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The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The Prospera Spectruum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) is a component of the Prospera Spectruum Negative Pressure Wound Therapy (NPWT) System.

The Prospera Spectruum™ Negative Pressure Wound Therapy System consists of:

• · Prospera Spectruum™ Negative Pressure Wound Therapy Unit
• · Disposable canister which collects wound exudate
• Prospera Spectruum™ Contour Dome

The Prospera Spectrum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C.Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Wound Therapy Unit (NP-7000) is a portable, rechargeable battery and mains powered, reusable, software-controlled unit used with a can provide continuous or variable applications of negative pressure to a wound in the user defined range between 25mmHg. The Prospera Spectruum™ Negative Pressure Wound Therapy System is designed for use in home, acute or extended care settings.

The compatible dressing components include a wound interface dressing applied to the wound covered with a semi-occlusive drape and is connected to the canister of the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) via a dual lumen dressing connection. This connection allows for the distribution of negative pressure to the wound bed and removal of wound exudate which is transported to the collection canister via the lumen.

The software within the Prospera Spectrum™ Negative Pressure Wound Therapy Unit (NP-7000) provides and maintains the prescribed pressure within the user defined range as well as alarming as neduced below the defined threshold. The alarms alert the user to conditions such as tubing blockages, a full canister, inactive therapy, low battery, and leaks in the system.

Additional features include:

• GPS for optional inventory management support
• Therapy history report via USB data port
• · Pre-set therapy options
• Event Log
• · User interface with flat buttons requiring depression for activation to reduce unintentional screen changes

• Confirmation screen to provide a visual notification to the user prior to device shutdown. The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) will continue delivering therapy and will not power off until the user stops therapy and acknowledges via user interface that the intent is to power off the unit.

This document is a 510(k) premarket notification for a medical device, the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000). The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of clinical efficacy or a multi-reader multi-case study for an AI algorithm.

However, based on the information provided, we can extract details regarding the non-clinical acceptance criteria and the bench testing conducted to support the device's functional performance. The document explicitly states "Clinical Tests: Not Applicable," meaning no direct clinical study was performed to assess patient outcomes or comparative effectiveness against human readers.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set (Bench/Usability): The document does not provide specific numerical sample sizes for the bench testing. For usability testing, it mentions "lay users who represent patients and lay caregivers" and "clinicians" but does not give a number for how many participated.
• Data Provenance: The tests described are non-clinical bench tests and usability tests conducted by the manufacturer (DeRoyal Industries, Inc.). The document does not specify country of origin for test data beyond indicating the company is based in Tennessee, USA. All testing appears to be prospective in nature, as it was conducted to support the 510(k) submission for this specific device.

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

• Non-Clinical Nature: This section is not applicable in the traditional sense of establishing ground truth for a clinical dataset using experts (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests is based on engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected functional performance.
• Usability Testing: For usability testing, "clinicians" and "lay users" were involved, serving as the "evaluators" against usability criteria. Their specific qualifications beyond "clinicians" are not detailed.

4. Adjudication Method for the Test Set

• Not Applicable: Given the non-clinical nature of the tests (bench testing, software assessment, usability testing against predetermined criteria), there was no adjudication method involving multiple experts establishing a "ground truth" for ambiguous cases, as would be common in diagnostic AI studies. Performance was assessed against predefined pass/fail criteria or expected functionality.

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

• No, not performed. The document explicitly states: "Clinical Tests: Not Applicable." This device is a Negative Pressure Wound Therapy Unit, not a diagnostic imaging AI algorithm, so an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable (Different Device Type): This is not an AI algorithm performing a diagnostic task. The device does contain software that controls its function (maintains pressure, activates alarms). Therefore, "standalone performance" refers to the device operating according to its specifications without human intervention, which is assessed through the functional bench testing and software assessment. The document confirms these tests show its function as intended.

7. The Type of Ground Truth Used

• Engineering Specifications and Regulatory Standards: For functional performance, the "ground truth" is defined by the device's design specifications (e.g., negative pressure range, alarm thresholds) and adherence to recognized industry standards (e.g., IEC 60601-1).
• Usability Criteria: For usability testing, the "ground truth" is established by the usability requirements and design principles outlined in standards like ISO 62366-1 and ANSI/AAMI HE 75.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device that requires a "training set" in the context of learning from data to perform a task like image interpretation. The software controls the device based on pre-programmed logic and parameters, not trained algorithms.

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

• Not Applicable: As there is no "training set" in the AI/ML sense, this question is not relevant to this device submission.

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