(442 days)
The Talley Venturi™ MiNO TG600/14 is intended for use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure wound therapy to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.
Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing.
Vacuum Pump Unit: Venturi MiNO NPWT TG600/14
Construction: Flame Retardant ABS
Dimensions / Weight: 105mm x 52mm x 112mm / 290g
Pressure Range: 80mmHg and 120mmHg
Here's an analysis of the provided text regarding the Venturi MiNO TG600/14 device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes performance tests but does not explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner that would be typical for clinical studies. Instead, it describes general performance checks and comparisons to predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied/Description) | Reported Device Performance |
|---|---|---|
| Air-tightness (Canister) | Pass for air-tightness, recognition of sensor pins, and acceptable loss of vacuum over a prescribed period. | Performed on 100% of production units. Confirmed. |
| Vacuum Pump Pressure | Achieve 120mmHg; measured flow and pressure meet defined minimum values. | Performed on 100% of production sub-assemblies. Confirmed. |
| Vacuum Pressure Levels | Maintain vacuum pressure levels over 48 hours. | Performed on 100% of assembled production pump units. Confirmed. |
| Final System Functionality | All functions, buttons, correct pressure calibration, air tightness, canister recognition, warning systems/alarms, and charging system operational. | Performed on 100% of production units. Confirmed. |
Important Note: The document focuses on production unit testing for quality control and comparison to predicate devices, rather than a clinical study with quantifiable clinical outcome-based acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) typically seen for diagnostic or AI-based devices. The "performance" here refers to the device meeting its specified technical functionalities.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the context of clinical or AI performance evaluation. The "tests" described are manufacturing quality control checks performed on 100% of production units (canister vacuum test, vacuum pump test, soak test, final system test).
- Sample Size for Test Set: Not applicable as this is a manufacturing quality control and non-clinical comparison for substantial equivalence, not a clinical study or AI model evaluation. The tests are applied to 100% of manufactured units.
- Data Provenance: The data comes from internal manufacturing testing of Talley Group Ltd. in Great Britain. This is non-clinical, internal test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical or AI studies, involves expert-derived labels or diagnoses. The tests described are functional and performance-based, where the "truth" is whether the device meets its engineering specifications. There is no mention of experts establishing a "ground truth" for these engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for clinical or image-based studies. This document describes functional engineering tests, not a study requiring expert adjudication.
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. This document does not describe an AI medical device, nor does it present any MRMC comparative effectiveness study. The device is a "Negative pressure wound therapy pump," which is a physical medical device, not an AI or diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is the engineering specification and expected functional behavior of the device (e.g., maintaining 120mmHg vacuum, air-tightness, correct alarm function). This is determined by the device's design and manufacturing standards, not by expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI algorithm.
§ 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.