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CollaWound wound dressing is intended for the management of wounds including:

• partial and full-thickness wounds
• diabetic ulcers
• venous ulcers
• pressure ulcers
• chronic vascular ulcers
• tunneled/undermined wounds
• surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• trauma wounds (abrasions, lacerations, secondary-degree burns, and skin tears)
• draining wounds

CollaWound wound dressing is a sterile, single use, disposable wound dressing comprised of cross-linked porous collagen matrix with yellow to off-yellow appearance and is supplied in sponge configuration. It forms a layer of thin film at the wound site and provides a biodegradable scaffold for the cell invasion and capillary growth.

The provided document describes a 510(k) premarket notification for the "CollaWound wound dressing." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a de novo study to establish specific performance acceptance criteria and then proving the device meets them.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable to this submission. The 510(k) process for this device focuses on demonstrating that it is as safe and effective as existing products.

Here's an analysis of the provided information based on your request, identifying what is present and what is not applicable:

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

• Not Applicable. The 510(k) submission for the CollaWound wound dressing does not include a table of specific numerical acceptance criteria (e.g., minimum tensile strength, maximum absorption rate, specific clinical outcome percentages) and corresponding reported device performance values from a study designed to meet those criteria.
• Instead, the submission states that "Biocompatibility tests have confirmed that CollaWound wound dressing meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993." This is a general statement of compliance with recognized standards, not a table of performance against predefined acceptance criteria for the device's function as a wound dressing.
• The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material.

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 performance study with a test set of patients or data to evaluate the device's efficacy against specific performance criteria. The biocompatibility tests would have involved specific sample sizes, but these are not for clinical performance.

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. As there is no described clinical test set for performance, there is no mention of experts used to establish ground truth for such a set.

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

• Not Applicable. There is no described clinical test set, so no adjudication method is 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

• Not Applicable. This device is a physical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant.

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 consensus, pathology, outcomes data, etc)

• Not Applicable. No clinical study for performance is described that would require a ground truth. For the biocompatibility tests, the ground truth would be established by the specific chemical and biological assays and their validated controls as per ISO 10993 and FDA guidelines.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing, as it does not involve machine learning or an algorithm.

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

• Not Applicable. No training set is mentioned or relevant.

Summary of Device Acceptance (based on the provided document):

The CollaWound wound dressing was accepted by the FDA based on the demonstration of substantial equivalence to four legally marketed predicate devices. The key elements for this acceptance were:

• Intended Use: The CollaWound wound dressing has the same intended use as the predicate devices (management of partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds, draining wounds).
• Technological Characteristics: The device is a collagen wound dressing, similar in technological characteristics to the predicates. It is a sterile, single-use, disposable, cross-linked porous collagen matrix.
• Material: The device is made of collagen, which is the same material as the predicate devices.
• Safety: Biocompatibility tests confirmed compliance with FDA Blue Book Memorandum G95-1 and ISO 10993. This demonstrated the safety profile of the material.

The FDA's decision, as stated in the letter, is that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was found to be as safe and effective as the existing products on the market without requiring new clinical trials to prove its efficacy against new performance criteria.

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CollaWound™ Hydrogel is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.

CollaWound™ Hydrogel is a collagen-based emulsion/liquid formulation comprising collagen derived from porcine hides. It is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.

The provided text describes a 510(k) submission for a wound dressing called CollaWound™ Hydrogel. It focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility testing. The document does not describe a study involving a "device" in the context of an AI/ML algorithm or software that would have performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested elements for describing an AI study are not applicable to this submission.

Here's a breakdown based on the information available:

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

This information is not applicable as the submission is for a material-based wound dressing, not a software or AI device with performance metrics. The "acceptance criteria" here relate to meeting biocompatibility standards and demonstrating substantial equivalence.

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. This is not an AI/ML algorithm study. The "testing" involved biocompatibility tests on the material itself.

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.

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.

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

Not applicable.

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

Not applicable. For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993/G95-1).

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of the Study:

The "study" described in the 510(k) summary for CollaWound™ Hydrogel primarily consists of biocompatibility testing to ensure the material is safe for its intended use, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence.

• Biocompatibility Study: The submission confirms that CollaWound™ Hydrogel underwent biocompatibility tests that met the requirements of ISO 10993/G95-1. This ensures the device material does not cause adverse biological reactions when in contact with the body. Details about the specific tests performed (e.g., cytotoxicity, sensitization, irritation, etc.), the number of samples, or the outcome of individual tests are not provided in this summary.
• Substantial Equivalence Study: The core of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The submission states that CollaWound™ Hydrogel is "substantially equivalent in material, function, technological characteristics and intended use to its predicate." The specific predicate device is not named in the provided text, but the claim of equivalence is a key finding for the FDA's approval. This often involves comparing device specifications, materials, manufacturing processes, intended uses, and any performance data if relevant.

In conclusion, the provided documentation focuses on the safety and equivalence of a physical wound dressing material, not on the performance of a digital or AI-driven diagnostic or treatment device. Therefore, the questions related to AI/ML study design are not relevant to this specific FDA submission.

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CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:

• Pressure ulcers
• Venous ulcers
• Vascular ulcers
• Diabetic ulcers
• Trauma wounds (abrasions, lacerations, skin tears)
• First and second degree burns
• Surgical wounds

CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain a moist environment at the wound site.

I am unable to extract acceptance criteria and study details from the provided document. The document is a 510(k) summary for a wound dressing (CollaWound™) and primarily focuses on establishing substantial equivalence to a predicate device, along with biocompatibility testing. It describes the device, its intended use, and states that product characterization and biocompatibility studies confirm its safety and equivalence.

However, the document does not contain information related to specific acceptance criteria, performance metrics, or study designs that would typically be associated with clinical performance studies or algorithm performance evaluations, as implied by your request.

Therefore, I cannot provide the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies. This type of information is generally found in more detailed clinical study reports or performance testing documentation, which is not present in this 510(k) summary.

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CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:

• Pressure ulcers
• Venous ulcers
• Vascular ulcers
• Diabetic ulcers
• Trauma wounds (abrasions, lacerations, skin tears)
• First and second degree burns
• Surgical wounds

CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.

This document is a 510(k) summary for the CollaWound™ dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial for a novel AI/software device would.

Based on the provided text, the device is a medical dressing and not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable to this submission.

Here's a breakdown of the available information relevant to your request, adapting the structure to fit the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary for a wound dressing primarily focuses on demonstrating safety and substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and performance metrics in the same way an AI/software device would. The "acceptance criteria" here are implicitly the requirements for biocompatibility and substantial equivalence to existing devices.

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

Not applicable. This is a medical device (wound dressing) submission, not an AI/software device with a "test set" in the computational sense. The "testing" referred to is biocompatibility testing and characterization studies, not performance evaluation on a dataset.

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

Not applicable. Ground truth establishment with experts is a concept relevant to AI/software performance evaluation. For this device, regulatory experts at the FDA review the submission for compliance and equivalence.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is relevant for AI/software performance evaluation.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This is not an AI/software device. Comparative effectiveness for a wound dressing would typically involve clinical trials comparing wound healing outcomes, which are not detailed in this 510(k) summary (a 510(k) focuses on substantial equivalence, not necessarily extensive clinical efficacy trials).

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

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/software. The "ground truth" for this submission is regulatory compliance (e.g., biocompatibility standards, established equivalence to predicate devices).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device with a "training set."

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

Not applicable. This is not an AI/software device with a "training set."

Summary of what the document does provide regarding the "study" (biocompatibility and characterization):

• Study Type: Product characterization studies and biocompatibility studies.
• Purpose: To demonstrate safety and substantial equivalence to predicate devices.
• Key Findings:
  • Biocompatibility tests confirmed compliance with ISO 10993/G95-1.
  • The device is substantially equivalent in material, function, technological characteristics, and intended use to several named predicate collagen-based wound dressings.
• Nature of "Acceptance": The FDA's acceptance of the 510(k) submission, based on the demonstrated substantial equivalence to predicate devices and adherence to safety standards.

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