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The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

• · Treatment of lymphedema
• · Treatment of chronic venous insufficiency
• · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
• · Reducing venous leg ulcer healing time
• · Reducing edema due to venous stasis
• Enhancing venous return
  The device is intended for home, and hospital use.

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT).
The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled 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 attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.

The provided text is a 510(k) summary for the ManaFlow device, a compressible limb sleeve system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size, standalone performance, type of ground truth) is not present in this document.

The document describes non-clinical tests performed to validate the design and assure conformance with voluntary design standards related to electrical safety and electromagnetic compatibility, as well as bench tests for physical, electrical, and performance requirements, and software verification. However, it does not provide specific performance metrics or acceptance criteria for those tests.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria for clinical performance or detailed quantitative results from those tests. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, functions, design, and adherence to electrical safety and EMC standards.

The closest to a "table of performance" is the comparison table (Table 1) which highlights identical or similar characteristics between the ManaFlow device and its predicates. This table, however, is for comparison of features and design principles, not for reporting quantitative performance against defined acceptance criteria.

Regarding Clinical Study Details (information missing from this 510(k) summary):

2. Sample sizes used for the test set and the data provenance: This document does not describe any clinical test set using patient data. The tests mentioned are non-clinical (bench tests, electrical safety, EMC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set using expert opinion for ground truth is described.
4. Adjudication method for the test set: Not applicable, as no clinical test set requiring adjudication is described.
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: Not applicable. This device is a physical medical device (compressible limb sleeve and pump), not an AI/imaging diagnostic device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used: For the non-clinical tests and substantial equivalence determination, the "ground truth" is largely defined by established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the performance characteristics of predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data).
8. The sample size for the training set: Not applicable, as this is not a machine learning device requiring a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to "proof":

The document demonstrates that the ManaFlow device meets the requirements for 510(k) clearance by proving substantial equivalence to legally marketed predicate devices. This is achieved by:

• Showing identical intended use and indications for use.
• Comparing design features and specifications: Table 1 meticulously compares ManaFlow's characteristics (e.g., operating principles, contraindications, target population, portability, pressure source, operating modes, working pressure, cycle time, alarms, sterility, materials) to its four predicate devices, highlighting they are identical or similar, and arguing that any differences do not raise new safety or effectiveness concerns.
• Conducting non-clinical tests:
  • Electrical Safety: Conformance to ANSI AAMI ES60601-1 standards.
  • Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 standards.
  • Bench Tests: Performed for physical requirements, electrical requirements, and performance requirements. (Specific results or acceptance criteria for these bench tests are not detailed in this summary).
  • Software Verification: Carried out according to FDA guidance for software in medical devices.
• Biocompatibility: Stated that skin contact components are identical to those of previously cleared devices (K160318 and K142640), thus confirming biocompatibility without new concerns.

The core of the "proof" is that the ManaFlow device functions fundamentally the same way, has the same intended use, and has passed the necessary engineering and safety tests as similar devices already on the market, thereby establishing it as "substantially equivalent" rather than requiring a de novo clinical trial to prove a new performance claim.

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