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The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.

The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy.

Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler.

The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization:

• . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation.
• The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit and 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit.

It's important to note that this document is an FDA 510(k) summary for a medical device (dressing kit), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies regarding ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this type of submission. The performance described here relates to the physical and functional characteristics of dressings in wound care, not algorithmic performance.

Acceptance Criteria and Device Performance (Not applicable for AI/ML specific criteria)

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a dressing kit. The "acceptance criteria" here are implied by the claim of substantial equivalence and are met through comparative analysis and leveraging existing clinical data for the predicate device, rather than new, large-scale clinical trials with pre-defined statistical endpoints for novel performance metrics.

Implicit Acceptance Criteria (Met by comparison and leveraging existing data):

• Functional Equivalence: The subject dressings perform the intended functions (negative pressure wound therapy, instillation, hydromechanical removal of infectious materials, non-viable tissue, and wound debris) comparably to the predicate devices.
• Material Equivalence/Safety: The materials of construction, physical properties, and sterilization methods are either identical or demonstrably safe and effective.
• Shelf-Life: The device maintains its stability and performance over the proposed shelf-life.
• Biocompatibility & Sterility: Meets all relevant FDA biocompatibility requirements and is sterile at a SAL of 10^-6.
• Clinical Efficacy (Leveraged): The device, in conjunction with the therapy unit, effectively promotes wound healing, granulation tissue formation, and removal of undesirable wound materials, as demonstrated by prior clinical data for the predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (As applicable to a medical device, not an AI/ML device):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (for Functional Equivalence/Bench Testing): Not explicitly stated numbers of devices tested. The "test set" here refers to samples subjected to bench tests (material comparisons, physical properties, finite element modeling, foam changes under negative pressure). The document states "production equivalent samples accelerated aged to the proposed shelf life" for shelf-life testing.
   • Clinical Data Provenance: The clinical data leveraged is from "literature-reported clinical data" from "21 retrieved reference publications" including "177 patients." This implies retrospective data from various clinical settings and possibly multiple countries, given it's a literature search. It is "real-world clinical evidence."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the typical AI/ML sense. For this medical device, "ground truth" for the bench tests would be established by validated measurement techniques and engineering specifications. For the clinical data, the "truth" is based on the reported clinical outcomes in the published literature (e.g., reduction in non-viable tissue, granulation tissue formation), which were assessed by the authors of those papers (presumably clinicians). The 510(k) relies on the validity of these published clinical observations.

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

   • Not applicable in the typical AI/ML sense. There was no human expert adjudication of model outputs or image interpretations. The "adjudication" for the bench tests would be through standard laboratory procedures and data analysis. For the clinical literature, the FDA reviews the cited publications for their relevance and applicability.

4. 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 not an AI-powered device. No MRMC study was performed.

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

   • Not applicable. This is not an AI-powered device/algorithm.

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

   • Bench Testing: Engineering specifications, validated measurement results, and comparative physical/mechanical properties.
   • Clinical "Ground Truth": For the clinical claims, the "ground truth" is based on the reported clinical outcomes data from the cited literature, specifically "evidence of reduction in non-viable wound tissue" and "impact on granulation tissue formation." Indirect endpoints included "decrease in the need for surgical debridement or visible evidence of reduction of nonviable tissue in photographs."

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The Prevena Restor™ Incision Management System consist of the following components for use together as a system:

• Prevena Plus Therapy Unit & canister
• Prevena Restor Adapti-Form Dressing:
  • Foam Dressing with a skin interface layer
  • V.A.C. Drape
  • SensaT.R.A.C. Pad
  • Hydrocolloid Sealing strips

The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units:

• ActiV.A.C. Therapy Unit,
• V.A.C. ULTA Therapy Unit, and
• V.A.C. Rx4 Therapy Unit.

The provided document describes the Prevena™ Restor™ Adapti-Form™ Dressing, a part of the Prevena™ Restor™ Incision Management System. It explicitly states that clinical and pre-clinical testing were NOT necessary to demonstrate substantial equivalence. Therefore, there are no acceptance criteria, performance data, or studies presented in this document that would typically involve sample sizes, expert qualifications, or ground truth establishment in the context of device performance in a clinical setting.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Prevena™ Restor™ Incision Management System, K181507) and a reference device (Prevena Plus Incision Management System, K153199) through a comparison of technological characteristics and non-clinical tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance criteria are not applicable based on the document's statement, the "acceptance criteria" here refer to the successful completion of non-clinical tests.

2. Sample size used for the test set and the data provenance

Not applicable. The document explicitly states that "Clinical and Pre-clinical testing were not necessary to demonstrate substantial equivalence." The non-clinical tests listed (e.g., negative pressure test, package integrity) do not involve human patient test sets in the typical sense; they assess product specifications and safety characteristics. Information about the sample size of materials or units used for these engineering/safety tests is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As clinical or pre-clinical performance studies were not conducted for substantial equivalence, there was no need for experts to establish ground truth on patient outcomes or diagnoses.

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

Not applicable. No clinical or pre-clinical performance studies involving adjudication were performed.

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. The device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a wound dressing, not an algorithm.

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

Not applicable. As clinical performance studies were not conducted, there was no ground truth related to patient conditions or diagnoses. The "ground truth" for the non-clinical tests would have been the pre-defined engineering and safety specifications or industry standards.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device, so there is no concept of a "training set."

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

Not applicable. No training set was involved.

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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 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

• 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion. and by removing exudate and infectious material.

• The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The Veraflo™ Cleanse Choice Complete Dressing Kit is intended to be used with the separately provided V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of Veraflo Therapy that provides V.A.C.® Therapy Negative Pressure Wound Therapy with an instillation option. The system kit provides sterile disposable components needed for delivery of Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M™ V.A.C. VeraT.R.A.C.™ Pad or 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set) and a wound measuring ruler. The kit components are intended to simplify wound dressing applications by replacing the multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.

The provided text describes the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit, which is a component of a powered suction pump system for wound therapy. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not involve an AI/ML algorithm or a study comparing AI performance against human readers. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" in the typical sense for an AI/ML device (e.g., AUC > X, sensitivity > Y). Instead, it focuses on verifying that the modified device performs as expected and meets existing predicate design requirements.

2. Sample size used for the test set and the data provenance

Not applicable for this type of device (medical device, not AI/ML). The "tests" performed were physical and biological evaluations of the dressing kit, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for the device's function (e.g., maintaining negative pressure) would be established through engineering and biological testing standards, not expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable.

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 device is a dressing kit for wound therapy, not an AI diagnostic or assistive tool.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Compliance with biological safety standards (ISO 10993-1).
• Demonstration of physical functionality (maintaining negative pressure, fluid removal) under simulated use conditions.
• Usability assessment against existing predicate device's usability profile.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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The V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option ( Veraflo™ Therapy).

· V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

· Veraflo™ Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C.® Ulta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

· V.A.C.® Therapy in the absence of instillation may also be used for:

o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The V.A.C. 8 Ulta Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions. The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative therapy for the removal of wound exudate and instilled solutions when applied. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillations and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for setting therapy parameters as well as help and alarm functions.

The document describes the V.A.C.® Ulta Negative Pressure Wound Therapy System, which is a negative pressure wound therapy system with an instillation feature. The submission for this device is a 510(k) premarket notification.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a tabular format with corresponding device performance values for all features. However, it states the performance specification for the new Smart Instill™ Feature and the general performance testing conclusion.

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

The document does not provide details on the sample size or provenance for the "performance testing" that documented the Smart Instill™ Feature's compliance. This testing is described as non-clinical.

For the human factors engineering assessment:

• Sample Size for Test Set: 30 subject nurses and doctors.
• Data Provenance: Not specified, but generally, human factors studies for medical devices are prospective and conducted in a simulated or real-world use environment. The document does not specify the country of origin.

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

• The document does not mention the use of experts to establish "ground truth" in the conventional sense for the performance testing or the human factors study.
• For the human factors study, 30 "subject nurses and doctors" were used as participants to assess usability and safety, but they were not establishing ground truth, rather their interactions with the device were the data. Their specific qualifications (e.g., years of experience) are not detailed beyond "nurses and doctors."

4. Adjudication Method

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where expert consensus is needed to establish ground truth from ambiguous cases. This type of adjudication is not described or indicated for either the non-clinical performance testing or the human factors assessment mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (Negative Pressure Wound Therapy System), not an AI-assisted diagnostic tool, so this type of study would not typically apply. The document focuses on performance specifications and human factors for the device itself.

6. Standalone Performance (Algorithm Only)

• The Smart Instill™ Feature involves software control, and its performance was "documented." This implies a standalone evaluation of the algorithm's ability to achieve saturation within the specified time frame. However, the exact methodology for this standalone testing is not detailed (e.g., if it was tested solely in simulation or on benchtop models without human interaction to verify the algorithm's output). The "performance testing" mentioned effectively serves as a standalone evaluation of the Smart Instill™ algorithm's functionality within the device.

7. Type of Ground Truth Used

• For the Smart Instill™ Feature: The "ground truth" would be objective measurements of fill volume and dressing saturation achieved within the 12-hour timeframe. This would likely be established through physical measurements on test setups (e.g., measuring liquid volume and observing saturation on wound models).
• For the human factors engineering assessment: The "ground truth" is established by observing user interactions and collecting feedback to determine if tasks can be performed safely and effectively. This is based on direct observation and qualitative/quantitative data from the participants.

8. Sample Size for the Training Set

• The document does not mention a "training set" as this is not an AI/machine learning model that requires a distinct training phase. It describes new software features, which are typically developed based on design specifications and then verified/validated.

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

• Since there is no mention of a training set in the context of an AI/ML model, this question is not applicable. The device's software features are developed based on established engineering principles and clinical requirements, rather than being "trained" on a dataset with ground truth labels.

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The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:

• ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.

· V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit is a component of the V.A.C.® Negative Pressure Wound Therapy (NPWT) Systems. The V.A.C. NPWT System is comprised of:

• Powered Negative Pressure Wound Therapy (NPWT) Unit ●
• A disposable canister which collects wound exudate
• A wound interface dressing .
• Semi-occlusive wound drape
• o Sensing pad and lumen

The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit provides sterile disposable components needed for delivery of negative pressure wound therapy. Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit includes:

• (1) V.A.C.® Granufoam™ Dressings (small, medium, or large) ●
• (1 or 2) V.A.C. Dermatac TM Drapes
• (1) SensaT.R.A.C.™ Pad ●
• (1) Ruler

This document (K212320) is a 510(k) summary for the 3M™ Dermatac™ Drape and V.A.C. Granufoam™ Dressing. It describes the device, its intended use, and how its performance was evaluated for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with corresponding "device performance" values for clinical efficacy. Instead, it focuses on verifying that the new device configuration (packaging Dermatac™ Drape with V.A.C. Granufoam™ Dressing and SensaT.R.A.C.™ Pad) and its sterilization method do not negatively impact its intended function or safety.

The acceptance criteria are implicitly met if the device functions as intended and maintains negative pressure within specifications, manages fluid exudate without unexpected alarms, and maintains sterile barrier integrity.

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

The document does not specify exact sample sizes for the individual tests (e.g., V.A.C.™ Negative Pressure Maintenance System Test, Package Integrity testing, Product performance testing). It states these were "non-clinical tests." Details regarding data provenance (e.g., country of origin, retrospective/prospective) are not provided as these were not clinical studies involving human subjects.

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

Not applicable. The tests performed were primarily engineering and performance verification tests, not diagnostic studies requiring expert adjudication of ground truth from clinical cases.

4. Adjudication Method for the Test Set:

Not applicable, as the tests were non-clinical performance and engineering evaluations, not clinical studies requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical performance data to demonstrate substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance. The device in question is a wound dressing kit, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

Not applicable. This device is a physical wound dressing kit, not an algorithm or AI-based software.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards, rather than expert consensus, pathology, or outcomes data typically associated with clinical ground truth. For instance, negative pressure maintenance was likely compared against predefined operational ranges, and sterility against established integrity standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.

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

Not applicable, for the same reason as item 8.

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Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, based on the provided document:

Acceptance Criteria and Device Performance

Note on "Acceptance Criteria": The document lists "Stated Values" for the chemical indicator, which represent the minimum conditions at which the indicator is designed to reach its endpoint (change color to "ACCEPT"). These are:

• VH2O2: 5.1 mg/L
• Exposure Time: 1 minute
• Temperature: 50°C

The general acceptance criteria for the nonclinical testing seem to be 'Pass' for each test, indicating that the device performed as expected under the tested conditions.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample size for the test set (e.g., how many individual indicators were tested for each sterilizer type or condition). It mentions "chemical indicator samples" for endpoint color stability and shelf life testing.
   • Data Provenance: The document implies the testing was conducted by the manufacturer, 3M Company, as part of their premarket notification. The location of the testing is not explicitly stated (e.g., country of origin), but it's likely internal to 3M's development and validation processes. The study is prospective as it's part of the premarket submission for a new device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of human experts to establish ground truth for reading the chemical indicator's color change. Chemical indicators are typically designed for objective visual interpretation, where the "ground truth" is defined by the physical/chemical properties of the indicator and its response to specific sterilization parameters, as determined by laboratory measurements of those parameters.
   • Therefore, this question is not directly applicable in the context of this device and study.

3. Adjudication method for the test set:

   • None specified. As mentioned above, the assessment of a chemical indicator's color change against defined "ACCEPT" or "REJECT" zones is generally a direct visual interpretation, not requiring expert adjudication in the same way, for example, a medical imaging diagnosis might. The endpoint specifications are based on the physical chemistry of the indicator.

4. 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. This is a chemical indicator, not an AI-powered diagnostic device or a system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant to this submission.

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

   • Not applicable. This is a physical chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical interaction with the sterilant.

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

   • The ground truth for this device is based on the defined physical/chemical parameters of the sterilization process (VH2O2 concentration, exposure time, and temperature) and the indicator's designed response to these parameters. The "Stated Values" (SV) in Table 1 define the minimum conditions for a successful ("ACCEPT") outcome. The "Health Care Facility Simulated Use Testing" and "Worst Case Sterilant Exposure Testing" would have used calibrated sterilization equipment to establish these ground truth conditions.

7. The sample size for the training set:

   • Not applicable. This device is a passive chemical indicator, not a machine learning model, so there is no "training set." Its design and performance are based on chemical engineering and empirical testing rather than iterative learning from data.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, this question is not relevant.

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The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile.

This document is a 510(k) Summary for the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a detailed "Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3" table. This table serves as the primary source for acceptance criteria and the reported performance of the subject device.

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The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.

The 3M™ High Performance Surgical Mask has a duckbill design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has ties to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. They may be produced with or without a face shield. This is a single use, disposable device, provided non-sterile.

This device is not made with Natural Rubber Latex.

The provided text is a 510(k) premarket notification for a surgical mask, which outlines its substantial equivalence to a predicate device based on performance specifications and safety. It is not a study proving device meeting acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and information as this document pertains to a physical medical device (surgical mask), not an AI/ML software device.

Key reasons why the request cannot be fulfilled based on the provided text:

• Device Type: The document is about a physical medical device (surgical mask), not a software-based AI/ML device.
• Acceptance Criteria for AI/ML: The acceptance criteria for AI/ML devices typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., and are evaluated against a ground truth established by experts. The criteria here are based on ASTM standards for surgical mask performance (e.g., fluid resistance, particulate filtration, bacterial filtration, flammability).
• Study Design: The document references "nonclinical tests" demonstrating equivalence to a predicate device based on performance specifications. This is not a description of a clinical study or a standalone AI/ML performance study as requested.
• Ground Truth, Sample Sizes, Experts, Adjudication: These concepts are relevant to studies evaluating diagnostic or predictive performance of AI/ML algorithms and are not applicable to the documentation of a surgical mask following ASTM standards.
• MRMC Comparative Effectiveness Study: Such studies compare human performance with and without AI assistance, which is not relevant for a surgical mask.

Therefore, the requested information (table of acceptance criteria with AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth types) cannot be extracted or inferred from the provided document.

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3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. Clarity Ultra Bracket is an esthetic bracket with a sliding door. The brackets are composed of aluminum oxide, which gives them a clear appearance. A nickel titanium wire serves as part of the door mechanism and is attached to the bracket using a cured adhesive. The brackets incorporate a water-soluble color placement indicator system. The archwire slot, vertical slot, and door are marked to facilitate bracket positioning. Tie wing(s) and/or door are color coded with dots to facilitate bracket identification. The brackets are available with or without APC™ Flash-Free pre-coated adhesive. The pre-coated adhesive ensures a consistent amount of adhesive on the bracket.

The provided document is a 510(k) Summary for the 3M™ Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System. It details the device's technical specifications and a comparison to predicate devices, but it does not contain information typically found in a study proving a device meets acceptance criteria, particularly for AI/machine learning devices.

The document discusses "Performance Testing" which refers to bench testing of mechanical properties, not clinical performance or AI algorithm performance. Therefore, I cannot extract information related to AI acceptance criteria or studies from this document.

For completeness, I will extract what is available regarding the device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Bench testing consistent with the clinical application and intended use was used to evaluate the performance of Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System compared to the predicate devices, Clarity™ Advanced and Damon 4Clear. Properties evaluated include: rotation play angle, wire rotation strength, shear-peel bond strength, torque strength, and squeeze debond strength. 3M Health Care has tested Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System and has concluded that the performance tests results demonstrate substantial equivalence to the predicate devices."

However, specific numerical "acceptance criteria" values or "reported device performance" values for these properties are not provided in the document. It only states that the device was found to be "substantially equivalent" to the predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing on the device itself, not a test set of data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant to this bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical bench testing. The "ground truth" in this context would be the measured mechanical properties of the devices.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

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