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The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

• Neurosurgery
• Gastrointestinal and Affiliated Organ Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General Surgery
• Orthopedic Surgery
• Gynecological Surgery
• Thoracic Surgery
• Laparoscopic Surgery

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.

This FDA 510(k) summary for the MicroAire LipoTower System (K113128) does not describe a study to prove the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Sound Surgical Technologies LLC - SoundVaser System, K022051) by comparing technical characteristics, indications for use, and compliance with recognized standards.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC/standalone studies are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the technical characteristics and standards compliance, which serve as a form of "acceptance criteria" for electro-mechanical medical devices like the MicroAire LipoTower System.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are primarily related to its technical specifications matching or being comparable to the predicate device, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.

Table of Acceptance Criteria (Technical/Compliance) and Reported Device Performance:

Study Information (as applicable to this type of device submission):

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

   • N/A. This submission does not describe a clinical performance study with a "test set" in the diagnostic sense. The testing performed would have been laboratory-based verification and validation against engineering specifications and regulatory standards. The provenance of such lab data is typically internal to the manufacturer or from accredited testing laboratories, not clinical patient data.

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

   • N/A. No ground truth established by experts for a diagnostic test set is mentioned.

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

   • N/A. No adjudication method for a diagnostic test set is mentioned.

4. 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:

   • N/A. This device is a surgical instrument (suction lipoplasty system), not an AI-powered diagnostic imaging device. No MRMC study was conducted or is relevant.

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

   • N/A. This device is not an algorithm; it is an electro-mechanical surgical system.

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

   • N/A. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance metrics (e.g., vacuum pressure, flow rates) validated through bench testing, not clinical diagnostic ground truth.

7. The sample size for the training set:

   • N/A. This device does not use machine learning algorithms that require a "training set."

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

   • N/A. Not applicable, as no training set is used.

Conclusion from the Document:

The document states in section 8, "Conclusion: The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and tested methods." This means the product's compliance with electrical safety, EMC standards, and its technical specifications, along with its intended use, were deemed sufficient to demonstrate substantial equivalence to the predicate device, not that it met a specific clinical performance acceptance criteria in terms of diagnostic accuracy.

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