(137 days)
The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
- Aid in the prevention of DVT ●
- . Enhance blood circulation
- Diminish post-operative pain and swelling .
- Reduce wound healing time .
- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
The Cirona™ 6300 disposable deep vein thrombosis prevention system (refer as Cirona 6300 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Cirona 6300 system consists of a pair of pump and sleeve assemblies.
The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.
The provided text describes the Cirona 6300 Disposable Deep Vein Thrombosis Prevention System and its 510(k) submission for substantial equivalence. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in comparison to a ground truth as would be typical for an AI/ML device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Innovamed Vena Pro, K133274) through a comparison of technological characteristics and various engineering/performance tests.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable or not provided in this type of submission.
Here's a breakdown of the information that is available based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy against a DVT diagnosis ground truth) nor does it report device performance in that manner. Instead, it lists several engineering and functional tests. The implied "acceptance criterion" for these tests is that the device performed as intended or demonstrated substantial equivalence to the predicate for those characteristics.
| Function Performance Tests | Reported Outcome/Conclusion |
|---|---|
| TR36.0001 Pressure Accuracy Test Report | Performed as intended, substantially equivalent to predicate |
| TR36.0002 Pressure Switch Test Report | Performed as intended, substantially equivalent to predicate |
| TR36.0003 Cirona 6300 Cycle Time Test Report | Performed as intended, substantially equivalent to predicate |
| TR36.0004 Alarm Function Test Report | Performed as intended, substantially equivalent to predicate |
| TR36.0005 Battery Life Test Report | Performed as intended, substantially equivalent to predicate |
| TR36.0010 Cirona 6300 Garment Burst Testing Report | Performed as intended, substantially equivalent to predicate |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Evaluated according to FDA Good Laboratory Practice |
| Electrical Safety and EMC (IEC 60601-1, -1-2, -1-6, -1-11) | Conducted according to standards |
| Software Verification and Validation | Conducted; software considered "moderate" level of concern |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any performance tests; implied to be laboratory samples of the device undergoing engineering testing.
- Data Provenance: Not applicable. These were engineering/bench tests, not clinical data.
- Retrospective/Prospective: Not applicable.
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. This document describes a physical medical device (intermittent pneumatic compression system) and its engineering validation, not an AI/ML diagnostic system that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Not applicable to the type of device and testing 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
- No. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the engineering tests would be the established engineering specifications and performance characteristics of the device being tested (e.g., a pressure gauge accurately measuring 50mmHg, a timer accurately measuring 50 seconds).
8. The sample size for the training set
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no machine learning training set involved.
In summary, this document is a 510(k) premarket notification for a physical medical device (DVT prevention system) based on substantial equivalence. It details engineering and functional tests to demonstrate the device meets its design requirements and is comparable to previously cleared devices. It does not involve AI/ML technology, clinical studies with human subjects, or the complex validation methodologies associated with AI systems described in your prompt.
§ 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).