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The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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.

When used on closed surgical incisions, the Invia Motion NPWT system is also 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 Invia Motion NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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.

When used on closed surgical incisions, the Invia Liberty NPWT system is also 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 Invia Liberty NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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.

When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also 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 Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Gauze Dressing Kit with FitPad in comunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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.

When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also 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 Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The labeling of the Invia Motion Negative Pressure Wound Therapy (NPWT) System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad has been modified to expand the indications for use to include closed surgical incisions. When used on closed surgical incisions, the devices are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

INVIA MOTION NPWT SYSTEM
The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Motion 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) facilitates use and information handling.

INVIA LIBERTY NPWT SYSTEM
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The 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) facilitates use and information handling.
A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.

INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD
The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.

This document describes the premarket notification for the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems, and their associated Foam and Gauze Dressing Kits with FitPad. The submission seeks to expand the indications for use to include closed surgical incisions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a "table of acceptance criteria" with numerical targets and corresponding device performance values in a typical format for a medical device study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implied by demonstrating substantial equivalence to predicate devices for the new expanded indication (closed surgical incisions) and by successful completion of various non-clinical performance and safety tests.

The "reported device performance" is described qualitatively through these tests.

Implied Acceptance Criteria and Reported Device Performance:

• A steady rise of negative pressure at test onset to the set vacuum level.
• A uniform and constant vacuum level throughout the test period.
• The vacuum level corresponds to the selected set vacuum level of the pump.
• The volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister.
• Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model.
• Compared equivalently to the predicate ActiV.A.C. Therapy Unit (K120033) for use on closed surgical incisions. |
  | Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices for the expanded indication. | The non-clinical tests described demonstrate that the device is substantially equivalent to the predicate devices for the new indication of closed surgical incisions. The differences do not introduce new intended uses or raise different questions of safety and effectiveness. |
  | Functional Equivalence: Non-significant changes to components (software, hardware, labeling, sterile packaging) maintain performance. | Software verification and validation testing were completed for non-significant changes. |

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

The document primarily describes non-clinical performance testing using simulated wound models.

• Sample size: Not explicitly stated as a numerical count of "cases" or "patients." Performance testing was conducted on "a closed surgical incision model and simulated wound exudates." The typical approach for such tests involves a sufficient number of runs or samples to demonstrate consistent performance within the system. Specific sample sizes for individual tests (e.g., bioburden, materials testing) are not detailed.
• Data Provenance: The studies are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human patients. Therefore, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply. The submitter is Medela AG, based in Baar Zug, Switzerland, implying the tests were likely conducted under their quality system, possibly internally or at contract labs.

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 is a non-clinical submission, and no ground truth established by medical experts (like radiologists) is relevant or mentioned. The "ground truth" for the performance testing cited would be engineering specifications and validated test methods to measure parameters like pressure, flow, and fluid removal accuracy against established standards and predicate device performance.

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

Not applicable. As a non-clinical performance study using simulated models, there is no need for adjudication by human experts as would be required for clinical image interpretation or diagnostic performance studies. The "results" are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The submission is for Negative Pressure Wound Therapy (NPWT) systems and dressings, which are physical medical devices, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its mechanical and functional design.

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

For the non-clinical performance testing, the "ground truth" is based on:

• Engineering Specifications: The device's predetermined operational parameters (e.g., set vacuum levels, flow rates).
• Validated Test Methods: Standardized procedures for measuring device performance (e.g., pressure output, fluid removal volume).
• Predicate Device Performance: Direct comparison to the established performance characteristics of the legally marketed predicate devices (ActiV.A.C. Therapy Unit K120033).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that uses training sets.

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

Not applicable, as no training set was used.

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The portable Medela® Invia Motion negative pressure wound therapy (NPWT) system is indicated 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 exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts.

The Medela Invia Motion Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Motion NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The INVIA Motion is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.

Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Invia Motion NPWT pump is a single patient use pump for continuous or intermittent operation and has a lifetime of 60 days.

Invia Motion NPWT pump is portable and can be operated independent of the electrical Invia Motion power supply due to a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.

Invia Motion NPWT system is intended for use in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity.

The provided text describes the Medela AG Invia Motion Negative Pressure Wound Therapy System and its 510(k) summary. However, it does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria in a quantifiable manner as commonly expected for medical device evaluations that utilize AI or advanced diagnostics.

Instead, the non-clinical tests described focus on regulatory compliance, usability, and bench testing to demonstrate performance equivalence to predicate devices, rather than establishing direct clinical efficacy or performance against predefined, quantitative acceptance criteria via a clinical study with a specified sample size and ground truth.

Therefore, many sections of your requested output cannot be populated from the provided text. I will fill in what information is available and note when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Study (a form of test set):

  • Sample Size: 15 Healthcare Professionals (HCPs) and 15 patient Lay Users (LUs).
  • Data Provenance: Conducted in the United States. Prospective (evaluation of users interacting with the device).

• Bench Testing:

  • Sample Size: Not specified.
  • Data Provenance: Not specified (likely in-house lab testing).

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

• Usability Study: The "ground truth" for the usability study was the successful completion of tasks and the identification/resolution of use errors. This was observed and assessed by the study administrators/evaluators, whose qualifications are not specified.
• Bench Testing: The "ground truth" for bench testing would be the engineering specifications and performance characteristics of the predicate device for comparison. No experts in the sense of clinical decision-makers were involved in establishing this ground truth from the provided text.

4. Adjudication method for the test set

• Usability Study: The text implies direct observation and assessment of user performance against predefined tasks and safety criteria. There is no mention of independent adjudication or a consensus method (like 2+1 or 3+1) among multiple observers.

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 MRMC study was done. The device is a Negative Pressure Wound Therapy System, not an AI-assisted diagnostic or imaging interpretation device.

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

• This is not applicable as the device is a therapeutic system, not an algorithm, and is operated by a human user (HCP or lay user).

7. The type of ground truth used

• Usability Study: Expert observation/assessment of user task completion and safety during device operation.
• Bench Testing: Engineering specifications and performance data of the device itself, and comparative performance data from predicate devices in simulated wound environments.
• Clinical: No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Not applicable. The device is a therapeutic system, not a machine learning algorithm that requires a training set.

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

• Not applicable. (See point 8).

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