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Rx Only (Pad and Ribbon Configurations)
Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns.

For Over-the-Counter use (Pad Configuration)
ALGS2 Ag Alginate Wound Dressing may be used for
. Minor Abrasions
Minor Lacerations
. Minor cuts
. Minor scalds and burns

ALGS2 Ag Alginate Wound Dressing is a soft, highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad only) dressing composed of calcium alginate and 0.95% ionic silver which allows for a maximum of 18 mg of silver for a 4 inch x 4 inch dressing. The silver present in the dressing is to prevent or inhibit growth of bacteria within the dressing absorbs wound fluid and creates a soft and cohesive gel which conforms to the wound surface and assists in maintaining a moist environment. The ALGS2 Ag Alginate Wound Dressing helps maintain a moist wound environment which is conducive to wound healing.

The ALGS2 Ag Alginate Wound Dressing is individually packaged in foil pouches and terminally sterilized by gamma radiation.

This document describes a 510(k) submission for the "ALGS2 Ag Alginate Wound Dressing" and its substantial equivalence to a predicate device, the "ALGS6 Ag Alginate Wound Dressing." The focus of the provided text is on demonstrating this equivalence through comparison of technological characteristics and performance testing related to biocompatibility and bench tests. Crucially, this submission does not involve an AI/ML powered device, nor does it detail a clinical study with human readers assessing AI performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML. The provided information relates to a medical device (wound dressing) and its physical, chemical, and biological properties, not an AI algorithm.

Specifically, the document focuses on:

• Device Description: ALGS2 Ag Alginate Wound Dressing is a sterile, single-use, nonwoven dressing composed of calcium alginate and 0.95% ionic silver.
• Indications for Use: For management of acute and chronic, partial and full thickness wounds (Rx Only) and minor abrasions, lacerations, cuts, scalds, and burns (OTC).
• Predicate Device: ALGS6 Ag Alginate Wound Dressing (K172570) from the same manufacturer.
• Technological Characteristics Comparison: A detailed table comparing parameters like Indications for Use, Intended Use, Device Design, Mechanism of Action, Antibacterial Material/Activity, Hydrophilic Material, Method of Affixation, Wear Time, Integral Removal, Single Use, Sterilization, and Primary Packaging. All parameters are deemed "Substantially Equivalent."
• Performance Data: This section lists biocompatibility and bench testing performed.
  • Biocompatibility Testing: Lists tests like Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity, Subchronic Toxicity, Implantation Effects (Wound Healing Study), and Bacterial Endotoxins Test. Methods for each are cited (e.g., ISO 10993 series, USP).
  • Performance Testing - Bench: Lists tests like Weight/Dimensions, Absorbency, Moisture Content, Acidity, Silver Content, Heavy Metal Analysis, and Evaluation of Antibacterial Effectiveness.

None of the requested components for an AI/ML study (e.g., test set sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are relevant to this 510(k) submission as it is for a traditional medical device (wound dressing), not an AI-powered one.

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Rx Only (Pad and ribbon Configurations)
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second-degree burns.

For Over-the-Counter use (Pad Configuration), ALGS6 Ag Alginate Wound Dressing may be used for:

• Minor Abrasions
• Minor Lacerations
• Minor cuts
• Minor scalds and burns

ALGS6 Ag Alginate Wound Dressing is a highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad) dressing composed of calcium alginate fiber, Lyocell fiber and 1.7% ionic silver which allows for a maximum of 30.6 mg of silver for a 4-inch dressing (0.306 mg per square centimeter). Silver is present in the dressing as a preservative to prevent or inhibit growth of bacteria within the dressing. The dressing absorbs high amounts of wound fluid and the bacteria contained in the wound fluid. The absorbed wound fluid in the dressing creates a soft and cohesive gel which assists in maintaining a moist environment. The moist wound healing environment and control of dressing bacteria supports the body's healing process.

The provided document is a 510(k) summary for the ALGS6 Ag Alginate Wound Dressing, seeking substantial equivalence to a predicate device. It describes the device, its intended use, and comparative testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing various performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device in the parameters listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and an animal wound healing study for performance evaluation. It does not mention human clinical trials or a "test set" in the context of diagnostic performance (e.g., patient images or data used to evaluate an AI algorithm).

• Bench Testing: The sample size for each specific bench test (e.g., absorbency, silver content) is not specified.
• Animal Wound Healing Study: The number of animals or wounds studied is not specified.
• Data Provenance: The location of the testing is not explicitly stated. The manufacturer is in China, and the correspondent is in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission is for a wound dressing, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. The wound healing study involved macroscopic and microscopic observation, likely by veterinary or histopathological experts, but their number and specific qualifications are not detailed.

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

This section is not applicable for the reasons stated above.

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

This section is not applicable as the device is a wound dressing, not an AI-powered diagnostic tool.

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

This section is not applicable as the device is a wound dressing, not an AI algorithm.

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

For the performance testing:

• Bench Testing: The "ground truth" for parameters like absorbency, silver content, pH, and antibacterial effectiveness is established by standardized laboratory methods and measurements.
• Wound Healing Study: The "ground truth" for wound healing was based on macroscopic and microscopic observations of the wounds in animals, likely involving histopathological analysis (a form of pathology).
• Biocompatibility Testing: The "ground truth" is based on standardized toxicity and reaction tests in biological systems (e.g., irritation, sensitization, systemic toxicity).

8. The sample size for the training set

This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set."

9. How the ground truth for the training set was established

This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set" or corresponding ground truth.

In summary, the provided document describes a 510(k) submission for a wound dressing, focusing on demonstrating substantial equivalence to a predicate device through a series of bench tests and an animal wound healing study. It does not involve AI, human reader studies, or diagnostic performance evaluation with expert consensus ground truth, which are typically found in submissions for AI/CADe medical devices.

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Rx:
The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of:

• Pressure sores
• Diabetic ulcers
• Leg ulcers
• Donor sites and graft sites
• Surgical wounds
• Skin abrasions and lacerations
• 1st and 2nd degree burns
• Trauma wounds

OTC:
The KA01 Chitosan Wound Dressing may be used for the management of:

• Minor cuts
• Minor scalds and 1st degree burns
• Abrasions
• Lacerations

The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal.

The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a variety of chronic and acute wounds. It is intended to be secured with a semi permeable adhesive secondary dressing and to remain in place up to 7 days depending on the level of exudate. Dressings are individually packed in paper/poly pouches and terminally sterilized to achieve a SAL 106. A range of dressing sizes between 25cm2 and 220cm2 is available.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, particularly with regards to the specific subsections you outlined (e.g., sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set).

This document is a 510(k) premarket notification letter from the FDA to Foshan United Medical Technologies LTD regarding their KA01 Chitosan Wound Dressing. It primarily focuses on the FDA's determination of substantial equivalence to predicate devices. While it mentions "Functional and Safety Testing" including "bench testing (absorbency, gel absorbency retention, moisture content, pH), viral inactivation testing, biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (accelerated aged and real time)," it does not provide any specific acceptance criteria, performance metrics, or details of the studies conducted to demonstrate these, nor does it refer to any clinical studies involving human readers or AI.

The document states that the manufacturer "considers the KA01 Chitosan Wound Dressing to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in intended use, design, mechanisms of action, technology and materials." This suggests the approval is based on substantial equivalence to existing devices rather than a direct demonstration of meeting new, quantifiable acceptance criteria through detailed clinical performance studies that you are asking for.

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