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The Petite Basic System™ is a sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The Petite Basic System™ consists of:

The pressure control unit (sometimes called "compressor" or . "pump"), supplies air at regulated pressure to a compression garment that is worn over the area to be treated.
Hoses that transfer the air from the pressure control unit to each of the . cells in the compression garment.
The compression garment (sometimes called a "sleeve"), fastened 0 around the area to be treated. Each garment contains 4 overlapping air cells. These air cells are filled with air from the pressure control unit in sequence, applying a compressive massage. Once the entire area has been compressed, the Petite Basic System™ pressure control unit releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.
The compress-and-release massage action of Petite Basic System™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

AI/ML Overview

Here's an analysis of the provided text regarding the Petite Basic System 701ELT, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a medical device (Petite Basic System 701ELT), which focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting specific quantitative clinical performance acceptance criteria in the typical sense of a novel device. The "acceptance criteria" here are effectively the demonstration of safety and effectiveness being equivalent to the predicate device, relying heavily on non-clinical testing and comparison of technological characteristics.

Acceptance Criterion (Implicit)	Reported Device Performance
Technological Equivalence to Predicate Device	Substantially equivalent. - Air Distribution Method: Uses a diaphragm (predicate uses rotating disc, but "Both devices provide the same output. No impact on safety & effectiveness as demonstrated by verification/validation testing performed"). - Accessories: 4-cell garments (predicate uses 4-12 cell garments). "Treated body areas are equivalent. Output is equivalent." - Cycle Time: Minimum 20 seconds, determined by pressure and pause settings (predicate: 30 seconds full cycle, 24 sec inflation, 2 sec hold, 4 sec deflation). "The 701ELT allows the physician to predefine the pressure level & pause time. 201Max allows the physician to predefine the pressure level." (Implies flexibility, not a degradation). - Display: Dial Selector (predicate: LCD). "Both display pressure values." - Software/Firmware: Proprietary (like predicate). Changes made "to remove the digital display feature, add overpressure timeout." (Implies improvements/simplifications, not degradation).
Safety and Effectiveness (Non-clinical)	Passed all tests based on pre-determined Pass/Fail criteria. - Standards Applied: IEC60601-1, IEC60601-2, and IEC TR-60721-2.
Maintain Intended Use	Same as predicate device: Primary lymphedema, Secondary lymphedema, Venous insufficiency, Venous stasis ulcers, Dysfunction of the "muscle pump."
Clinical Equivalence (Implicit from substantial equivalence)	No direct clinical study was conducted for this 510(k) submission, as substantial equivalence to a legally marketed predicate device (Lympha Press 201Max) was asserted based on technological and non-clinical performance.

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

Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission relies on non-clinical engineering and performance testing.
Data Provenance: The studies were non-clinical engineering tests (e.g., electrical safety, electromagnetic compatibility, environmental testing based on standards like IEC60601-1, IEC60601-2, and IEC TR-60721-2). The specific location of this testing is not detailed, but the manufacturer is based in Israel. This is a submission for a medical device in the USA.

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

This information is not provided. For non-clinical engineering tests (like those against IEC standards), the "ground truth" is established by the design specifications and the requirements of the standards themselves, not by expert medical opinion. The "experts" would be the engineers and quality assurance professionals performing and evaluating the tests.

4. Adjudication Method for the Test Set

Not applicable. Testing against engineering standards typically involves pass/fail criteria based on objective measurements, not a consensus or adjudication process among experts in the way clinical ground truth is often established.

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 MRMC study was done. This device is a pneumatic compression therapy system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable.

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

No standalone algorithm performance study was done. This device does not feature an "algorithm-only" component in the way AI/ML devices might. Its operation is purely mechanical/electronic, providing pneumatic compression therapy.

7. The Type of Ground Truth Used

For the non-clinical performance and safety testing, the "ground truth" was the compliance with established international standards (IEC60601 series, IEC TR-60721-2) and the design specifications of the device. This is a regulatory "ground truth" indicating the device meets recognized safety and performance benchmarks for its classification.

8. The Sample Size for the Training Set

Not applicable. This submission describes a hardware medical device; it is not an AI/ML device that requires a training set of data.

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

Not applicable. As established in point 8, there is no training set for this type of device.

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