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The Avance® NPWT system, with associated products are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Mölnlycke Health Care has developed a Negative Pressure Wound Therapy System in conjunction with Medela AG, which consists of the Avance® NPWT Pump (which is the Medela INVIA Liberty pump cleared under K080357) and the Avance® Foam Dressing Kits (subject of this submission). The Invia Liberty pump will be private labeled with the Avance® NPWT Pump This pump is compatible with the Avance® Foam Dressing Kits described in the branding. below Table. The Avance Foam Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.

This device is not an AI/ML powered device. It is a Negative Pressure Wound Therapy (NPWT) system. The document does not contain information about acceptance criteria and device performance in the context of AI/ML, human readers, or ground truth establishment.

A table of acceptance criteria and reported device performance cannot be generated in the requested format because the provided document does not specify quantitative acceptance criteria for the Avance® Foam Dressing Kits as they would be for an AI/ML device. Instead, the performance is described qualitatively based on non-clinical tests.

However, based on the provided text, here's a summary of the performance data:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for each test. The document refers to "the wound model" and "the system" in singular, implying specific setups or instances rather than a large dataset.
• Data Provenance: Not specified, but based on the context, these are likely laboratory or in-vitro tests conducted internally by the manufacturer or a third-party testing facility.

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

• Not applicable as this is not an AI/ML device and ground truth in the context of expert review is not relevant for the described performance tests. The performance is based on physical measurements and observation of the device's function.

4. Adjudication method for the test set:

• Not applicable. The performance tests are objective measurements of the device's physical functions, not subject to expert adjudication.

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/ML device, and no MRMC studies are mentioned.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device itself operating as intended.

7. The type of ground truth used:

• The "ground truth" for the performance tests described would be based on physical standards and objective measurements of vacuum levels, fluid transport efficiency, and sustained operation, rather than expert consensus, pathology, or outcomes data typically associated with clinical or AI performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

• Not applicable. No training set for an AI/ML algorithm is involved.

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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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