Search Results

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."

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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

Skin Barrier Film is a liquid intended for use as a film-forming product. Upon application to intact or damaged skin, this product forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.

Skin Barrier Film is a liquid intended for use as a film-forming product.

I am sorry, but the provided text from the FDA letter does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter for a "Skin Barrier Film" (K092712), indicating that the device has been found substantially equivalent to a predicate device.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

It then goes on to outline regulatory requirements and disclaimers, but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or expert qualifications for a test study.
3. Information about ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.
4. Information about standalone algorithm performance or training set details.

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

Ask a specific question about this device

Ecocel® is a hydrosoluble lacquer indicated to protect intact or damaged nails from the effects of moisture, friction (rubbing) or shear (tearing), relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility).

Ecocel® is a water-soluble lacquer contained in a glass bottle (1.5 or 3.3 mL) with a nylon brush fitted on the polypropylene screw cap.

The provided documentation for the Ecocel® device (K083087) does not contain sufficient information to describe specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

The document is a 510(k) summary for a Class I liquid bandage, Ecocel®, seeking substantial equivalence to existing predicate devices. It primarily focuses on the regulatory submission process and the determination of substantial equivalence by the FDA.

Here's an analysis based on the available information:

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

   • Not provided. The document states that Polichem submitted "summaries of preclinical studies, including biocompatibility and laboratory studies, and the reports from clinical studies as well as the post market experience in Europe that substantiate Ecocel's performance both in vitro as well as its in vivo use." However, no specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds, or performance metrics) or corresponding reported performance data are detailed.

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

   • Not provided. The summary mentions "clinical studies" and "post market experience in Europe" but does not specify sample sizes, design (retrospective or prospective), or the exact country of origin for the data.

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/Not provided. This type of information is typically relevant for medical imaging or diagnostic devices where expert consensus is used to establish ground truth for classification tasks. For a liquid bandage, ground truth would likely be established through objective measures of efficacy (e.g., reduction in nail splitting) or patient-reported outcomes, rather than expert interpretation of images. The document does not detail how outcomes were assessed or by whom.

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

   • Not applicable/Not provided. Similar to point 3, adjudication methods are usually applied to expert reviews in diagnostic studies. For a liquid bandage, if patient-reported outcomes or clinical assessments were used, the method of resolving discrepancies would be detailed, but this is not present in the summary.

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. MRMC studies are specific to diagnostic devices where human readers interpret cases, often with or without AI assistance. This device is a liquid bandage, not an AI-powered diagnostic tool. Therefore, an MRMC study would not be relevant.

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

   • Not applicable. This device is a topical medical product, not an algorithm, so a standalone algorithm performance study is not relevant.

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

   • Inferred to be outcomes data and possibly subjective assessments. The indications for use state "relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility)." "Relief of symptoms and signs" would likely be measured through patient diaries, clinical assessments (e.g., visual scores of nail integrity), or other objective measures of nail health. The document does not explicitly state the methodology.

8. The sample size for the training set

   • Not applicable/Not provided. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. If clinical studies were performed, the number of subjects in those studies would be the relevant "sample size," but this is not specified.

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

   • Not applicable/Not provided. As there is no training set for an algorithm, this question is not relevant. For the clinical studies mentioned, the "ground truth" (i.e., whether the treatment was effective) would be based on the pre-defined endpoints and measurement methodologies of those studies, which are not detailed.

In summary, the provided 510(k) summary for Ecocel® confirms its regulatory clearance based on substantial equivalence. However, it does not offer the granular detail on acceptance criteria, study methodologies, sample sizes, or ground truth establishment that would be present in a comprehensive study report, especially one for an AI or diagnostic device. The document states that the device's performance was substantiated by "preclinical studies" and "clinical studies," but the specifics of these studies are not disclosed in this summary.

Ask a specific question about this device