(373 days)
UNO 30 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, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. UNO 30 is a single patient use device.
The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound. The unit provides negative pressure at either 80mmHg or 125mmHg in continuous mode and 80mmHg/30mmHg or 125mmHg/30mmHg in variable mode. The UNO 30 NPWT system includes dressing and canister.
Here's an analysis of the provided text regarding the acceptance criteria and study for the UNO 30 device:
The provided text is a 510(k) Premarket Notification for the UNO 30, a Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to predicate devices, rather than a novel claim requiring extensive clinical trials or an AI's performance evaluation. Therefore, the information you're asking for, particularly concerning AI performance metrics, clinical study design, and expert adjudication, is not present in this document. The device is a physical medical device (pump, dressings, canister), not an AI-powered diagnostic or assistive tool.
However, I can extract the relevant information available for the device as described.
Acceptance Criteria and Device Performance (Based on "Technological Characteristics" and "Discussion of nonclinical and clinical testing" sections)
This document doesn't present "acceptance criteria" in the typical sense of performance thresholds for an AI or diagnostic device. Instead, it focuses on demonstrating that the UNO 30 maintains similar technical characteristics and safety/effectiveness as its predicate devices, primarily the Genadyne UNO (K180840) with an extended use-life.
The key "performance" aspect evaluated here is the extended device lifespan to 30 days while maintaining the functionality of the predicate.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Implied by Predicate & Device Purpose) | Reported Device Performance (UNO 30) |
|---|---|---|
| Max Vacuum | Comparable to predicate (125 mmHg or 144 mmHg) | 125 mmHg |
| Battery Type | Alkaline-Manganese Dioxide AA (QU1500) | Alkaline-Manganese Dioxide AA (QU1500) |
| Power (Battery) | 3V DC | 3V DC |
| Dimensions / Weight | 3" x 4.4" x 2.4" / 400g | 3" x 4.4" x 2.4" / 400g |
| Device Lifespan | Extended from 7 days (primary predicate) to 30 days (secondary predicate) | 30 days (Bench tests confirmed functionality for 30 days and unit shutdown after 30 days) |
| Software Level of Concern | Moderate (per FDA guidance) | Moderate (appropriate documentation included) |
| Pressure Precision | Functional during 30-day use-life | Bench tested and verified as functioning appropriately during the course of 30 days. |
| Battery Life | Functional during 30-day use-life | Bench tested and verified as functioning appropriately during the course of 30 days. Unit does not turn on even with new batteries after 30 days. |
| Absorbance | Functional during 30-day use-life | Bench tested and verified as functioning appropriately during the course of 30 days. |
| Alert Functionality | Functional during 30-day use-life | Bench tested and verified as functioning appropriately during the course of 30 days. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes bench testing, not a clinical study involving patients or data sets. Therefore, there's no "sample size for the test set" in the context of patient data, nor a country of origin for such data. The tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical pump, not an AI or diagnostic tool requiring ground truth established by experts for performance evaluation. The "ground truth" here is the expected physical performance of the device (e.g., maintaining pressure, battery life, proper shutdown).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is bench testing of a physical device, there's no expert adjudication involved in the sense of reviewing outputs or diagnoses.
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
Not applicable. This document is about a physical NPWT device, not an AI or diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI. The software component mentioned is for device control and functionality, not for standalone diagnostic or assistive performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests was the engineering specifications and expected functional performance of the device (e.g., a pressure reading close to 125 mmHg, battery lasting for a certain duration, a specific alert triggering correctly). This is based on established engineering principles and the device's design requirements.
8. The sample size for the training set
Not applicable. There is no AI or machine learning model that requires a "training set" described in this document.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.