(77 days)
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
| Acceptance Criteria (Not Explicitly Stated but Inferred from Equivalence Claim) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Pressure Delivery Range: Equivalent to predicate device (up to 65 mmHg) | Pressure Delivery Range: Programmable up to 65 mmHg. |
| Cycle Time: Equivalent to predicate device (approximately 60-75 seconds/leg) | Cycle Time: Approximately 60 seconds/leg (one inflation/deflation cycle). Configurable cycle time (60-75 seconds). |
| Inflation Fill Time: Equivalent to predicate device | Inflation Fill Time: Approximately 10-12 seconds. |
| Cuff (Garment) Fill Time: Equivalent to predicate device | Cuff (Garment) Fill Time: Verified as equivalent to predicate. |
| Electrical Safety: Meets relevant standards | Electrical Safety: Validated against IEC 60601-1. |
| System Operation: Equivalent to predicate device | System Operation: Verified as equivalent to predicate. |
| Intended Use: Matches predicate device | Intended Use: Matches predicate device (DVT prevention, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, aid in treatment of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous and arterial insufficiency, reduction of edema). |
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.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).