the device as evidenced by the biocompatibility testing and antimicrobial effectiveness testing which is the same testing that was performed on the predicate device" and "does not affect the effectiveness... based on the fact that the mechanism of action for both... is as a wound wash provided by the mechanical action of the fluid." |
  | Biocompatibility/Safety | Device must be biocompatible for patient contact (limited exposure, breached/compromised surfaces). | Biocompatibility Testing: The device passed tests according to ISO 10993 standards:
• Cytotoxicity (ISO 10993-5:2009)
• Irritation (ISO 10993-10:2010)
• Sensitization (ISO 10993-10:2010)
  These are standard tests for patient-contacting medical devices. |
  | Antimicrobial Effectiveness (as preservative) | The silver component effectively inhibits microbial growth within the solution during storage. | Antimicrobial Effectiveness Testing: "The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which was established through testing in accordance with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger." |
  | Stability/Shelf Life | Device maintains specifications over its claimed shelf life. | Stability Testing: "Stability testing was performed on real time aged samples to establish a shelf life of 3 years. The testing demonstrated that the wound wash maintains its specifications over the three year shelf life." |

Inapplicable Questions (as this is not an AI/imaging device submission):

2. Sample sized used for the test set and the data provenance: N/A - No "test set" in the AI sense. Testing refers to laboratory and bench testing of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - "Ground truth" in this context refers to established scientific/medical principles for biocompatibility, antimicrobial preservation, and the physical/chemical properties of the solution.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A - Not an AI device assessing images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A - Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - Ground truth here is based on chemical/biological test standards (e.g., ISO 10993 for biocompatibility, USP for antimicrobial effectiveness) and comparison to the predicate device's established safety and effectiveness profile.
8. The sample size for the training set: N/A - No training set.
9. How the ground truth for the training set was established: N/A - No training set.

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ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing.

The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP OTC™ Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a popopen screw cap on the other end).

The provided document is a 510(k) summary for a medical device called ASAP OTC™ Wound Dressing Gel. It details the device's characteristics, its intended use, and how it compares to a predicate device to establish substantial equivalence. However, it does not describe a study involving acceptance criteria and a detailed statistical analysis of device performance in the context of typical AI/ML device evaluations.

Instead, this document focuses on biocompatibility testing and antimicrobial effectiveness testing to establish the safety and basic functionality of the wound dressing gel. The "acceptance criteria" here are implied by meeting the standards of ISO 10993 for biocompatibility and USP for antimicrobial effectiveness.

Therefore, many of the requested specific points regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are common for AI/ML device evaluations, are not applicable to this type of device submission.

Here's an analysis based on the information provided, highlighting the differences in evaluation methodology:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as one might see in an AI/ML clinical study. Instead, performance is demonstrated by conformance to recognized standards and by comparison to a predicate device.

Study Information (Based on available document):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for AI/ML. For biocompatibility and antimicrobial testing, the sample sizes would be determined by the respective standards (ISO 10993 and USP ). These are laboratory-based tests, not human subject studies.
   • Data Provenance: The studies are laboratory-based (biocompatibility and antimicrobial effectiveness). This is not retrospective or prospective human clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this type of device evaluation. Ground truth for biocompatibility and antimicrobial effectiveness is established by the methods and criteria defined in the specific standards (ISO 10993, USP ).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study requiring human expert adjudication of clinical findings.

4. 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 wound dressing gel, not an AI/ML diagnostic or assistive tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm-based device. The "performance" is the inherent physical, chemical, and biological properties of the gel.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For biocompatibility, the "ground truth" is adherence to established biological safety criteria as defined by ISO 10993, assessed through various biological reactivity tests (e.g., cytotoxicity, sensitization, irritation).
   • For antimicrobial effectiveness, the "ground truth" is defined by the inhibition of specified microbial growth according to the quantitative criteria of USP . This is a direct microbiologic assessment.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI/ML algorithm that requires training data. Device formulation and manufacturing processes are developed through R&D, not a "training set" in the AI sense.

8. How the ground truth for the training set was established:

   • Not applicable as there is no "training set" in the AI/ML context.

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