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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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The PlasmaFlight is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. This device can be used to:

• Temporarily increase blood circulation in the treated areas;
• Temporary relief of minor muscle aches and pains.

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.

The provided text describes the 510(k) summary for the device "PlasmaFlight," a portable inflatable tube massager. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical characteristics and compliance with voluntary standards, rather than extensive clinical efficacy studies with specific acceptance criteria and detailed performance claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement for ground truth, and MRMC studies are not present in this document. The document's purpose is to show equivalence and safety/effectiveness via design and performance testing against standards, not to prove clinical performance against new acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to the predicate device.

Here's an attempt to answer your questions based on the provided text, indicating "Not explicitly stated" where the information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria for clinical performance or a reported device performance in terms of efficacy metrics (e.g., specific percentage increase in blood circulation, or reduction in pain levels). Instead, it focuses on demonstrating that the PlasmaFlight's specifications and functions are "Identical or similar" to the predicate device, thereby showing "Substantial Equivalence".

The "acceptance criteria" for this submission would implicitly be that the device's characteristics and performance, as demonstrated through non-clinical tests and comparison, do not raise new questions of safety or effectiveness compared to the predicate device.

Here's a table summarizing the comparisons (which serve as the basis for "acceptance" in a substantial equivalence claim):

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

• Sample Size for Test Set: Not explicitly stated. The submission relies on "Non-Clinical Tests" (bench tests) and comparison to the predicate device, not a specific clinical test set involving human subjects to evaluate new performance metrics.
• Data Provenance: Not applicable for clinical data. The "tests" mentioned are non-clinical (bench tests) and compliance with standards.

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

• Not applicable. This is a 510(k) submission for a physical therapy device demonstrating substantial equivalence, not an AI/imaging device requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring adjudication in this document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/imaging device, and no MRMC study was conducted or is relevant for this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical therapy device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth," in the context of this submission, is effectively the established safety and effectiveness profile of the legally marketed predicate device and compliance with recognized voluntary standards for medical device safety and performance. There is no "ground truth" derived from expert consensus, pathology, or outcomes data for new clinical claims.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning/AI device that requires a training set.

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

• Not applicable. This is not a machine learning/AI device, so there is no training set or associated ground truth.

Summary of the Study Proving Substantial Equivalence:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to the predicate) is primarily a comparative analysis of technical characteristics and non-clinical bench testing.

• Non-Clinical Tests Performed:

  • Design Validation and Conformance with Voluntary Standards:
    • ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)" - for electrical safety.
    • IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests" - for electromagnetic compatibility.
  • Bench Tests: Performed on physical requirements, electrical requirements, and performance requirements.
  • Software Verification: Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (as the device uses a microprocessor).

• Conclusion: The tests and comparison performed demonstrate that the PlasmaFlight is substantially equivalent to the predicate device, implying it is as safe and effective as the legally marketed predicate device. The minor differences noted (e.g., in power supply details, charging time, dimensions, weight, operating modes, working pressure, cycle time, cleaning, disposal) were deemed not to raise any new issues of safety or effectiveness.

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