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Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin.

Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have.

Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.

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This document is a 510(k) premarket notification letter from the FDA regarding the Hydrofera Bacteriostatic Wound Dressing. It declares substantial equivalence to a predicate device and outlines regulatory compliance. However, it does not contain the specific information required to answer your questions about acceptance criteria and study details.

The provided text does not include any information about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC effectiveness study, standalone performance study, type of ground truth, or training set details for any study.

This document is a regulatory approval letter, not a study report. To obtain the information you're looking for, you would need access to the actual 510(k) submission documentation, which would include the performance data and potentially the study details that led to this approval.

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Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.

Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge-like characteristics. The two pigments have been added to render the material bacteriostatic.

This 510(k) summary (K013462) describes a wound dressing and does not contain the detailed information required to answer all parts of your request. This type of regulatory submission focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with specific acceptance criteria and detailed test results as would be found in a clinical trial report or a more extensive engineering test report.

Based on the provided text, here's what can be extracted and what information is not available:

Information from the document:

• Device Proprietary Name: Hydrofera Bacteriostatic Wound Dressing
• Device Common Name: Wound dressing external use
• Intended Use: External dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, and superficial post-surgical incisions, and other external wounds inflicted by trauma.
• Predicate Devices: Ultrafera wound dressing (K964614) and Hydrofera Bacteriostatic Nasal Dressing (K983276)
• Sterility: Sterilized by either gamma or electron beam radiation to an SAL 10-6.

Based on the provided text, the following information is NOT available and therefore cannot be included in the table:

1. A table of acceptance criteria and the reported device performance: This document is a 510(k) summary, which focuses on substantial equivalence. It does not contain performance acceptance criteria or a study detailing device performance against such criteria. The "Performance standards: None" entry refers to the absence of specific FDA-mandated performance standards for this unclassified device type, not a lack of internal performance testing.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: Not applicable. This is a physical wound dressing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wound dressing, not an algorithm.
7. The type of ground truth used: Not applicable for this type of device and submission.
8. The sample size for the training set: Not applicable for this type of device and submission.
9. How the ground truth for the training set was established: Not applicable for this type of device and submission.

The 510(k) summary indicates that "safety and effectiveness information will be provided for this marketed device upon request by interested persons." This suggests that performance data may exist but is not part of this summary document. For a physical device like a wound dressing, performance data would typically involve biocompatibility testing, tensile strength, absorption rates, bacteriostatic efficacy (as claimed by the device name, though not detailed in this summary), and potentially clinical observations for efficacy, but these details are absent from the provided 510(k) summary.

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