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Prescription Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

OTC Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

LUOFUCON® Skin and Wound Cleanser is a clear, colorless solution with a mild odor. It helps in the mechanical removal of debris and foreign materials from the skin, wounds, or application sites. This product contains 0.1% w/w polyhexamethylene biguanide (PHMB) as a preservative, which helps inhibit the growth of microorganisms in the solution.

LUOFUCON® Skin and Wound Cleanser is available in various packaging forms, such as Spray, Mist, Squeeze, and Bottle models. They can be suited for different clinical situations.

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The Hemastyl Wound Gel is indicated for use as follows:

Hemastyl Wound Gel

Rx: Management of wounds such

• 1st degree burns and 2nd degree superficial burns
• stasis ulcers
• pressure ulcers
• diabetic ulcers
• lacerations
• abrasions
• skin tears
• surgical incision sites
• device insertion site wounds
• graft sites
• donor sites

OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.

Hemastyl™ Wound Dressing is a repeat use, amorphous hydrogel containing silver chloride (AgCl), cupric chloride (CuCl2) and ferric chloride (FeCl3) as preservatives and HA and fish collagen for use in the management of wounds.

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The Tegaderm™ Post-Op Transparent Antimicrobial Dressing is a waterproof, single use, sterile dressing with Chlorhexidine Gluconate (CHG), intended to be used on adult patients by healthcare professionals to cover and protect closed surgical incisions or laparoscopic incision and a percutaneous device(s) (e.g., sutures, staples, tissue adhesives).

Tegaderm™ Post-Op Transparent Antimicrobial Dressing includes a transparent adhesive dressing and an integrated transparent gel pad containing Chlorhexidine Gluconate (CHG) at a concentration of 1.2% (w/w). The transparent adhesive dressing provides a barrier against external contamination including fluids (waterproof), bacteria, mold and yeast, and is classified as a breached skin contact device intended for use on closed incisions.

In vitro testing (log reduction and barrier testing) demonstrates that the CHG gel pad in the Tegaderm™ Post-Op Transparent Antimicrobial Dressing has an antimicrobial effect against, gram-positive and gram-negative bacteria, yeast, and mold in the dressing. The gel pad absorbs fluid. Tegaderm™ Post-Op Transparent Antimicrobial Dressing is transparent, allowing for continual site observation, and is breathable, allowing moisture vapor exchange.

The device is sterile. Terminal sterilization is conducted with ethylene oxide.

As part of the Predetermined Change Control Plan, the Tegaderm™ Post-Op Transparent Antimicrobial Dressing design will be updated to include bodily fluid barrier protection. This product requirement will be tested per the ASTM Method F1670 Synthetic Blood Penetration standard.

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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 <51>, USP <151>). 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.

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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.

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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.

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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 <51>): 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 <85>): 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.

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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 <85> and USP <51> 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.

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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 <51>) 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.

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