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Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ 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.

Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Partial-thickness burns
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds.

Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.TM Negative Pressure Wound Therapy.

3MTM Promogran Prisma™ is comprised of a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC), 55% collagen and 1 % silver ORC. Silver ORC contains 25% w/w ionically bound silver.

It is a primary dressing that can be cut with scissors to fit the wound and used in combination with either a semiocclusive or non-occlusive secondary dressing. The dressing is hexagonal in shape, provided in two sizes (28 cm² and 123 cm²) that are packaged in a hexagonal thermoformed tray and sterilized by gamma irradiation.

As described in the product labeling, when used with the ActiV.A.C.TM Negative Pressure Wound Therapy System, seven slits are cut into the 3M™ Promogran Prisma™ by the health care provider before applying the dressing and the components of the ActiV.A.C.™ Negative Pressure Wound Therapy System.

After reviewing the provided document, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested.

The document is an FDA 510(k) clearance letter and its associated summary for the PROMOGRAN PRISMA Matrix wound dressing. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and performance data for an AI/ML-driven medical device.

Here's why the requested information cannot be extracted:

• Device Type: PROMOGRAN PRISMA Matrix is a wound dressing, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system.
• Study Focus: The "Performance Data" section (page 11) explicitly states:
  • "Summary of non-clinical tests conducted for determination of substantial equivalence": This refers to biocompatibility and bench studies for the physical dressing and its compatibility with Negative Pressure Wound Therapy, not an algorithm's performance.
  • "Summary of clinical tests conducted for determination of substantial equivalence": This states "No clinical tests were necessary to demonstrate acceptable use of the Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy." It mentions a "human factors engineering assessment" with 30 subject nurses and doctors to ensure changes to labeling for combined use are safe and effective. This is not a study proving an AI/ML device's diagnostic performance.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, image analysis, diagnostic performance metrics (e.g., sensitivity, specificity, AUC), ground truth establishment by experts, test sets, training sets, or MRMC studies, all of which are pertinent to AI/ML device evaluations.

Therefore, the requested tables and details pertaining to AI/ML device acceptance criteria and performance studies are not present in this document. The document describes a traditional medical device's clearance process based on substantial equivalence.

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The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as:

• first and second degree burns
• severe sunburns
• superficial injuries, cuts, abrasions and surgical wounds

The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

• Pressure (stage I-IV) and venous stasis ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Donor sites and grafts

Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.

The Keratec Wound Dressings are not intended to be used on third degree burns.

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are designed as chronic wound treatment devices for dry to heavily exuding wounds. The Keratec Wound Dressings are sterile, single-use wound care dressings that include keratin proteins derived from sheep wool for use in moist wound management.

The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.

Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.

Kerafoam is a keratin film coated on a polyurethane foam substrate for use in multilayered advanced wound dressings. The keratin film is in matrix form with soluble keratin proteins. The Kerafoam product forms a gel when in contact with wound exudates. The Kerafoam provides the exudate management features of other advanced moist wound dressings.

Keraderm is open-celled foam derived from freeze-dried keratin protein. Keraderm is re-absorbed into the developing tissue without traumatic dressing changes. Keraderm provides a bio-absorbable "scaffold" for the rapid growth of new tissue in three dimensions. Keraderm is provided in an acellular form of keratin protein.

The Keratec Wound Dressings (Keratec Keragel, Kerafoam, and Keraderm) are wound care dressings containing keratin proteins from sheep wool, intended for moist wound management.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific quantifiable acceptance criteria in a tabular format with corresponding reported device performance metrics. Instead, it relies on a comparison to predicate devices and a general statement of positive performance testing.

2. Sample Size Used for the Test Set and Data Provenance

The summary states that "Extensive bench, biocompatibility, animal and clinical testing have been performed." However, it does not specify the sample size for any of these test sets. The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The document does not detail how specific ground truths for "safety" or "efficacy" were established by experts for the performance testing.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1) for establishing ground truth in performance testing is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a wound dressing, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Keratec Wound Dressings are physical medical devices (dressings) and do not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The document broadly refers to "safety and efficacy" demonstrated through "bench, biocompatibility, animal and clinical testing." This implies that the ground truth for these tests would have been established through:

• Bench Testing: Engineering specifications, material properties, absorption rates (measurable parameters).
• Biocompatibility Testing: Standards-based biological response (e.g., cytotoxicity, sensitization, irritation).
• Animal Testing: Physiological responses, wound healing rates, tissue integration in animal models.
• Clinical Testing: Clinical outcomes related to wound healing, adverse event rates, patient comfort (likely adjudicated by healthcare professionals, though not explicitly stated).

8. The Sample Size for the Training Set

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices.

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