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LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

LUOFUCON® Silicone Ag Foam Dressing with Border has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mg/cm² silver ions, a supper absorbent fibre pad, a vapor permeable waterproof film, and release PE films. LUOFUCON® Silicone Ag Foam Dressing with Border can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silicone Ag Foam Dressing with Border). It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner you've requested (e.g., performance metrics with statistical significance, sample sizes for test sets, expert ground truth adjudication).

This document is a regulatory submission focused on demonstrating equivalence to already approved devices, not necessarily a detailed report of a new clinical or performance study with acceptance criteria listed in a typical research format.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative acceptance limits for "physical performance" are not detailed. The criteria are largely based on meeting established ISO standards for biocompatibility and demonstrating comparable antibacterial activity to predicate devices.

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

• Sample Size for Test Set: Not specified. The document mentions "Modified ASTM E2149-13a was used to evaluate the antibacterial preservative activity of the subject device." However, it does not state the number of samples used in this testing.
• Data Provenance: The antibacterial testing was likely conducted in a lab environment in China by Huizhou Foryou Medical Devices Co., Ltd., given the manufacturer's location. The document does not specify if the testing involved human data or was purely laboratory-based. Given the nature of the device (dressing) and the tests mentioned (biocompatibility, antibacterial activity), it's highly probable these are laboratory tests, not human trials.

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

• Not applicable / Not specified. This document describes laboratory performance testing (biocompatibility, antibacterial activity), not a clinical study requiring expert ground truth for a test set.

4. Adjudication method for the test set

• Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple experts. This document describes laboratory testing against established standards, not human interpretation.

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

• Not applicable. This device is a wound dressing, not an AI-powered diagnostic tool that would involve human readers or AI assistance.

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

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

7. The type of ground truth used

• For Biocompatibility: Defined by ISO standards (ISO 10993-5, 10993-10, 10993-11). The "ground truth" is adherence to these normative documents.
• For Antibacterial Activity: Defined by the ASTM E2149-13a standard and achieving a specified log reduction (>4 log reduction) over a specific duration (seven days). This is a laboratory-based 'ground truth.'

8. The sample size for the training set

• Not applicable. This document describes a physical medical device (wound dressing) and its performance testing, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set for a machine learning model is involved.

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LUOFUCON® Silicone Ag foam dressing is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

LUOFUCON® Silicone Ag foam dressing has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mq/cm² silver ions, a vapor permeable waterproof film. LUOFUCON® Silicone Ag foam dressing can absorb exudates, maintains a moist wound healing environment and has good antibacterial preservative properties within the dressing. It has been shown that antibacterial preservative effectiveness within the dressing for up to 7days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014. LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants: The first variant, Non-Border Silicone Ag Foam dressing consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The second variant, Silicone Ag Foam dressing With Border consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (A thin non woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel). The dressing has white or light brown appearance and is available in the form of pad and in different sizes of pouch package. All dressings use the same material of backing film, foam pad, silicone gel and release film. With Border version additionally adds a thin non woven as foam auxiliary layer, but it wouldn't impact the product properties.

The provided document, a 510(k) Premarket Notification for the LUOFUCON® Silicone Ag Foam Dressing (K160022), primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a complex diagnostic or AI-driven medical device.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or AUC) for an AI device is not applicable to this document. This submission details the physical device's characteristics, manufacturing, and basic performance features like biocompatibility and antibacterial activity.

However, I can extract the relevant information that is presented in the document concerning how this medical device demonstrates its intended function and safety.

Here's a breakdown based on the provided text, addressing your points where possible and noting when information is N/A:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for this device are largely based on physicochemical properties, biocompatibility, and the in vitro antibacterial activity, demonstrating it functions similarly to its predicate devices and poses no new safety or efficacy concerns.

Study Details (Relevant to this device type):

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of a "test set" for clinical performance. The studies mentioned (biocompatibility, antibacterial activity) would have involved specific sample sizes as per the respective ISO and AATCC standards. These are typically in vitro or animal tests, not large patient cohorts.
   • Data Provenance: The studies are in vitro (e.g., antibacterial) and in vivo (biocompatibility animal studies or in vitro cell-based tests referenced by ISO standards). The document does not specify the country of origin for the data generation, but the manufacturer is Huizhou Foryou Medical Devices Co., Ltd. from P.R. China. The studies are not described as retrospective or prospective clinical studies on human patients for efficacy, but rather laboratory-based performance and safety testing.

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

   • N/A. This information is not relevant or provided for this type of device submission. Ground truth, in the context of diagnostic AI, refers to expert consensus on disease presence/absence. For a wound dressing, ground truth is established through validated laboratory methods and standardized biocompatibility testing protocols, not by expert reads of images.

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

   • N/A. Not applicable, as this is not a diagnostic device involving human interpretation of clinical data requiring adjudication.

4. 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:

   • N/A. Not applicable. MRMC studies are for diagnostic devices, especially those that assist human readers. This is a medical dressing.

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

   • N/A. Not applicable. This is not an algorithmic device.

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

   • Ground Truth: For biocompatibility, ground truth is established by the results of standardized tests against ISO criteria (e.g., cell viability for cytotoxicity, skin reaction in animal models for irritation). For antibacterial activity, ground truth is based on quantitative microbial reduction against a control, as per the specified AATCC method. This is laboratory-derived ground truth, not clinical outcomes in patients.

7. The sample size for the training set:

   • N/A. Not applicable. There is no "training set" as this is not a machine learning/AI device.

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

   • N/A. Not applicable. There is no "training set."

Summary of Device Rationale for Acceptance:

The acceptance of the LUOFUCON® Silicone Ag Foam Dressing (K160022) by the FDA is based on demonstrating substantial equivalence to existing, legally marketed predicate devices (Mepilex Border Ag Dressing (K100029) and LUOFUCON® Silver PU Antibacterial Foam Dressing (K140954)). This is achieved by showing that the subject device has:

• Similar intended use, design, and materials to the predicates.
• Comparable performance characteristics, particularly in terms of in vitro antibacterial preservative activity (meeting the ">4 log reduction for seven days for all six bacteria" criterion) and duration (seven days).
• Demonstrated biocompatibility (passing ISO 10993-5, -10, and -11 for cytotoxicity, irritation, sensitization, and systematic toxicity).
• Validated sterilization process (EO in accordance with ISO 11135: 2014).

The submission argues that any minor differences (e.g., sterilization method, presence of a silicone layer) do not impact the device's safety or effectiveness compared to the predicates. The studies mentioned are primarily laboratory-based performance tests and biocompatibility assessments, not clinical trials on patient populations.

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