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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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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.

• For Superficial Incisional SSI (all wounds analyzed for depth): OR of 0.19 (95% CI: 0.08, 0.46), showing a significant reduction. (5 studies)
• For Class I wounds: OR of 0.36 (95% CI: 0.24, 0.55) for overall SSI, consistent reduction. (11 studies)
• For Class II wounds: OR of 0.27 (95% CI: 0.11, 0.68) for overall SSI, consistent reduction. (3 studies)
• For high-risk patients (overall SSI): OR of 0.40 (95% CI: 0.27, 0.62). Greater absolute percentage reduction observed (5.5% in treatment vs. 12.9% in control vs. 4.2% vs. 5.8% in overall). (9 studies) |
  | Device demonstrates acceptable safety profile. | Similar Safety Profile to Conventional Dressings: No significant differences in Adverse Events (AEs) or Serious Adverse Events (SAEs) between PREVENA and control groups in the 3 studies that reported this data. Post-market data (7 years, hundreds of thousands of units shipped) consistent with anticipated AEs (skin irritation, blisters, pain, etc.), and no device-related SAEs. |
  | Non-clinical performance (pressure maintenance, exudate removal, alarms). | Device capable of maintaining -125±25 mmHg, removing simulated wound fluid, and alarms function as intended under worst-case scenarios. |
  | Usability demonstrated. | Usability testing showed intended users can operate the device (reviewed from prior 510(k) K141017). |

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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