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The V.A.C. DERMATACTM Drape is an accessory to the:

· ACTIV.A.C.™, INFOV.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™ 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 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 closed environment and removing exudates via the application of negative pressure wound therapy.

The V.A.C. DERMATAC Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C. Therapy System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.

The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure.

The V.A.C. Therapy System is comprised of the following:

• . Software controlled neqative pressure therapy unit
• . Disposable canister which collects wound exudate
• . Polyurethane foam dressing
• Semi-occlusive wound drape

The provided text describes the V.A.C. DERMATAC Drape, an accessory for Negative Pressure Wound Therapy (NPWT) Systems, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested (e.g., performance metrics like sensitivity, specificity, AUC, or comparative effectiveness with human readers).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a human factors assessment. The "study" mentioned is a set of engineering and biocompatibility tests, not a clinical trial or an AI performance study with ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, or training set details as that information is not present in the provided text.

Here's what I can extract based on the provided document:

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

| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
| Biocompatibility | Met requirements according to ISO 10993 series testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Chemical Characterization, Leachable Substances). |
| Shelf Life (Packaging Integrity) | Met all requirements after 3 cycles of EtO sterilization and simulated shipping, for an accelerated aged equivalent of 2 years real time (shelf life stated as 1 year). |
| Adhesive Peel Test (Force required to remove drape) | Met specification requirements. |
| Moisture Vapor Transmission Rate (MVTR) | Met minimum requirements when using ASTM E96/E96M (Upright Cup Method at 38°C and 10%RH). |
| Negative Pressure Maintenance System Test (Maintain negative pressure with simulated wound exudate, maximum air leak, worst-case dressing, max use life, re-application cycling) | Capable of maintaining negative pressure within specification, including after re-application cycling. |
| Peel Adhesion with Re-Application Cycling Testing (Peel force after multiple re-applications) | Capable of meeting specification for peel adhesion after multiple re-applications and removals. |
| Human Factors (Safe and effective use by representative users) | 30 representative users found the new user interface could be safely and effectively used. |

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

• Test Set Sample Size:
  • Biocompatibility: Not specified, but involved testing according to ISO standards.
  • Shelf Life: Not specified for unit count.
  • Adhesive Peel Test: Not specified for unit count.
  • Moisture Vapor Transmission Rate Test: Not specified for unit count.
  • Negative Pressure Maintenance System Test: Not specified for unit count.
  • Peel Adhesion with Re-Application Cycling Testing: Not specified for unit count.
  • Human Factors: 30 representative users.
• Data Provenance: The tests described are laboratory/engineering tests conducted to assess physical and biological properties. A "country of origin for data" is not applicable in the context of these non-clinical tests. These are considered prospective tests performed on the device to prove its characteristics.

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

• This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests, not studies requiring expert-adjudicated ground truth. The human factors study involved "representative users" but didn't establish ground truth for a diagnostic task.

4. Adjudication method for the test set:

• This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests.

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, an MRMC comparative effectiveness study was not done. The device is a wound drape, not an AI diagnostic tool for human readers.

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

• This question is not applicable as the device is a wound drape, not an algorithm or AI system.

7. The type of ground truth used:

• Not applicable in the context of diagnostic ground truth. The "ground truth" for these tests was established by meeting engineering specifications and ISO standards (e.g., passing a biocompatibility test means no cytotoxic effect, maintaining negative pressure within a specified range).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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The Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The Medela® INVIA Liberty pump is an innovative suction pump to help promote wound healing. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® INVIA Liberty are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® INVIA Liberty ideally suited for Negative Pressure Wound Therapy (NPWT).

The Medela® INVIA Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® INVIA Liberty suction pump has an electronic measuring and monitoring system with optical and acoustic status display. It is a "medium vacuum" suction pump and has a suction capacity of 5 liters per minute and a maximum vacuum up to -27 kPa (-200 mmHg). The pump is marked "low flow - medium vacuum".

A variety of reusable and disposable accessories to help promote wound healing are available.

The Medela® INVIA Wound Therapy device, specifically the INVIA Liberty suction pump, was cleared through a Traditional 510(k) submission, asserting substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, the input document does not contain the full set of information requested because it describes a 510(k) submission for substantial equivalence rather than a study testing against acceptance criteria. A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device, often relying on comparison of technological characteristics and performance data, rather than a clinical trial with specific performance targets.

Here's an analysis of the provided text in the context of your request:

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

• No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on demonstrating "identical performance characteristics" and "identical technology" to predicate devices.
• The document states: "The Medela® INVIA Liberty suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices."
• Performance information mentioned is descriptive:
  • "maximum suction performance"
  • "quiet, dependable operation"
  • "suction capacity of 5 liters per minute"
  • "maximum vacuum up to -27 kPa (-200 mmHg)."
  • "marked 'low flow - medium vacuum'"
  • These are descriptions of the device's capabilities, not specific acceptance criteria from a study with corresponding results.

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

• No test set or associated sample size is mentioned. The submission is a regulatory filing for substantial equivalence, not a report of a specific study that used a test set to evaluate performance metrics against acceptance criteria.

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. As there is no mention of a test set, there is no discussion of experts establishing ground truth for such a set.

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

• Not applicable. No test set is described.

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 powered suction pump and the submission does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is a physical medical device (suction pump) used for wound therapy, not a diagnostic algorithm.

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

• Not applicable. No specific "ground truth" as a reference standard for performance evaluation is mentioned, as the submission focuses on equivalence to existing devices based on technical characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so no training set is relevant.

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

• Not applicable. No training set is relevant.

In summary: The provided document is a 510(k) summary for a powered suction pump, intended to demonstrate substantial equivalence to predicate devices. It does not describe a performance study with defined acceptance criteria, test sets, or ground truth establishment in the manner typically associated with device performance evaluation against specific metrics, especially for AI/ML devices. The "study" mentioned is the 510(k) submission process itself, where the device's design and technical specifications are compared to similar already-approved devices.

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The V.A.C. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.

The V.A.C.® GranuFoam™ Silver dressing is a modification to the V.A.C. product line of black, reticulated, polyurethane foam dressings, designed specifically for use with the V.A.C. family of feedback-controlled devices, including the miniV.A.C. 9, V.A.C.® Freedom™ and V.A.C.® ATS™ systems, all currently marketed by KCI under 510(k) K032310. The modification is the addition of a silver containing coating to the GranuFoam™ dressing to allow for a silver option to the dressing line.

The provided text is a 510(k) summary for the V.A.C.® GranuFoam™ Silver Dressing. It does not describe an AI/ML device or a study proving its performance against specific acceptance criteria in the way typically expected for such devices (e.g., sensitivity, specificity, AUC). Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a medical dressing, primarily through bench testing for biocompatibility and in-vitro antimicrobial effectiveness.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not present or not applicable in the context of this type of medical device submission.

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

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

• Sample Size: Not specified in the document for any testing.
• Data Provenance: Not specified, but tests were conducted by "licensed commercial reference laboratories" under GLP studies (Good Laboratory Practice), suggesting adherence to established scientific and regulatory standards. The 510(k) summary originated from Kinetic Concepts, Inc. in San Antonio, TX, USA, suggesting the data is likely from or overseen by US entities.

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. The ground truth for biocompatibility and antimicrobial effectiveness would be established through laboratory testing and standardized assays, not expert consensus in the clinical sense.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical and often image-based studies involving human interpretation. The reported studies are bench and in-vitro tests.

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 medical dressing, not an AI/ML diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a medical dressing, not an algorithm.

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

• Biocompatibility: Established through standardized GLP (Good Laboratory Practice) studies in accordance with ISO-10993 for surface devices in contact with breached or compromised surfaces. This involves specific assays to determine toxicity, irritation, and sensitization. The "ground truth" is adherence to these established safety norms determined by the test results.
• Antimicrobial Effectiveness: Established through "separate in-vitro laboratory evaluations" using "licensed commercial reference laboratories." The "ground truth" here is the measured antimicrobial activity against specific microorganisms under controlled laboratory conditions.

8. The sample size for the training set

Not applicable. This device is a medical dressing, not an AI/ML model that requires a training set.

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

Not applicable. This device is a medical dressing, not an AI/ML model that requires a training set.

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