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The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it 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. 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, it 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 exudates via the application of negative pressure wound therapy.

The 3M™ ActiV.A.C.™ Canister - 300ml with Gel is a component of the ActiV.A.C.™ Negative Pressure Wound Therapy System, also referred to as the ActiV.A.C. ™ Therapy System. The ActiV.A.C. ™ Therapy System consists of:

• · an ACTIV.A.C. ™ Therapy Unit,
• · a disposable canister which collects wound exudate (the subject of this submission),
• · a wound interface dressing,
• · a semi-occlusive wound drape, and
• · a sensing pad and lumen.

The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration.

The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp.

The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically the 3M™ ActiV.A.C.™ Canister - 300ml with Gel. This device is a component of a Negative Pressure Wound Therapy (NPWT) system.

The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This means the device is as safe and effective as a device already on the market and does not introduce new questions of safety or effectiveness.

Crucially, this type of submission does not typically involve the kind of clinical study data with acceptance criteria and ground truth that would be found in a novel device approval or a software as a medical device (SaMD) submission. Instead, it relies on demonstrating equivalence through comparison of technical characteristics, intended use, and performance data if there are significant changes.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document because it's not required for a 510(k) submission for this type of device (a medical device component, specifically a canister for NPWT).

The document explicitly states:

• "There was no performance data or biocompatibility performed to demonstrate equivalence." (Page 7)
• "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence." (Page 7)

The change being reviewed for this specific 510(k) (K241134) for the 3M™ ActiV.A.C.™ Canister - 300ml with Gel is that the "Canister will be provided entirely non-sterile. All other design features remain identical." (Page 6). This is a change in the sterilization method/status, not a new or significantly changed functional device or a software product requiring AI performance metrics.

In summary, none of the specific details you requested (acceptance criteria table, study sample sizes, expert details, adjudication, MRMC, standalone performance, etc.) are available in this document because the nature of the 510(k) submission for this device did not require such studies.

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The PREVENA PLUS Incision Management System (No Ag) is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy.

The PREVENA PLUS DUO Incision Management System (No Ag) 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.

Negative pressure wound therapy system for application to surgically closed incisions. The system consists of a therapy unit (PREVENA PLUS™ 125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit), dressing and canister. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. Application of negative pressure wound therapy to an incision site that is closed via staples or sutures helps draw the incision edges together and remove fluid from the incision site into a canister fitted to the therapy unit. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference.

The provided document is a 510(k) premarket notification for the PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Management System (No Ag). This document, while detailing the process of seeking FDA clearance for a medical device, does not contain the acceptance criteria or a study proving the device meets those criteria in the typical format of an AI/ML-based diagnostic device.

The device described is a negative pressure wound therapy system, a physical medical device, not a software or AI-driven diagnostic tool that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, the questions related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "ground truth establishment for training set") are not applicable to the information provided in this document.

The acceptance criteria in this context are related to the safety, efficacy, and conformance to design specifications of the physical device, and its substantial equivalence to a predicate device.

However, I can extract the relevant information from the document regarding the device's validation:

1. Table of acceptance criteria and reported device performance:

Note: The document states "Conclusions drawn: The PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Managements Systems (No Ag) are substantially equivalent to the predicate device systems with respect to indications for use and technology." This "substantial equivalence" is the primary acceptance criterion for 510(k) clearance, rather than specific performance metrics against a defined "ground truth" as seen in AI/ML diagnostic tools.

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

• The document does not specify sample sizes for the system performance, biocompatibility, or material equivalency tests.
• Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typically in a detailed study report, not the 510(k) summary.

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

• This is not applicable as the studies conducted are engineering and biocompatibility tests on a physical device, not diagnostic performance evaluations requiring expert review against a ground truth.

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

• Not applicable for the types of tests 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 is a physical medical device, not an AI-based 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 a physical medical device.

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

• For "System Performance Testing," the ground truth would be the device's design specifications for negative pressure delivery, fluid removal, etc.
• For "Biocompatibility testing," the ground truth would be established by ISO 10993-1 standards (e.g., absence of cytotoxicity, irritation, sensitization).
• For "Material specification equivalency testing with respect to Horizontal Wicking performance," the ground truth would be the performance of the predicate device and established material specifications for wicking.
• No "expert consensus," "pathology," or "outcomes data" in the typical sense of diagnostic ground truth is mentioned for these engineering/material tests.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

• Not applicable.

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PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and 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 125 and PREVENA PLUS 125 Therapy Units ("PREVENA pumps") are singleuse, compact and portable powered suction pumps. The therapy units are packaged with compatible sterile canisters (45 ml for PREVENA 125 or 150 ml for PREVENA PLUS 125) and sterile tubing set. The therapy units can be used with compatible, legally marketed wound dressings classified under 21 CFR 878.4780, such as the PEEL & PLACE dressing and the CUSTOMIZABLE dressing, which, when combined are referred to as the PREVENA Incision Management Systems ("PREVENA systems"). The PREVENA Incision Management Systems deliver a pre-set, continuous negative pressure of 125 mmHz to the incision site. The systems are intended to be applied to incision sites immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The therapy units can be used up to 192 hours, after which they will automatically shut off.

The provided text describes the regulatory evaluation of the PREVENA 125 and PREVENA PLUS 125 Therapy Units, focusing on clinical evidence from a systematic literature review and meta-analyses rather than a single, dedicated device performance study with specific acceptance criteria that would typically be seen for AI/ML devices. Therefore, a direct table of "acceptance criteria and reported device performance" as one might expect for a diagnostic AI/ML device is not explicitly present in the document.

However, based on the meta-analysis results and the FDA's granted indications for use, we can infer the "acceptance criteria" were met by demonstrating a favorable trend in reducing SSI and seroma, particularly in specific subgroups. The study essentially is the meta-analysis of existing clinical data.

Here's an interpretation of the information provided, structured to address your points, with explanations where direct parallels to AI/ML device criteria are not exact due to the nature of this submission (a device for wound therapy, not an AI/ML diagnostic).

Inferred Acceptance Criteria and Reported Device Performance (Based on Meta-Analysis Conclusion)

While explicit numerical acceptance criteria for a single study were not provided, the FDA's granting of the De Novo request signifies that the overall body of evidence from the meta-analysis met the regulatory standard for demonstrating safety and effectiveness for the specified indications. The "acceptance" was based on a "small but consistent trend" and "greater absolute percentage reduction" in specific high-risk populations.

Study Details:

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

   • Test Set Sample Size:
     • For SSI meta-analysis: 20 prospective studies, total of up to 6,403 evaluable patients (1,367 in PREVENA group, 5,036 in control group).
     • For Seroma meta-analysis: 7 prospective studies, total of 952 evaluable patients (366 in PREVENA group, 586 in control group).
   • Data Provenance: The data comes from a systematic literature review and meta-analyses of published and unpublished prospective clinical studies. The geographic origin of these individual studies is not explicitly stated but implied to be global as it's a literature search. The studies are prospective. Seven articles identified as retrospective were removed to minimize bias.

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

   • Study Selection/Ground Truth Establishment:
     • Study Selection: Six (6) independent reviewers performed the initial study selection. A subset of two (2) independent reviewers assessed abstracts and manuscripts for inclusion/exclusion criteria. When discordance was identified, these two reviewers deliberated until a consensus was reached.
     • Characteristic Extraction: At least two additional independent reviewers extracted study characteristics.
     • Wound Classification (Ground Truth for Subgroup Analysis): CDC wound classification was assigned to each study by "two individuals with appropriate medical and clinical trials background."
   • Qualifications: The specific qualifications (e.g., number of years of experience, board certification) of these reviewers/experts are not detailed beyond "independent reviewers" and "individuals with appropriate medical and clinical trials background."

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

   • Study Selection: "When discordance was identified, the two reviewers deliberated until a consensus was reached." This suggests a consensus-based adjudication among the two reviewers, rather than a third expert "tie-breaker" (2+1).
   • Wound Classification: "a CDC wound classification was assigned by two individuals with appropriate medical and clinical trials background." It is implied a consensus or adjudication method was used if there was disagreement, but not explicitly stated.

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, an MRMC study was NOT done. This submission is for a medical device (a wound therapy unit), not an AI/ML diagnostic or assistive technology for human readers. The study is a meta-analysis of clinical trials comparing the device to conventional wound dressings. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

   • Not applicable. This is a physical wound therapy device, not a standalone algorithm. Its performance is evaluated in a clinical context on patients.

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

   • The "ground truth" for effectiveness (reduction in SSI and seroma) was the clinical outcomes data reported directly by the individual prospective studies included in the meta-analysis. These outcomes were typically assessed by the clinical investigators of each respective study.

7. The sample size for the training set:

   • Not applicable. This is a device, not an AI/ML model that requires a training set. The "training data" in a broader sense would be all the accumulated medical knowledge and device design iterations that led to the PREVENA system. The studies reviewed form the evidence base for its effectiveness, not a training set for an algorithm.

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

   • Not applicable. As stated above, there is no AI/ML training set in this context.

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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 ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it 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. 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, it is 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 ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) System. The ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) system consists of:

• ACTIV.A.C. TM Therapy Unit (the subject of this submission)
• disposable canister which collects wound exudate
• a wound interface dressing
• . semi-occlusive wound drape
• sensing pad and lumen

The ACTIV.A.C. ™ Therapy Unit is a portable, battery-powered, reusable, software-controlled therapy unit that can provide continuous or intermittent applications of negative pressure to the wound bed in the selectable range of -25mmHg to -200mmHg. The ACTV.A.C.™ Therapy Unit is designed for the application of Negative Pressure Wound Therapy in the home, acute or extended care setting. The open cells of the dressing, to which the therapy unit is connected via pad and lumen, enables distribution of the negative pressure across the surface of the wound bed, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.

Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that contains preset therapy settings based on wound type, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.

The provided text describes the ACTIV.A.C.™ Therapy Unit, a negative pressure wound therapy (NPWT) system. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to pre-existing devices (predicates K063692 and K120033) rather than defining specific, quantifiable acceptance criteria with numerical performance targets in the context of a "device performance" column. Instead, the "reported device performance" is described as the device functioning "as intended" and all test results being "as expected."

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

The document describes non-clinical testing for the ACTIV.A.C.™ Therapy Unit. It does not refer to a "test set" in the context of patient data or clinical trials. The tests conducted are:

• Conformance to 60601-1 standards: This likely involved laboratory testing of the device itself.
• Software assessment: This involved reviewing the software against FDA guidance.
• Negative Pressure Maintenance System Test: This involved testing the device's ability to maintain negative pressure and manage fluid.
• Extreme Environmental Storage Conditions test: This involved subjecting the device to various temperatures.

Therefore, there is no patient-specific sample size for a test set, and no data provenance in terms of country of origin or retrospective/prospective study design as these were non-clinical, in-vitro tests of the device's engineering performance.

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

Not applicable. As described above, this was non-clinical engineering and software testing. Ground truth in this context would be defined by engineering specifications and regulatory standards, not by expert medical opinion on patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no need for adjudication of patient data.

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

No. This document describes a 510(k) submission for a medical device (ACTIV.A.C.™ Therapy Unit), which focuses on demonstrating substantial equivalence through non-clinical performance and technological characteristics. It does not involve a multi-reader multi-case (MRMC) study or evaluate the improvement of human readers with or without AI assistance. The device is a physically applied NPWT unit, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. The ACTIV.A.C.™ Therapy Unit is a hardware and software system, not an algorithm. The software is integral to the device's function (e.g., controlling pressure, alarms). Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests described would be based on:

• Engineering specifications and design requirements: For tests like negative pressure maintenance and environmental conditions.
• Regulatory standards: Specifically, IEC 60601-1 for basic safety and essential performance.
• FDA guidance documents: For software assessment.

This is primarily engineering and regulatory compliance-based ground truth, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set of data. The "software" mentioned refers to the operational software embedded in the device, not an AI model trained on a dataset.

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

Not applicable, as there is no training set for a machine learning algorithm.

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The PREVENA RESTOR(TM) Incision Management System 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 negative pressure technology for the subject device is the same as that for the predicate device systems. The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.

The provided text is a 510(k) summary for the PREVENA RESTOR™ Incision Management System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through clinical studies typical of novel algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an FDA 510(k) clearance for this device is not applicable in the way it might be for a new AI/ML-based diagnostic device requiring performance against clinical endpoints.

Instead, the submission relies on demonstrating that the new device (PREVENA RESTOR™) is substantially equivalent to previously cleared predicate devices (K180855, K161897, K153199) by comparing technological characteristics and showing that a specific performance aspect (delivery of continuous negative pressure) is equivalent.

Here's a breakdown of the relevant information provided, with explanations for why some requested elements are not present:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" were demonstrating substantial equivalence to predicate devices in areas such as design, materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.
• Reported Device Performance:
  • Performance Claim: The PREVENA RESTOR™ Incision Management System is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.

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

• Not Applicable in this context. The "test set" here refers to bench testing performed on the device itself, not a clinical data set or a dataset for an AI algorithm. The text describes "bench testing" to demonstrate performance, but does not specify sample sizes or data provenance for this engineering testing. It falls under "non-clinical tests."

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. This device is a negative pressure wound therapy system, not a diagnostic AI/ML algorithm requiring expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" for its performance is its ability to mechanically deliver negative pressure as specified, which is evaluated through engineering bench tests, not expert review.

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

• Not Applicable. As explained above, this is not a study assessing diagnostic performance where adjudication methods for ground truth would be relevant.

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 not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

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

• Not Applicable. This is a medical device, not a standalone algorithm.

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

• Not Applicable in the traditional sense of diagnostic devices. For this mechanical device, the "ground truth" for its function is its ability to maintain a specified negative pressure. This is determined by engineering measurements against known physical standards and specifications during bench testing.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary regarding the study:

The study referenced is "Bench testing" which demonstrated substantial equivalence to predicate devices. This bench testing focused on the device's ability to maintain continuous negative pressure at -125 mmHg within specifications under various conditions (worst-case air leak rate and fluid input) over its intended duration of use. The 510(k) states that "No clinical tests were necessary" and "No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use." This indicates that the regulatory pathway for this particular device relied entirely on non-clinical (bench) testing to demonstrate substantial equivalence, rather than extensive clinical trials or performance studies against defined clinical endpoints.

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The PREVENA PLUS Incision Management System 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 PLUS DUO Incision Management System 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 PLUS 125 Unit is a component of a the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a maximum of fourteen (14) days depending on the surgeon's preference.

The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination.

The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

This document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the manner typically seen for algorithmic performance (e.g., sensitivity, specificity, AUC). Instead, it's a 510(k) submission for a medical device (a Negative Pressure Wound Therapy system) that focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical bench testing.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or estimable from the provided text for an AI/algorithm-based device.

Here's an attempt to answer the questions based only on the provided document:

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

Based on the document, the primary "acceptance criterion" for this 510(k) submission is the demonstration of substantial equivalence to a predicate device, specifically regarding the sustained delivery of negative pressure.

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

This information is not provided. The document states that "Bench testing demonstrated..." but does not detail the sample size (number of units tested, number of test runs) or data provenance. Since it's bench testing, it's not human data and thus retrospective/prospective or country of origin isn't directly applicable in the same way as for clinical studies.

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)

This information is not applicable/provided. The ground truth for bench testing typically involves engineering specifications and measurements against those specifications, not expert human assessment.

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

This information is not applicable/provided. Adjudication methods are relevant for human expert review processes, which are not described for this bench testing.

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

This information is not applicable/provided. No MRMC study was conducted, as this is a physical medical device (negative pressure wound therapy unit), not an AI algorithm assisting human readers. The document explicitly states: "No clinical tests were necessary." and "No usability testing was required, as there has been no change to the user interface or to the Instructions for Use."

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

This information is not applicable/provided. This is a physical device, not an algorithm. The performance described is the standalone performance of the device itself (its ability to maintain negative pressure).

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

The ground truth for the bench testing would be the engineering specifications and established physical principles for continuous negative pressure delivery at -125 mmHg, as determined by internal R&D and quality standards. Specific details are not provided, but it's fundamentally based on measured physical parameters against design requirements.

8. The sample size for the training set

This information is not applicable/provided. This is not an AI/machine learning device that uses a "training set."

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

This information is not applicable/provided. This is not an AI/machine learning device.

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The PREVENA PLUS Incision Management System 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 PLUS DUO Incision Management System 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 negative pressure technology for the subject device systems is the same as that for the predicate device systems. The PREVENA PLUS 125 Therapy Unit is a component of the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

The provided text is a 510(k) Summary for the PREVENA PLUS Incision Management System and PREVENA PLUS DUO Incision Management System. It details an FDA submission for substantial equivalence.

Based on the provided information, there are no acceptance criteria or studies proving device performance in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC, human reader improvement with AI assistance).

This document describes a medical device related to negative pressure wound therapy and its equivalence to predicate devices, not an AI/ML powered device. The "Performance Data" section specifically states:

• "Bench testing demonstrated that the PREVENA PLUS 125 Therapy Unit is able to deliver continuous negative pressure at 125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 7 day test. Alarms for blockage, leakage and full canister were tested with both the PREVENA PLUS and the PREVENA PLUS DUO Systems and met specifications."
• "Electrical safety and electromechanical emissions testing confirm that the subject therapy unit meets the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 ... IEC 60601-1-2 ... IEC 60601-6 ... IEC 60601-1-8 ... IEC 60601-1-11."
• "The new lithium battery has been verified to meet IEC 62133 Edition 2.0 2012-12."
• "No clinical tests were necessary. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use."

This indicates performance criteria related to mechanical function, electrical safety, and alarm systems of a physical medical device, not analytical or clinical performance of an AI model.

Therefore, I cannot provide the requested information regarding AI/ML performance criteria and studies.

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The V.A.C.VIA™ Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, the V.A.C.VIA™ 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 exudates and infectious material. Open wound types include: chronic, acute, traunatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, the V.A.C.VIA™ is intended to manage the environment of surgical incisions that continue to drain following sutured closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The negative pressure technology for the subject device is the same as that of the predicate device.

The therapy unit is a component of the therapy system which provides negative pressure wound therapy to the wound site for up to 7 days.

Negative pressure is created by the therapy unit by means of one software-controlled diaphragm pump which allows for a lightweight, single use therapy unit that provides for negative pressure wound therapy at either -75 or -125 mmHg. Negative pressure is delivered to the wound site through tubing to a dressing placed over the wound site.

This FDA 510(k) Summary describes a medical device, the V.A.C.VIA™ Negative Pressure Wound Therapy Unit, and its substantial equivalence to a predicate device. As such, the information provided is limited to what is relevant for a 510(k) submission, which focuses on demonstrating equivalence rather than comprehensive performance studies with detailed acceptance criteria typically found in clinical trials for novel devices.

Therefore, many of the requested elements (detailed performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established) are not explicitly present in the provided document.

Here's an overview based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Bench testing demonstrated that the V.A.C.VIA™ Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input during a 3 and 7-day test."

Specific numerical acceptance criteria for pressure delivery, air leak rate, or fluid input are not provided. However, the device is considered to have met the performance expectations by demonstrating "substantial equivalence" to the predicate device under these challenging conditions.

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

• Sample Size: Not specified. The document only mentions "worst case conditions of air leak rate and fluid input" for the bench testing.
• Data Provenance: The study was "bench testing." No country of origin is specified for the data, and it is inherently prospective as it involves testing the manufactured device.

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

Not applicable. The study was bench testing of physical performance parameters (negative pressure, air leak, fluid input, electrical safety). There was no "ground truth" in the clinical sense established by human experts.

4. Adjudication Method:

Not applicable, as there was no expert review or human assessment of clinical outcomes.

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

No. This was bench testing of a physical device. A MRMC study is relevant for diagnostic or AI-assisted interpretation tasks.

6. Standalone Performance:

Yes, the performance testing was standalone in the sense that it measured the device's physical performance parameters directly, without human intervention in the continuous delivery of negative pressure, the management of air leaks, or fluid input during the test duration. However, it's not "standalone" in the AI sense of an algorithm operating without human oversight, as this is a mechanical pump.

7. Type of Ground Truth Used:

For the performance aspects, the "ground truth" was based on engineering specifications and recognized international standards (e.g., for electrical safety, battery safety). For the "delivery of continuous negative pressure," the ground truth would be the expected pressure output based on the device's design and a reference standard measurement.

8. Sample Size for the Training Set:

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

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

Not applicable, as there is no training set for this type of device.

In summary of the study:

The study involved bench testing to demonstrate that the updated V.A.C.VIA™ Negative Pressure Wound Therapy Unit is substantially equivalent to its predicate device (K132741). The testing focused on the device's ability to maintain continuous negative pressure (-125 mmHg) under simulated "worst-case" conditions for air leaks and fluid input over 3 and 7-day periods. Additionally, the device was confirmed to meet various electrical safety and performance standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11) and the new lithium battery met IEC 62133. No clinical or usability testing was deemed necessary due to the nature of the changes (internal components and external power supply updates) and the unchanged user interface and instructions for use.

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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 with an instillation option.

Negative Pressure Wound 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.

Instillation 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 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.

Negative Pressure Wound Therapy in the absence of instillation may also be used for:

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.

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.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 pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.

Here's a breakdown of the acceptance criteria and study information for the V.A.C.ULTA™ Negative Pressure Wound Therapy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for a specific "device." Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and a human factors assessment. The "acceptance criteria" can be inferred from the tests performed and their documented positive results.

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

• Software and Electrical/EMC Testing: The sample sizes for these tests are not explicitly stated in terms of "cases" or "patients." These are typically engineering and laboratory tests performed on the device itself.
• Negative Pressure Performance Testing: The sample size for materials/configurations tested is not explicitly stated. This would involve laboratory testing of the device under various conditions (exudate, leaks, dressing configurations) rather than human subjects.
• Human Factors Engineering Assessment (Test Set):
  • Sample Size: 30 subject nurses and doctors.
  • Data Provenance: This was a prospective study, likely conducted in a controlled environment (e.g., simulation lab, usability testing facility) to assess the new software features. The country of origin is not specified but would presumably be the US given the FDA submission.

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

• For the non-clinical engineering tests (software, electrical, negative pressure performance), the "ground truth" is established by the specifications and standards themselves, and the expertise lies with the engineers and testing personnel who perform and verify compliance. The number and qualifications of these experts are not detailed in this summary.
• For the human factors engineering assessment, the "ground truth" is the ability of all 30 subject nurses and doctors to safely and effectively use the new features. These 30 subjects are the "test set" and implicitly establish the "ground truth" through their direct interaction and feedback, as they represent the intended end-users. Their overarching qualification is that they are healthcare professionals (nurses and doctors) who would typically use such a device. The summary does not specify their years of experience or sub-specialties.

4. Adjudication Method for the Test Set

• Non-clinical Tests: Adjudication is typically based on whether the device meets predefined technical specifications and standards. This would involve internal engineering verification and validation processes, and potentially third-party certification. The summary does not detail a specific adjudication method beyond stating that the device was "certified" and "documented" to meet standards.
• Human Factors Engineering Assessment: The summary states that the assessment "indicated that the new features could be safely and effectively used by all test subjects." This implies a consensus or universal success among the 30 subjects, effectively meaning no formal "adjudication" (like 2+1) was needed if all participants demonstrated safe and effective use. If there were discrepancies or difficulties, a different adjudication mechanism might have been employed, but it is not mentioned.

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 document describes a 510(k) submission for a physical medical device (Negative Pressure Wound Therapy System) with updated software features. It is not an AI-powered diagnostic or interpretive device, so an MRMC study comparing human readers with and without AI assistance is not applicable here.

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

• Not applicable. The V.A.C.ULTA™ system is a therapy device that involves a human operator to apply and manage the therapy. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that performs a standalone function without human interaction for which standalone performance would be measured. The software updates are for user enhancements and control of the therapy, not an autonomous diagnostic or interpretive function.

7. The type of ground truth used

• Non-clinical performance specifications and user experience.
  • For software, electrical safety, EMC, and negative pressure performance, the ground truth is established by adherence to recognized national and international standards (e.g., AAMI/ANSI ES60601-1, IEC 60601 series) and the internal performance specifications of the device (e.g., specific mmHg ranges for therapy).
  • For the human factors assessment, the ground truth is the demonstrable ability of typical users (nurses and doctors) to safely and effectively operate the device with its new features.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a non-AI medical device. The software updates are for user interface and control enhancements, not for an AI model that requires a "training set" of data.

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

• Not applicable. As there is no AI model requiring a training set, the concept of establishing ground truth for a training set does not apply here.

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