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Innovative Technologies Hydrucolloids & Intelligent Hydrocolloids can be used for the management of wounds including, minor scalds and burns, superficial wounds such as abrasions, lacerations and minor cuts and as a protective dressing for such uses as minor blisters. This wound dressing may also bo used under the care of a health care professional for such wounds as, partial - full thickness wounds i. o. artorial ulcers, venous ulcers and diabetic ulcers, post operative surgical wounds. donor sites. If at any time you are unsure of the above conditions or the type of wound consult a health care professional. Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional

Highly floxible and conformable gol formula dressings, which absorb wound exudate producing a soft, gel mass which allows pasy removal of the dressing roducing the potential for delicate peri- wound tissue damage during dressing changes. Innovative Technologies Intelligent wound dressings utilize an intelligent film which allows moisture to transpire the hydrocolloid whilst providing a barrier to water and bacteria

The provided document is a 510(k) premarket notification for Hydrocolloid and Intelligent Hydrocolloid Wound Dressings. It outlines the device's description, intended use, and indicates substantial equivalence to a previously cleared device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.

The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence. It confirms that "Biocompatability results presented in 510(k) K971126 remain current, no changes to raw materials or components which would require the submission of new toxicity data." This suggests that previous testing for the predicate device K971126 is being leveraged, but the specifics of that testing are not detailed here.

Therefore, I cannot provide the requested information from the given text.

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Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment.

The provided text does not contain any information about acceptance criteria, device performance, or any studies with specific metrics.

The document is a 510(k) submission for the "Al-Gen Calcium Alginate Dressing," focusing on establishing substantial equivalence to a predicate device (K953781). The "Testing Summary" section explicitly states: "Biocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data." This indicates that no new testing was performed or reported for this specific 510(k) submission to demonstrate performance against new acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on prior biocompatibility data and substantial equivalence, not on a new performance study with specific acceptance criteria.

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Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:

• Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
  Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.

This document is a 510(k) summary for the 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. It states that substantial equivalence was provided in previous 510(k) applications (K953781 and K980989) and that biocompatibility test results were also presented in those previous applications. Therefore, there is no new study or acceptance criteria information in the provided text to describe.

The letter explicitly states: "The 510(k) submission was not re-reviewed." (Page 0, K982638, Jun 11, 2023 letter) and "This letter corrects our substantially equivalent letter of August 21, 1998." (Page 1, K982638, Mar 1 9 2007 letter). This indicates that the current document is an administrative update and a correction to previous approvals, not a new submission with new performance studies.

Hence, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details. This information would have been contained in the original 510(k) submissions (K953781 and K980989) which are not provided here.

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Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including: . Minor scalds and burns Superficial Wounds such as Abrasions, Laccrations, and cuts t This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.

Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds. Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing. The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.

The provided document is a 510(k) summary for the "Innovative Technologies Transparent and Intelligent Film Wound Dressings." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that 510(k) summaries, especially those from 1998, typically focus on demonstrating substantial equivalence through a comparison to a predicate device, rather than presenting de novo clinical study data that would include detailed acceptance criteria and performance studies of the novel device itself. The provided text does not contain a detailed study report with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

Therefore, the following information is based on the available text, and where specific details are missing (as they are not part of a 510(k) summary of this nature), it will be explicitly stated.

Acceptance Criteria and Device Performance

As this is a 510(k) submission from 1998 for wound dressings, the "device performance" and "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device and the general functional description of the dressings. There are no explicit quantitative performance metrics or acceptance criteria stated in the document as would be found in a modern clinical study report for an AI/advanced medical device.

The "performance" is described in terms of its functional properties and intended use:

Specific Study Details (Based on Available Text)

1. A table of acceptance criteria and the reported device performance:
Provided above based on the functional description and intended use, as explicit quantitative criteria are not present in this 510(k) summary.

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

• Not applicable / Not provided. This document is a 510(k) premarket notification. It does not describe a new clinical study with a test set in the way a modern AI/diagnostic device submission would. The basis for substantial equivalence typically relies on existing data or performance of the predicate device, or non-clinical (e.g., benchtop) testing for the new device.
• The manufacturer is based in the United Kingdom.

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. No specific clinical test set for ground truth establishment is described for this device in this document.

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

• Not applicable / Not provided. No clinical test set 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 / Not provided. This device is a wound dressing, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant to this product.

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

• Not applicable / Not provided. This device is a physical wound dressing and does not involve an algorithm.

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

• Not applicable / Not provided. No specific ground truth for a clinical study is detailed for this 510(k) submission. The "truth" for such devices is typically established through a combination of manufacturing standards, biocompatibility testing, material science, and prior clinical use experience of similar predicate devices, demonstrating the physical and biological properties meet safety and performance expectations.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable / Not provided. As above, no training set is relevant.

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Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.

The provided document is a 510(k) premarket notification for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to establish new acceptance criteria and prove performance against them.

Therefore, many of the requested elements for describing an acceptance criteria study are not directly available in this type of document. Specifically, there is no detailed information on a clinical trial or performance study that would generate acceptance criteria and report device performance against them in the format requested.

However, I can extract information related to the device's claims and the type of testing performed to support its safety.

Here's a breakdown of what can be inferred or explicitly stated from the document, acknowledging the limitations inherent in a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria and reported device performance in a quantitative table as typically seen in a dedicated performance study. The 510(k) process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The "performance" here is primarily an assertion that it meets the safety profile and intended use of the predicate.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance study with acceptance criteria. The document mentions "Biocompatibility test results presented in Attachment 4," but details like sample size for these biocompatibility tests are not provided in the summary.
• Data Provenance: The biocompatibility testing likely occurred in a laboratory setting. The country of origin for the manufacturing company is the United Kingdom. Whether the biocompatibility data originates from the UK or elsewhere is not specified. The document does not describe retrospective or prospective clinical studies to evaluate performance against acceptance criteria.

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

Not applicable. The "ground truth" in a 510(k) for a dressing is typically established through regulatory standards, predicate device performance, and laboratory testing for characteristics like biocompatibility, sterility, etc. There's no mention of a test set requiring expert adjudication for a "ground truth" as would be the case for diagnostic accuracy studies.

4. Adjudication Method for the Test Set:

Not applicable for this type of submission.

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

No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study focuses on improving human reader performance with AI assistance, which is outside the scope of an alginate wound dressing's submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, this is not relevant for an alginate wound dressing. This concept applies to AI/ML software as a medical device.

7. Type of Ground Truth Used:

For the safety claims, the "ground truth" would be established by:

• Biocompatibility testing standards: These tests (e.g., cytotoxicity, sensitization, irritation) assess the device's interaction with biological systems. The results are compared against established benchmarks for safety, rather than an "expert consensus."
• Predicate device characteristics: Substantial equivalence relies on comparing the new device's materials, design, intended use, and performance claims to a legally marketed predicate device (K953781). The predicate's established safety and effectiveness serve as a form of "ground truth" for comparison.

8. Sample Size for the Training Set:

Not applicable. This document does not describe the development or training of an algorithm or AI system.

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

Not applicable.

Summary of Device Performance (from the document):

While not a quantitative table with pre-defined acceptance criteria, the document states:

• Biocompatibility: "Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use." This implicitly means the device met accepted benchmarks for biocompatibility.
• Intended Use: The device is deemed "substantially equivalent" to a predicate for its intended use on partial and full thickness wounds with moderate to heavy exudate (e.g., pressure ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, dermal lesions) and to help control minor bleeding. This means its performance in these areas is considered comparable to the predicate.

Key takeaway: This document is a regulatory submission for premarket notification (510(k)), not a detailed performance study with explicit acceptance criteria for a novel device. Its purpose is to demonstrate that the new device is as safe and effective as a previously cleared predicate device, largely through comparison of materials, design, and intended use, supported by general safety testing like biocompatibility.

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FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.:

• · Pressure Ulcers
• · Venous Stasis Ulcers
• · Diabetic Ulcers
• · 1* and 2nd Degree Burns
• · Surgical Wounds
• · Trauma Wounds
• · Dermal Lesions (Cuts, abrasions, etc)

FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as:

• · Superficial cuts
• · Abrasions
• · Lacerations
• Minor scalds
• Minor bums
• Minor skin irritations

FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing.

FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds.

FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes.

The provided text is a 510(k) premarket notification for the FlexiGel-G Hydrogel Wound Dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics as might be found for novel technologies or higher-risk devices.

Therefore, the document does not contain the direct explicit information requested regarding acceptance criteria and a study proving the device meets them in the format of a typical clinical trial. Instead, it relies on demonstrating similarity to a predicate device and fulfilling regulatory requirements for safety and efficacy based on that comparison.

Here's a breakdown of what can be inferred or explicitly stated from the document, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" here: For a 510(k), the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This means it must have the same intended use, the same technological characteristics, or if there are differences, those differences do not raise different questions of safety and effectiveness. The table above highlights the comparative features presented to demonstrate this equivalence. The "performance" is simply the reported characteristics of the device.

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

• None stated. The submission relies on laboratory testing (biocompatibility, fluid dynamics) and comparison to a predicate device, not a human-subjects test set in the sense of a clinical trial. The "data" provenance for fluid dynamics and composition would be internal lab testing, likely from the UK.

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. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance.

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

• Not applicable. No such test set or adjudication method 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

• No MRMC study was done. This device is a wound dressing, not an AI-based diagnostic tool.

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

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

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

• The "ground truth" equivalent in this context is the established safety and efficacy profile of the predicate device (Intrasite™ Gel) and the demonstration through laboratory testing (biocompatibility, physical properties like fluid donation/absorption) that FlexiGel-G performs similarly and meets recognized safety standards. For sterility, the ground truth is meeting a 10^-6 SAL via an overkill method.

8. The sample size for the training set

• Not applicable. This device is a physical wound dressing; there is no "training set" in the machine learning sense. The "development" and "testing" involved product formulation, manufacturing process validation (like sterilization), and biocompatibility testing.

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

• Not applicable. As above, no training set. The safety and performance validation methods are described:
  • Sterilization: Overkill method to achieve a Sterility Assurance Level (SAL) of 10^-6 per ANSI / AAMI / ISO11134 - 993.
  • Biocompatibility: Testing successfully completed per ISO/Tripartite guidelines for cytotoxicity, haemolysis, acute systemic toxicity, skin irritation, and sensitisation.
  • Functional Characteristics: Laboratory measurements of fluid donation and absorption, compared to the predicate device.

In summary: The provided document is a 510(k) premarket notification. Its "study" is primarily a comparison to a legally marketed predicate device and demonstration of compliance with relevant safety standards and performance characteristics through laboratory testing, not a clinical trial with human subjects and specific performance metrics in the way a diagnostic AI or novel therapeutic device would require. The "acceptance criteria" revolve around proving substantial equivalence and meeting established international standards for sterility and biocompatibility.

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Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including:

• Partial full thickness wounds, ie. arterial, venous, diabetic ulcers
• Post-operative surgical wounds
• Superficial burns (1st & 2nd degree)
• Donor Sites
• Trauma Wounds
• Dermal Lesions
• Protective dressing

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing. Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration. Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10^-6.

The provided text is a 510(k) premarket notification for a medical device, specifically Innovative Technologies' Hydrocolloid with Zinc Wound Dressing. This document is a regulatory submission for market clearance and does not describe a study that establishes acceptance criteria and proves the device meets them in the way a clinical or performance study would for an AI/ML diagnostic device.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device. The "acceptance criteria" here are essentially the characteristics and performance of the predicate devices. The "study" is the comparison made between the new device and the predicate devices.

Let's break down why this information is not present in the format requested, and then extract what is available:

Why the requested information (for AI/ML diagnostic devices) is not directly applicable:

• Acceptance Criteria & Device Performance Table (for AI/ML): This typically involves performance metrics like sensitivity, specificity, AUC, etc., measured against a gold standard for a diagnostic task. For a wound dressing, performance is assessed differently (e.g., biocompatibility, absorbency, sterility, wound healing environment).
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone (for AI/ML): These are concepts specifically related to the evaluation of diagnostic algorithms. They do not apply to the evaluation of a physical wound dressing in the same manner.
• Training Set (for AI/ML): This is irrelevant as there's no algorithm being trained.

Information Extracted from the provided document, reframed as closely as possible to the request's intent for a non-AI/ML device:

1. Table of Acceptance Criteria (Predicate Characteristics) and Reported Device Performance (New Device Characteristics):

The document uses a comparative table to show that the new device's characteristics are similar to the predicate devices. The "acceptance criteria" are implied to be the characteristics of the predicate devices, and the "reported device performance" are the characteristics of the Innovative Technologies Hydrocolloid with Zinc.

2. Sample size used for the test set and the data provenance:
This type of information is not applicable to a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to predicate devices rather than a performance study on a specific test set of cases. The "data provenance" for the predicate devices would be their own regulatory submissions and market history.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as understood in AI/ML is not a concept for wound dressings in this context. Substantial equivalence relies on comparing product design, materials, and intended use as assessed by regulatory bodies.

4. Adjudication method used 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 is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used:
For the purpose of substantial equivalence, the "ground truth" is effectively the established safety and effectiveness of the legally marketed predicate devices. The document states:

• "Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products [predicate devices]."
• The device is found "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

8. The sample size for the training set:
Not applicable. There is no AI algorithm or training set.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device (wound dressing) seeking market clearance through substantial equivalence. It is not an AI/ML device, and thus the requested specific details regarding AI/ML study design and evaluation metrics are not present or applicable. The "study" for this device is the comparison of its characteristics and indications for use against established predicate devices.

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Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:

• Pressure sores
• . Superficial burns
• Abrasions
• . Lacerations
• . Post-operative surgical wounds
• . Donor Sites
• . Trauma Wounds
• Dermal Lesions
• IV Sites .
• Fixation device ●

Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers. Dressings are supplied sterile in single use blister packs.

This submission, K973312, is for Transparent Film and Intelligent Film Dressings. The submission does not contain information about acceptance criteria or a study to prove the device meets these criteria. Instead, it describes a substantial equivalence comparison to a predicate device (Hydroderm, K935796).

Here's a breakdown of the provided information, noting the absence of the requested points:

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

This information is not provided in the submission. The document lists comparative features between the applicant's devices and the predicate device, but these are characteristics, not pre-defined acceptance criteria with performance targets.

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Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as:

• Pressure Ulcers .
• Arterial Ulcers .. ●
• . Venous Ulcers
• . Diabetic Ulcers
• . l st & 2nd Degree Burns
• Donor Sites .
• . Trauma Wounds
• Dermal Lesions

Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: Dermagran™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.

The provided document, K973283, is a 510(k) premarket notification for a medical device (Innovative Technologies' Alginate / Zinc Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting a full clinical study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance in the way you've outlined (including a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

The document primarily details:

• Device Description: Innovative Technologies' Alginate / Zinc Wound Dressing is a combination of two existing 510(k) products. It's a sterile, primary wound dressing for moderate to heavily exuding partial to full thickness wounds, forming a gel with wound exudate.
• Predicate Devices: Dermagran™ Zinc-Saline Wet Dressing (K913344) and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing (K953781).
• Comparative Features Table: This table compares the new device with the predicate devices across characteristics like material, non-therapeutic additives, surface, integrity, indications, packaging, and sterilization method. This comparison is the core of demonstrating substantial equivalence, showing that the new device is "similar in design, composition and function" to the predicates.
• Safety and Effectiveness: "Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products." This refers to the predicate devices, implying that the new combination product inherits this safety and effectiveness.
• FDA Determination: The FDA determined the device is substantially equivalent to pre-amendment devices and can be marketed, subject to certain labeling limitations (e.g., not for third-degree burns, no claims of accelerating healing, no long-term dressing claims, not a treatment/cure).
• Indications for Use: The FDA-cleared indications for the Alginate / Zinc Wound Dressing are for the management of moderate to heavily exuding partial to full thickness wounds such as Pressure Ulcers, Arterial Ulcers, Venous Ulcers, Diabetic Ulcers, 1st & 2nd Degree Burns, Donor Sites, Trauma Wounds, and Dermal Lesions.

In summary, this document is a 510(k) notification, which establishes substantial equivalence rather than presenting a performance study against predefined acceptance criteria.

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Innovalive Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including.

• Partial full thickness wounds, ie artenal, venous, diabetic ulocrs .
• Post-operative surgical wounds
• Donor Eiles
• Trauma Wounds
• Dermal Lesions
• Profective dressing

Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds. The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes. Dressings are supplied sterile in single use blister packs.

The provided text is related to a 510(k) submission for "Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings." This document is a regulatory submission for medical devices, specifically seeking clearance to market a device based on its substantial equivalence to a legally marketed predicate device.

Key Observation:
The document does not describe a study that proves the device meets specific acceptance criteria. Instead, it outlines the regulatory review process for a 510(k) submission. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as the predicate. This is typically achieved by comparing the new device's technological characteristics, indications for use, and performance data (if available and relevant for equivalence) to the predicate device. It does not generally involve a new clinical study with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission would for novel devices.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on:

• Device Description: Hydrocolloid and Intelligent Hydrocolloid Wound Dressings.
• Intended Use: Management of various wounds (dermal ulcers, superficial wounds, burns, donor sites, post-operative wounds, protective dressings).
• Comparison to a Predicate Device: Duoderm CGF / Extra Thin Hydrocolloid Dressings manufactured by Convatec, highlighting similarities in composition, surface, indications for use, transparency, self-adhesiveness, and sterilization method.
• Safety Assertions: Biocompatibility testing completed.
• Regulatory Clearance: A letter from the FDA determining substantial equivalence, along with limitations on labeling claims.

To directly answer your request based on the provided text, while acknowledging the absence of a detailed study report:

Acceptance Criteria and Device Performance Study (Not Applicable as a standalone study report is not provided)

The provided document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics. The implicit "acceptance criteria" for a 510(k) submission is that the device is as safe and effective as the predicate device.

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

Since no specific acceptance criteria for a new study are outlined, and no new performance data comparing against such criteria is presented, this table cannot be created from the text. The document does, however, provide a comparative table between the applicant's device and the predicate device, showing their similar characteristics:

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

Not applicable. The document does not describe a clinical "test set" in the context of a new study designed to meet specific performance criteria. The evaluation is based on a comparison to a predicate device and existing regulatory standards (e.g., for sterilization and biocompatibility).

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. No "ground truth" establishment for a test set is described as part of a clinical performance study. The expertise cited is related to quality assurance and regulatory affairs (Priscilla Whitehead, Director of QA/RA for Innovative Technologies).

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

Not applicable. No test set requiring expert 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. The device is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to "human readers improving with AI" is not relevant to this device.

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

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

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

Not applicable. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established regulatory approval and safety profile of the legally marketed predicate device (Duoderm CGF / Extra Thin Hydrocolloid Dressings by Convatec), combined with the Innovative Technologies' device meeting relevant standards for sterilization and biocompatibility.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or diagnostic algorithm device.

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

Not applicable. There is no mention of a training set.

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