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LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silver Collagen Dressing) and describes its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and various tests performed to demonstrate its safety and performance. However, it does not explicitly state "acceptance criteria" as a set of quantified thresholds for performance, nor does it describe a study specifically designed to prove all elements of acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Puracol® Plus Ag MicroScaffold™ Wound Dressing), rather than defining and meeting specific, quantifiable acceptance criteria. The tests conducted are primarily to show that the subject device performs similarly to the predicate and meets general safety and performance standards for wound dressings.

Therefore, many of the requested fields cannot be directly extracted from the provided text in the manner specified. I will answer based on the information that is available, and indicate where information is not provided.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance outcomes. Instead, it states that "The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

Here's an attempt to infer and summarize based on the provided "Performance Test-bench" section and the comparison table. It's important to note that the specific numerical acceptance criteria for each test are not provided in this document.

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

• Sample size: Not specified. The document mentions "a series of bench tests" and "an in-vitro antibacterial effectiveness test" but does not provide the number of samples or specimens used for each test.
• Data provenance: Not specified. The tests appear to be laboratory-based ("bench tests," "in-vitro") conducted by the manufacturer or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as this is a pre-market submission based on non-clinical testing.

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

Not applicable. This device is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles for material properties, sterilization efficacy, and biological safety, as defined by international standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set

Not applicable. See #3.

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-assisted diagnostic or therapeutic device involving human readers.

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

Not applicable. See #5.

7. The type of ground truth used

For the non-clinical tests described:

• Sterility: Established by documented validation methods (ISO 11137-1/-2) demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
• Shelf-life: Established by real-time aging tests compliant with FDA guidance.
• Biocompatibility: Established by adherence to ISO 10993-1 standards and FDA guidance, with specific tests conducted (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, etc.).
• Performance (Physical/Chemical): Established by standard laboratory testing methodologies for properties like appearance, size, loss on drying, tensile strength, free swell absorption, pH value, and silver content.
• Antibacterial effectiveness: Established by an in-vitro test.
• Animal-Derived Materials Safety: Established by compliance with FDA guidance and ISO 22442 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See #8.

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Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

• (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
• (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.

The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.

Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

The provided text is a 510(k) Summary for a medical device (LUOFUCON® Silicone Ag+ Foam Dressing). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component, which is what your request implies about typical 'acceptance criteria' and 'study' information.

Therefore, I cannot extract the information you requested about AI/software performance, such as:

• Table of acceptance criteria and reported device performance (for AI/software): The document reports performance testing for the physical dressing (e.g., adhesive property, water absorbency, pH value, MVTR, waterproofness, antibacterial effectiveness, sterility), but not for any AI/software components.
• Sample size for the test set and data provenance: Not applicable as there's no AI/software test set.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can provide the acceptance criteria and performance data for the physical medical device as reported in the document:

The document describes various performance tests conducted to ensure the subject device is substantially equivalent to the predicate device. It doesn't present these as strict "acceptance criteria" with numerical targets in a table, but rather lists the tests performed and implies that the device "met all design specifications" and was "Substantially Equivalent (SE)" to the predicate with identical performance specifications.

Here's a summary of the performance tests mentioned for the physical device:

Performance Testing for LUOFUCON® Silicone Ag+ Foam Dressing

Additional Context from the document:

• Study Design/Purpose: The overall study described in the 510(k) submission is to demonstrate substantial equivalence of the LUOFUCON® Silicone Ag+ Foam Dressing to a legally marketed predicate device (K223360), not to establish novel performance criteria for an AI/software component.
• Modifications: The only modification to the predicate device was the addition of a new, larger size to the Non-Bordered and Transfer models. The document states, "the material properties of the subject device and predicate device remain the same and the performance specifications are also identical, the difference in size does not affect the effectiveness of the product."
• Clinical Study: No clinical studies were conducted for the subject device.
• Biocompatibility Testing: No additional biocompatibility tests were conducted for this submission. All biocompatibility data were leveraged from the predicate device (K223360) and included tests according to ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP 41-N36.
• Ground Truth (for the physical device): The "ground truth" for the physical device performance is established by adherence to recognized international and national standards (ASTM, BS EN, USP, ISO). The reported performance indicates that the device met the requirements of these standards and, by extension, is substantially equivalent to a predicate device that also meets these standards.

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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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LUOFUCON® Collagen Particles is intended for the management of wounds including:

• · Full thickness and partial thickness wounds
• · Pressure (stage I-IV) and venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Venous stasis and diabetic ulcers
• · 1st and superficial second-degree burns
• Cuts
• Abrasions
• · Surgical wounds

LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

This is a 510(k) Premarket Notification for a medical device (LUOFUCON® Collagen Particles, a collagen wound dressing) seeking substantial equivalence to a legally marketed predicate device. The information provided in this document focuses on demonstrating substantial equivalence for a collagen wound dressing, not an AI/Software as a Medical Device (SaMD).

Therefore, the specific criteria you've asked for, such as "acceptance criteria for an AI/SaMD study," "sample size for the test set," "number of experts for ground truth," "MRMC study," "standalone AI performance," and "training set details," are not applicable to this type of medical device submission.

This document demonstrates substantial equivalence through:

1. Comparison to a Predicate Device (K171645): Showing that the subject device has similar indications for use, technological characteristics (material, animal source, physical structure, biodegradability, mode of action), and manufacturing processes.

   • Acceptance Criteria: Substantial equivalence based on these comparisons.
   • Device Performance: The detailed comparison table (Table 1) outlines the similarities and minor differences. The document explicitly states: "LUOFUCON® Collagen Particles has the similar indications for use, and very similar technological characteristics to the predicate device(K171645). Both devices are 100% collagen and are designed as powder form, Tyvek packaging, single-use, sterile product. Their main production process includes drying, grinding, and irradiation sterilization. The subject and predicate devices employ the same mode of action in that both devices contain an absorbent nature that maintains a moist wound environment to support wound healing."

2. Non-Clinical Data/Information: Providing data on sterilization, shelf-life, biocompatibility, and performance bench tests to ensure safety and performance.

   • Acceptance Criteria: Meeting relevant ISO standards (ISO 11137-1/-2 for sterilization, ISO 10993-1 for biocompatibility, ISO 22442 for animal-derived materials safety) and demonstrating that the device meets performance requirements.
   • Device Performance:
     • Sterilization and Shelf-Life: "LUOFUCON® Collagen Particles is sterilized using Gamma radiation to a sterility assurance level of 10-6." and "a real-time aging test was conducted to demonstrate the shelf-life of LUOFUCON® Collagen Particles."
     • Biocompatibility: "The results showed that LUOFUCON® Collagen Particles meets biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance, and it raised no new safety concerns for biocompatibility to the predicate device."
     • Performance Test-bench: "Test results confirm that the subject device meets all product performance requirements and demonstrates substantial equivalence to the predicate device." Specific tests conducted include: Appearance, Weight, Sieving rate, Loss on drying, Free swell absorption, pH value, Heavy metal, Hydroxyproline assay, Endotoxin content, Sterility, In-Vitro degradation.
     • Animal-Derived Materials Safety: "the requirements of safety is compliant with FDA quidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards."

In summary, for this specific submission of a collagen wound dressing, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device through detailed comparison and non-clinical testing, rather than performance metrics for an AI algorithm.

The document does not contain any information related to AI/SaMD testing, human reader studies, or ground truth establishment in the context of an AI system.

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Prescription Use: LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use: LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

• (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
• (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
  The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
  Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

The provided text describes the regulatory clearance of a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML performance.

The document is a 510(k) Premarket Notification from the FDA for a wound dressing, specifically the LUOFUCON® Silicone Ag+ Foam Dressing. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through AI/ML performance metrics.

The "Performance Data" section (page 7) details various performance testing related to the physical and biological characteristics of the wound dressing, such as:

• Adhesive property: conducted with ASTM D6195-03
• Water absorbency: conducted with BS EN 13726-1
• pH Value: conducted with USP pH.
• MVTR (Moisture Vapor Transmission Rate): conducted with BS EN 13726-2
• Waterproofness: conducted with BS EN 13726-3
• EO and ECH residuals: conducted with ISO 10993-7
• Antibacterial effectiveness: in vitro simulated use testing.
• Sterility: conducted with ISO 11737-2:2019
• Biocompatibility testing (Cytotoxicity, Implantation, Intracutaneous Reactivity, Sensitization, Systemic toxicity, Material-mediated pyrogenicity) according to ISO 10993 standards.
• Animal Study: A Porcine Wound Healing Study.

The document explicitly states: "No clinical studies were conducted for the subject device." and there is no mention of any AI/ML components in the device or its evaluation. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and studies proving AI device performance.

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Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing.

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

LUOFUCON® Silver Gelling Fiber Surgical Dressing is a sterile post-operative dressing, comprising of polyurethane film, super absorbent fiber non-woven pad, silver gelling fiber non-woven pad (wound contact) containing 1.1% (w/w) ionic silver, and silicone qel. A windowed self-adhesive silicone skin contact layer plays a role of minimizing the trauma on removal, and alleviating the leakage of exudate.

The compliance and the softness of the dressing are improved effectively by using the notched non-woven pad, thus it is easier to apply on the wounds/parts which are difficult to paste. The highly absorbent dressing has a strong exudate management. When absorbing the wound fluid, the dressing will form a soft gel to support a moist wound healing environment. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.

Based on in vitro performance data, the LUOFUCON® Silver Gelling Fiber Surgical Dressing is waterproofness and breathable. The polyurethane film of dressing provides a microbial barrier to prevent the microbial penetrating through it, and the silver component prevents the growth of the bacteria within the dressing up to 7 days.

I am sorry, but the provided text describes a medical device (surgical dressing) that is not an AI/ML powered device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study details for an AI-powered device. The text does not contain information on AI/ML models, test sets, ground truth establishment, or human-in-the-loop performance.

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Prescription Use:
LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial second- degree burns, donor sites, surgical wounds, lacerations and abrasions.

OTC Use:
LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

LUOFUCON® Aq+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is a sterile, single-use wound dressing. The device has a single or multi-layer structure and its foam layer is containing 0.40mg/cm² maximum content of ionic silver. According to the different composition of product structure, the device provides three models: Easy, Backing and Adhesive.

• (a) The first model, Easy, consist of a single exudate absorption layer (Polyurethane foam containing silver compound).
• (b) The second model, Backing, consist of a backing layer (Polyurethane film); an exudate absorption layer (Polyurethane foam containing silver compound).
• (c) The third model, Adhesive, consist of a self-adhesive layer (Adhesive tape); an exudate absorption layer (Polyurethane foam containing silver compound); a release liner covers on the adhesive tape.

Depending on its exudate absorption layer, the device can absorb wound exudates and maintain a moist wound healing environment. As wound exudates are absorbed, the silver ions released from the polyurethane foam to assist in inhabiting bacterial growth within the dressing for up to 7days, as demonstrated in vitro. The polyurethane film of dressing is waterproof and breathable which can provide a microbial barrier to prevent the microbial penetrating through it.

This is a 510(k) premarket notification for a medical device called LUOFUCON® Ag+ Foam Dressing and LUOFUCON® Ag+ Antibacterial Foam Dressing. It is important to understand that a 510(k) submission seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to set new performance criteria or conduct studies proving superiority. Therefore, the information provided focuses on showing that the new device is as safe and effective as existing ones.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit acceptance criteria with numerical targets alongside reported device performance in the way one might expect for a diagnostic AI device. Instead, the performance data provided are primarily bench performance tests and biocompatibility tests, which largely demonstrate the physical and biological characteristics of the wound dressing and confirm it meets established standards for such devices. The "acceptance criteria" are implied by the standards chosen (e.g., BS EN 13726-1 for water absorbency, ISO 10993 for biocompatibility).

Here's a breakdown based on the provided text:

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

This document describes a medical device (wound dressing), not an AI/software device. Therefore, the concepts of "test set" and "data provenance" (e.g., country of origin, retrospective/prospective) are not directly applicable in the same way they would be for an AI algorithm.

• The "test set" for the bench performance tests would be samples of the LUOFUCON® Ag+ Foam Dressing itself. The number of samples tested for each bench test is not specified, but it would typically follow the requirements of the respective ISO/EN standards.
• The "test set" for the animal study was a cohort of pigs. The number of animals used is not specified.
• There's no mention of human clinical data or patient data "test sets" for evaluation in this submission.

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

This is not applicable as the device is a wound dressing, not an AI diagnostic system requiring expert interpretation for ground truth establishment. The performance is assessed against established physical, chemical, and biological standards.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device like a wound dressing. Adjudication methods like "2+1" or "3+1" are typical for establishing ground truth in image interpretation studies for AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, 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-assisted diagnostic tool.

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

Not applicable as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Bench Performance Tests: The "ground truth" is defined by specific quantitative and qualitative criteria outlined in international and national standards (e.g., BS EN, USP, ISO). These are objective measurements.
• Biocompatibility Tests: The "ground truth" is based on the absence of adverse biological reactions as defined by ISO 10993 standards.
• Animal Study: The "ground truth" for wound healing was based on observations and measurements within a porcine model, comparing the effect of the device to control or normal healing processes. The precise metrics are not detailed but generally involve macroscopic and microscopic evaluation of wound closure, inflammation, and tissue regeneration.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process of the wound dressing is well-established, and its characteristics are determined by its materials and design, not by learning from a dataset.

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

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

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LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.

The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.

When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.

LUOFUCON® Collagen Wound Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

The provided text is a 510(k) summary for the LUOFUCON® Collagen Wound Dressing, which is a medical device intended for wound management. The document states that the device is substantially equivalent to a predicate device (Medline Collagen Wound Dressing, K060456).

The document does not describe a study in the context of comparing the device to human readers or an AI algorithm, but rather a set of bench tests and biocompatibility tests to demonstrate safety and effectiveness for its intended use, and to prove substantial equivalence to a predicate device. This is typical for a 510(k) submission for a wound dressing, which is not an AI-powered diagnostic device.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's a breakdown based on the available information:

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

The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics. Instead, it states that "the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

However, we can infer some "performance requirements" that were tested:

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

Not applicable in the context of an AI/human reader study. The document refers to "non-clinical data and performance data" and "bench tests" performed on the device itself. Specific sample sizes for these tests (e.g., number of dressings tested for tensile strength) are not provided in this summary.

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

Not applicable. There is no mention of a test set with ground truth established by experts, as this is not an AI diagnostic device.

4. Adjudication method 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-powered device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

Not applicable. The "ground truth" here is the physical, chemical, biological, and safety characteristics of the device being evaluated against established standards and the characteristics of the predicate device. For example, for sterility, the ground truth is "sterile at SAL 10^-6". For biocompatibility, the ground truth is "meeting ISO 10993-1 requirements".

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a machine learning model for this medical device submission.

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

Not applicable.

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Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

The provided document is a 510(k) summary for the LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various physical, chemical, and biological properties, as well as general performance attributes relevant to wound care gels.

The table below summarizes the comparative data presented, which implicitly serves as "acceptance criteria" by showing the subject device is comparable to the predicate/reference devices for key properties and performance aspects.

The document states: "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." The "acceptance criteria" for these performance tests are implicitly met if the test results demonstrate comparable performance attributes to the predicate/reference devices, supporting the claim of 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)

The document does not detail specific sample sizes for the performance tests listed (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness). These are typically bench tests or in vitro studies, not requiring human patient test sets.

For the Animal Study (Porcine Wound Healing Study):

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country or retrospective/prospective). This was an animal study, not human clinical data.

For Clinical Studies:

• Sample Size: "No clinical study was conducted."
• Data Provenance: Not applicable, as no human clinical data was used for direct performance evaluation of this device.

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 to this submission. The device is a wound care gel, not an AI or diagnostic medical device that requires expert adjudication for a test set. The efficacy (or non-inhibition of wound healing) was assessed in an animal model and through comparative performance testing.

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

This information is not applicable. As mentioned above, this is not an AI/diagnostic device that relies on expert adjudication for ground truth.

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. An MRMC study is relevant for AI/diagnostic imaging devices. This submission concerns a wound care gel.

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

This information is not applicable. This question refers to AI algorithm performance.

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

For the various performance tests (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness):

• Ground Truth: These properties are determined through standardized laboratory testing methods (e.g., EN 13726-1, USP , USP , USP ). The "ground truth" is the quantitative or qualitative result obtained from these validated methods.

For the Biocompatibility Testing:

• Ground Truth: Compliance with ISO 10993 standards. The "ground truth" is the biological response (or lack thereof) observed in standardized in vitro and in vivo biocompatibility tests, interpreted by toxicologists or biologists.

For the Animal Study (Porcine Wound Healing Study):

• Ground Truth: Histological and macroscopic assessment of wound healing, and observation for adverse biological reactions. This ground truth is established by veterinary pathologists or researchers.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

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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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