(241 days)
To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: - Lymphedema. - · Primary and secondary (including post-surgery, radio or chemotherapy). - . Chronic Edema of Venous Origin - Chronic venous insufficiency. . - Acute and chronic wounds including venous leg ulcers and post- surgical wounds. . IPC may also be beneficial in the management of: - . Lipoedema. - Varicose veins . - Postoperative Venous Ligation or Stripping . - . Sports injuries - Post Traumatic Edema . - . Lymphatic Filariasis
The Hydroven 12 system comprises of a range of inflatable sleeves. inserts and a compatible air pump. The sleeves fit around patients' upper and lower limbs. The sleeves contain separate but overlapping air chambers that intermittently compress the limbs in a specific sequence. The resultant pressure on the patient's limb tissues promotes the transport of fluids and proteins. The inflatable inserts can be added to allow large circumference limbs to be treated. The pump provides the compressed air to the sleeves with user selected pressures and sequence of operation.
The provided text is a 510(k) summary for the Hydroven 12 Pump and Garments, a medical device for intermittent pneumatic compression therapy. This document aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not available in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy thresholds) for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Lympha Press Plus and compression Garments, K013331) through various engineering and performance tests. The "acceptance criteria" are implied to be "compliance with standard" or "Passed" for functional and safety tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Full validation of pump software / hardware functionality, including User Interface and Therapy delivery | Passed |
| Performance testing garments - Pressure cyclic test (with Leg and Arm garments) | Passed |
| Electrical Testing to Standard ANSI/AAMI ES60601-1:2005/(R)2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Complies with Standard |
| EMC testing to Standard IEC 60601-1-2, 2007 | Complies with Standard |
| Environmental Stability testing (Storage / Distribution Test, Operational Temperature / Humidity Test) | Passed |
| Equivalent pressure profiles to predicate device | Achieved |
| Similar garment construction and substantially equivalent therapy delivery to predicate device | Achieved |
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 tests mentioned (software/hardware validation, pressure cyclic test, electrical, EMC, environmental) are typically engineering and bench tests, not clinical studies with human subjects that would have a "test set" in the context of AI or diagnostic device evaluation.
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 provided. As explained above, this document is focused on engineering testing and substantial equivalence, not clinical validation requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable and not provided. The Hydroven 12 is a physical therapy device (intermittent pneumatic compression pump and garments), not an AI-powered diagnostic or interpretive device that would involve human "readers" or AI assistance in that sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. The device is an electro-mechanical system, not an algorithm in the AI sense. Its standalone performance is assessed by the "Passed" or "Complies with Standard" results for its functional and safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering tests would be the established specifications, performance requirements, and regulatory standards (e.g., pressure output accuracy, electrical safety limits, EMC compliance). It is not expert consensus, pathology, or outcomes data in the clinical sense because it's not a diagnostic device.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" in the context of machine learning or AI, as this is not an AI device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
§ 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).