(28 days)
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonded to a foam inner liner bonded to an inner lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The devices are terminally sterilized with Ethylene Oxide (EO) gas.
The provided text describes the acceptance criteria and performance testing for the VasoPress DVT Garment (sterile). It does not contain information about a study proving the device meets the acceptance criteria in the context of clinical effectiveness or performance against a ground truth. Instead, the performance testing focuses on manufacturing quality control.
Here's the breakdown of the information that can be extracted:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bladder integrity: pressurize to 120 mmHg | Bladders are pressurized to 120 |
| Dwell for 30 seconds | Dwell for thirty (30) seconds |
| Drop in pressure not above 20 mmHg | No drop in pressure above 20 mmHg |
(Note: The reported performance is a statement of the test methodology and expected outcome rather than specific numerical results from a study.)
2. Sample Size Used for the Test Set and Data Provenance
The document states "100% verification of bladder integrity via leak test." This implies a sample size of 100% of manufactured devices for this specific test.
Data Provenance: The data provenance is not explicitly mentioned as coming from a specific country or being retrospective/prospective in a clinical research sense. It relates to manufacturing quality control checks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing described is a technical test of bladder integrity, not a clinical assessment requiring expert interpretation or ground truth establishment in the traditional sense of a medical device study (e.g., image analysis, diagnosis).
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is a pass/fail technical test, not a subjective assessment requiring consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in the provided text. The document focuses on manufacturing and technological equivalence.
6. Standalone Performance Study
No, a standalone (algorithm-only without human-in-the-loop performance) study was not done. This device is a physical, pneumatic compression device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this performance test is the physical property of bladder integrity per the specified pressure and leak parameters. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. The device is a physical product, and the performance testing described relates to manufacturing quality, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and performance testing.
§ 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).