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Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites.

Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.

The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier.

Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.

The provided document is a 510(k) premarket notification decision letter and summary for a medical device called "Dakin's Skin and Wound Cleanser." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria and detailed study results typical for novel devices or significant modifications.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert adjudication, MRMC studies, or standalone algorithm performance.

Here's why and what information is present:

• Lack of Acceptance Criteria and Performance Data: The 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing (e.g., biocompatibility, stability, shelf-life, antimicrobial effectiveness) to show the new device performs as intended and is as safe and effective as the predicate, but it doesn't involve establishing and meeting clinical performance acceptance criteria in the same way a PMA (Premarket Approval) submission for a novel device would.
• The "Study" Mentioned: The document mentions a "Preclinical Wound Healing Study in Yucatan miniature swine" (page 6). This is a preclinical animal study, not a human clinical trial. Its purpose was to show that "Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites." This is a comparative study against the predicate and a control, aimed at showing non-inferiority in terms of healing inhibition in a preclinical model, not establishing clinical effectiveness or meeting specific performance metrics with human data.
• No Information on AI/Algorithm Performance: The device is a "Dakin's Skin and Wound Cleanser," which is a topical solution (sodium hypochlorite). It is not an AI-powered diagnostic or therapeutic device. Therefore, questions regarding MRMC studies, standalone algorithm performance, training/test sets for AI, expert adjudication for ground truth of an AI model, and data provenance related to AI model development are not applicable to this device or document.

Summary of what can be extracted from the document:

• Device Name: Dakin's Skin and Wound Cleanser
• Predicate Device: Patrin Pharma, Inc. – Hy-Chlo Wound Solution (K113312)
• Indications for Use (similar for both proposed and predicate):
  • OTC: Cleansing of minor cuts, lacerations, abrasions, minor wounds, and removal of foreign objects.
  • Professional Use: Cleansing of acute, chronic, and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second-degree burns, and grafted and donor sites.
• Non-clinical Performance Testing (mentioned on page 6):
  • Biocompatibility (Cytotoxicity, Sensitization, Dermal Irritation)
  • Preclinical Wound Healing Study in Yucatan miniature swine
  • Antimicrobial (preservative testing) - meets USP criteria for antimicrobial effectiveness.

In conclusion, this document is a regulatory approval notice for a topical wound cleanser based on substantial equivalence to an existing product, not a study report for an AI device or a device requiring complex clinical performance acceptance criteria and human clinical trials as per your prompt's questions.

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