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Collatek Powder may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage I-IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatek® Powder is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to fill in full and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is able to conform to any wound site. Collatek® Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. Collatek® Powder's collagen is an insoluble fibrous type 1 bovine collagen derived from cowhide. Collatek® Powder will be available in a 1 gram size packet, additional sizes may be introduced at a later time.

The provided document does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria using metrics like sensitivity, specificity, or accuracy. This submission is for a Traditional 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device based on design, function, materials, and intended use, rather than a performance study against quantitative acceptance criteria for diagnostic or AI-based devices.

Instead, the document focuses on demonstrating that the Collatek® Powder is substantially equivalent to existing predicate devices (hyCURE® Powder, Comfeel® Powder, and Medifil® II Particles) by comparing:

1. Indications for Use: Collatek® Powder's indications are comparable to the predicate devices.
2. Instructions for Use: The manner of use is similar to other wound care products and predicate devices.
3. Technological Characteristics: Collatek® Powder is analogous in design to the predicate devices, being a hydrocolloid wound dressing designed for moderate to high exudating wounds.
4. Materials: The material (fibrous Type I bovine collagen) is the same as some predicate devices.
5. Safety: Biocompatibility testing confirmed compliance with FDA Blue Book Memorandum G95-1 and ISO 10993. (Results are reported to be in Appendix K, which is not provided).
6. Sterility and Packaging: Sterilization methods and packaging are described, with validation in accordance with ANSI/AAMI/ISO 11137-1994.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance study details as they are typically associated with AI/diagnostic device submissions. The information requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) is not relevant or present in this type of 510(k) submission for a wound dressing.

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