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AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

• For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
• For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications.
The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.

The provided text is an FDA 510(k) summary for a medical device: "AMSure Sterile Water, and Sterile Normal Saline for Wound Flush." This document outlines the manufacturer's claim that their device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about an AI/algorithm-driven device, nor does it present data from a "study that proves the device meets the acceptance criteria" in the way one would for an AI-powered diagnostic tool.

The acceptance criteria mentioned are related to:

• Biocompatibility: Ensuring the materials are safe for patient contact.
• Performance: Meeting USP standards for sterile saline and sterile water.
• Stability: Maintaining properties after accelerated aging.

The "studies" are described as "Nonclinical Testing (Bench)" and include:

• Biocompatibility testing: Demonstrated biological safety.
• Performance testing: Demonstrated meeting USP standards.
• Stability testing: Evaluated properties after accelerated aging.

The conclusion is that the device "passed all acceptance criteria."

Given this, I cannot provide the detailed information requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided text. The device in question is a simple medical product (sterile water/saline for wound flush), not a complex AI diagnostic system.

Therefore, the table and other detailed points will reflect the lack of this information from the provided document.

Acceptance Criteria and Device Performance (Based on provided document)

Study Details (Information Not Available or Applicable for this type of device)

1. Sample size used for the test set and the data provenance: Not applicable. The "tests" were benchtop performance, biocompatibility, and stability testing on the product itself, not a clinical study on patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound flush solution is based on chemical composition and sterility standards (USP), not expert clinical review of images or data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring 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 sterile water/saline, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component to this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was based on established industry standards and regulations for medical devices, specifically USP for chemical composition and sterility, and ISO10993 for biocompatibility.
7. The sample size for the training set: Not applicable. There is no training set as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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