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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:

1. A table of acceptance criteria and reported device performance related to clinical outcomes.
2. Sample sizes for test or training sets for a clinical study.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods for a clinical test set.
5. MRMC comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set (if it were an AI/ML device).
9. 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.

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The ActiveCare+S.F.T. and ActiveCare+DTx Systems are portable, ambulatory, sequential. intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment.

These devices are indicated for use in:

• Preventing Deep Vein Thrombosis (DVT)
• Diminishing post-operative pain and swelling
• Reducing wound healing time
• Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) (Venous Thromboembolism (VTE))
• Treatment of venous stasis
• Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
• Enhancing blood circulation
• Treatment of chronic venous insufficiency
• Reducing edema

The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.

In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow.

The ActiveCare+DTx and ActiveCare+S.F.T. Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing patient mobility and ease of use. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf – single or double, compression of the thigh – single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.

The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.

In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool.

The provided text is a 510(k) summary for the Medical Compression System (DBN) Ltd.'s ActiveCare+S.F.T. and ActiveCare+DTx devices. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or any detailed study data that proves the device meets specific performance criteria.

The "Performance Data" section merely states: "Testing referenced in support of this submission includes: Electrical Safety, EMC, Usability, Software Validation, Risk Analysis, internal testing and published Clinical Literature. The data provided demonstrates that the modified ActiveCare+S.F.T. and ActiveCare+DTx Systems are substantially equivalent to its predicates, and raises no new safety or effectiveness issues."

This is a general statement and does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance data.
• Types of ground truth used.
• Sample size for the training set.
• Method for establishing ground truth for the training set.

Therefore, I cannot fulfill your request for this specific information based on the provided document. The document focuses on demonstrating substantial equivalence through a summary of regulatory and general testing, rather than presenting detailed performance efficacy data against specific acceptance criteria.

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