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Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.

OTC:
LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.

LUOFUCON® Extra Silver Gelling Fiber Dressing Plus is a soft, conformable, sterile dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and polyethylene terephthalate fibers, 1.1% (w/w) ionic silver, and stitched with lyocell fibers. This conformable dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
The silver ions help to inhibit microbial growth in the dressing for up to seven days. Additionally, based on in vitro testing, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus also provides a barrier against bacterial penetration.

The provided text describes a medical device called "LUOFUCON® Extra Silver Gelling Fiber Dressing Plus" and "LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus" and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria and a study proving device performance as typically understood for AI/ML-based devices, which involves metrics like sensitivity, specificity, or AUC, and clinical study details.

Instead, this document focuses on demonstrating substantial equivalence for a wound dressing through comparative performance testing against a predicate device and safety assessments (biocompatibility, antimicrobial effectiveness, and animal testing).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the context of typical AI/ML device performance metrics. The information available details performance and safety comparisons to a predicate device and relevant standards.

However, I can extract the closest information available, reinterpreting "acceptance criteria" as performance specifications and "study" as the testing performed.

Closest interpretation of acceptance criteria and reported device performance from the provided text:

Information not available or not applicable in this context:

1. Sample size used for the test set and the data provenance: Not applicable in the context of device performance metrics for diagnostic or AI/ML devices. The "test set" here refers to the physical units of the wound dressing that underwent various laboratory and animal tests. No specific sample sizes are given for each individual performance test (e.g., how many dressings were tested for absorption capacity). The provenance of the testing is "Huizhou Foryou Medical Devices Co., Ltd." in China.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound dressing would typically involve laboratory measurements, histological analysis, or clinical observation in animal models, not expert consensus on diagnostic interpretations.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a wound dressing, not an AI diagnostic/assistance device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For performance tests, the "ground truth" would be the standard measurement methods and criteria (e.g., EN 13726-1 for absorption, AATCC TM100 for antimicrobial effectiveness). For the animal study, it would be direct observation of "wound healing performance characteristic and histopathology."
7. The sample size for the training set: Not applicable, this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

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Prescription Use: Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites; Traumatic wounds. OTC Use: Extra Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.

Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment. A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

This document is an FDA 510(k) summary for a medical device called "Extra Silver Gelling Fiber Dressing". It describes the device and compares it to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for this type of device (wound dressing) typically relies on demonstrating substantial equivalence to a predicate device rather than strict quantitative performance acceptance criteria for clinical efficacy in the same way a diagnostic AI device might. However, it does specify acceptance criteria for non-clinical tests.

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

This document describes non-clinical laboratory testing and equivalence comparisons. It does not involve a "test set" in the context of clinical data for an AI algorithm.

• Sample Size for Test Set: Not applicable in the context of clinical data for AI; non-clinical tests typically use replicate samples of the device itself.
• Data Provenance: Not applicable for clinical data; non-clinical lab tests are performed according to recognized standards.

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

Not applicable. This device is a wound dressing, not an AI diagnostic system requiring expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. This document pertains to non-clinical testing and substantial equivalence for a physical medical device, not a diagnostic AI system with an adjudication process for a test set.

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-assisted diagnostic device.

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

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 tests, the "ground truth" is defined by the specific parameters and methods outlined in the referenced ISO, ASTM, USP, and AATCC standards. For example, for cytotoxicity, the "ground truth" is the observation of cell viability against negative/positive controls as per ISO 10993-5. For antibacterial effectiveness, it's the measured log-reduction of bacterial colonies as per AATCC 100-2012.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:

Partial thickness burns (second degree);

Diabetic foot ulcers;

Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);

Pressure ulcers (partial and full thickness);

Donor sites;

Surgical wounds;

Traumatic wounds.

OTC:

LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.

LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.

The provided text describes the 510(k) submission for the LUOFUCON® Extra Silver Gelling Fiber Dressing and LUOFUCON® Silver Antibacterial Gelling Fiber Dressing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study methodologies, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in this type of regulatory document, which is primarily focused on a comparison to existing devices.

However, based on the information available, here's what can be extracted:

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

The document implicitly uses the performance of the predicate devices as a comparative benchmark. Explicit acceptance criteria in a quantitative sense are mentioned for some tests.

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: The tests are described as "in vitro testing" and a "porcine full thickness dermal wound healing study." This indicates a mix of lab-based and animal model studies. The country of origin of the data is not specified, but the manufacturer is based in China. The studies are assumed to be prospective as they are conducted for this 510(k) submission.

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. The document describes laboratory and animal studies, not human clinical trials that would typically involve expert-established ground truth.

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

Not applicable. This is not a clinical study involving human readers or interpretation requiring adjudication.

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 for a wound dressing, not a diagnostic AI device.

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

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

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

For the in vitro tests, the ground truth is established by the standardized methods themselves (e.g., AATCC TM100 for antibacterial effectiveness). For the porcine study, the ground truth would be based on direct observation of wound healing performance and histopathology, as assessed by the researchers conducting the study.

8. The sample size for the training set:

Not applicable. This is for a wound dressing, not a machine learning model.

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

Not applicable. This is for a wound dressing, not a machine learning model.

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OTC Use: Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. Prescription Use: Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites: Traumatic wounds.

Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

This document describes the Silver Gelling Fiber Dressing's acceptance criteria and how it was proven to meet them.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance metrics in a numerical sense; rather, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests and a comparison of characteristics. The performance is largely demonstrated by meeting established standards and showing comparable properties to the predicate.

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

• Biocompatibility Tests (ISO 10993 series): The document does not specify exact sample sizes for these in vitro and in vivo (systemic toxicity) tests. The standards themselves typically outline sample size requirements. Provenance is not explicitly stated but these are laboratory tests following international standards.
• Sterility & Packaging Integrity Tests (ASTM, USP): No specific sample sizes are mentioned, but these are standard laboratory tests. Provenance not specified.
• Antibacterial Activity (AATCC 100-2012): No specific sample size is mentioned in terms of the number of dressings tested, but it describes testing against "four gram-positive bacteria" and "four gram-negative bacteria." Provenance not specified but these are in vitro laboratory tests.
• Porcine Wound Healing Study: The document refers to "the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing)." It does not specify the number of porcine subjects used. This is an animal study, not human data. The provenance of the animals or the location of the study is not specified. All studies appear to be retrospective in the context of the 510(k) submission, meaning they were completed prior to the submission.

There is no test set of human subjects/patients for clinical performance evaluation mentioned in this submission. The "test set" for performance evaluation is primarily in vitro and animal models.

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

Not applicable. The study is for a medical dressing and focuses on non-clinical performance and substantial equivalence to a predicate device. There is no expert-established ground truth in the context of diagnostic or interpretive accuracy, as would be relevant for an AI/CADe device. The "ground truth" for the non-clinical tests is established by the methods outlined in international and national standards (e.g., cell viability in cytotoxicity tests, bacterial counts in antimicrobial tests).

4. Adjudication Method for the Test Set:

Not applicable, as there is no human-interpreted test set requiring adjudication in this context. The non-clinical tests directly measure physical, chemical, or biological properties against established standards or compare them to a control/predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical dressing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI/algorithm-based device. The "device" is a physical wound dressing. The tests performed are "standalone" in the sense that they assess the intrinsic properties and performance of the dressing itself without human intervention in its function.

7. The Type of Ground Truth Used:

• Biocompatibility: Established by standardized methods measuring cellular response (cytotoxicity, irritation, sensitization) and systemic effects. For the porcine study, the ground truth was the wound healing characteristics observed in the animal model.
• Sterility & Packaging Integrity: Established by adherence to validated sterilization methodologies and standardized tests for seal strength and integrity, and bacterial endotoxins.
• Antibacterial Activity: Established by measuring the log-reduction of specific challenge organisms according to the AATCC 100-2012 standard.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device 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 device.

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