(245 days)
Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. Genadyne UNO is a single patient use device.
The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and study information for the Genadyne UNO Negative Pressure Wound Therapy System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for performance tests in a tabular format with corresponding reported values. Instead, it states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, based on the non-clinical testing discussion, we can infer the types of performance aspects tested.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Pressure Precision | "Results were within the acceptable limit" |
| Absorbance | "Results were within the acceptable limit" |
| Alert Functionality | "Results were within the acceptable limit" |
| Biocompatibility | "The data and results show that the device is biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical case series from 15 patients with closed surgical incisions were provided as supplementary performance data in support of the safety of the device."
- Sample Size for Test Set: 15 patients
- Data Provenance: Not explicitly stated, but clinical case series generally imply prospective or retrospective data from a clinical setting.
- Retrospective/Prospective: Not specified, but "case series" can be either.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to a "clinical case series" as "supplementary performance data," but it does not describe how the outcomes for these 15 patients were adjudicated or evaluated by experts to establish a 'ground truth' for device performance in the context of an AI/algorithm. This device is a physical pump, not an AI diagnostic tool, therefore, the concept of "ground truth" as typically applied to image analysis or diagnostic algorithms doesn't directly apply in the same way. The "ground truth" here would relate to the patient's actual wound healing and safety outcomes, which would likely have been determined by the treating clinicians.
4. Adjudication Method for the Test Set
Not applicable/Not provided. As noted above, this isn't an AI diagnostic device where expert adjudication of outputs would typically be required. The "clinical case series" would involve patient follow-up and clinical assessment by healthcare professionals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation where multiple readers evaluate cases with and without AI assistance). The Genadyne UNO is a Negative Pressure Wound Therapy System, which is a therapeutic device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Genadyne UNO is a physical medical device (a powered suction pump for wound therapy), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
For the clinical case series, the "ground truth" would be the clinical outcomes observed in the 15 patients regarding wound healing, removal of exudates/infectious material, and absence of adverse events associated with the device's use. This would be based on clinical assessment and patient follow-up by healthcare professionals. For the bench tests, the ground truth would be based on objective measurements of physical parameters (pressure, absorbance, alert function) against predefined engineering specifications.
8. The Sample Size for the Training Set
Not applicable. As the Genadyne UNO is a physical medical device and not an AI/Machine Learning algorithm, there is no "training set." The device's performance is established through bench testing and clinical observations, not through a learning process from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.