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The RENASYS Y-Connector can only be used with RENASYS TOUCH and RENASYS GO systems.

RENASYS TOUCH and RENASYS GO are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids. wound exudates and infectious materials.

The following wound types may be used with a RENASYS system that is utilizing a RENAS YS Y-connector:

• Flaps and grafts (only in one wound configuration)
• Open abdomen (only in one wound configuration & only with RENASYS TOUCH and RENASYS AB Abdominal Kit)
• Chronic .
• . Acute
• . Traumatic
• . Sub-Acute and dehisced wounds
• . Ulcers (such as pressure or diabetic)
• Partial-thickness burns

The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

When the RENASYS Y-Connector is used with the RENASYS AB Abdominal Kit with Soft Port (only in one wound configuration), it is indicated for temporary bridging of abdominal wall openings where is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS Y-connector is an accessory device to the previously cleared RENASYS TOUCH (K153209) pump for use on one wound only. It is only intended to be used in conjunction with RENASYS Negative Pressure Wound Therapy (NPWT) system which is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

The RENASYS Y-Connector can be used to connect one or two wounds of the same etiologies through two RENASYS Soft Ports to a single pump. The Y-Connector is constructed of PVC tubing and is compatible with Smith & Nephew RENASYS Foam, RENASYS Gauze and RENASYS Abdominal dressing kits with Soft Port (it can only be used on one wound with the RENASYS Abdominal dressing kits and only with RENASYS TOUCH).

The provided text describes a 510(k) summary for the RENASYS Y-Connector, demonstrating substantial equivalence to a predicate device, rather than an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components usually associated with AI/ML devices (such as MRMC studies, training/test sets, expert adjudication for ground truth, and specific performance metrics like sensitivity/specificity/AUC) are not applicable or detailed in this submission.

However, I can extract the acceptance criteria and study information related to the performance of the negative pressure wound therapy (NPWT) system with the new Y-Connector, which are based on non-clinical bench testing.

Here's the information parsed from the document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact sample size (number of units/tests) for each bench test. It uses phrases like "for all test configurations," "all units tested," and "none of the RENASYS Y-Connector units."
• Data Provenance: The studies were non-clinical bench tests conducted to support regulatory submission. The country of origin for the data is not explicitly stated, but the submitter's address is "Smith & Nephew Medical Limited, Hull, United Kingdom," suggesting the tests were likely conducted or overseen by them. The studies are by nature prospective, as they were specifically designed and executed for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• This section is not applicable for this type of device and study. The "ground truth" for these bench tests is defined by mechanical measurements and engineering standards (e.g., maintaining negative pressure, alarm functionality, tensile strength according to ISO standards), not by human expert interpretation or consensus as would be the case for image-based AI/ML diagnostic devices.

4. Adjudication Method:

• Not applicable for these bench tests. Adjudication is relevant for subjective assessments, typically found in clinical studies involving multiple human readers or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic AI devices where human reader performance (e.g., radiologists, pathologists) with and without AI assistance is compared. The RENASYS Y-Connector is a physical accessory to an NPWT system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable. There is no "algorithm" in the sense of an AI model being evaluated. The performance evaluated is that of the physical device and its interaction with the NPWT system.

7. Type of Ground Truth Used:

• The ground truth metrics are based on pre-defined engineering and performance specifications and international standards (e.g., ISO 8536-4 for tensile strength). For example, "maintaining negative pressure within the test requirements" and "alarms functioned as intended." This is a form of objective, quantitative ground truth.

8. Sample Size for Training Set:

• Not applicable. This submission does not describe an AI/ML device that requires a training set. The device is a physical component, and its design and manufacturing are informed by engineering principles, not machine learning training data.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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