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Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings.

The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy System), 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 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.

The Prevena™ Plus 125 Therapy Unit may be used part of as either of these systems:

A) Prevena Incision Management System Consist of:

• Prevena™ Therapy Unit .
• Prevena 150mL Canister & adaptor .
• Prevena Dressing kit ●

B) Prevena Plus Negative Pressure Wound Therapy System Consist of:

• Prevena™ Plus 125 Therapy Unit .
• Prevena 150mL Canister & adaptor .
• V.A.C. Dressing kit ●

The Prevena™ Plus Incision Management System (Prevena™ Plus Therapy Unit when used with Prevena Dressings) is designed for use over linear, non-linear, intersecting incisions.

The Prevena™ Plus Negative Pressure Wound Therapy System (Prevena™ Plus Therapy Unit when used with V.A.C. Dressings) is designed for use in a variety of open wound types such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The Prevena Plus 125 Therapy Units are negative pressure pumps that deliver -125mmHg continuously for up to 7 or 14 days.

The provided text is a 510(k) premarket notification summary for the Prevena Plus 125 Therapy Unit. It describes the device's indications for use, comparison to predicate devices, and performance data. However, it does not include a detailed study proving that the device meets specific acceptance criteria in the way typically required for AI/ML-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance data presented refers to non-clinical tests and human factors evaluation for a negative pressure wound therapy device, not a diagnostic AI system with performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested elements for an AI/ML device study are not applicable or present in this document. I will answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a non-AI/ML negative pressure wound therapy device seeking substantial equivalence, "acceptance criteria" and "device performance" are framed differently than for an AI diagnostic algorithm. The document states that the device functions "as intended" and maintains "negative pressure within specifications." Specific quantitative acceptance criteria (e.g., minimum pressure maintained, maximum leakage) are not detailed in this summary, nor are corresponding "reported device performance" values in a comparative table for such criteria.

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

• Sample Size: Not specified in the non-clinical tests mentioned. The "negative pressure test" and "human factors evaluation" would likely involve laboratory or simulated testing rather than patient data in the context of an established device's performance characteristics.
• Data Provenance: Not applicable in the context of patient data for an AI/ML algorithm. These are non-clinical (laboratory/engineering) tests.

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

Not applicable. There is no ground truth established by experts as this is not a diagnostic AI/ML device study.

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

Not applicable. There is no ground truth established by experts.

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. This device is a negative pressure wound therapy unit, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an AI algorithm. The device performance stands alone as a physical therapy unit.

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

Not applicable. The "ground truth" for the non-clinical tests would be engineering specifications and functional requirements (e.g., pressure output, functionality as per design).

8. The sample size for the training set

Not applicable. There is no AI/ML model with a training set described in this document.

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

Not applicable. There is no AI/ML model with a training set described in this document.

Summary of the Study per the Document:

The provided document describes a 510(k) submission for the Prevena Plus 125 Therapy Unit, aimed at demonstrating substantial equivalence to predicate devices. The "studies" conducted were non-clinical tests and a human factors evaluation. These tests confirmed that the device "maintains negative pressure within specifications" and "functioned as intended" when used with V.A.C. Dressings. The purpose was to show that adding the "open wound" indication, similar to a reference device, does not raise new questions of safety or effectiveness. The standard for substantial equivalence for this type of medical device does not typically require the extensive clinical validation and AI-specific study details requested in the prompt.

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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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