(155 days)
The Devon 62 DVT Prevention Therapy Device is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments.
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Devon 62 DVT Prevention Therapy Device, with a pair of extension tubing, is for use with Cirona DVT calf-thigh and foot garments (sleeves). The device alternatively inflates the two garments and mimic the natural walking pace to enhance circulation. The compression supplied by the device provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calfthigh and foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
The provided text is a 510(k) summary for the Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria for device performance. As such, it does not contain the level of detail typically found in reports of diagnostic or AI-driven device performance.
Therefore, many of the requested categories cannot be fully addressed from the provided text. However, based on the information present, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document lists "Function Performance Tests" with the implied acceptance criteria being that the device performs "as intended" and is "substantially equivalent to the predicate." Specific numerical acceptance criteria are not provided in this summary.
| Test Category | Specific Test | Reported Performance (Implied Acceptance) |
|---|---|---|
| Function Performance Tests | TR68.J001: System Level Software Test | Device performing as intended, substantially equivalent to the predicate. |
| TR68.J002: Pressure Accuracy Test | Device performing as intended, substantially equivalent to the predicate. | |
| TR68.J003: Cycle Time Test | Device performing as intended, substantially equivalent to the predicate. | |
| TR68.J004: Alarm Function Test | Device performing as intended, substantially equivalent to the predicate. | |
| TR68.J005: Pressure Sensor Calibration | Device performing as intended, substantially equivalent to the predicate. | |
| TR68.J006: Battery Life Test | Device performing as intended, substantially equivalent to the predicate. | |
| Electrical Safety | IEC 60601-1:2005 + A1:2012 | Tests conducted according to standards, device is substantially equivalent. |
| EMC | IEC 60601-1-2: 2014 | Tests conducted according to standards, device is substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "samples of the device underwent function and mechanical testing" but does not specify the sample size for these tests. There is no information regarding data provenance (country of origin, retrospective/prospective) as these are non-clinical performance tests.
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 not provided. The performance tests described are related to direct device function (software, pressure, cycle time, alarms, battery life), not diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the tests are for device functional performance, not for ground truth establishment by experts.
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 MRMC comparative effectiveness study was performed or described. This device is a DVT prevention therapy device, not an AI-driven diagnostic or interpretative tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The Devon 62 DVT Prevention Therapy Device is a physical medical device (pneumatic compression device) that operates autonomously to apply pressure. It does not involve algorithms for diagnostic interpretation or human-in-the-loop performance testing in the sense of AI-driven tools.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests would be the pre-defined engineering specifications and expected operational parameters of the device (e.g., specific pressure levels, cycle timings, alarm conditions, battery duration). These are intrinsic to the device's design and manufacturing standards, not external clinical data.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, this is not an AI/machine learning device.
§ 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).