(163 days)
The RF1400 Active Compression Wrap is intended to be a portable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs:
· Aid in the prevention of DVT (deep vein thrombosis);
• Enhance blood circulation;
· Diminish post-operative pain and swelling;
- · Reduce wound healing time;
· Aid in the treatment and healing of: stasis dermatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs;
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
· Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema, or ligament sprains.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
The RF1400 Active Compression Wrap is a lightweight, portable, rechargeable battery powered, prescriptive device that helps stimulate blood flow in the lower limb through the use of intermittent sequential compression. The wrap contains nickel titanium, martensite phase change wires, using a battery-powered microprocessor to "excite" and "relax" the wires resulting in compression. The battery and microprocessor components are protectively housed in a plastic controller case that is permanently attached to the wrap. A single, touch control button interface and a RGB LED light indicator provide the user interface, and there is a port for connecting the battery charger plug. The wrap is available in a wide range of sizes XS, S, M, and L, to accommodate varying anatomy sizes.
The wrap is divided into three discrete zones which are externally applied to the limb. After one zone is fully activated for a period of time and turns off, then the next zone is activated. This cycle continues until all three zones have activated and turned off. Then the sequence is repeated after a short delay. This cycle repeats until the unit is turned off. The wrap may be used on one or both legs. When used on both legs, the wraps operately. The wrap is supplied with a rechargeable battery, which can be charged when not in use.
The provided text describes a 510(k) premarket notification for a medical device called the "RF1400 Active Compression Wrap." This device is intended to stimulate blood flow in the legs through intermittent sequential compression. However, the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical outcomes or a comparison against human performance.
The provided text focuses on:
- Regulatory clearance (510(k) summary): It primarily describes the device, its intended use, contraindications, and why it is considered "substantially equivalent" to predicate devices based on technological characteristics and bench testing.
- Nonclinical testing: It mentions electrical safety, EMC, software validation, environmental/shipping, life cycle, and performance testing (biocompatibility, surface temperature, equivalent pressure delivery, cycle time).
Therefore, I cannot provide a detailed answer to your request, specifically regarding:
- A table of acceptance criteria and reported device performance related to clinical outcomes.
- Sample sizes for test or training sets for a clinical study.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods for a clinical test set.
- MRMC comparative effectiveness study or human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set (if it were an AI/ML device).
- How ground truth for the training set was established.
This document pertains to a mechanical compression device, not typically an AI/ML device, and the substantial equivalence determination for such devices often relies on engineering specifications and bench testing demonstrating equivalent function to existing predicate devices, rather than large-scale clinical outcome studies in the same way an AI diagnostic device might require.
In summary, the provided document does not contain the information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance, particularly as it relates to AI/ML device evaluation.
§ 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).