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The Circul8 Pro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · 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 and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The Circul8 Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescription device. The device is intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous return due to an increased risk from blood clots.
The subject device is a modification of the predicate device in K193020, which includes:

• modification of the plastic housing the electronically controlled air pump unit and solenoid valve,
• relocation of the tactile touch control switch from the front of the housing to the housing,
• introduction of LED display to replace the tricolored LED for ON, LOW BATTERY, CHARGE COMPLETED indications, and the blue LED for indicating a leak or low pressure alarm,
• removal of the micro USB port for obtaining usage (patient compliance) data,
• no longer labeling cuff as either left leg cuff or right leg cuff,
• cuffs are filled to 55 mmHg pressure
• introduces Night Mode, which minimizes light disturbances from the LEDs during patient resting times.
• increased battery life.
  Both the subject device and predicate device utilize pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid value of trol components are protectively housed in a plastic case that is permanently attached to the inflatable cuff.

Here's a breakdown of the acceptance criteria and the study information for the Circul8 Pro Vascular Therapy System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Design verification test results demonstrate the true mean (average) proportion, with a 5% margin of error and at the 90% confidence level," for various physical, performance, and electrical requirements. However, the specific sample size (N number of devices or measurements) for these tests is not provided in the given text.

The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of design verification tests, they are typically prospective, conducted on manufactured units.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described (measurements of size, weight, pressure, electrical characteristics, software function, and compliance with standards) are objective engineering and performance evaluations. There is no indication that expert "ground truth" was established in the clinical sense for the described verification tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. The tests performed are objective measurements and compliance checks against predefined specifications and standards, not evaluations requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the document. The Circul8 Pro Vascular Therapy System is a physical therapy device (compressible limb sleeve), not an AI-assisted diagnostic or imaging device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the Circul8 Pro Vascular Therapy System. It is a physical device, and while it has software for controlling its functions, it is not an algorithm that operates in a standalone diagnostic or interpretative capacity. Its performance is evaluated based on its physical, electrical, and functional compliance.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on engineering specifications, physical measurements, functional performance parameters (e.g., pressure output, battery voltage), and compliance with established electrical safety and electromagnetic compatibility international standards (IEC 60601 series, IEC 62133-2). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense being used as ground truth for these design verification tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is not a machine learning or AI-based system that requires a "training set" in the context of developing an algorithm from data. The software updates mentioned are for controlling the device's functions and user interface, not for learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of machine learning for this device.

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CIRCUL8 Luxe, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation:
• · Diminish post-operative pain and swelling:
• · Reduce wound healing time;

· Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The CIRCUL8 Luxe DVT Prevention Device is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The purpose of the CIRCUL8 Luxe is to aid in the prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is accomplished by an electronically controlled pump delivering a set amount of air to the leg cuffs that, in turn, compress the calf or calves to aid blood flow out of the lower extremities. The pump will inflate each leg cuff to a pre-set pressure of 60mmHg (± 5 mmHg) and deflate once the pressure is reached. The cycles are repeated on each unit until the power is turned off. Internal rechargeable batteries (Li ion) allow the CIRCUL8 Luxe to be completely portable, thus preventing interruptions in treatment.

The provided document describes a 510(k) premarket notification for the CIRCUL8 Luxe DVT Prevention Device. This regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with extensive acceptance criteria for complex AI algorithms.

Therefore, many of the typical acceptance criteria and study elements associated with AI/ML-driven medical devices (like MRMC studies, expert adjudication for ground truth of an AI, or large sample sizes for AI training/test sets) are not applicable to this traditional medical device submission. The device is a pneumatic compression system, not an AI/ML diagnostic or prognostic tool.

However, I can extract the available information related to performance testing and acceptance criteria as presented in the document based on the device's function.

CIRCUL8 Luxe DVT Prevention Device: Acceptance Criteria and Performance (Non-AI Device)

This document describes a traditional medical device (a pneumatic compression system) and its substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely related to engineering specifications and safety/performance benchmarks for a physical device, not AI model performance metrics. The "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences to Predicate:
The document also compares the CIRCUL8 Luxe's technical specifications to its predicate device (PlasmaFlow Vascular Therapy System) and notes the following "similarities" which can be interpreted as demonstrating acceptable performance relative to the predicate:

• Operating Pressure: CIRCUL8 Luxe: 60 mmHg (±5mmHg or ~8%); Predicate: 55 mmHg. Comment: "Similar; Circul8 Luxe has a tolerance of ±5mmHG from 60mmHG which equals 55mmHG to 65mmHG. The predicate's working pressure falls within the same range." This implies the predicate's 55mmHg falls within the acceptable range of the subject device's operation.
• Cycle Time: Both 60 seconds. Comment: "Same."
• System Alarms/Indicators: Both have alarms for low battery and pressure errors. CIRCUL8 Luxe's alarms cause shutoff after 30 seconds, Predicate's after 10 seconds. CIRCUL8 Luxe also has an "Adapter Error." Comment: "Similar; appropriate alarms to mitigate risks are provided in both devices, however different terminology is used (battery critical vs low battery error)."
• Physical Dimensions/Weight: Are considered "similar" despite slight numerical differences, not impacting safety or effectiveness.
• Power Supply: Different chargers with different voltage capacity, but considered "similar".
• Temperature & Humidity Operating Environment: Considered "similar" despite minor differences in specified ranges.
• Pressure Tolerances: CIRCUL8 Luxe has 8%, Predicate has 5%. Comment: "Similar; Circul8 Luxe device claims to have a wider percentage of pressure tolerance."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of units or cycles tested for each non-clinical bench test. It reports "average maximum pressure," "average cycle time," "average leakage test value," and "average burst pressure," implying that multiple measurements were taken on one or more devices.
• Data Provenance: The data originates from non-clinical bench testing conducted by the device manufacturer (Ortho8 Inc.). The tests were performed to confirm that the device meets design, safety, and performance requirements and does not raise new concerns about safety and effectiveness.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This is a traditional medical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for the device's performance is adherence to engineering specifications and international standards, measured directly by laboratory equipment during bench testing.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical bench testing of a physical device against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This is a physical medical device, not a diagnostic AI intended to assist human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• Not Applicable. This device does not feature a standalone algorithm in the typical sense of AI/ML performance. Its "performance" is its mechanical function (delivering pressure for DVT prevention).

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by:
  • Engineering Specifications: Pre-defined pressure levels, cycle times, alarm responses, etc.
  • International Standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 10993-5/10 (Biocompatibility), IEC 62133-2 (Li-ion battery).
  • Comparison to Predicate Device: Demonstrating similar performance characteristics to a legally marketed device.

8. Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. There is no "training set" for this traditional medical device.

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