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The Medela® INVIA Wound Therapy 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 pump is an innovative suction pump to help promote wound healing. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® INVIA Liberty are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® INVIA Liberty ideally suited for Negative Pressure Wound Therapy (NPWT).

The Medela® 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) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® INVIA Liberty suction pump has an electronic measuring and monitoring system with optical and acoustic status display. It is a "medium vacuum" suction pump and has a suction capacity of 5 liters per minute and a maximum vacuum up to -27 kPa (-200 mmHg). The pump is marked "low flow - medium vacuum".

A variety of reusable and disposable accessories to help promote wound healing are available.

The Medela® INVIA Wound Therapy device, specifically the INVIA Liberty suction pump, was cleared through a Traditional 510(k) submission, asserting substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, the input document does not contain the full set of information requested because it describes a 510(k) submission for substantial equivalence rather than a study testing against acceptance criteria. A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device, often relying on comparison of technological characteristics and performance data, rather than a clinical trial with specific performance targets.

Here's an analysis of the provided text in the context of your request:

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

• No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on demonstrating "identical performance characteristics" and "identical technology" to predicate devices.
• The document states: "The Medela® INVIA Liberty suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices."
• Performance information mentioned is descriptive:
  • "maximum suction performance"
  • "quiet, dependable operation"
  • "suction capacity of 5 liters per minute"
  • "maximum vacuum up to -27 kPa (-200 mmHg)."
  • "marked 'low flow - medium vacuum'"
  • These are descriptions of the device's capabilities, not specific acceptance criteria from a study with corresponding results.

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

• No test set or associated sample size is mentioned. The submission is a regulatory filing for substantial equivalence, not a report of a specific study that used a test set to evaluate performance metrics against acceptance criteria.

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. As there is no mention of a test set, there is no discussion of experts establishing ground truth for such a set.

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

• Not applicable. No test set is 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 a powered suction pump and the submission does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is a physical medical device (suction pump) used for wound therapy, not a diagnostic algorithm.

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

• Not applicable. No specific "ground truth" as a reference standard for performance evaluation is mentioned, as the submission focuses on equivalence to existing devices based on technical characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so no training set is relevant.

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

• Not applicable. No training set is relevant.

In summary: The provided document is a 510(k) summary for a powered suction pump, intended to demonstrate substantial equivalence to predicate devices. It does not describe a performance study with defined acceptance criteria, test sets, or ground truth establishment in the manner typically associated with device performance evaluation against specific metrics, especially for AI/ML devices. The "study" mentioned is the 510(k) submission process itself, where the device's design and technical specifications are compared to similar already-approved devices.

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