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.

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The Circulator Boot System - alone or in combination with other drug or device therapies - may be used to treat:

• peripheral arterial disease
• chronic lymphedema
• ischemic lesions
• claudication pain
• necrotizing cellulitis
• venous stasis ulcers
• stasis dermatitis
• thrombophlebitis

The Circulator Boot is an end diastolic pneumatic compression device made up of several components. A double walled plastic bag is placed over the leg of the patient and then placed inside a rigid plastic "boot". The boot is then attached to a valve system which is connected to an air supply. The valve is also connected to an EKG QRS monitor that times the compression cycle to occur after a variable (operator selectable) delay following the QRS signal.

This 510(k) summary does not contain sufficient information to describe the acceptance criteria or a study that proves the device meets those criteria in the format requested. The document is a regulatory submission for premarket notification of a medical device, the "Circulator Boot," seeking substantial equivalence to existing devices. It focuses on device description, indications for use, and a comparison to predicate devices, but lacks detailed performance data or a study report with specific acceptance criteria.

Specifically, the following information is missing from the provided text to complete the requested table and study description:

1. A table of acceptance criteria and the reported device performance: The document mentions that the new model has "increased accuracy of timing and easier user interface" compared to the old model, with the new model being "accurate to within +/- 0.002 seconds" versus the old model's "+/- 0.05 seconds." This is a performance specification, but not a formally defined acceptance criterion that would be part of a study design to demonstrate safety and effectiveness. There are no other performance metrics or acceptance criteria provided.

2. Sample size used for the test set and the data provenance: No information on any test set size or data origin is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth experts is provided.

4. Adjudication method: No information on an adjudication method is provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study.

6. Standalone performance study: While it mentions improved timing accuracy, it does not describe a formal standalone performance study with detailed methodology, metrics, and acceptance criteria.

7. Type of ground truth used: No information on ground truth is provided.

8. Sample size for the training set: No information on a training set is provided, as this is not an AI/ML device in the modern sense.

9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary of available information related to performance:

The document primarily focuses on establishing "substantial equivalence" of the "Circulator Boot" to legally marketed predicate devices, as required for a 510(k) submission. The only performance-related detail provided is:

• Improved Timing Accuracy: The new Circulator Boot model is accurate to within +/- 0.002 seconds, whereas the original model varied timing by as much as +/- 0.05 seconds. This indicates a technical improvement but is presented as a feature rather than the result of a formal study proving specific acceptance criteria.

Without more detailed information, it is impossible to complete the requested output.

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