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The IRRISEPT™ Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

IRRISEPT™ Wound Debridement and Cleansing System is a manual, self-contained irrigation device with 0.05% Chlorhexidine Gluconate (CHG) solution. The mechanical action effectively loosens and removes wound debris. The CHG acts as a preservative to help inhibit microbial growth in the solution.

The IRRISEPT™ Wound Debridement and Cleansing System is straightforward and uncomplicated to use. The User opens a prepackaged box, which contains one bottle and one splashquard. The bottle is opened by twisting off its "T" cap seal. The splashguard is then removed from its pouch and screwed directly onto the bottle. The IRRISEPT™ Wound Debridement and Cleansing System is now ready for use. The IRRISEPT™ Wound Debridement and Cleansing System can produce 7-8 psi of pressure as recommended by College of Emergency Physician's (A.C.E.P) for effective wound American cleansing/irrigation. This pressure is sufficient to agitate, loosen and remove debris from wounds.

The incredients of the solution are 0.05% Chlorhexidine Gluconate (CHG) in Sterile Water for Irrigation, USP (99.95%).

This document is a 510(k) summary for the IRRISEPT™ Wound Debridement and Cleansing System. It focuses on establishing substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study data in the way one might expect for a novel device requiring extensive clinical trials.

Therefore, the requested information cannot be fully extracted as defined in the prompt, particularly for elements related to detailed performance metrics against acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance. This type of submission relies on demonstrating that the new device operates similarly to and is as safe and effective as devices already on the market.

However, based on the provided text, I can infer and extract some relevant points about how the device's acceptable performance is implied and referenced, even if not explicitly presented as a formal acceptance criteria table.

Here's a breakdown of what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criterion is implicitly tied to substantial equivalence to predicate devices, particularly regarding its ability to generate sufficient pressure for wound cleansing.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. This type of 510(k) submission generally does not involve a specific "test set" of patient data in the clinical trial sense for performance metrics like sensitivity/specificity. The evaluation relies on comparing technical characteristics and intended use to existing devices.
• Data Provenance: Not applicable in the context of a clinical test set. The claim of 7-8 psi pressure references recommendations from the American College of Emergency Physicians (A.C.E.P), indicating a reliance on established clinical guidelines for appropriate pressure levels in wound irrigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not applicable. There is no mention of a "test set" requiring expert ground truth for performance evaluation. The substantial equivalence argument rests on engineering specifications and comparison to predicate devices, not subjective expert assessment of device performance on a dataset.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no test set requiring multi-expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, this type of study was not done. The device is a wound cleansing system, not an imaging diagnostic tool that would typically involve MRMC studies.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This device is a manual, human-operated medical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: For the pressure claim, the "ground truth" is established clinical guidelines from the American College of Emergency Physicians (A.C.E.P) regarding effective wound irrigation pressure (7-8 psi). For the general function, the ground truth is the established performance and safety profile of the predicate devices.

8. The sample size for the training set:

• Sample Size: Not applicable. There is no concept of a "training set" for this type of medical device submission. The device's design and features are based on established engineering principles and comparison to predicate devices, not machine learning or AI models.

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

• Ground Truth Establishment: Not applicable, as there is no training set.

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