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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 it creates 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.

The Invia Foam Dressing Kit with FitPad is appropriate for use on the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts

Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad are to be used only with the approved therapy units.

Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and Grafts

INVIA FOAM DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a foam, a suction interface (Invia FitPad) and transparent film (one or more pieces depending on the kit size). The foam is manufactured using a reticulate flexible polyether and polyurethane hydrophobic material, with a high tensile strength (20 PSI*) and charcoal color. The FitPad suction interface features a quick connecting interface to the canister tubing for easy and secure connection. The transparent film is designed with self-explanatory markings to facilitate the ease of use.

INVIA GAUZE DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a gauze pad, one or two transparent films (depending on the kit size), a suction interface (Invia FitPad), and saline.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Invia Dressing Kits with FitPad:

This document primarily describes non-clinical and one specific clinical test related to the Invia Foam Dressing Kits with FitPad and Invia Gauze Dressing Kits with FitPad. It is a 510(k) summary for premarket notification, aiming to establish substantial equivalence to predicate devices, rather than a detailed report of a clinical trial proving specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in the context of this traditional medical device submission.

However, I can extract the acceptance criteria and study information that are present.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria with corresponding reported device performance values in the way one would expect for an AI/ML device (e.g., "sensitivity > 90%"). Instead, it lists compliance with established standards and general performance characteristics demonstrated.

Missing Information and Not Applicable Categories for this Device Type:

2. Sample size used for the test set and the data provenance: Not specified in this document for the non-clinical tests. For the clinical skin irritation study, the sample size is not stated, nor is the data provenance beyond "a clinical study was conducted". This is not a study on an AI/ML algorithm or diagnostic device with a "test set" in the common sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests (biocompatibility, sterilization, pressure maintenance) is established through standardized laboratory analyses and measurements, not expert consensus on images or medical records.
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 device is an NPWT dressing kit, not an AI/ML diagnostic or assistive tool.
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 biocompatibility: In vitro and in vivo models according to ISO 10993 series.
   • For sterilization: Microbiological tests (e.g., sterility assurance level verification).
   • For pressure performance: Engineering measurements and functional testing.
   • For skin irritation: Clinical observation and assessment as per ISO 10993-10 Annex C.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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

The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Liberty NPWT pump provides continuous or intermittent operation.

The Invia Liberty NPWT system may be used 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 Invia Liberty NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.

The provided FDA 510(k) summary for the Medela Invia Liberty Negative Pressure Wound Therapy System does not contain acceptance criteria or study results in the format requested for an AI/ML device.

This document describes a medical device (a wound therapy pump) that is a hardware device with some software/firmware components, not an AI/ML diagnostic or prognostic tool. Therefore, the questions regarding AI/ML-specific performance metrics, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this submission.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML structure:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable in the Requested AI/ML format.
• The document presents a comparison table (within "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE") between the Invia Liberty NPWT System and its predicate device (Invia Wound Therapy K080357). This table compares specifications like suction capacity, max/min vacuum, therapy modes, and accessories.
• Performance is implied by equivalence to the predicate device and compliance with relevant safety and performance standards, rather than specific numerical acceptance criteria for diagnostic performance. For instance, suction capacity is reported as "5 l/min" for both the new device and the predicate, indicating equivalence.

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

• Not Applicable. This is not a study assessing an AI/ML model's performance on a dataset. The non-clinical tests described are for hardware functionality, electrical safety, usability, and biocompatibility.

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

• Not Applicable. "Ground truth" in the context of AI/ML diagnostic algorithms is not relevant here. The device's functionality is verified through engineering tests and adherence to standards.

4. Adjudication method for the test set:

• Not Applicable. No expert adjudication process is described as this is not a diagnostic device where different interpretations need to be reconciled.

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 device is a treatment delivery system, not a diagnostic tool that assists human readers. No MRMC study was conducted or would be relevant.

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

• Not Applicable. The device is the "algorithm" and hardware combination for delivering negative pressure wound therapy. "Standalone performance" would refer to its core function of delivering therapy safely and effectively, which is covered by the non-clinical tests.

7. The type of ground truth used:

• Not Applicable. The "ground truth" for this device's performance is established by engineering specifications, physical measurements (e.g., suction capacity, vacuum levels), and compliance with recognized safety and performance standards (e.g., IEC 60601 series).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the AI/ML sense. The device's firmware and algorithms are developed through traditional software engineering and control system design, not machine learning from a large dataset.

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

• Not Applicable. As there's no training set, there's no ground truth for it in this context.

Summary of what the document does describe regarding device validation:

The validation of the Invia Liberty Negative Pressure Wound Therapy System is based on non-clinical tests demonstrating its safety, effectiveness, and substantial equivalence to a legally marketed predicate device. This includes:

• Risk Analysis: To identify and mitigate potential hazards.
• Software Validation: For the device's firmware and control algorithms.
• Hardware Integration Testing: Ensuring all components work together correctly.
• Electrical Safety and Electromagnetic Compatibility Testing: Adherence to IEC 60601-1 and IEC 60601-1-2 standards.
• Safety Testing for Home Use: Adherence to IEC 60601-1-11 standard.
• Usability Evaluation: Adherence to IEC 60601-1-6 and IEC 62366 Standards.
• Performance Testing: Demonstrating functionality with Medela Invia Gauze Kits and Avance Foam Kits, including the double lumen tubing and quick connector. This would involve verifying that the pump achieves the specified negative pressures and suction in various configurations.
• Biocompatibility Testing: For materials in contact with the patient (cytotoxicity, sensitization, irritation).
• Cleaning Methods Validation: For reusable components.
• Sterilization Validation and Shelf Life Confirmation: For sterile components.

No clinical testing was performed for this 510(k) submission. The device is deemed substantially equivalent based on technological characteristics and non-clinical performance data compared to the predicate device.

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