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The TT101 Wound Care Dressing is indicated for the management of exuding wounds including: Diabetic ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds

TT101 Wound Care Dressing is a sterile primary dressing comprised of phosphorylated cellulose, formed into a sheet approximately 3 mm thick cut into various size pieces. When placed on a wound, the dressing provides a moist wound environment that is supportive to wound healing.

The provided text does not include information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets acceptance criteria. The text is a 510(k) summary and regulatory letter for a wound dressing, focusing on its substantial equivalence to a predicate device and its intended use.

Therefore, I cannot populate the requested table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement. The document primarily addresses regulatory clearance for a physical medical device (wound dressing) based on substantial equivalence, not performance metrics derived from a study to establish acceptance criteria.

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Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.

Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular etiologies
• Full-thickness & partial thickness wounds
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds

Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision.

Collagen-ORC Antimicrobial Matrix is a sterile primary dressing comprised of freeze-dried composite of 55 % collagen, 44 % ORC, 1 % silver-ORC. Silver-ORC contains 25 % w/w ionically bound silver.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria for the "Collagen-ORC Antimicrobial Matrix."

The document is a 510(k) summary for a medical device submitted to the FDA. It details the device name, submitter's information, classification, description, and indications for use. It also states that biocompatibility studies were conducted, demonstrating the device to be "non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." However, it does not provide specific acceptance criteria for these biocompatibility studies, nor does it present a detailed study comparing the device's performance against any set criteria.

The 510(k) process primarily determines substantial equivalence to a predicate device, rather than requiring extensive clinical trials with predefined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) application would.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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