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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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