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The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types:

chronic
· acute
· traumatic
subacute and dehisced wounds
· partial-thickness burns
· ulcers (such as diabetic or pressure)
· flaps and grafts.

The extriCARE® 3000 Negative Pressure Wound Therapy System is intended for use in healthcare facilities.

Device Description

The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) pump is a portable, rechargeable, battery-powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) is packaged and provided with the following components:

1. extriCARE 3000 Negative Pressure Wound Therapy Pump
1. extriCARE 3000 100cc Collection Canister

The extriCARE® 3000 Negative Pressure Wound Therapy (NPWT) pump accessories that are included in this 510(k) application and will be commercialized separately are the following:

1. extriCARE® 3000 100cc Collection Canister (additional canister replacements)
1. extriCARE® 3000 400cc Collection Canister

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a quantitative format for specific clinical outcomes. Instead, it describes various non-clinical tests conducted and states that the device "met all test requirements" or "acceptance criteria established."

Here's a summary of the non-clinical tests and their reported outcomes:

Test Category	Acceptance Criteria (Implied / Stated in Document)	Reported Device Performance
Sterility	Device is provided non-sterile. No specific sterility acceptance criteria for the device as manufactured.	The extriCARE 3000 and its predicate are provided non-sterile.
Biocompatibility	Pump unit and collection canisters have transient contact; no additional testing conducted (implied acceptance based on transient contact).	No additional biocompatibility testing was conducted on the pump and collection canisters.
Electrical Safety	Compliance with IEC 60601-1:2005+AMD1:2012 and IEC 60601-1-11:2015 standards.	Device met all test requirements for electrical safety.
EMC Evaluation	Compliance with IEC 60601-1-2:2014 standard.	Device met all test requirements for EMC.
Performance Testing (Bench)	Functionality of key process parameters (e.g., negative pressure generation, output). Specific quantitative criteria are not detailed.	All parameters tested were found to meet acceptance criteria established.
Package Transportation	Compliance with ISTA 3A requirements.	All tested parameters were found to meet acceptance criteria established.
Usability/Human Factors	Intended user group found to meet expected use goals. Specific criteria are not detailed.	Usability testing was performed to confirm that the intended user group was found to meet expected use goals.

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

The document primarily describes non-clinical bench testing. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, no sample size for a patient test set or data provenance (country of origin, retrospective/prospective) is provided. The "test sets" referred to are related to the individual non-clinical tests (e.g., electrical safety, EMC).

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

Given that the document focuses on non-clinical testing and does not detail a clinical "test set" with patient data requiring ground truth establishment, this information is not applicable and therefore not provided.

4. Adjudication Method for the Test Set

As no clinical "test set" or ground truth establishment by experts is described, adjudication methods are not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission is for a Negative Pressure Wound Therapy (NPWT) system, which is a medical device, not typically an AI-powered diagnostic tool that would undergo MRMC studies for human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study is not applicable as the device is a physical medical device (NPWT pump) and not an algorithm or AI system for diagnostic interpretation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by adherence to recognized engineering standards (e.g., IEC standards for electrical safety and EMC) and pre-defined performance specifications set by the manufacturer for the device's functionality. This is not "expert consensus, pathology, or outcomes data" in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical NPWT system, not an AI model that would require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

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