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TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.

TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.

The provided text describes a 510(k) premarket notification for a medical device called "TearRepair Liquid Skin Protectant." This submission seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "Marathon No Sting Liquid Skin Protectant" (K133443).

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. The "TearRepair Liquid Skin Protectant" is a physical medical device (liquid bandage) and not an AI/ML-powered device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of device in the provided text.
2. Sample size used for the test set and the data provenance: Not provided, as this is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as this is not an AI/ML study.
4. Adjudication method for the test set: Not provided, as this is not an AI/ML study.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used: Not applicable, as this is not an AI/ML study.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document focuses on non-clinical bench testing and biocompatibility testing for a physical liquid skin protectant, as summarized below:

Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety based on current industry standards, indicating that TearRepair is substantially equivalent to the predicate device:

Bench Testing:

• Mechanical Testing/Adhesive strength testing
• Heat of Polymerization
• Moisture Vapor Transmission Rate
• Setting Time of Liquid Skin Protectant
• Applicator Functionality

Biocompatibility (ISO 10993 series):

• Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Irritation (ISO 10993-10)
• Acute systemic toxicity (ISO 10993-11)
• Material-mediated pyrogenicity (ISO 10993-11, USP )
• Subacute toxicity (ISO 10993-11)
• Implantation (ISO 10993-6)

Acceptance Criteria and Reported Device Performance
The document states that "No FDA performance standards have been established for TearRepair." Therefore, while specific tests are listed, the explicit quantitative acceptance criteria and the numerical reported performance for each test are not provided in the given text. The conclusion merely states that the results "indicate that TearRepair is substantially equivalent to the predicate device" and "does not raise different questions of safety or effectiveness compared to the predicate devices."

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Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability.

Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.

The provided text describes a 510(k) premarket notification for the Rochal Bioshield Silicone Film. This document is a submission for medical device clearance, not a study report for an AI/ML powered device. Therefore, the information requested about acceptance criteria, specific study design for device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.

The document primarily focuses on demonstrating the substantial equivalence of the Rochal Bioshield Silicone Film to legally marketed predicate devices through comparisons of indications for use, product film appearance, and functions, as well as general performance testing related to biocompatibility and sterility.

Here's a breakdown of what can be extracted and what is missing:

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

The document provides a comparison table between the subject device (Rochal Bioshield Silicone Film), a predicate device (KeriCure Advanced Liquid Bandage), and a reference device (No Sting Barrier Film). While it lists features being compared, it does not outline specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device.

Reported Performance (General):

• Biocompatibility: Passed ISO 10993 studies (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis, and toxicological risk assessment).
• Sterility: Gamma sterility verified using USP 71, Sterility Tests.
• Shelf life: Real-time aging study indicates the product is stable and effective for the proposed shelf life.

Missing Information (due to the nature of the document):

• Specific quantitative acceptance criteria for each 'feature being compared'.
• Detailed quantitative performance benchmarks or statistical results from the device's operation.

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 provided in the document. The document refers to "biocompatibility studies" and a "real-time aging study," but no details on sample sizes or data provenance are given for these tests. This is not an AI/ML device, so there is no "test set" in that context.

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 applicable and not provided. The device is a physical product (liquid bandage), not an AI/ML system that requires expert-established ground truth for performance evaluation in the context of diagnostic or prognostic tasks.

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

This information is not applicable and not provided for the same reasons as point 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:

This information is not applicable and not provided. This is not an AI-assisted device, therefore no MRMC study with human readers assisting with AI would have been performed.

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

This information is not applicable and not provided. This is not an algorithm or AI system.

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

This information is not applicable and not provided. As a physical product, the "ground truth" for its performance would typically be based on established scientific methods for measuring physical and chemical properties (e.g., film formation, permeability, biological response in specific tests) rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI/ML system that requires a "training set."

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

This information is not applicable and not provided. The device is not an AI/ML system.

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Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.

Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.

The provided text is a 510(k) summary for the Aleo BME Liquid Bandage. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, it does not contain specific acceptance criteria or the details of a study with reported device performance metrics in the format requested.

It states that "Physical, mechanical and preservative effectiveness testing results confirm that the Aleo BME Liquid Bandage meets the product design specifications" and that "performance testing of the Aleo BME Liquid Bandage was compared to the predicate devices," but it does not provide the actual criteria or results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided document.

The document focuses on the regulatory submission for substantial equivalence based on the device's design, function, and intended use being similar to existing legally marketed devices, rather than a detailed presentation of performance data against specific acceptance criteria.

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The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.

The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.

SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.

Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.

This document is a 510(k) Premarket Notification from the FDA regarding the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set. It establishes substantial equivalence to existing predicate devices, indicating that no new clinical study was required to prove safety and effectiveness for a new medical device. Instead, the submission focuses on demonstrating that the new packaging configurations and additional kit components of the subject devices do not alter their fundamental safety and performance characteristics compared to the previously cleared predicate devices.

Therefore, the typical acceptance criteria and study design for proving the performance of a novel AI-powered medical device are not applicable in this context. This submission is for a conventional medical device (infusion sets and needles) and relies on bench testing, material comparisons, and risk management rather than clinical performance studies with AI.

However, I can extract information related to the acceptance criteria for this specific submission, which pertains to the device's substantial equivalence and safety/performance after changes, rather than a de novo AI device.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable to this submission):

For this 510(k) submission, the "acceptance criteria" are not related to a specific performance metric of an AI model (like accuracy, sensitivity, specificity). Instead, they revolve around demonstrating that the new configurations and kit components of the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set maintain the same safety and performance profiles as their cleared predicate devices.

The document implicitly states that for the original devices (the predicates), their performance was deemed acceptable for their stated indications. For this new submission, the acceptance criteria are met by demonstrating "substantial equivalence" based on:

• Product Code
• Review Branch
• Intended Use
• Indications for Use
• General Device Description
• Y-Site presence
• Duration of Use
• Device Materials
• Sterility Method (Ethylene Oxide)
• Sterility Assurance Level (SAL 10-6)
• Number of Uses (Single-use)
• Anatomical Site Use
• Principle of Operation
• Safety Infusion Set Device Components
• Sizes (Needle Gauge, Needle Length)
• Needle OD
• Tubing Dimensions (ID, OD, Length)
  Note: The addition of new kit components is acknowledged but they are themselves legally marketed, cleared devices. |
  | Safety and Performance After Changes: The new packaging configurations and additional kit components do not negatively impact the biological safety or functional efficacy of the devices. | Met: "Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use." (Page 14) |

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

• This 510(k) submission does not involve a "test set" in the context of an AI model's performance on clinical data.
• The evaluation is based on "safety and performance tests" (Page 15) conducted on the physical devices and their components. The document does not specify the sample sizes for these bench tests, but it states that the "kit components met all predetermined acceptance criteria" and that a "risk management" process was followed.
• Data provenance is not applicable in the sense of patient data from specific countries or retrospective/prospective studies. The "data" here refers to engineering and biocompatibility test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This is not applicable as there is no "ground truth" in the context of clinical images or patient data being interpreted by AI.
• The ground for proving substantial equivalence relates to regulatory standards, engineering specifications, and established biocompatibility principles. The FDA review team acts as the expert body for evaluating this submission.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This submission is for physical medical devices (infusion sets/needles), not an AI algorithm assisting human readers. Therefore, there is no AI assistance component to measure improvement.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• The "ground truth" in this submission is the accepted safety and performance of the predicate devices and the physical/chemical characteristics of the materials and design, verified through bench testing and adherence to recognized standards (e.g., sterilization, biocompatibility, risk management according to ISO 14971:2012).

8. Sample Size for the Training Set:

• Not applicable. There is no AI model or training set involved.

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

• Not applicable for the reasons stated above.

In summary, this FDA 510(k) document demonstrates substantial equivalence for conventional medical devices after a minor change (new packaging/kit components), rather than proving the performance of a novel AI-powered medical device through clinical studies. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence and ensuring that the modified devices maintain their established safety and functional efficacy through engineering and biocompatibility testing.

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Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.

3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacylate is dispersed in a non-stinging solvent. The film is colorless and non-cytotoxic. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.

The provided text describes the 3M™ Cavilon™ Advanced Skin Protectant, a Class I liquid bandage. However, it does not contain information related to a study that establishes acceptance criteria for an AI/ML powered device, nor does it report on the performance of such a device against those criteria.

The document is a 510(k) premarket notification summary for a physical medical device (skin protectant). It outlines the device's description, indications for use, comparison to predicate devices, and performance data from biocompatibility, bench, and clinical studies.

Therefore, I cannot provide the requested table and study details about AI/ML device acceptance criteria and performance based on the input document.

To directly answer the specific points you requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes general performance data for a physical skin protectant (biocompatibility, durability, wash-off resistance), not AI/ML performance metrics.
2. Sample sizes used for the test set and the data provenance:
   • Test Set Sample Size: The clinical studies mentioned healthy subjects, but specific sample sizes are not provided in this summary for the "durability study" or the "wash off resistance study."
   • Data Provenance: The document does not specify the country of origin of the data. The studies are described as "Controlled, randomized open label durability study on healthy subjects" and "Prospective, open label wash off resistance study on healthy subjects," indicating they were prospective clinical studies.
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 and therefore not present. The studies are evaluating the physical properties and effectiveness of a skin protectant on human skin, not an AI's diagnostic or predictive capabilities requiring expert-established ground truth.
4. Adjudication method for the test set: This information is not applicable and therefore not present.
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 and therefore not present. The device is a physical skin protectant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable and therefore not present. The device is a physical skin protectant.
7. The type of ground truth used: For the clinical studies, the "ground truth" would likely be direct observation of skin condition, barrier effectiveness, and durability, potentially through clinical assessments by healthcare professionals or physical measurements, but this is not detailed in the summary. For the biocompatibility and bench tests, ground truth is established by standardized laboratory testing methods and measurements.
8. The sample size for the training set: This information is not applicable and therefore not present, as the device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: This information is not applicable and therefore not present.

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Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.

Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.

The provided document describes the Atteris No Sting Skin Protectant and its performance characteristics, primarily to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation (e.g., diagnostic accuracy on a test set). Instead, it details performance testing to substantiate specific product claims related to its physical and biological properties.

Therefore, many of the requested sections related to AI device evaluation (such as sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to the information contained in this document.

However, I can extract the acceptance criteria (claims) and the reported device performance from the provided text for the aspects that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of inapplicable AI/Software Device Evaluation Criteria:

The following items are not applicable as this document describes a physical medical device (skin protectant) and its chemical/biological properties, not an AI/software device for diagnostic or predictive purposes.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Details of the Studies Conducted (as per the document):

• No Sting:
  • Study: Human testing using the Skin Trauma After Razor Shaving (STARS) bioassay.
  • Purpose: To determine if the protectant caused subjective stinging when applied to skin challenged by dry shaving.
• Barrier Film:
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Method: Carbon retention test method.
• Sterile:
  • Study: USP 71, Sterility Tests.
  • Sample Size: 10 test samples.
  • Conditions: After 2 months of accelerated aging.
• Breathable:
  • Study: Oxygen and moisture vapor transmission rate testing.
• Biocompatible:
  • Study: Testing consistent with ISO 10993.
  • Specific Tests:
    • Cytotoxicity: L929 Agar Diffusion Test (Direct Contact); ISO Final GLP Report: 15-04007-G1. Test article: Atteris Skin Protectant on mouse fibroblast L929 cells.
    • Direct Primary Skin Irritation: ISO Final GLP Report: 15-04007-G2. Test article: Atteris Skin Protectant on abraded skin sites of New Zealand White rabbits (single topical minimum 4-hour application).
    • Direct Buehler Sensitization: ISO Final GLP Project: 15-04007-G3. Test article: Atteris Skin Protectant on albino guinea pigs (topical application).
• Dries in ~60 seconds:
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Purpose: To determine dry time.
• Good in Skin Folds (non-self-adherent):
  • Study: Human testing conducted at cyberDERM Clinical Studies.
  • Comparison: To the commercial control, 3M Cavilon No Sting Barrier Film.
• Single Patient Use (Use life-28 days after opening):
  • Study: Use life testing.
  • Method: Product opened, sprayed, left open for 28 days, then re-tested to confirm performance characteristics.

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KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear, breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.

The provided text describes information about the KeriCure™ Advanced Liquid Bandage, a medical device, and its substantial equivalence to predicate devices, focusing on performance and biocompatibility testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, human expert involvement, or AI-related effectiveness.

Here's an analysis of what is available vs. what is not:

Information Present in the Document:

• Device Name: KeriCure™ Advanced Liquid Bandage, KeriCure™ Liquid Bandage, KeriCure Natural Seal™ Liquid Bandage.
• Intended Use: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions (for Advanced version).
• Product Code: KMF (Liquid bandage)
• Regulatory Class: Class I
• Predicate Devices: K083913 – NUVADERM – Chesson Labs; K991920 – Dermaphylyx Hydrophilic Wound Dressing, Dermaphylyx, Inc.
• Biocompatibility Testing: Passed ISO 10993-10 for irritation and skin sensitization. Cytotoxicity testing performed according to 10993-5, with spray applicator scoring 1.
• Shelf Life Testing: Performed according to ISO11737-1, ASTM F1980, USP-51 and USP-35, indicating a 12-month shelf life.
• Performance Testing (General): "Performance testing for KeriCure™ Liquid Bandages was performed according to the following standards: ASTM 570, ASTM D638-10, ASTM D789, E96/ E96M-10. The applicant device passed all testing requirements with results similar to the predicate devices in terms of performance capabilities."
• Substantial Equivalence: Claimed based on similar fundamental technological characteristics (flexible wound management, moisture barrier, absorptive qualities, infection protection) and verified by test results in design, materials, and intended use.

Information NOT present in the Document (that you requested):

1. A table of acceptance criteria and the reported device performance: While general statements about "passing all testing requirements" are made, specific numerical acceptance criteria (e.g., "tear strength must be > X N/mm") and the device's exact reported performance values are not provided.
2. Sample size used for the test set and the data provenance: The document mentions "testing requirements" and "test results" but does not specify the sample sizes (e.g., number of bandages tested, number of subjects in a trial) or the origin of the data (e.g., country, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This device is a liquid bandage, not typically an AI-driven diagnostic tool that relies on expert interpretation of images or other data for ground truth establishment. Therefore, this information is not relevant or present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.
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 explicitly for AI-assisted diagnostic or interpretative devices. The KeriCure™ Advanced Liquid Bandage is a physical wound dressing; it does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance characteristics mentioned (e.g., elasticity, water vapor transmission), the "ground truth" would be established by the defined parameters within the ASTM/ISO standards themselves, rather than expert consensus or pathology data. For biocompatibility, the ground truth is the absence of irritation, sensitization, or cytotoxicity as defined by the ISO standards.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary: The provided text details the regulatory clearance for a liquid bandage, including its intended use, predicate devices, and general statements about biocompatibility and performance testing against established standards. However, it lacks the specific quantitative data, study designs, and human expert involvement details that would be found in a submission for an AI-powered diagnostic device or a study designed to evaluate human performance with and without AI assistance.

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Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).

Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a premarket notification for a medical device (Marathon No Sting Liquid Skin Protectant). It discusses the regulatory classification and general controls applicable to the device.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies for an AI/algorithm-based medical device.

Therefore, I cannot fulfill your request for this information based on the provided text.

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The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.

Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted

The medical device in question is the Iodofoam® Iodophor Foam Dressing. The study provided focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific performance acceptance criteria for a novel device.

The 510(k) summary provided indicates that the primary approach to establishing substantial equivalence for the Iodofoam® Iodophor Foam Dressing was through comparison to legally marketed predicate devices: Iodoflex® Pads (K940414) and Iodosorb® Gel (K905069).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a new device having to meet specific performance thresholds. Instead, it demonstrates that the Iodofoam® device's characteristics are "substantially equivalent" to two predicate devices. The study aimed to show that the new device's performance falls within the range or is comparable to existing, legally marketed devices for key characteristics.

The table below presents the comparative data points used to demonstrate substantial equivalence, which effectively serve as the "acceptance criteria" through a bracketing or comparability approach.

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

Cumulative Iodine Release:

• Sample Size: "three independent lots of each device" (Iodofoam®, Iodosorb®, and Iodoflex®). The exact number of samples per lot is not specified but implies multiple measurements per lot to establish average and lot-specific profiles.
• Data Provenance: In vitro study, conducted in distilled water under agitation at 37°C. The country of origin of the data is not specified but is implied to be from an independent lab commissioned by Progressive WoundCare Technologies. The study is prospective in nature since it was conducted specifically for this 510(k) submission.

Biocompatibility Testing & In Vivo Histology/Wound Healing Model:

• Sample Size:
  • Cytotoxicity (ISO): Not specified, typically uses cell cultures.
  • Intracutaneous Reactivity (ISO): Not specified, typically involves animal subjects.
  • Guinea Pig Maximization Testing (ISO): Not specified, typically involves animal subjects.
  • In Vivo Porcine Wound Healing Model: Not specified, but involved comparing Iodofoam®, Iodoflex®, and "PVA controls."
• Data Provenance: The document states "an independent in vitro study" for iodine release and "Biocompatibility testing (per ISO 10993)" and "in vivo porcine wound healing model" for other aspects. The country of origin is not mentioned. These studies were prospective, conducted for the purpose of the 510(k) submission.

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

This inquiry is not directly applicable to the type of device and studies presented. The studies involve laboratory measurements (iodine release, cytotoxicity, histology) and animal models, not human interpretation requiring expert consensus on a test set. Therefore, there are no "experts used to establish ground truth" in the context of clinical interpretation, nor are qualifications mentioned. The ground truth is established through standardized laboratory procedures and measurement protocols.

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

Not applicable. This concept is typically relevant for studies where subjective human interpretation (e.g., radiology reads) requires reconciliation or consensus, which is not the case for these laboratory and animal model studies.

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. An MRMC study is relevant for evaluating diagnostic systems involving human readers and typically artificial intelligence. The Iodofoam® Iodophor Foam Dressing is a physical wound dressing, and its evaluation does not involve human readers or AI in a diagnostic context.

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

Not applicable. This concept applies to AI algorithms and is irrelevant for a physical wound dressing device.

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

For the studies presented:

• Cumulative Iodine Release: The ground truth is objective quantitative measurement of iodine concentration (in ppm) over time through chemical analysis.
• Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Guinea Pig Maximization): The ground truth is derived from standardized in vitro and in vivo biological assays according to ISO 10993, which produce measurable endpoints (e.g., cell viability, erythema, edema).
• In Vivo Histology and Wound Healing Model: The ground truth is derived from histological examination of tissue samples and macroscopic observation/measurement of wound healing parameters in an animal model, often assessed by trained histopathologists or researchers.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The studies described are for direct characterization and comparison to predicate devices.

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

Not applicable, as there is no training set for this type of device evaluation.

Ask a specific question about this device

[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.

This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.

The provided text is related to a 510(k) summary for a "Liquid Bandage" device intended for nail dystrophy. However, the document does not describe acceptance criteria for software, an AI-powered device, or a study that uses a test set, ground truth, experts, or comparative effectiveness studies.

The document outlines the regulatory submission for a medical device (liquid bandage for nail dystrophy), comparing it to a predicate device (Ecocel®). It discusses general biocompatibility testing, preclinical studies, laboratory studies, and clinical safety studies to demonstrate substantial equivalence to the predicate.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information regarding software performance, AI, test sets, ground truth establishment, expert involvement, or comparative effectiveness with human readers is not present in the provided text.

The text mentions "clinical studies" for safety but gives no details about their design, sample size, or specific outcomes in relation to predefined performance acceptance criteria for a diagnostic or AI device.

Ask a specific question about this device