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The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.

The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference.

The PAL® Infiltration System is comprised of the following components that are subject to this 510K:

• INF-PUMP PAL Infiltration Pump
• Accessories
  • o PAL-INF-1600 Infiltration Tubing
  • o PAL-INF-XXXXX Single-Use Infiltration Cannulas
  • o PAL-INF-RXXXXX Multi-Use Infiltration Cannula
  • o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable
  • o INF-FOOT-1, Infiltration Foot Switch

The provided document is a 510(k) Pre-Market Notification for a medical device (MicroAire PAL Infiltration System). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials or performance studies with acceptance criteria in the typical sense of AI/algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially related to AI/algorithms), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.

The document describes engineering and biocompatibility testing, primarily against established standards, to demonstrate that the new device performs similarly and is as safe as its predicate. It does not involve AI, image analysis, or diagnostic/prognostic output that would require the typical performance study elements you've listed.

Here's a breakdown based on the document's content, explaining why your specific questions are not directly answerable in this context:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable in the AI/algorithmic sense. The "acceptance criteria" here are met through demonstrating compliance with recognized standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety) and internal specifications for functional parameters (e.g., flow rate). The document states: "Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."
• Reported Performance (Functional, not diagnostic):
  • Infiltration Pump Flow Rate: "meets internal specifications" (No specific numerical target or range is given in the public summary, only that it passed).
  • Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity per ISO 10993-5, -10, -11, and USP .
  • Electrical Safety: Passed per IEC 60601-1.
  • Electromagnetic Disturbance (EMD) testing: Passed per IEC 60601-1-2.
  • Transportation Testing: "Demonstrates package integrity maintained" per ASTM D4169.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This device is a mechanical pump and associated cannulas/tubing. Performance testing refers to engineering tests on a limited number of manufactured units or materials, not a "test set" of patient data for an algorithm. There is no patient data involved in these performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No "ground truth" in the clinical/interpretive sense is established as there's no AI or diagnostic component.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No clinical/interpretive test set or adjudication is relevant here.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. No ground truth for clinical outcomes in this context. Performance is measured against engineering specifications and international standards.

8. The sample size for the training set:

• Not Applicable. No training set, as there is no AI/machine learning component.

9. How the ground truth for the training set was established:

• Not Applicable. No training set or associated ground truth.

In summary: The provided document is a direct FDA 510(k) submission that demonstrates substantial equivalence for a physical medical device (an infiltration pump) through engineering and biocompatibility testing against established standards, not through AI/algorithm performance studies or clinical trials involving patient data analysis. Your questions are tailored for AI/ML device submissions, which is a different regulatory pathway and type of evidence.

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