Search Results

The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.

The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery charger, temperature control unit, warming card, and a clean dressing called a wound cover that supports the warming card and holds it away from the wound and skin.

The wound cover is a disposable, single-patient-use wound dressing. It is comprised of a thin shell, a window, and a foam frame. The shell has an adhesive border to hold the wound cover in place. It is water-resistant and can be easily cleaned. A clear window in the center of the wound cover allows the caregiver to view and assess the wound, and a pocket on top of the window holds the warming card used during warming therapy. The foam frame absorbs wound fluid (exudate), and keeps the pocket above the wound surface so neither the window nor the warming card contact the wound.

The provided document is a 510(k) premarket notification for a medical device called the "Augustine Medical Wound Care System, Model 68XXX". It describes a device that maintains moisture and body temperature in wound beds. However, the document explicitly states that "No additional testing was performed" for this specific 510(k) submission (K020077) because it's a "Special 510(k) Modified Device" and "does not differ in design, technology, materials, or size relative to the cleared device, nor its intended use" (page 5).

Therefore, this document does not contain information about acceptance criteria or a study proving that this specific modified device meets acceptance criteria. It refers to a previously cleared device (Augustine Medical Wound Cover, Model 68XXX, K963293) as its equivalent marketed device. To answer your questions, one would need to access the documentation for K963293.

Based solely on the provided text for K020077, I cannot complete the table or answer most of your detailed questions regarding acceptance criteria and a study that proves the device meets those criteria.

However, I can provide limited information based on the explicitly stated lack of new testing:

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

• Acceptance Criteria: Not specified in this document for K020077.
• Reported Device Performance: Not reported in this document for K020077 as no new testing was performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for K020077, as no new test set was used. The document states "No additional testing was performed".

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 for K020077, as no new test set was used and thus no new ground truth was established by experts for this submission.

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

• Not applicable for K020077, as no new test set was used.

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

• No MRMC study was done for K020077. This device is a wound dressing system, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

• Not applicable. This is a physical wound care system, not an algorithm.

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

• Not specified for K020077, as no new testing was performed. For the predicate device, it would likely involve clinical outcomes, efficacy in maintaining moisture and temperature, and safety data.

8. The sample size for the training set

• Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm that requires a training set.

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

• Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm.

In summary, the provided K020077 document is a "Special 510(k) Modified Device" submission, indicating that the device is substantially equivalent to a previously cleared device (K963293) and no new performance testing was conducted for this specific submission.

Ask a specific question about this device