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510(k) Data Aggregation
(71 days)
LYMPHA PRESS 201MAX, MODEL 201MAX
Treatment of primary lymphedema, secondary lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the muscle pump.
Mego Afek's Lympha Press 201MAX™ Compression Therapy Device utilizes an air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) which is placed on a body part. This helps to push excessive interstitial fluid in the treated body part, back into the venous and lymphatic systems; improve fluid circulation; and thus treat the symptoms of a variety of lymphatic and venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by a mechanical mechanism, pressure knobs and an LCD display. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model Lympha Press 201MAX™ device, each garment contains up to 12 overlapping pressure cells. The sleeve fits on the affected body part and can be easily adjusted to any size within the sleeve tolerance.
The provided document is a 510(k) summary for the Lympha Press Model 201MAX™ Compression Therapy Device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study with specific acceptance criteria and reported device performance in the way a clinical trial or a performance study for an AI/CADe device would.
This document describes a medical device called "Lympha Press Model 201MAX™ Compression Therapy Device" which is a physical device (an air compression pump with compressible limb sleeves) and not an AI/CADe (Computer-Aided Detection/Diagnosis) device, nor a product that would typically involve acceptance criteria and a study in the context of AI/CADe performance (e.g., sensitivity, specificity, AUC).
The "Test Data" section primarily describes safety and performance testing for a physical medical device and its software validation, ensuring it meets functional specifications and complies with electrical safety and electromagnetic compatibility standards. It does not provide clinical performance metrics like those typically associated with AI studies (e.g., AUC, sensitivity, specificity, F1-score).
Therefore, I cannot fulfill the request for the following information as it is not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document lists standards and functional specifications that were tested (e.g., pressure accuracy, cycle time, noise measurements) but does not provide specific quantitative acceptance criteria or reported numerical results for these, nor does it present clinical performance metrics typical for AI/CADe.
- Sample size used for the test set and the data provenance: Not applicable to the type of testing described (functional and safety testing of a physical device).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/CADe device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is for direct therapeutic use by a patient, not an AI algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for this device relates to engineering specifications and safety standards, not diagnostic outcomes.
- The sample size for the training set: Not applicable, as there is no mention of machine learning or AI.
- How the ground truth for the training set was established: Not applicable.
However, I can extract information related to the device's functional testing and compliance:
Acceptance Criteria and Device Performance (Based on provided text - interpreted as functional and safety compliance):
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance (Compliance) |
|---|---|---|
| Software Validation | FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002) & relevant IEEE standards. | Validation performed, software documentation written according to standards. |
| Electrical Safety | IEC/EN60601-1:1988 (am1-91, am2-95) - Medical Electrical Equipment Part 1: General Requirements for Safety. | Complies with the standard. |
| Electromagnetic Compatibility | IEC/EN 60601-1-2 (2005/ 2001) - Medical Electrical Equipment-Part 1: General requirements for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests. | Complies with the standard. |
| Functional Specifications | Defined functional specifications for the device. Includes aspects like: pressure accuracy (at 15℃, 30℃, -40°C, +70°C, and mains voltages 127V & 103V), cycle time, pressure vs. time cycle sequence, distributor failure testing, cyclic redundancy testing, sensor stability calibration testing, pressure gradient testing, calibration procedure validation, and noise measurements. | Testing confirmed that the device met all its functional specifications. (Specific quantitative results for each spec are not detailed). |
| Substantial Equivalence (Overall) | Comparison to predicate devices (Lympha Press Optimal Model 1201AP, Lympha Press Plus Model 1033) in terms of "sequential inflation and deflation of cells within compression sleeves," "inflation/deflation pressures and sequences," and "operating modes." | Concluded to be substantially equivalent in safety and efficacy. |
This document focuses on regulatory compliance for a physical medical device, not performance benchmarks for an AI algorithm.
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