Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat:

Poor arterial flow in extremities associated with:

• . Ischemic ulcers
• Rest pain or claudication (pain with walking) ◆
• t Threatened gangrene

• Insufficient blood supply at an amputation site

• Persisting ischemia after embolectomy or bypass surgery
• . Pre- and post-arterial reconstruction to improve runoff

Diabetes complicated by the above or other conditions possibly related to arterial insufficiency including:

• Nocturnal leg cramps .
• Necrobiosis diabeticorum

Venous diseases (once risk of emboli minimized):

• . Prophylaxis of deep vein thrombophlebitis
• Edema and induration associated with chronic venous stasis .
• Venous stasis ulcers .

Athletic injuries: "Charlie horses", pulled muscles, and edematous muscles

The Circulator Boot Systems are designed to allow pneumatic compression therapy to any extremity (its whole or a part) as prescribed by a physician. A computer within a heart monitor delays compressions after the detection of the QRS complex to allow maximum inflow of blood into the extremities and signals release of the extremity 0.04 seconds before the time of the next QRS complex to maximally reduce afterload and heart work. The part to be treated is first placed into a double-walled plastic disposable bag (legs or arms) or enclosed by a small cuff (such as an elbow). The bagged extremity is then placed within a rigid plastic boot which is adjusted to limit the dead space around the leg. In the case of K792354, adjustment for differences in the length of the extremity is made by applying one of three different length Long Boots ("A". "B" or "C") while adjustments in the width of the extremity is made by moving inner walls snuggly against the part; adjustments for the A-P (anterior-posterior) dimension are accomplished by arcing the thick plastic aprons attached to the inner side of the lateral movable walls tightly down over the extremity.

The new "Multicrus" boot K082134 is likewise a rigid plastic boot but telescoping and adjustable in all three dimensions: length, height and width to minimize the space around the bagged leg. It is composed of eight overlapping right-angled plastic pieces which are applied firmly against the extremity. Thus, a piece might be placed under the thigh and knee and against the inner part of the leg (as high up the leg as desired). A second piece may be placed against the lateral aspect of the thigh and knee with its bottom section under the first part. These two parts are pushed together to snuggly hug the inner and lateral parts of the extremity. A third part may then be placed against the inner calf and under the heel and distal part of the first part. A fourth part is placed against the lateral calf and foot and under the heel and the third part and under the second part. The third and fourth parts are again pushed together to snuggly hug the calf and foot. The vertical wall of the fifth part is placed between the vertical walls of the first and third parts while its horizontal wall is placed over the upper leg, again as far up the leg as desired. The vertical wall of the sixth part is placed between the vertical walls of the second and fourth parts and its horizontal part is placed to overlap the thigh and the fifth part. Finally, a seventh and eighth part are placed over the top of the lower leg and foot and over the distal horizontal aspects of the fifth and sixth parts and again are pushed together to minimize the dead space around the lower leg. All are held in place by Velcro patches between the overlapping parts and by straps surrounding the assembled boot.

The valve assembly is attached to a plate included on the top of the eighth part and connected then to the compressed air line and the heart monitor. The technician adjusts the pressure knob of the valve assembly as needed to achieve the desired pressure in all of the boot systems. Desired pressures were gained in every patient treated with the Multicrus boot during its five weeks of clinical usage. With all of our boot systems, the physician is encouraged to improvise as necessary to treat patients with special needs (e.g. deformed legs that cannot be straightened out sufficiently to enter our rigid boots). A small cuff is one such improvisation that has allowed treatment of portions of any extremity in concert with treatment of the legs in the Long Boots. This small "Cuff Boot"consists of a juvenile blood pressure cuff to surround the extremity (perhaps a tennis elbow) with a bladder from an adult blood pressure cuff connected to both it and a air-bulb. The bladder is placed over the thigh and beneath the plastic airbag of the Long Boot and, hence, is compressed simultaneously with the leg. The small cuff applies pressure in end-diastole with the same pressure introduced into the Long Boot.

The provided text does not contain information about acceptance criteria or a study designed to prove a device meets specific performance metrics. Instead, it is a Premarket Notification 510(k) Summary for the "Multicrus Circulator Boot System," focusing on demonstrating substantial equivalence to a predicate device.

The document discusses the device's description, intended use, and a summary of technological characteristics compared to predicate devices. It states: "The summary above shows that there are no new questions of safety and effectiveness for the Multicrus Boot as compared to the predicate device."

It includes a section titled "SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807 .92(b)( 1 Y)3)", which mentions: "The Verification and Validation data was accumulated in the clinic." However, no details about specific acceptance criteria, study design, sample sizes, ground truth establishment, or performance metrics are provided.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth, adjudication methods, or MRMC studies, as this information is not present in the provided text.

Ask a specific question about this device

Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP ) Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock

Vasomedical's EECP Therapy System Model TS3, Model TS3 with Pulse Oximetry and Model MC-2 have been previously described to FDA. The EECP® Therapy System Model TS4 with/without Pulse Oximetery is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set.

The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The signals are obtained non-invasively. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is selected by the operator and then monitored and maintained automatically. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system a printer is used to produce hard copy of site and patient identification and physiologic data.

The Treatment Table is a padded table assembly and is set at a height convenient for both patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses.

The electrocardiogram of the patient is detected to initiate triggering of the inflation/deflation valves at appropriate times during the cardiac cycle. External pressure is applied via a patient Cuff Set to the lower extremities of the patient in synchronization with the resting, diastolic phase of the heart cycle, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. This pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary arterial perfusion pressure and coronary arterial blood flow (diastolic augmentation), as well as venous return to the right side of the heart. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload).

The provided text is a 510(k) summary for the Vasomedical EECP® Therapy System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics and study design elements requested in your prompt.

The document is a regulatory submission focused on establishing substantial equivalence, primarily by comparing technological characteristics and intended use to a previously cleared device. It does not include performance data or clinical study results in the manner you are asking for.

Therefore, I cannot fulfill your request for the table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because that data is not present in the provided text.

Ask a specific question about this device

The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

The CardioMedics CardiAssist™ ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, angina pectoris, myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads.

This CardiAssist™ ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The provided text is a 510(k) summary for the CardioMedics, Inc. CardiAssist Counterpulsation System Mark 3000. It focuses on demonstrating substantial equivalence to a predicate device for an expanded indication (treatment of non-chronic angina pectoris patients).

The submission does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is provided.
• No information about sample sizes (test or training set), data provenance, number or qualifications of experts, or adjudication methods is present.
• No mention of MRMC comparative effectiveness studies or standalone algorithm performance is made.
• The type of ground truth used is not specified.
• No details on how ground truth for a training set (if one existed, which is not stated) was established are given.

Instead, the submission primarily focuses on:

• Device Description: Explaining how the CardiAssist ECP System works (sequential compression of legs during diastole to enhance perfusion).
• Intended Use/Indications for Use: Listing the conditions the device is intended to treat (angina pectoris, congestive heart failure, myocardial infarction, cardiogenic shock).
• Comparison to Predicate Device: Stating that the new device is substantially equivalent in function and intended use to a previously cleared CardiAssist ECP System (K022107) and the Vasomedical EECP Therapy System Model TS3 (K020857). The key difference is an expanded indication to include non-chronic angina pectoris patients, with the claim that this does not change the safety or effectiveness.
• Regulatory Information: Including contact details, classification, and the FDA's clearance letter.

This type of 510(k) submission, especially for an expanded indication where technological and functional characteristics are identical to a predicate, often relies on demonstrating that the new indication does not introduce new questions of safety or effectiveness, rather than providing completely new performance study data if the core technology remains unchanged. The claim here is that the treatment of "all angina pectoris patients" (including non-chronic ones) "does not significantly change the safety or effectiveness of the device."

Ask a specific question about this device