(52 days)
The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.
The RENASYS™ EZ NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ is suitable for use in both a hospital and homecare setting.
RENASYS™ EZ is compatible with existing Smith & Nephew wound dressing kits currently on the market.
The provided information does not contain details about acceptance criteria or a specific study proving the device meets those criteria beyond general statements. The document is a 510(k) summary for the RENASYS™ EZ Negative Pressure Wound Therapy system, focusing on demonstrating substantial equivalence to predicate devices.
Here's what can be extracted and what is missing based on your request:
Missing Information: Most of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. This type of detail is typically found in the full 510(k) submission, not the summary.
Here's a breakdown of the available information:
- Device: RENASYS™ EZ Negative Pressure Wound Therapy (NPWT) system.
- Purpose of the K091470 submission: To demonstrate substantial equivalence to previously cleared predicate devices (RENASYS™ EZ NPWT System K082426 and RENASYS™ GO NPWT System K083375).
- Method for demonstrating substantial equivalence: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use."
What we know about the "study":
The document states: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was conducted, but it does not describe the specific study methodologies, acceptance criteria, or results in detail. The testing was likely designed to show that the new device performs comparably to the predicate devices in terms of its core functionality (creating negative pressure, removing fluids).
Based on the provided text, I cannot complete most of the requested table and sections.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document states "Performance testing... has been successfully completed," but does not detail specific acceptance criteria (e.g., pressure range accuracy, flow rate, battery life targets, alarm thresholds) or quantitative results. | Not provided. The document states the device "is substantially equivalent... and is safe and effective," but does not offer specific numerical performance metrics. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. Given the nature of a negative pressure wound therapy device, the "test set" would likely refer to physical device testing rather than a clinical dataset of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For a device like this, the "ground truth" would likely be based on engineering specifications and direct measurement against those specifications, rather than expert interpretation of data.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified.
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
- MRMC Study: No, this is highly unlikely for a negative pressure wound therapy device. MRMC studies are typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is not an AI algorithm. Its performance is inherent to its mechanical and electronic function.
7. The type of ground truth used
- Type of Ground Truth: Likely engineering specifications and direct physical measurements (e.g., pressure gauges, flow meters). The document only broadly mentions "Performance testing."
8. The sample size for the training set
- Sample Size: Not applicable. This is not an AI/machine learning device that would require a 'training set.'
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.