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The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.

The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.

This document describes a 510(k) premarket notification for the Avance Abdominal Dressing Kit. It is not an AI/ML device, and therefore does not contain information about acceptance criteria for AI/ML performance, study details for AI/ML models, or ground truth establishment.

Based on the provided text, here's what can be extracted regarding the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" but does not quantify the number of tests or samples.
• Data Provenance: Not applicable. This is bench testing, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. The "ground truth" here refers to pre-defined engineering and biocompatibility standards, not expert interpretations of medical data.

4. Adjudication method for the test set

• Not applicable. Performance was assessed against pre-defined technical criteria.

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/ML device; therefore, no MRMC study with human readers and AI assistance was conducted or discussed.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance relates to the dressing kit's physical and functional properties, evaluated during bench testing.

7. The type of ground truth used

• Engineering and Biocompatibility Standards: The ground truth for this device's performance evaluation were established engineering specifications for fluid transport and ISO 10993-1 standards for biocompatibility.

8. The sample size for the training set

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

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

• Not applicable. No training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is based on established medical device standards and engineering principles.

Summary relevant to the prompt:

This document describes a medical device undergoing 510(k) clearance, which is a process to demonstrate substantial equivalence to a legally marketed predicate device. The evaluation focuses on the device's physical and functional properties, as well as its biocompatibility. It is not an AI/ML device, hence most of the questions related to AI/ML specific criteria (like training/test sets, expert adjudication, MRMC studies, etc.) are not applicable. The studies mentioned are "non-clinical testing" focusing on ISO standards and bench testing for fluid transport.

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The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.

This document describes the FDA 510(k) clearance for the Molnlycke Health Care US, LLC Avance Foam Dressing Kit - XL. This is an add-on to an existing Negative Pressure Wound Therapy (NPWT) system. As such, the submission focuses on demonstrating that the new component (the XL foam dressing) does not negatively impact the overall system's safety and effectiveness compared to the previously cleared system.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a specific table with acceptance criteria values and reported device performance. It generally states that "all predefined acceptance criteria were met" for the bench tests conducted.

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

The document does not specify the sample size for the bench tests. It only mentions that "Bench testing has been performed." The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software. No experts were used to establish ground truth in the context of diagnostic interpretation.

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

This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software.

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

This information is not applicable. No MRMC study was conducted as this is not an AI/diagnostic software.

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

This information is not applicable. This is not an AI algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering and functional specifications for the NPWT system's ability to transport fluid and deliver pressure. The document implicitly states that these functional requirements were met.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

This information is not applicable as there is no training set.

Summary of Device Acceptance Criteria and Study:

The Avance Foam Dressing Kit - XL is an addition to an existing Negative Pressure Wound Therapy (NPWT) system. The acceptance criteria focus on demonstrating that this new, larger dressing component does not negatively affect the overall system's functional performance and biocompatibility.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

The document does not provide specific numerical acceptance criteria or performance metrics but states compliance.

Study Details:

• Type of Study: Non-clinical bench testing.
• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified.
• Ground Truth Establishment: For bench testing, the ground truth would be based on engineering specifications and validated test methods for fluid transport and pressure delivery within NPWT systems.
• Clinical Data: No clinical data was required or submitted to support substantial equivalence.
• AI/Machine Learning Specifics: Not applicable; this device is a physical medical dressing, not an AI algorithm.

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The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:

• Antimicrobial gauze dressing
• Avance Transparent Film or Avance Film with Safetac technology
• Avance ViewPad

This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.

However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:

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

The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.

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

The document does not specify the sample sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench testing."

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):

This information is not applicable and not provided. The testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.

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 not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.

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

This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.

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

For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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