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Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.

The following indications for use are for Prescription and Over-the-Counter Use:

Dermaphylyx Skin Protectors are intended for the prevention of:

• Blisters .
• Friction Burns .

Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.

Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.

The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability

The provided text describes a 510(k) premarket notification for the "Dermaphylyx Skin Protector." This document primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a clinical study with detailed acceptance criteria and performance data as typically found for complex medical devices or AI algorithms.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they are not typically part of a 510(k) submission for a simple, unclassified device like a skin protector.

Based on the provided information, here's what can be extracted:

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

Since this is a 510(k) submission for a skin protector, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is not quantified with specific metrics in the way an AI algorithm's performance would be (e.g., sensitivity, specificity).

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

• Not applicable. This document does not describe a clinical study with a test set of human subjects or data in the context of device performance testing for an AI algorithm. A 510(k) for a simple device like this typically relies on material characterization, biocompatibility, and functional testing, not a "test set" in the sense of evaluating diagnostic accuracy.

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

• Not applicable. Ground truth establishment by experts is not described as part of this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. Adjudication is not 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

• No. This is not a diagnostic device or AI algorithm, so an MRMC study is not relevant or described.

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

• Not applicable. This is not an algorithm, so standalone performance is not relevant.

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

• The "ground truth" for this device's acceptance is its substantial equivalence to a legally marketed predicate device (Spyroflex® Skin Protectors, Innovative Technologies US, Inc.), as determined by the FDA based on shared indications for use, technological characteristics (implied similarity in function and composition), and safety. There isn't a "ground truth" derived from patient outcomes or expert consensus in the typical sense of evaluating a diagnostic or AI device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm, so there is no training set.

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

• Not applicable. There is no training set.

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Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds.

The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Burns, (superficial)
Abrasions and lacerations
Incisions

Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.

The following indications for use are for Over-the-Counter Use:
Minor Burns
Minor cuts
Minor abrasions
Minor lacerations

Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive. Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.

This looks like a 510(k) premarket notification for a wound dressing, which typically doesn't involve the kind of performance studies with acceptance criteria, sample sizes, expert ground truth, and statistical analyses that are common for AI/ML-driven diagnostic devices.

The documents provided are for the Dermaphylyx Hydrophilic Foam Wound Dressing. This is a medical device, specifically a wound dressing, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria in terms of sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, or training/test set ground truth as commonly discussed for AI/ML devices do not apply here.

Instead, for a device like a wound dressing, the "acceptance criteria" and "study" would relate to its physical and biological properties, such as:

• Sterility: Demonstrated through microbiological testing.
• Biocompatibility: Demonstrated through ISO 10993 testing (cytotoxicity, irritation, sensitization).
• Absorptive capacity: Measured through specialized laboratory tests.
• Tensile strength/durability: Measured through mechanical testing.
• Adhesion (if applicable): Measured through peel strength tests.
• Shelf-life stability: Demonstrated through accelerated and real-time aging studies.

The provided documents focus on establishing substantial equivalence to predicate devices already on the market (Spyrofoam® Wound Dressings and Hydrasorb® Sterile Dressings). This is the primary regulatory pathway for many Class I and II medical devices that do not raise new questions of safety and effectiveness.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance, as they are not applicable to the Dermaphylyx Hydrophilic Foam Wound Dressing.

The "study" here is the substantial equivalence argument, which relies on comparing the device's characteristics and intended use to legally marketed predicate devices, not on clinical performance studies in the way you might expect for an AI diagnostic.

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Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound.

The following Indications are for Prescription Use or under the direction of a health care professional:

• Venous ulcers
• Diabctic ulcers
• Pressure ulcers
• Ancrial ulcers
• Superficial burns
• Abrasions and laccrations
• Donor sites
• Postoperative wounds

The following Indications are for Over-the-Counter Usc:

• Abrasions
• Minor Burns
• Minor Cuts
• Minor Laccrations

Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.

Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.

This document is a 510(k) summary for the Dermaphylyx Calcium Alginate Wound Dressing, submitted by Dermaphylyx, Inc. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not contain information regarding acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to the acceptance criteria for an AI/ML device.

The provided text describes a medical device (wound dressing) and aims to establish its substantial equivalence to existing devices based on its description, intended use, and general characteristics. It is not an AI/ML device, and therefore, the requested information (acceptance criteria, study performance characteristics, sample sizes, etc.) related to AI/ML device validation does not apply to this submission.

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Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,

The following Indications are for Prescription Use or under the direction of a health care professional:

Venous ulcers
Diabetic ulcers
Pressure ulcers
Arterial ulcers
Superficial burns
Abrasions and lacerations
Donor sites
Incisions

The following Indications are for Over-the-Counter Use:

Abrasions
Minor Burns
Minor Cuts
Minor Lacerations

Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.

Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.

The provided text is a 510(k) summary for a medical device (Dermaphylyx Absorbent Fiber Wound Dressing). It discusses the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than direct performance testing against predefined criteria.

The information regarding acceptance criteria and a study to prove meeting them would typically be found in a more detailed technical report or clinical study summary, which is not present in this 510(k) summary document.

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Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding.

The following Indications are for Prescription Use or under the direction of a health care professional:

• Venous ulcers
• Diabctic ulcers
• Pressure ulcers
• Arterial ulcers
• Superficial burns
• Abrasions and lacerations
• Donor sites
• Postoperative wounds

The following Indications are for Over-the-Counter Use:

• Abrasions
• Minor Burns
• Minor Cuts
• Minor Lacerations

Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.

This document is a 510(k) premarket notification for the Dermaphylyx Calcium Alginate Wound Dressing. It declares substantial equivalence (SE) to previously marketed devices and does not contain detailed information about a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, I cannot provide the requested information. This document is focused on obtaining regulatory clearance by demonstrating substantial equivalence, not on presenting results from a performance study against predefined acceptance criteria.

Specifically, there is no mention of:

• Quantitative acceptance criteria for device performance.
• A study design (sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, standalone performance).
• Any reported device performance against such criteria.

The 510(k) summary states that "Dermaphylyx Calcium Alginate Wound Dressings are substantially equivalent to Innovative Technologies Calcium Alginate Wound Dressings (Innovative Technologies Group, Ltd.) and Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories)." This substantial equivalence claim is the basis for regulatory approval, not a separate performance study with acceptance criteria as typically found for software or diagnostic devices.

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Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds.

The following Indications are for Prescription Use or under the direction of a health care professional:
Dermal Ulcers
Donor Sites
Incisions
Superficial Burns
Abrasions and lacerations
IV Catheter Sites

The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Blisters
As a Cover for gauze and gel bandages.

Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. The wound contact surface is composed of a porous adhesive. A second layer consists of a polyurethane film which is waterproof and dirt proof while maintaining breathability.

The provided document is a 510(k) summary for the Dermaphylyx Film Wound Dressing. It describes the product, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or answer the specific questions about study details from this input. The 510(k) summary is a declaration of substantial equivalence, not a detailed report of clinical or performance testing with specific metrics and methodologies.

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Dermaphylyx Hydrocolloid Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds.

The following Indications are for Prescription Use or under the direction of a health care professional:

Venous stasis ulcers Diabetic ulcers Pressure sores Blisters

Superficial burns Abrasions and laccrations Donor sites

The following Indications are for Over-the-Counter Use:

Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters

Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive.

The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt while maintaining breathability.

This 510(k) submission for the Dermaphylyx Hydrocolloid Wound Dressing describes its intended use and claims substantial equivalence to an existing device (SpyroColloid® Wound Dressings). However, it does not provide any specific acceptance criteria or details of a study that proves the device meets such criteria.

The provided document is a 510(k) summary and the FDA's response letter. A 510(k) summary typically includes:

• A description of the device.
• Intended use.
• Comparison to a predicate device to establish substantial equivalence.
• A brief summary of any performance data if available, but it's not always required to be extensive for substantial equivalence claims.

In this specific document, the focus is on establishing equivalence to the predicate wound dressing based on material composition and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.

Here's how I would address your request based on the available information:

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

• Self-adhesive, semi-occlusive, absorptive hydrocolloid wound dressing.
• Provides a barrier to exogenous water/dirt while maintaining breathability.
• Intended for management of partial and full thickness wounds (venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial burns, abrasions, lacerations, donor sites).
• Over-the-counter use for abrasions, minor cuts, minor lacerations, minor burns, and blisters. | The device, Dermaphylyx Hydrocolloid Wound Dressing, is described as meeting these characteristics, aligning with the predicate device. The FDA's letter states: "We have reviewed your Section 510(k) notification... It is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified..." |

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

• Sample size: Not applicable. The document does not describe a clinical performance study with a test set.
• Data provenance: Not applicable.

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. The document does not describe a study involving expert assessment of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This 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

• Not applicable. This device is a wound dressing, not an algorithm.

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

• Not applicable, as a performance study generating ground truth data is not described in this document. The "ground truth" for a 510(k) for a simple device like this is typically the established performance and safety profile of the predicate device.

8. The sample size for the training set

• Not applicable. There is no training set described as this is not an AI/ML device.

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

• Not applicable.

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Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.

The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears

The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters

Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive. Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable. The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability

The provided document is a 510(k) premarket notification for the Dermaflex™ Foam Wound Dressing. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document is a regulatory approval letter from the FDA, confirming the device is substantially equivalent to legally marketed predicate devices, subject to certain labeling limitations. This type of regulatory submission primarily relies on demonstrating equivalence to existing devices rather than presenting novel clinical study data against specific performance acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided input.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document does not describe specific numerical acceptance criteria or performance metrics derived from a study. The FDA's 510(k) clearance process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, often through bench testing (e.g., absorbency, breathability), biocompatibility, and sometimes limited clinical testing to support specific claims if different from the predicate, but not usually against pre-defined numerical performance acceptance criteria in the way a diagnostic AI device would.

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

• Cannot be provided. The document does not mention any test set, sample sizes, or data provenance from a study for the Dermaflex™ device.

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

• Cannot be provided. No such information is present.

4. Adjudication method for the test set

• Cannot be provided. No such information is 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

• Cannot be provided. This is not relevant to a wound dressing device and no such study is mentioned.

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

• Cannot be provided. This is not relevant to a wound dressing device.

7. The type of ground truth used

• Cannot be provided. This concept (ground truth) is not applicable to the information provided about a wound dressing.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned.

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

• Cannot be provided. No training set or ground truth in that context is mentioned.

Information that is available (or can be inferred from the context of a 510(k) for such a device):

The device is a Dermaflex™ Foam Wound Dressing.
It is intended for use in the management of partial and full-thickness wounds.
Its mechanism of action involves providing a moist wound environment, absorption, and breathability, while also being adhesive and conformable, and providing a barrier against dirt.

Predicated Devices:
The Dermaflex™ Foam Wound Dressing is substantially equivalent to:

• Spyroflex® Wound Dressings (Innovative Technologies US. Inc.)
• Flexzan Topical Wound Dressings (Dow Hickarn Pharmaceuticals. Inc.)

These predicate devices are described as self-adhesive wound dressings which provide a degree of absorption and breathability, intended for managing a wide variety of wounds. The "acceptance criteria" here is effectively demonstrating substantial equivalence to these legally marketed devices. This would typically involve showing similar performance in terms of:

• Biocompatibility: Non-toxic, non-irritating (standard ISO 10993 tests).
• Physical Properties: Adhesion strength, absorption capacity, breathability (Moisture Vapor Transmission Rate - MVTR), conformability.
• Sterility: Demonstrated sterile until opened/damaged.
• Shelf Life: Stability over time.

The document does not provide specific test results or numerical thresholds for these properties, but regulatory clearance hinges on them being comparable to the predicate devices.

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