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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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