(103 days)
Renasys™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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 GO 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 GO is suitable for use in both a hospital and homecare setting and includes a shoulder strap and carry case for portability.
Renasys GO is compatible with existing Smith & Nephew wound dressing kits currently on the market.
The provided text describes the Renasys™ GO Negative Pressure Wound Therapy device and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.
The document states that "Performance testing and electrical safety testing has been successfully completed to demonstrate that tooling and enounced and ally equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was performed, but the specifics requested in your prompt are not present.
Therefore, many of the sections below will state "Not provided in the document."
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied) |
|---|---|
| (Not explicitly stated, generally involves safety and effectiveness for intended use consistent with predicate devices) | Performance testing and electrical safety testing successfully completed to demonstrate equivalence to marketed devices and safety/effectiveness for intended use. |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not provided in the document.
- Data Provenance: Not provided in the document. The filing is from the USA (Smith & Nephew, Inc., St. Petersburg, FL and Largo, FL). It is a premarket notification for a medical device seeking substantial equivalence, which typically relies on laboratory testing and comparison to predicate devices rather than clinical trials with patient data for this product type. The text mentions "performance testing," which strongly suggests laboratory-based testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document. Given the description of "performance testing and electrical safety testing," it is unlikely that "ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology) was established for a test set, as this likely refers to engineering and functional performance.
4. Adjudication method for the test set
Not provided in the document.
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
No, an MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device (a negative pressure wound therapy pump). The device is a physical pump, not an AI diagnostic tool that human readers would use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicit in the statement "Performance testing and electrical safety testing has been successfully completed." This refers to the device's functional performance in isolation. The testing would assess parameters like pressure delivery, suction efficacy, battery life, alarm functions, and electrical safety standards without human interaction to "improve" the device's basic function.
7. The type of ground truth used
The "ground truth" for this type of device would likely be engineering specifications, performance standards (e.g., specific pressure levels, flow rates, alarm triggers), and electrical safety standards (e.g., IEC standards). The document implies these were used by stating "Performance testing and electrical safety testing has been successfully completed."
8. The sample size for the training set
Not applicable/Not provided in the document. This device is a hardware product, not a software algorithm that would typically have a "training set" in the machine learning sense. The "training" for such a device would be its iterative design and engineering testing.
9. How the ground truth for the training set was established
Not applicable/Not provided in the document.
§ 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.