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Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.

Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that contains sodium hypochlorite and hypochlorous acid as preservatives to prevent the growth of microorganisms within the container during shelf-life.

The provided text is a 510(k) summary for the Microdacyn Hydrogel, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria in the manner you've outlined for an AI/algorithm-based device.

The information you are asking for, such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are typically relevant for AI/ML-driven diagnostic or prognostic devices.

The Microdacyn Hydrogel is a wound dressing that relies on its physical and chemical properties for its intended use, not on complex data analysis or AI algorithms. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are addressed through a comparison with a predicate device and standard performance and biocompatibility testing.

Here's an attempt to structure the available information per your request, with the understanding that many fields will be "N/A" due to the nature of the device:

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

• Rx Management of wounds associated with dermal irritation, sores, injuries, ulcers of dermal tissue.
• Rx Use on first and second-degree burns, exuding wounds (leg ulcers, pressure ulcers, diabetic ulcers), and mechanically/surgically debrided wounds.
• OTC Use on minor skin irritations, lacerations, abrasions, minor burns.
• OTC Management of irritation from minor sunburn. | Determined to have the same intended use as the predicate device (Microcyn Skin and Wound HydroGel (K093585)).
  The Indications for Use are almost identical, lacking only the explicit mention of "itch and pain relief" from the predicate. The FDA clearing the 510(k) indicates acceptance of this proposed use. |
  | Technological Characteristics:
• Where Used: RX Only; OTC
• Delivery System: Hydrogel
• Mechanism of Action: Maintaining a moist wound environment.
• Composition: Water (96.524%), Sodium Magnesium Fluorosilicate (3.000%), Sodium Phosphate (0.400%), Sodium Chloride (0.066%), Hypochlorous acid (0.008%), Sodium Hypochlorite (0.002%)
• Sterilization: Non-sterile
• Shelf Life: Acceptable shelf life
• Specification: Viscosity
• Container closure system: 50 mL, 100 mL, 200 mL PET bottles with PP Snap-top screw cap and lift 'n' peel liner. | Determined to have the same technological characteristics as the predicate device.
• Where Used: Same as predicate.
• Delivery System: Same as predicate.
• Mechanism of Action: Same as predicate.
• Composition: Same as predicate.
• Sterilization: Same as predicate.
• Shelf Life: 24 months (longer than predicate's 18 months, which is generally acceptable if proven stable).
• Specification: Viscosity: 12,000-20,000 cP (same as predicate's specification according to the table, though the predicate's value isn't explicitly stated).
• Container closure system: Expanded options (50mL, 100mL, 200mL) compared to predicate's 2oz, but within acceptable parameters for hydrogel. |
  | Safety and Effectiveness:
• Biocompatibility
• Antimicrobial Effectiveness | Biocompatibility Testing:
• Met ISO-10993-1 Biological Evaluation of Medical Devices.
  Performance Testing:
• Met USP Antimicrobial Effectiveness Testing . |

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

• Sample Size: Not applicable in the context of an "AI test set." The performance data is derived from standard laboratory testing for biocompatibility and antimicrobial effectiveness, not from human subject data or a diagnostic test set.
• Data Provenance: Not applicable in the context of clinical data provenance. The tests are laboratory-based, adhering to ISO and USP standards.

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

• Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device. The "ground truth" for the performance data comes from the established scientific standards of ISO-10993-1 and USP .

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

• Not applicable. Adjudication methods are relevant for human interpretation or clinical endpoint assessments, not for laboratory performance tests of a hydrogel.

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 hydrogel wound dressing, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

• Not applicable. There is no algorithm to assess.

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

• Not applicable in the AI/ML context. For this device, the "ground truth" is defined by adherence to established international and pharmacopeial standards for biocompatibility (ISO-10993-1) and antimicrobial effectiveness (USP ).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the machine learning sense.

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

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

In summary: The Microdacyn Hydrogel is a non-AI/ML device. Its acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device (Microcyn Skin and Wound HydroGel) through a comparison of intended use and technological characteristics, supplemented by standard laboratory-based performance (biocompatibility and antimicrobial effectiveness) testing, rather than studies involving human data sets, expert review, or AI algorithm validation.

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Rx Indications for Use: Under the supervision of a healthcare professional, Microdacyn Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

Microdacyn Wound Care Solution is a clear solution that aids in the mechanical removal of debris and foreign material from the application site. The solution contains sodium hypochlorite and hypochlorous acid as preservatives to reduce/prevent the growth of microorganisms within the solution.

This document is a 510(k) Pre-market Notification summary for a medical device called "Microdacyn Wound Care Solution." It categorizes the device as unclassified and uses predicate devices to establish substantial equivalence.

The document does not describe acceptance criteria or a study proving the device meets the acceptance criteria in the manner one would typically expect for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics, indications for use, safety, and performance.

Therefore, I cannot provide the information requested in the prompt (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) because the provided text does not contain this type of data or study design. The "performance testing" mentioned is an "Antimicrobial Effectiveness Test" (USP ), which is a microbiological test, not a clinical performance study measuring accuracy or efficacy in the context of disease diagnosis or treatment effectiveness in a human population.

Here's why the requested information isn't present in this type of submission:

• Device Type: Microdacyn Wound Care Solution is a physical chemical product (a wound cleanser), not an AI/ML diagnostic or prognostic device.
• Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. For devices like this, the "acceptance criteria" are based on comparing characteristics like composition, mechanism of action, intended use, and safety, rather than statistical performance metrics from a clinical trial.
• "Study" Definition: The "studies" mentioned (Biocompatibility and Antimicrobial Effectiveness Tests) are laboratory tests to ensure safety and product integrity, not clinical trials to assess diagnostic accuracy or the impact of an AI algorithm on human reader performance.

If this were an AI/ML device submission, the requested information would be crucial. However, for this specific 510(k) for a wound care solution, the provided text contains the relevant information for its regulatory pathway.

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Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.

OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.

The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of >1000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.

This document describes a 510(k) premarket notification for the Microcyn Antimicrobial Hydrogel. The core of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a disease state or clinical outcome. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of clinical performance metrics are not directly applicable here.

However, we can interpret the "acceptance criteria" as the required testing to demonstrate substantial equivalence and "reported device performance" as the results of those tests confirming equivalence to the predicates.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission proving substantial equivalence for a medical device (a wound hydrogel), not a diagnostic algorithm, several of your requested points related to AI/algorithm performance studies, ground truth establishment, expert consensus, and reader studies are not applicable to this document. The document implicitly states that these tests demonstrate that the device is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance.

Here's why the other points are not applicable or cannot be answered from the provided text:

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

• Not Applicable / Not Provided: This device is a hydrogel, not a diagnostic algorithm tested on a dataset of patient cases. The "test sets" here would be samples of the hydrogel subject to physical, chemical, and biological testing as per standards. The document does not specify the number of samples used for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of product testing.

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)

• Not Applicable: There is no "ground truth" in the context of clinical disease states or image interpretation for a wound hydrogel being cleared via substantial equivalence. The "truth" is established by adherence to recognized standards for biocompatibility and bench performance, and by comparison to the established predicate devices.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to establish a definitive diagnosis or reference standard. This is not relevant for the physical, chemical, and biological testing of a hydrogel.

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 product is a hydrogel, not an AI-powered diagnostic device or an AI assistant for human readers. Therefore, MRMC studies and the concept of "human readers improving with AI" are entirely irrelevant to this submission.

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

• Not Applicable: This is not an algorithm.

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

• Not Applicable: As explained in point 3, there is no "ground truth" in the clinical diagnostic sense for this device. The "ground truth" for its performance is compliance with established physical, chemical, and biological specifications and equivalence to predicates already on the market.

8. The sample size for the training set

• Not Applicable: This device does not involve a "training set" as it is not an AI/ML algorithm.

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

• Not Applicable: As explained in point 8.

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Rx Indication: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.

The Alevicyn SG Antimicrobial Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer. Ingredients: Water, sodium lithium magnesium fluorosilicate, dimethicone, sodium phosphate, sodium bicarbonate, sodium chloride, sodium sulfate, with hypochlorous acid and sodium hypochlorite as gel preservatives.

The document provided describes a 510(k) Premarket Notification for the Alevicyn SG Antimicrobial Gel. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on showing equivalence through comparison and specific performance data, rather than detailing a direct study to "prove acceptance criteria" in the way one might for a novel device.

However, I can extract the acceptance criteria (specifications) and reported performance data based on the provided "Performance Data" section.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for any of the biocompatibility or bench tests. It also does not specify the country of origin or whether the data was retrospective or prospective. The nature of these tests (e.g., in-vitro toxicology, chemical property testing) typically involves lab-based experiments rather than human clinical trials with "test sets" in the traditional sense.

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

This information is not applicable and not provided in the document. For device submissions based on predicate equivalence and bench/biocompatibility testing, the "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1, USP ) and internal specifications for chemical and physical properties. There are no "experts" establishing ground truth in the context of clinical interpretation, as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or assessments, particularly for AI image interpretation. The studies described here are laboratory-based performance and safety evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI vs. Without AI Assistance

This information is not applicable and not provided. MRMC studies are relevant for evaluating diagnostic imaging systems (often AI-powered) where human readers interpret cases. The Alevicyn SG Antimicrobial Gel is a topical medical device, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, again typically for AI-driven diagnostic tools. This device is not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by:

• Adherence to recognized international standards like ISO 10993-1 ("Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process").
• FDA biocompatibility guidance (issued June 16, 2016).

For bench testing, the ground truth is established by:

• Internal specifications defined for pH, viscosity, FAC.
• Adherence to recognized pharmacopeial standards like **USP ** for antimicrobial preservative effectiveness.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical product (gel) and does not involve AI or machine learning models that require training sets.

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

This information is not applicable and not provided, for the same reason as above (no AI/ML training set).

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Rx Indications: Under the supervision of a healthcare professional, Microcyn Antimicrobial Skin and Wound Cleanser is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: Microcyn Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

The Microcyn Antimicrobial Skin and Wound Cleanser is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds.

The provided text describes a 510(k) summary for the Microcyn Antimicrobial Skin and Wound Cleanser, which sought to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve a device that requires performance against specific clinical acceptance criteria in the same way a novel AI algorithm might. Instead, the focus is on showing that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details, such as human-in-the-loop studies, AI training/test sets, and expert adjudication, are not applicable to this type of medical device submission.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

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

Since this is a substantial equivalence determination for a wound cleanser, the "acceptance criteria" are not defined as specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to demonstrating similar technological characteristics, safety, and effectiveness to predicate devices. The "reported device performance" is primarily about meeting various bench and biocompatibility testing standards and showing comparable properties to the predicate devices.

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

• Not Applicable. This is a wound cleanser, not a diagnostic device relying on a "test set" of patient data for performance evaluation in the context of AI. The performance data consists of laboratory bench tests and biocompatibility studies.

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

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

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 is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. Ground truth in the context of AI or complex diagnostic accuracy is not relevant here. The "ground truth" for this device's efficacy and safety relies on established scientific methods for evaluating chemical composition, microbiological effectiveness, physical properties (pH, osmolality), and biocompatibility.

8. The sample size for the training set:

• Not Applicable. This is not an AI algorithm; there is no "training set."

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

• Not Applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a wound care product. The "study" demonstrating that the device meets "acceptance criteria" primarily refers to biocompatibility testing and bench testing (e.g., chemical properties, microbiological preservative efficacy, shelf-life testing) to show that the device is safe, performs as intended, and is substantially equivalent to existing predicate devices. It does not involve clinical studies with patient data, AI algorithms, or expert ground truthing as would be seen for diagnostic software.

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Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: Microcyn Plus Antimicrobial™ Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

The Microcyn Plus Antimicrobial Wound Care Solution is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds. The solution is supplied in glass bottles with lined caps with a pH range of 3.5 - 6.0. Ingredients: water, sodium chloride, hypochlorous acid.

The provided text describes a 510(k) summary for the Microcyn Plus Antimicrobial Wound Care Solution, which evaluates its substantial equivalence to predicate devices. This type of submission relies on demonstrating similarity to already legally marketed devices rather than conducting a full clinical study to prove efficacy, especially for Class I or II devices where such extensive studies might not be required.

Therefore, the information regarding acceptance criteria and performance is focused on bench testing and biocompatibility to prove the device's similarity and safety, rather than a clinical trial with human subjects, AI performance metrics, or complex ground truth establishment.

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

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

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the way one might expect for an AI/diagnostic device. Instead, the performance data provided are primarily for bench testing to ensure the new device functions similarly to the predicate devices and meets safety standards.

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

This information is not applicable or not provided in the context of this 510(k) summary. The testing described is laboratory-based bench testing and biocompatibility assessments, not a clinical trial with a "test set" of patient data.

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

This information is not applicable or not provided. Since there isn't a "test set" of clinical data requiring expert review for ground truth, this aspect is not part of the submission. The ground truth for chemical and physical properties comes from established scientific methods and readings.

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

This information is not applicable or not provided. There is no clinical test set requiring 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

This information is not applicable. The device is a wound care solution, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to this submission.

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

This information is not applicable. The device is not an algorithm or AI.

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

The "ground truth" for the tests performed is based on established laboratory standards, chemical analysis, and microbiological testing methodologies. For example:

• Biocompatibility: Adherence to ISO standards and FDA guidelines.
• pH, Osmolality, FAC: Instrumental measurements against known chemical standards.
• Preservative Effectiveness: Standardized microbiological challenge tests (USP ) against recognized microbial strains.

8. The sample size for the training set

This information is not applicable or not provided. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The development and formulation of the solution would involve iterative testing, but not in the sense of a machine learning training set size.

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

This information is not applicable or not provided. As above, there is no "training set" for an AI algorithm. The development of the solution would rely on scientific principles and established chemical and biological testing methods for quality control and formulation, rather than a labeled "ground truth" for training an algorithm.

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Rx Indications for Use: Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including 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/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

The Hydrocleanse Antimicrobial Skin and Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and device irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.

The provided document is a 510(k) premarket notification for a medical device (Hydrocleanse Antimicrobial Skin and Wound Solution). It primarily discusses the device's substantial equivalence to predicate devices based on intended use, technological characteristics, safety, and effectiveness.

Crucially, this document does NOT describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, specifically regarding performance metrics like sensitivity, specificity, or AUC, a test set, ground truth establishment by experts, or MRMC studies.

Instead, the "Performance Data" section details:

• Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. This ensures the material is safe for biological interaction.
• Bench Testing: This includes physical and chemical property tests (package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC)) and **USP ** testing for preservative effectiveness against specific bacteria (Proteus mirabilis, Serratia marcescens, Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), and Acinetobacter baumannii).

These tests are standard for a liquid medical device like a wound solution, but they are not related to an AI/ML algorithm's performance.

Therefore, because the document describes a chemical/physical product and not an AI/ML device, the requested information cannot be extracted. I cannot fill in the table or answer the questions related to AI/ML device performance, ground truth, expert opinions, or MRMC studies based on this document.

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