Search Results

The DVTCare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and 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 subject 'DVTCare CA5' is a light weight, portable, prescriptive device intended to aid in prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This functionality is accomplished through the use of electronically controlled pump unit delivering a set amount of air to the leg cuffs that, in turn, compresses the calf(s) to aid blood flow out of the lower extremities. The pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 locking, plastic quick disconnects for air tube connection, and an external power supply input jack. The device is provided with non-serviceable battery to allow user portability, and an external power supply for mains connection.

During device operation, the pump unit provides air to the cuff through flexible plastic tubing, inflating it to a specified pressure (set by user or healthcare provider), to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. The device software ensures the cycle time is a minimum of 60 seconds (the is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). This is done to prevent excessive stimulation of the limb.

Here's a breakdown of the acceptance criteria and the study information for the DVTCare CA5 device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the DVTCare CA5 are primarily demonstrated through comparisons to predicate devices and extensive non-clinical bench testing. The key performance characteristics are outlined in the comparison table and further supported by test reports.

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria

The document describes non-clinical bench testing as the primary method to prove the device meets acceptance criteria and demonstrates substantial equivalence to predicate devices. There is no mention of clinical studies involving human subjects.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices. The "test set" refers to the DVTCare CA5 device itself, which underwent a series of validation tests. It's implied that typical design verification and validation testing for a medical device involves one or more units of the final device.
• Data Provenance: The testing was "in-house bench testing for design, software and performance validation" by the manufacturer (Ossur Americas Inc.), and "evaluated by third-party test laboratories" for specific standards (Electrical safety, EMC, Environmental, Vibration). This indicates a combination of internal and external validation. The country of origin for the data (beyond the company's location in Foothill Ranch, CA) is not specified further. The studies are by nature prospective as they are conducted on a manufactured device to verify its performance against design specifications and regulatory standards.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The testing was performed by "third-party test laboratories" for compliance standards and by internal "design, software and performance validation" teams. The qualifications of these individuals are not detailed, but it's implied they are experts in electrical safety, EMC, environmental testing, vibration testing, and device design/software validation.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned are objective compliance tests against established standards (e.g., IEC, UL, MIL-STD) and internal design specifications. There's no subjective assessment requiring adjudication in the context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses human interpretation of medical images or data, which is not relevant for this device (a DVT prevention pump).

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

Yes, the testing described is primarily standalone performance of the device's hardware and software. The device itself (the pump unit) functions autonomously based on its programming to deliver pneumatic compression. Its performance is evaluated based on its ability to meet specified pressure, cycle time, hold time, safety, and operational parameters, without human intervention during the functional tests.

7. The type of ground truth used

The "ground truth" for the non-clinical testing consists of:

• Regulatory Standards: IEC/UL/CAN60601-1 (Electrical safety), IEC 60601-1-2 (EMC), MIL-STD 810D, section 514.3-1 (Vibration integrity).
• Design Specifications: Internal design requirements for working pressure, cycle time, hold time, battery performance, software functions, etc.
• Predicate Device Characteristics: The performance parameters of the legally marketed predicate devices served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models that require a "training set" of data.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Ask a specific question about this device

The Compression Care Flight is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (greater than 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and 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 Compression Care Flight system is a light weight, portable, prescriptive device that helps stimulate blood flow in the legs through the use of pneumatically controlled, single chamber leg cuff(s), actuated by an electronically controlled pump unit and solenoid valves. All pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 plastic quick disconnects for air tube connection, and an external power supply input jack. The option exists for the unit to be used in single leg or double leg modes. The control unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for mains connection.

The provided text describes a 510(k) submission for the "Compression Care Flight" device, a pneumatic compression device. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DVTcare™ CA5) through non-clinical testing.

Here's an analysis of what information is available and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

Study Details:

The submission does not describe a clinical study in the typical sense with human subjects, control groups, or specific quantitative acceptance criteria for patient outcomes. It relies on non-clinical bench testing to demonstrate performance characteristics are substantially equivalent or superior to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified. The document refers to "bench testing" and "design validation" without detailing the number of units tested.
• Data Provenance: The testing was conducted by Medical Minds LLC. No specific country of origin for the data is mentioned beyond the company's location in Allendale, MI. The testing appears to be retrospective in the sense that it's performed on the device prototypes/pre-production units to demonstrate compliance with design requirements and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as the described testing is non-clinical bench testing. There is no "ground truth" in the context of expert medical review. The "ground truth" for non-clinical tests would be the established engineering/performance specifications and standards (e.g., IEC 60601-1 for electrical safety, or the performance specifications of the predicate device).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not applicable as the described testing is non-clinical bench testing and does not involve human interpretation or subjective assessment that would require adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a pneumatic compression device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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

• This question is not applicable to this device. The "Compression Care Flight" is a physical medical device, not an algorithm, and its performance is assessed directly through its mechanical and electrical functions, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical testing, the "ground truth" would be established engineering specifications, performance standards (like IEC 60601-1), and the known performance characteristics of the predicate device (DVTcare™ CA5). There is no "expert consensus," "pathology," or "outcomes data" ground truth described in this submission for its performance evaluation.

8. The sample size for the training set

• Not applicable. This device is hardware; it 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. As above, there is no "training set" for this device.

Ask a specific question about this device