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MicroAire® PAL® Single-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.

The MicroAire® PAL liposuction family of instruments is intended to be used for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Single-Use Cannulas consists of stainless-steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for a standard vacuum (suction) tubing. The MicroAire® Single-Use Cannulas are supplied sterile by the manufacturer through a validated gamma irradiation process. The Single-Use Cannula are offered in various diameters (2.4, 3.0, 4 and 5.0mm diameters), lengths (15, 22, and 30 cm) and with various types of distal fenestrations (Single Port, Mercedes, Bent Flared Mercedes, Double Mercedes, Bent Mercedes, Tri-Port III, Helixed Tri-Port III, Spatula, Multi-Hole, Del Vecchio Track-12).

The provided text is a 510(k) Summary for a medical device (PAL Single-Use Cannulas) and does not describe acceptance criteria, a study proving the device meets those criteria, or any information related to AI/ML performance.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Indications for Use
• Principles of Operation
• Technological Characteristics
• Performance Testing (non-clinical)

Therefore, I cannot provide the requested information. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm only) performance data.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Performance Data" section (point 9 in the K192694 summary) lists various engineering and biocompatibility tests performed (e.g., Sterilization validation, Biocompatibility testing, Mechanical Tensile Testing, Air leakage and tubing connection force test, Vacuum pressure testing, Transportation Testing). These tests have "specifications" or demonstrate compliance (e.g., "Met specifications," "PASSED," "demonstrates SAL of 10^-6"), but these are not the "acceptance criteria" for an AI/ML system's diagnostic performance as implied by your request. They are engineering and safety performance criteria for a physical medical device.

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