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Collatek Foam may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage I-IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.

This 510(k) summary for the Collatek® Foam wound dressing does not describe a study involving performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Therefore, the device does not have explicit acceptance criteria or a study "proving" it meets those criteria in the traditional sense of a performance study.

Here's a breakdown based on the information provided, highlighting what is not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient samples. The evidence relies on direct comparison to predicate devices and biocompatibility testing. The biocompatibility tests were likely performed on material samples, not patient data.

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

• Not Applicable. No test set with ground truth established by experts is described for performance evaluation.

4. Adjudication method for the test set

• Not Applicable. No test set with ground truth adjudication is 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 is a wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

• Not Applicable. For the performance as a wound dressing, the "ground truth" for substantial equivalence is based on the established safety and effectiveness profile of the predicate devices, material properties, and proven biocompatibility and sterility. There isn't an "expert consensus," "pathology," or "outcomes data" specifically collected for this device's performance in a clinical study to establish a ground truth.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided is a demonstration of substantial equivalence to legally marketed predicate devices (VigiFOAM® and SkinTemp®) for the same intended use. This is common for 510(k) clearances, especially for devices where the technology is well-understood and similar alternatives exist.

The key elements used to "prove" substantial equivalence are:

• Comparison to Predicate Devices: A side-by-side comparison (Table 1-2.1.2 is mentioned but not provided in the excerpt) showing similarity in:
  • Indications for Use
  • Instructions for Use
  • Technological Characteristics (design, fluid handling)
  • Materials (constituents)
• Biocompatibility Testing: Performed by North American Science Associates, Inc. (NAMSA) in accordance with Good Laboratory Practices (GLP), demonstrating the device meets or exceeds FDA Blue Book Memorandum G95-1 and ISO 10993 requirements. This addresses safety.
• Sterility Validation: Confirmation that the sterilization process (electron beam) achieves a Sterility Assurance Level (SAL) of 10^-6 (implied) in accordance with ANSI/AAMI/ISO 11137-1994. This addresses sterility.

Essentially, the company is arguing that because their device is fundamentally the same as already cleared devices, and it passes standard safety and sterility tests, it is equally safe and effective.

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Collatek Sheet may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage 1-1V) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.

The provided 510(k) summary for the "Collatek® Sheet" wound dressing primarily focuses on establishing substantial equivalence to predicate devices through comparisons of design, function, materials, and intended use. It does not describe a study that involves acceptance criteria and device performance in the way typically expected for a detailed clinical or performance study report.

Instead, the submission states:

"Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device. Collatek® Sheet is designed to absorb light amounts of exudates while forming a protective gelatinous barrier. The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing."

And regarding safety:

"Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GLP. Biocompatibility data has shown that Collatek® Sheet is safe for use as a medical device for wound care management and is substantially equivalent to the commercially available predicate devices (Cutinova® hydro and DuoDerm® CGF)."

Given the information provided, I cannot populate the table or answer most of your specific questions related to acceptance criteria and a study proving its performance against those criteria, as the document details a substantial equivalence claim based on comparison to existing devices and bench testing/biocompatibility rather than a direct performance study with defined acceptance criteria and clinical outcomes.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Information Not Provided: The document mentions "bench testing" and "Biocompatibility tests" but does not specify sample sizes for these tests or the data provenance.

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)

• Information Not Applicable/Provided: This type of information is typically relevant for studies involving human judgment (e.g., image interpretation, clinical assessment). The described "bench testing" and "biocompatibility testing" are laboratory evaluations, not dependent on expert ground truth in the clinical sense.

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

• Information Not Applicable/Provided: Adjudication methods are typically used in clinical trials or studies where human assessment is involved. This is not described for the bench or biocompatibility testing mentioned.

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, an MRMC comparative effectiveness study was not done. This type of study is not mentioned or implied in the document.

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

• Information Not Applicable/Provided: The device is a wound dressing, not an algorithm or AI. Standalone performance as an algorithm is not relevant.

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

• For bench testing: The "ground truth" would be established by validated test methods and physical/chemical properties, measured against established standards or predicate device performance.
• For biocompatibility testing: The "ground truth" is adherence to specific ISO standards (ISO10993) and FDA guidelines (FDA Blue Book Memorandum G95-J), assessed through specific laboratory assays (e.g., cytotoxicity, sensitization, irritation).
• No clinical ground truth (expert consensus, pathology, outcomes data) derived from patient studies is described in this 510(k) summary.

8. The sample size for the training set

• Information Not Applicable/Provided: The device is a physical wound dressing, not a machine learning algorithm that requires a training set.

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

• Information Not Applicable/Provided: As above, this is not relevant for this type of device.

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• 1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds.
• 2. To be used on a temporary and emergency basis in the management of an open pneumothorax condition.
• 3. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.

Not Found

I am sorry, but the provided text from the FDA letter about the "FastSeal Chest Wound Dressing" (K990079) does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.

The letter is a 510(k) clearance document, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include details on performance studies or their methodologies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings.

The SimpliCare Transparent Wound Dressing is indicated for use on wounds including:

• minor burns and scalds .
• superficial cuts, lacerations and abrasions ●
• minor irritations of the skin .

This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as:

• pressure ulcers .
• lacerations/abrasions .
• surgical incisions .
• . second degree burns
• donor sites .

In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device

The Hollister SimpliCare Transparent Wound Dressing is a polyurethane film that is backed with a pressure sensitive acrylic adhesive. A unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Transparent Wound Dressing is designed to have a high moisture vapor transmission rate and is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Transparent Wound Dressing provides a barrier to viral and bacterial contaminates and other external contaminants such as feces and urine while the dressing remains intact without leakage.

The dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels, and foam dressings.

The Hollister Transparent Wound Dressing is presented sterile and is available in a variety of sizes to accommodate various sizes of wounds.

The provided document is a 510(k) premarket notification for a medical device (Hollister SimpliCare Transparent Wound Dressing) and not a study report that describes acceptance criteria and device performance in the context of an AI/ML powered device.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and the reported device performance: This document does not specify performance metrics or acceptance criteria for device efficacy in the way an AI/ML study would. It describes the device's intended function and biocompatibility.
• Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of an AI/ML evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant to the type of device described.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document discusses:

• Device Description: A polyurethane film dressing with a pressure-sensitive acrylic adhesive, designed for moist wound healing, barrier protection, and use on IV sites or as a secondary fixation device.
• Intended Use: Various wound types (minor burns, cuts, abrasions, pressure ulcers, surgical incisions, second-degree burns, donor sites), IV sites, and secondary fixation.
• Technological Characteristics: Permeable to moisture vapor and oxygen, material biocompatibility assessed per standards (EN 30993, G95-1, USP).
• Substantial Equivalence: Claimed to be substantially equivalent to predicate devices (Bioclusive Transparent Dressing, EpiVIEW Thin Film Dressing).

This document is a regulatory submission demonstrating the device's safety and effectiveness in comparison to existing devices, not a study evaluating an AI/ML algorithm's performance against specific acceptance criteria.

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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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The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:

(a) Stage I and II pressure sores (decubitus ulcers)

(b) Skin tears or lacerations

(c) Superficial burns and abrasions

(d) Surgical wounds

Transparent Dressing

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Giltech Plus Transparent Dressing." This document addresses the substantial equivalence of the device and its indications for use, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical details of device validation.

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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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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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Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).

This document is a 510(k) summary for a medical device called Mepitel® Non Adherent Silicone Dressing. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is the regulatory pathway for this type of device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This process typically involves comparisons of material composition, intended use, and technological characteristics, and often includes biocompatibility testing. It generally does not involve detailed performance studies with acceptance criteria in the way described in your request for AI/diagnostic devices.

Here's why the requested information cannot be found in the provided text:

• Type of Device: This is a wound dressing, not an AI, diagnostic, or image-generating device. Its evaluation focuses on biocompatibility, physical properties, and a comparison to an existing similar product, rather than performance metrics like sensitivity, specificity, or reader improvement.
• Regulatory Pathway: The 510(k) pathway for wound dressings relies heavily on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and is as safe and effective as one already on the market. It does not typically require performance studies with detailed acceptance criteria and ground truth establishment as would be required for a novel diagnostic or AI device.

Therefore, none of the specific points you asked for (acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information) are present in this 510(k) summary. The study mentioned ("Mepitel have been found to be non-toxic and non-irritating when tested in accordance with the ISO 10993 Part I") is a biocompatibility test, not a performance study as requested.

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