(87 days)
The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Veep Thrombosis) in patients at risk.
The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.
The provided document is a 510(k) summary for the Microtek Medical, Inc. Venodyne DVT Advantage, 810 Compression System. It describes the device, its intended use, and its technological characteristics. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML device.
The documentation focuses on demonstrating substantial equivalence to predicate devices. The "study" mentioned is primarily focused on safety and performance verification against established electrical safety, radio disturbance, radio noise emissions, and electromagnetic compatibility standards, along with general controller features, compression cycle operation, alarm modes, and battery operations.
Here's a breakdown of the requested information based only on the provided text, and where the information is absent:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary from Document) |
|---|---|
| Electrical Safety (UL 60601-1, CAN/CSA C22.2 601.1-M90, CAN/CSA C22.2 601.1S1-94, CAN/CSA C22.2 601.1B-98) | Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Radio Disturbance (EN 55011:2007) | Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Radio Noise Emissions (FCC part 18) | Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Electromagnetic Compatibility (EN 60601-1-2:2007) | Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| General controller features performance | Verification and Validation testing was performed... Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Compression cycle operation | Verification and Validation testing was performed... Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Alarm modes functionality | Verification and Validation testing was performed... Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
| Battery operations | Verification and Validation testing was performed... Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s). |
Note: The document states that "Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s)." This is the overarching "performance" reported in relation to the standards and functional tests. Specific quantitative acceptance thresholds (e.g., "must meet X% accuracy" or "must not deviate by more than Y units") are not provided in this summary. The acceptance criteria essentially infer meeting the standards listed or performing comparably to the predicate device in functional tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is for engineering and functional verification, not clinical data testing with a "test set" in the context of an AI/ML device.
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)
This information is not applicable and therefore not provided in the document. The device is a pneumatic compression system, not an AI/ML diagnostic system requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (a pneumatic compression system).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided in the document, as it's not an algorithm-only device. The testing focused on the physical device's performance against safety and functional standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and therefore not provided in the document. The "ground truth" for the tests performed would be the specifications outlined in the referenced electrical safety, EMC, and functional standards.
8. The sample size for the training set
This information is not applicable and therefore not provided in the document, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided in the document, as this is not an AI/ML device requiring a training set with ground truth.
§ 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).