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Over the Counter Use: To be worn inside the bra to:

• Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding .
• Absorb milk leakage .
• Protect the nipple from abrasion and friction damage caused by bra or clothing .
• Help alleviate discomfort .
• Protect clothing from milk leakage .

FERRIS PolyMem® STERILE BREAST PAD

This document is a 510(k) clearance letter from the FDA for a medical device called "Ferris PolyMem® STERILE BREAST PAD". It does not describe acceptance criteria, a study proving device performance, or any of the other information requested in the prompt related to an AI/algorithm-based device.

Therefore, I cannot provide the requested information from the given text.

The document is a regulatory approval for a physical medical device (breast pad), not a software or AI-driven device that would involve performance metrics like accuracy, sensitivity, specificity, or studies with test sets, ground truth, or expert adjudications.

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For the management of: Pressure Ulcers (Stages I-IV), Leg ulcers, Diabetic ulcers, Venous stasis ulcers, Donor and graft sites, Dermatologic disorders, Acute wounds, Skin tears, 1st and 2nd degree burns

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Polymem Silver Wound Dressing." It is not a document that would contain information about acceptance criteria, device performance studies, or the specifics of a clinical trial in the way an AI/ML device submission would.

The letter grants clearance based on a determination of substantial equivalence to a legally marketed predicate device. This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, often through bench testing and sometimes animal studies, but not necessarily through the kind of human clinical trials with specific acceptance criteria and detailed statistical analysis that would be present in an AI/ML device submission.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it does not contain that type of data. The document focuses on the regulatory clearance process rather than the clinical study data itself.

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Ask a specific question about this device

Ostomy Tube Sites
Drainage Tube Sites
Gastrointestinal Tube Sites
Feeding Tube Sites

FERRIS POLYOSTOMY STERILE WOUND DRESSING

The provided text is a 510(k) clearance letter from the FDA for a device called "PolyOstomy Sterile Wound Dressing". This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, expert qualifications, or adjudication methods.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical and clinical study data used to establish substantial equivalence. To answer your request, one would typically need access to the actual 510(k) submission, which would include the performance data and supporting studies.

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Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers

FERRIS ... LOLLEWIC CARLY WOUND FILLER

The provided document is a 510(k) clearance letter from the FDA for a wound filler product named "PolyMem PolyWic Sterile Cavity Wound Filler". This document does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the regulatory clearance of the device based on its substantial equivalence to a legally marketed predicate device, its intended uses, and limitations on its labeling claims.

Therefore, I cannot provide the requested information as it is not present in the given text.

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For the management of
Leg ulcers
Venous ulcers
Diabetic ulcers
Arterial ulcers
Abrasions
Second degree burns
Full and partial thickness pressure ulcers
Dehisced incisions

Ferris PolyMem Calcium Alginate Dressing

The provided document is a 510(k) clearance letter from the FDA for the Ferris PolyMem Calcium Alginate Dressing. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Therefore, I cannot answer your request based on the provided text. The document is a regulatory approval, not a technical report detailing study results.

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For the management, including cushioning of, and absorption of fluid around: Tracheostomy tube sites drainage tube sites Gastrointestinal tube sites feeding tube sites

FERRIS POLYMEM POLYTUBE TUBE SITE DRESSING

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria. The text is a regulatory letter from the FDA regarding the 510(k) clearance of the Ferris Mfg. Corporation's Polytube device. It discusses the device's classification, marketing limitations, and general regulatory compliance. There is no mention of specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input.

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