Search Results

Dermalage for over-the-counter use is intended for cleansing wounds for the removal of foreign material, such as debris and dirt, from dermal wounds.

Dermalage is a liquid solution intended for cleansing wounds. The solution is applied by spraying directly onto the affected area until wet and then allowed to air dry. When sprayed, Dermalage moves across the wound bed by mechanical action to aid in the removal of foreign objects such as dirt and debris from granulating wounds. The Dermalage solution is provided in a bottle with a manual spray pump configuration.

Dermalage is a combination product that contains water, sodium laureth sulfate, sodium lauryl sulfoacetate, disodium laureth sulfosuccinate, cocamidopropyl betaine, sorbitol, Imidazolidinyl Urea, and sodium hydroxide. Imidazolidinyl Urea acts solely as a preservative to inhibit growth of microorganisms within the product before opening and between uses.

Dermalage is limited to use by a single patient for up to 24 hours.

The provided FDA 510(k) Clearance Letter for Dermalage (K243166) does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm effectiveness. The document focuses on demonstrating substantial equivalence to a predicate device (K103713 Elta Wound Cleanser) for its intended use as a wound cleanser through various safety and performance tests.

Here's a breakdown of the requested information based on the provided document:

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

The document does not specify quantitative acceptance criteria for device performance in the context of cleaning wounds (e.g., a specific percentage of debris removal). Instead, it lists various safety and effectiveness tests:

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 does not provide details on specific sample sizes for the performance tests (e.g., number of test subjects or samples for biocompatibility, shelf-life, or antimicrobial effectiveness). The data provenance (country of origin, retrospective/prospective) is also not specified.

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 information is not provided in the document. The tests described (biocompatibility, shelf-life, antimicrobial effectiveness, etc.) are standard laboratory and ISO-based assessments, not typically requiring "experts to establish ground truth" in the same way an AI diagnostic device for image analysis would.

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

This information is not provided. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which are not detailed in this document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. This type of study is relevant for AI-powered diagnostic or assistive devices where human-AI interaction is evaluated. Dermalage is a physical wound cleanser, not an AI or algorithmic device.

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

A standalone performance study for an algorithm was not mentioned as Dermalage is a liquid wound cleanser, not an algorithmic device.

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

For the performance and safety tests listed (biocompatibility, shelf-life, antimicrobial effectiveness), the "ground truth" would be established by the validated and standardized protocols of the respective ISO standards (10993 series) and USP monographs (e.g., USP , USP ). These standards define the methods and criteria for determining cytotoxicity, irritation, sensitization, acute toxicity, pyrogenicity, and antimicrobial effectiveness.

8. The sample size for the training set

This information is not applicable as Dermalage is not an AI/machine learning device that requires a "training set."

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

This information is not applicable for the same reason as above.

Summary:

The provided FDA 510(k) clearance letter pertains to a physical medical device (a wound cleanser), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the questions related to AI device evaluation (sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not addressed or applicable in this context. The document focuses on demonstrating the substantial equivalence of Dermalage to a predicate wound cleanser through standard biocompatibility, chemical, and stability testing, confirming its safety and effectiveness for its intended use.

Ask a specific question about this device

Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.

The provided FDA 510(k) clearance letter for Granudacyn® Wound Irrigation Solution (K243415) does not contain information about acceptance criteria or a study that uses a device to meet acceptance criteria in the context of AI/ML or diagnostic performance.

This document pertains to a medical device that is a wound wash solution, not an AI-powered diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device (Vashe® Wound Solution) through non-clinical testing of its physical and chemical properties and general effectiveness as a wound care product.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of device and regulatory submission presented.

The "Clinical Data Summary – Subject Device" section explicitly states: "Clinical Testing: Clinical data is not required." and "No clinical data was required to support substantial equivalence." This further confirms that no studies proving diagnostic accuracy or clinical effectiveness in a human cohort were conducted or needed for this clearance.

In summary, the provided text does not contain the information required to answer your specific questions related to AI/ML device performance and acceptance criteria.

Ask a specific question about this device

Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

The provided FDA 510(k) clearance letter and summary for Bonvadis® do not contain any information regarding clinical performance studies, such as those involving human readers or expert panels, nor do they specify acceptance criteria for such studies.

The acceptance criteria mentioned in the document are primarily related to non-clinical performance tests proving the device's physical properties, safety, and functionality.

Here's the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical performance acceptance criteria or corresponding results are provided in the document, the table below focuses on the non-clinical tests mentioned. The document states that the results "meet the criteria" or "demonstrated that the device is as safe, effective, and performs as well as the predicate devices," implying successful completion of these tests against internal or regulatory standards, though specific numerical criteria are not detailed.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for clinical performance. The document exclusively refers to non-clinical tests on the device itself (e.g., stability, physical properties, biocompatibility). There is no mention of a "test set" of patient data or images.

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

Not applicable/Not provided. As there are no clinical performance studies or test sets involving patient data, no experts were used to establish ground truth for such a purpose.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned as there were no clinical performance studies requiring expert review of data.

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/Not provided. This device is a topical wound dressing, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

Not applicable/Not provided. This device is a physical product (wound dressing), not a software algorithm.

7. The type of ground truth used

Not applicable/Not provided for clinical performance. For the non-clinical tests, the "ground truth" refers to established scientific and regulatory standards (e.g., USP monographs for microbial limits, pH, preservative efficacy) against which the device's physical and chemical properties were measured.

8. The sample size for the training set

Not applicable/Not provided. This refers to clinical or AI model training data, neither of which are mentioned or relevant to the non-clinical tests described for this wound dressing.

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

Not applicable/Not provided. As there is no mention of a training set for an AI model or clinical study, this information is not available.

Ask a specific question about this device

The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications:

• For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns.
• To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement.

The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses:

• Use with dermal irritation, sores, injuries and ulcers of dermal tissues.
• Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions.
• Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a hypochlorous acid hydrogel solution applied topically to skin and wound areas.

The hydrogel dressing is supplied in various packaging configurations. The OTC hydrogel and the prescription use hydrogel contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel during shelf-life. The OTC and RX products are supplied non-sterile.

It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document for "Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel" pertains to a medical device (a topical hydrogel), specifically a wound care product, and not an AI/software as a medical device (SaMD).

Therefore, the concepts of acceptance criteria for an AI model, training sets, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this type of medical device clearance. The "study that proves the device meets the acceptance criteria" in this context refers to standard non-clinical testing for medical devices.

The FDA 510(k) summary provided details on standard medical device testing, which includes:

• Biocompatibility Testing (ISO 10993 series): To ensure the device is safe for contact with the human body (e.g., cytotoxicity, irritation, sensitization, local effects after implantation, chemical characterization).
• Antimicrobial Effectiveness Testing (USP ): To demonstrate the product's ability to inhibit microbial growth within the container (as it contains hypochlorous acid as a preservative).
• Bacterial Endotoxins Test (USP ): To ensure levels of endotoxins are safe.

Therefore, I cannot fulfill the request as stated because the provided input does not describe an AI/software device and thus does not contain the information requested about AI model acceptance criteria and validation.

If you have a document describing an AI/SaMD product, I would be happy to analyze it according to your requested criteria.

Ask a specific question about this device

Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.

Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.

Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).

Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.

Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.

This document is a 510(k) clearance letter for a medical device called "Spectricept Skin and Wound Cleanser." It states that the device is substantially equivalent to a previously cleared predicate device (K213514). It is a chemical product, not an AI/ML powered device, so many of the requested categories related to AI performance are not applicable.

Here's the summary of the information provided for the Spectricept Skin and Wound Cleanser:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a chemical product clearance, the "acceptance criteria" are related to safety and performance through non-clinical testing, rather than performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device. The "reported device performance" indicates that the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the device is a chemical cleanser and the evaluation is based on non-clinical laboratory testing, not a dataset of patient cases. The testing involves standardized laboratory procedures and materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant here. The "ground truth" for the non-clinical tests is adherence to established international standards and laboratory protocols performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in AI/ML performance studies. Here, the "truth" is determined by the outcome of a standardized laboratory test against a defined pass/fail criterion.

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 is not applicable. The device is a wound cleanser, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This is not applicable. The device is a liquid chemical cleanser, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's clearance is based on:

• Established International Standards: Such as ISO 10993 series and ASTM F756 for biocompatibility.
• Pharmacopoeial Standards: Such as USP and USP for microbiological evaluation.
• Chemical Composition Analysis: Assuring the formulation is as specified.
• The comparison to the predicate device (K213514) relies on the fact that the two devices are identical in formulation, mechanism of action, and intended use, and the additional biocompatibility testing supported an extended contact time.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for this type of device clearance. The device is a chemical product, not an AI/ML model trained on data.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

Ask a specific question about this device

SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.

SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.

The provided text describes a 510(k) premarket notification for a medical device called "SiOxC Cream". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a topical cream, primarily through:

• Comparison of technological characteristics: This involves comparing the composition, principle of operation, preservative, available offerings, reapplication frequency, sterility, and biocompatibility of the SiOxC Cream with a predicate device (EPICERAM® Skin Barrier Emulsion).
• Non-clinical performance testing: This includes characterization of pH, viscosity, macroscopic and microscopic appearance, and preservative effectiveness testing (USP ) to support shelf-life.
• Biocompatibility testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23.
• Human Repeat Insult Patch Test (HRIPT): This study assessed the potential for dermal irritation and sensitization.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to an AI/ML medical device, because the provided text is for a topical cream and lacks any mention of AI/ML or corresponding performance metrics.

The text states that SiOxC Cream is a "skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment." and that it is "unclassified". This is a non-AI/ML product review.

Ask a specific question about this device

Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.

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 sterile water/saline, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.

8. The sample size for the training set: Not applicable. There is no training set for an AI/software.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

Ask a specific question about this device

LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silver Collagen Dressing) and describes its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and various tests performed to demonstrate its safety and performance. However, it does not explicitly state "acceptance criteria" as a set of quantified thresholds for performance, nor does it describe a study specifically designed to prove all elements of acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Puracol® Plus Ag MicroScaffold™ Wound Dressing), rather than defining and meeting specific, quantifiable acceptance criteria. The tests conducted are primarily to show that the subject device performs similarly to the predicate and meets general safety and performance standards for wound dressings.

Therefore, many of the requested fields cannot be directly extracted from the provided text in the manner specified. I will answer based on the information that is available, and indicate where information is not provided.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance outcomes. Instead, it states that "The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

Here's an attempt to infer and summarize based on the provided "Performance Test-bench" section and the comparison table. It's important to note that the specific numerical acceptance criteria for each test are not provided in this document.

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified. The document mentions "a series of bench tests" and "an in-vitro antibacterial effectiveness test" but does not provide the number of samples or specimens used for each test.
• Data provenance: Not specified. The tests appear to be laboratory-based ("bench tests," "in-vitro") conducted by the manufacturer or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as this is a pre-market submission based on non-clinical testing.

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

Not applicable. This device is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles for material properties, sterilization efficacy, and biological safety, as defined by international standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set

Not applicable. See #3.

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 wound dressing, not an AI-assisted diagnostic or therapeutic device involving human readers.

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

Not applicable. See #5.

7. The type of ground truth used

For the non-clinical tests described:

• Sterility: Established by documented validation methods (ISO 11137-1/-2) demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
• Shelf-life: Established by real-time aging tests compliant with FDA guidance.
• Biocompatibility: Established by adherence to ISO 10993-1 standards and FDA guidance, with specific tests conducted (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, etc.).
• Performance (Physical/Chemical): Established by standard laboratory testing methodologies for properties like appearance, size, loss on drying, tensile strength, free swell absorption, pH value, and silver content.
• Antibacterial effectiveness: Established by an in-vitro test.
• Animal-Derived Materials Safety: Established by compliance with FDA guidance and ISO 22442 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See #8.

Ask a specific question about this device

Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.

Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.

The provided document is an FDA 510(k) clearance letter for a medical device (Atrauman® Ag antimicrobial wound dressing) and its associated 510(k) summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not typically include information about sophisticated AI/ML driven diagnostic devices, multi-reader multi-case (MRMC) studies, or ground truth establishment in the context of diagnostic performance.

Therefore, many of the requested items related to AI/ML performance, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted:

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

The document doesn't present acceptance criteria and performance in a direct "criteria vs. reported data" table format as one might find for a diagnostic device. Instead, it states that the device was evaluated and met standards. The "performance" is implicitly the successful demonstration of meeting these standards.

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

Not applicable. This is a medical device (wound dressing) and the evaluation involves non-clinical laboratory testing, not a "test set" of patient data for diagnostic performance. The testing was conducted on samples of the device itself.

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

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., expert consensus on medical images) is not relevant for this type of non-clinical device testing.

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

Not applicable. This is not a study involving human reader interpretation or adjudication.

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 document pertains to a wound dressing, not an AI-driven diagnostic or assistive device.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" here is the defined performance and safety standards for medical devices (e.g., ISO, EN, ASTM standards) and the results of laboratory tests conducted to demonstrate compliance with these standards. For example:

• Biocompatibility: In vitro and in vivo test results against established toxicology profiles.
• Antimicrobial Effectiveness: Laboratory culture results demonstrating bacterial growth inhibition.
• Sterilization: Microbiological testing (e.g., bioburden, sterility testing) results.
• Shelf-life: Real-time aging studies and performance testing after aging.

8. The sample size for the training set:

Not applicable. This is not a machine learning device, so there is no training set. The tests were performed on representative samples of the manufactured device.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

• (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
• (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.

The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.

Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

The provided text is a 510(k) Summary for a medical device (LUOFUCON® Silicone Ag+ Foam Dressing). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component, which is what your request implies about typical 'acceptance criteria' and 'study' information.

Therefore, I cannot extract the information you requested about AI/software performance, such as:

• Table of acceptance criteria and reported device performance (for AI/software): The document reports performance testing for the physical dressing (e.g., adhesive property, water absorbency, pH value, MVTR, waterproofness, antibacterial effectiveness, sterility), but not for any AI/software components.
• Sample size for the test set and data provenance: Not applicable as there's no AI/software test set.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can provide the acceptance criteria and performance data for the physical medical device as reported in the document:

The document describes various performance tests conducted to ensure the subject device is substantially equivalent to the predicate device. It doesn't present these as strict "acceptance criteria" with numerical targets in a table, but rather lists the tests performed and implies that the device "met all design specifications" and was "Substantially Equivalent (SE)" to the predicate with identical performance specifications.

Here's a summary of the performance tests mentioned for the physical device:

Performance Testing for LUOFUCON® Silicone Ag+ Foam Dressing

Additional Context from the document:

• Study Design/Purpose: The overall study described in the 510(k) submission is to demonstrate substantial equivalence of the LUOFUCON® Silicone Ag+ Foam Dressing to a legally marketed predicate device (K223360), not to establish novel performance criteria for an AI/software component.
• Modifications: The only modification to the predicate device was the addition of a new, larger size to the Non-Bordered and Transfer models. The document states, "the material properties of the subject device and predicate device remain the same and the performance specifications are also identical, the difference in size does not affect the effectiveness of the product."
• Clinical Study: No clinical studies were conducted for the subject device.
• Biocompatibility Testing: No additional biocompatibility tests were conducted for this submission. All biocompatibility data were leveraged from the predicate device (K223360) and included tests according to ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP 41-N36.
• Ground Truth (for the physical device): The "ground truth" for the physical device performance is established by adherence to recognized international and national standards (ASTM, BS EN, USP, ISO). The reported performance indicates that the device met the requirements of these standards and, by extension, is substantially equivalent to a predicate device that also meets these standards.

Ask a specific question about this device