(190 days)
The Trinity II Single Chamber DVT System Pump (with sleeves), is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism. The intended patient population is adult with the environment of use being hospital, clinic.
The Trinity II Single Chamber DVT Pump is a device designed to reduce pooling of blood and increase venous blood flow in the lower extremities of recumbent patients. It uses compressible limb sleeves.
The provided text describes a medical device submission (Trinity II Single Chamber DVT Pump) seeking substantial equivalence to a predicate device. However, it does not contain acceptance criteria for the device's performance, nor does it detail any study proving the device meets specific performance criteria beyond electrical safety, EMI, alarm and timing tests, Y2K compliance, and risk analysis.
The submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump) based on similar indications for use, operating principles, and minor parameter differences (pump pressure range).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it is not present in the provided text.
Here's what I can extract based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the text in the context of clinical or performance acceptance criteria for the device itself. The text mentions "Testing" for electrical safety, EMI, alarm and timing, Y2K, and risk analysis, but these are general safety and engineering tests, not performance acceptance criteria for the DVT pump's therapeutic effect.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. The submission does not detail any clinical performance study with a test set.
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):
Not applicable/Not provided. No clinical performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No clinical performance study is described.
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/Not provided. This device is a DVT pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This device is a medical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/Not provided. No clinical performance study is described.
8. The sample size for the training set:
Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.
9. How the ground truth for the training set was established:
Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.
Summary of available "testing" information:
| Test Type | Reported Compliance/Finding |
|---|---|
| Electrical Safety | Tested to UL 2601. |
| EMI | Tested to IEC 801-2, -3, -4, -5, IEC 1000-4-11, and EN 61000-4-5, -4-11. |
| Alarm and Timing | Tested to Delphi Consulting Group protocol. |
| Y2K | Software has been tested for any problems with year 2000 problem. Software does not retain dates. |
| Risk Analysis | Per EN 1441 and EN 46001. |
| Substantial Equivalence | Concluded to be equivalent in safety and efficacy to the predicate device (Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump, K881632) based on feature comparison (pump pressure range, default pressure, cycle time, indications). |
§ 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).