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HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.

HylaGuard Moisturizing Cream is a non-sterile, off-white, low odor, fragrance free, topical device product. HylaGuard Moisturizing Cream forms a semi-permeable, physical barrier that moisturizes and protects skin. HylaGuard Moisturizing Cream is an over-the-counter (OTC) device. The same device has been cleared for prescription use in K150914 under the name of Dash-Topic Plus Cream.

The provided document is a 510(k) premarket notification for a medical device called "HylaGuard Moisturizing Cream." This device is a topical cream intended for the dressing and management of minor skin irritations and minor burns. The document outlines comparisons to a predicate device ("MimyX Cream") to demonstrate substantial equivalence, but it does not describe a study involving AI/ML performance, human readers, or image analysis for detection or diagnosis.

Therefore, I cannot extract the information required to answer your questions about AI/ML acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies. The document describes non-clinical testing related to biocompatibility and stability of a topical cream, not diagnostic performance of an AI/ML system.

The acceptance criteria and study proving the device meets them are related to the cream's physical, chemical, and biological properties, not AI/ML performance.

Here's the relevant information that can be extracted, though it doesn't align with your request for AI/ML-related details:

Device Type: Topical Moisturizing Cream (Drug/Wound Dressing)
Regulatory Pathway: 510(k) Premarket Notification
Demonstration of Safety and Effectiveness: Substantial Equivalence to a predicate device (MimyX Cream) based on similar indications for use, technological characteristics (oil-in-water emulsion with humectant and emollient components), and non-clinical performance data.

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Regarding the other points of your request:

• Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the cream tested for biocompatibility and stability, not a dataset for an AI/ML model.
• Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a topical cream's biocompatibility is established through standardized laboratory tests, not expert consensus on medical images.
• Adjudication method: Not applicable. No human interpretation or AI/ML output requiring adjudication.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This study is for a cream, not an AI/ML diagnostic tool.
• Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. No algorithm is being validated.
• The type of ground truth used: For biocompatibility, the ground truth is the biological response of cells/skin to the material as per ISO standards. For stability, it's the measured physical and chemical properties over time.
• The sample size for the training set: Not applicable. No AI/ML training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional medical device (topical cream) and its non-clinical testing for safety and performance, not an AI/ML-based medical device. Therefore, the questions posed, which are highly specific to AI/ML device validation, cannot be answered from this document.

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Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Hylatopic TM Emollient Foam is indicated for use in:

• · Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis .

Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.

This document is a 510(k) Premarket Notification for a medical device called Hylatopic™ Emollient Foam. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information elements cannot be fully extracted as they are typical for a study demonstrating analytical or clinical performance of a diagnostic or therapeutic device through specified metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative measures of clinical effectiveness) and therefore no reported performance against such criteria. The submission is for substantial equivalence to predicates, implying similar intended use and safety profiles.

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

Not applicable. The document does not describe a clinical study with a "test set" in the context of device performance evaluation. The submission is based on comparison to predicate devices and functional/performance testing of the product itself.

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

Not applicable. There is no mention of a "test set" requiring expert-established ground truth for device performance evaluation.

4. Adjudication method for the test set:

Not applicable. No "test set" and corresponding adjudication method are described.

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 topical Emollient Foam, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no mention of a "ground truth" as typically defined for performance studies of diagnostic or AI devices. The basis for the 510(k) is substantial equivalence, functional testing, and intended use as an emollient foam.

8. The sample size for the training set:

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

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

Not applicable. As above, this is not an AI/machine learning model.

Summary of what the document does state regarding "Tests and Conclusions":

"Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Emollient Foam and all results are satisfactory."

This statement indicates that internal testing was performed to ensure the device met its functional specifications and was safe for its intended use. However, it does not provide details on:

• Specific acceptance criteria for this testing (e.g., pH limits, viscosity, stability, microbiological purity, etc.).
• The actual results of these tests.
• Whether these tests involved human subjects or were solely bench/lab tests.

The 510(k) process for this type of device (a topical emollient foam) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices with the same intended use and similar technological characteristics, rather than extensive clinical efficacy trials against strict performance metrics. The stated "Tests and Conclusions" are sufficient for a 510(k) submission where substantial equivalence is the primary pathway to market.

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FOR TOPICAL DERMATOLOGICAL USE ONLY

Description Rx Product:
Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Description OTC Product:
MimyX Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor burns, including sunburn.

MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.

This document, a 510(k) Pre-Market Notification for MimyX™ Cream, describes a topical emulsion for managing and relieving symptoms of various dermatoses. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML-based medical devices.

Instead, this submission focuses on "substantial equivalence" to previously cleared devices (Biafine® Wound Dressing Emulsion and Sinclair Wound and Skin Emulsion), which is a common pathway for medical device clearance. The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of MimyXTM Cream and results are satisfactory," but it does not provide the specifics of these tests or their results.

Therefore, for the information requested in your prompt, I can only provide an assessment based on the available text, with the understanding that many of the specific details you're looking for (e.g., sample sizes, expert qualifications, adjudication methods) are not present in this type of regulatory submission.

Here's an attempt to answer your questions based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Available. The document does not describe a clinical trial or a test set in the context of an AI/ML algorithm. It mentions "functional and performance testing" but provides no details on participant numbers, study design, or data origin (e.g., country, retrospective/prospective).

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

• Not Applicable/Not Available. This information relates to the establishment of ground truth for a diagnostic or prognostic device, typically through expert review of data. MimyX™ Cream is a topical therapeutic emulsion, and the regulatory submission pathway (510(k) substantial equivalence) does not typically require this type of ground truth establishment.

4. Adjudication method for the test set

• Not Applicable/Not Available. As above, this concept doesn't apply to this type of device and submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable/Not Available. MimyX™ Cream is a product (cream), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant.

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

• Not Applicable/Not Available. This is not an AI/ML algorithm, so standalone performance is not relevant.

7. The type of ground truth used

• Not Available. For this type of product, "ground truth" might refer to established clinical endpoints (e.g., reduction in itching scores, improvement in skin barrier function, physician global assessment of dermatitis severity). However, the document does not specify what specific endpoints were measured or how their "truth" was established in the mentioned "functional and performance testing." The primary "truth" for this submission is that it is "substantially equivalent" to predicate devices already on the market for similar indications, implying comparable safety and efficacy profiles.

8. The sample size for the training set

• Not Applicable/Not Available. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable/Not Available. As above, no training set for an AI/ML algorithm exists for this product.

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Professional Indications (Prescription Use):

Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites

The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.

The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.

Please provide me with the specific section of the document that describes the acceptance criteria and study results. The provided text discusses the device description, intended use, comparison to predicate devices, and a general summary of preclinical performance studies and conclusions. However, it does not explicitly detail specific acceptance criteria values or present a table of device performance against these criteria as requested in your prompt.

Without that specific information, I cannot complete the table or the detailed breakdown of the study you've requested.

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The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.

The provided text describes the X-Static® SILVERSEAL™ Hydrogel Wound Dressing, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.

The "Assessment of Performance Data" section primarily focuses on safety testing (cytotoxicity, sensitization, intracutaneous, and acute reactivity) performed in accordance with ISO 10993 standards. It explicitly states, "All antibiotic claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting." This means there is no clinical data presented to support performance related to antimicrobial efficacy on actual wounds or other clinical outcomes.

Therefore, I cannot fill out the requested table or answer the questions related to performance criteria, sample sizes for test/training sets, expert involvement, or AI-related metrics because this information is not present in the provided document.

The document discusses:

• Safety Assessments: The device underwent standard tests for cytotoxicity, sensitization, intracutaneous, and acute reactivity as per ISO 10993.
• Antimicrobial Claims Basis: Antimicrobial claims are based solely on in vitro studies, and the effect has not been studied in a clinical setting.

Without further information describing performance criteria and a study that assesses the device against those criteria (beyond basic safety), a complete answer to your request cannot be generated from the given text.

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TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "TenderWet® Active." This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/software device that requires extensive performance studies against acceptance criteria in the manner you've outlined.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

This document solely confirms that the FDA has reviewed the submission (K040517) for the TenderWet® Active device and determined it is substantially equivalent to existing devices, allowing it to be marketed. It does not contain primary study data or performance metrics against specific acceptance criteria.

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These dressings are intended for OTC use on wounds such as:

• Minor cuts and grazes .
• Minor scalds and burns .
• Insect bites .

MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:

• . Third degree burns

MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.

The provided 510(k) summary for MedTrade Product's Antiseptic Barrier Hydrogel Dressings does not contain information typically found in acceptance criteria or a detailed study report for device performance in the context of diagnostic or AI-enabled medical devices. This document is for a medical device (a dressing) and focuses on its substantial equivalence to a predicate device and its physical and chemical properties and general safety, rather than statistical performance metrics like sensitivity, specificity, accuracy, or reader improvement.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The information that can be inferred or directly stated is provided below.

Acceptance Criteria and Study for MedTrade Product's Antiseptic Barrier Hydrogel Dressings

This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (MedTrade Product's Hydrogel Island Dressings K002504) and outlines the product's physical characteristics, intended use, and general safety testing. It does not include performance data or acceptance criteria related to diagnostic accuracy, reader performance improvement, or AI algorithm standalone performance, as these are not relevant for this type of medical dressing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document does not specify a "test set" in the context of evaluating diagnostic performance.
• Biocompatibility testing would have involved specific animal and/or in-vitro samples, but the sample sizes and detailed data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.

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

• Not applicable as this is not a diagnostic device involving expert interpretation of data. Ground truth, in this context, would relate to the successful completion of specific standardized tests (e.g., sterility, biocompatibility), which are typically pass/fail criteria against established scientific guidelines, not expert consensus.

4. Adjudication method for the test set:

• Not applicable.

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-enabled diagnostic device or software.

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

• Not applicable as this is not an algorithm or AI device.

7. The type of ground truth used:

• For sterility: Laboratory testing against a Sterility Assurance Level (SAL) of 10⁻⁶ per specified ISO/AAMI standards.
• For biocompatibility: Successful completion of tests (Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity, Hemocompatibility/Hemolysis) based on ISO/Tripartite guidelines.
• For antiseptic barrier activity: "Shown to have 'Antiseptic Barrier activity'" - the specific method or ground truth definition is not provided in this summary but would typically involve standardized microbiological challenge tests.

8. The sample size for the training set:

• Not applicable as this is not an AI-enabled device that requires a training set.

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

• Not applicable.

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FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.

Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (OTC) use.

Here's a breakdown of the acceptance criteria and the study information for the SINCLAIR WOUND AND SKIN EMULSION™ based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a sample size for a test set. It mentions "Functional and performance testing," but does not detail the methodology, sample sizes, or provenance of the data (e.g., country of origin, retrospective or prospective) for these tests.

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

The provided document does not mention or describe the use of experts to establish ground truth for any test set.

4. Adjudication Method for the Test Set

The provided document does not mention or describe any adjudication method for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, not direct comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not performed or reported in the provided document. This device is a wound and skin emulsion, not an AI algorithm. The functional and performance testing mentioned refers to the physical and chemical properties and likely biocompability of the emulsion itself.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable or discussed in this submission. The "ground truth" for this device's performance would likely be established through standardized methods for assessing biocompatibility, stability, physical properties (e.g., viscosity, pH), and potentially in-vitro or in-vivo wound healing models, though these specifics are not detailed in the document. The substantial equivalence relies on comparison to predicate devices.

8. Sample Size for the Training Set

A "training set" is relevant for machine learning algorithms. Since this device is a topical emulsion and not an AI/ML algorithm, the concept of a training set does not apply to this submission.

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

As the concept of a training set does not apply, how its ground truth was established is not applicable to this submission.

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The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.

The device is intended for one-time use.

Not Found

This 510(k) summary for the XYLOS™ XCell® Antimicrobial Dressing focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence to predicate devices based on similar intended use, technological characteristics, and performance, rather than providing specific performance metrics against pre-defined acceptance criteria for a new clinical study.

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

This information is not applicable to this 510(k) summary as no specific test set data from a study proving device performance is presented. The submission relies on comparison to predicate devices.

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 for the same reason as above.

4. Adjudication Method for the Test Set

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

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 dressing, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a wound dressing, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no specific study data or ground truth establishment is detailed for this 510(k) beyond demonstrating equivalence to existing legally marketed devices. The "ground truth" here is effectively that the predicate devices are safe and effective.

8. The Sample Size for the Training Set

This information is not applicable as the device is a wound dressing, not an algorithm that requires a training set.

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

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

Summary based on the provided 510(k) information:

The provided document is a 510(k) summary for a medical device (wound dressing) aiming for market clearance based on substantial equivalence to predicate devices. It does not contain details of a specific study designed to meet pre-defined acceptance criteria with quantifiable performance metrics, as would be expected for a novel device requiring such a study. The "proof" is the demonstration of similarity to already cleared devices.

The key points from the document pertinent to its clearance are:

• Intended Use: Similar to predicate devices (partial and full-thickness wounds, absorb exudates, moist wound environment, barrier to microbial colonization/penetration, protection against abrasion, desiccation, external contamination, etc.).
• Technological Characteristics: Implied to be similar to predicate devices.
• Performance: Implied to be similar to predicate devices, but no specific performance data from a new study is provided to establish new acceptance criteria.

The 510(k) process primarily confirms that a new device is as safe and effective as (substantially equivalent to) an already legally marketed device, rather than requiring exhaustive de novo clinical trials to prove performance against specific new criteria.

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CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full- thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites

CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive, and absorptive. The wound contact surface is composed of an antibiotic containing hydrogel. The OTC antibiotic mixture used consists of the following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. A second outer layer consists of a polymeric film.

The provided text is a 510(k) summary for a medical device called "CardioTech Antibiotic Hydrogel Wound Dressing." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of the device's performance against specific acceptance criteria. Therefore, the document does not contain the information requested in questions 1 through 9 regarding acceptance criteria and a study demonstrating performance.

Here's why and what the document does provide:

• Substantial Equivalence: The core of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is typically done by comparing characteristics like intended use, technology, materials, and performance data if relevant.
• Lack of Performance Study Details: The provided text does not describe a specific clinical or performance study that rigorously tests the CardioTech Antibiotic Hydrogel Wound Dressing against predefined acceptance criteria. Instead, it relies on the established safety and efficacy of its predicate devices to argue for its own.
• Focus on Description and Indication: The document details the device's components (hydrogel with antibiotics, polymeric film), its indications for use (various types of wounds), and its classification.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text. The information simply isn't present in this regulatory summary.

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