(165 days)
The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:
- Distal augmentations
- Proximal augmentations
- Reflux measurements of specific venous valves
- Vein Mapping
- Locating suitable distal vessel for bypass
The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and deflating the placed cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.
The provided 510(k) summary for the AugEase™ device primarily focuses on demonstrating substantial equivalence to a predicate device (VenaPulse Model VP-25) based on technical characteristics and intended use. It does not present a study with specific acceptance criteria and detailed device performance metrics in the way a clinical study or a standalone AI algorithm performance study would.
Instead, the submission relies on non-clinical tests to ensure the device's safety and fundamental functional equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative way to compare against a clinical or AI-driven outcome. Instead, it lists technical characteristics for comparison against the predicate device. The implicit acceptance criterion is that the AugEase™ device's characteristics are similar enough to the predicate device to ensure similar performance and safety.
| Feature | Acceptance Criteria (Implicit: Similar to Predicate) | Reported AugEase™ Performance |
|---|---|---|
| Intended Use | Match predicate's indications for use | Matches predicate's indications for use |
| Technological Characteristics | 1. MANUAL | |
| 2. PNEUMATIC | ||
| 3. 0.8L MAXIMUM VOLUME | ||
| 4. RAPID INFLATION CUFF | ||
| 5. LARGE DIAMETER HOSE | ||
| Mode of Operation | Rapid inflation and deflation, foot actuated | Rapid inflation and deflation, Foot actuated |
| Inflation/Deflation Rise/Fall Time | Approximately 300 milliseconds (predicate) | 0.5 seconds |
| Pressure Range | 0-240 mmHg | 0-240 mm/Hg |
| Safety Feature | Alarm (predicate) | 1. Check Valve 1.0 psi |
- 300mm/Hg Gauge |
| Instructions for Use | Yes | Yes |
| Non-sterile | Yes | Yes |
The document also lists several "Product Validation Testing" items, which are non-clinical safety/material tests rather than performance-based acceptance criteria related to efficacy. These include:
- Burst pressure
- Materials testing
- Cytotoxicity Test
- Sensitization Test
- Irritation and Intracutaneous Reactivity Test
- Tensile Strength Test
- Method of attachment (Velcro or straps)
- Seal Strength Comparison
- Cuff Leak Testing
The reported performance for these tests is that they were "Product Validation Testing," implying that results met internal specifications, but no numerical results or acceptance thresholds are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (a foot-actuated augmentation device) and its 510(k) submission for substantial equivalence. It does not involve a "test set" in the context of an AI/algorithm study or a clinical trial with patient data. The validation is based on engineering and materials testing, as listed under "Product Validation Testing." There is no mention of patient data, clinical images, or any form of "test set" in the context of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is not a study involving diagnostic interpretation or comparison of an algorithm's output against human experts, there is no "ground truth" established by experts in this context. The evaluation is against engineering specifications and comparison to a predicate device's technical characteristics.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication in the context of an AI/clinical study.
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 device is a physical augmentation device, not an AI or imaging diagnostic tool that would be evaluated with MRMC studies or human reader improvement metrics.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical, non-AI medical device. There is no algorithm to evaluate in standalone mode.
7. The Type of Ground Truth Used
For the physical and functional tests listed (e.g., burst pressure, seal strength, inflation/deflation time), the "ground truth" would be established by engineering specifications and validated testing methods. For the purpose of substantial equivalence, the "ground truth" is also the characteristics and performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve a "training set" as it is for a physical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).