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The MicroAire PAL Manual Wand and Multi 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 indicated for use 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 Multi-Use Cannula consists of a stainless steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for standard vacuum (suction) tubing.

The MicroAire® Multi-Use Cannula is supplied non-sterilized by the user, and may be steam sterilized for use on subsequent patients. The Multi-Use Cannula are offered in various diameters (2.4mm, 4.0mm and 5.0mm diameters), lengths (15cm, 30cm and 40 cm) and with various types of distal fenestrations (Mercedes, Flared Mercedes, Double Mercedes, Offset Double Mercedes, Tri-Port II, Mirrored Tri-Port III, Tri-Port III, Helixed Tri-Port III, Multi-Hole, Del Vecchio Track-12).

The MicroAire® PAL Manual Wand (PAL-730) is indicated for use in 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 Multi-Use Cannulas are supplied non-sterilized by the user prior to use, and may be steam sterilized for use on subsequent patients

The provided document is a 510(k) Premarket Notification from the FDA for the MicroAire PAL Multi-Use Cannula and PAL Manual Wand. It asserts substantial equivalence to legally marketed predicate devices rather than proving independent acceptance criteria through a standalone study with human data.

Therefore, the study design and results typically associated with AI/ML-driven medical devices (e.g., test set sample size, expert ground truth, MRMC studies, effect sizes) are not applicable to this submission. This device is a traditional mechanical surgical instrument, not an AI/ML device.

However, I can extract information about the non-clinical performance data which serves as the "proof" that the device meets its acceptance criteria for substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Non-Clinical Performance) and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not applicable in the context of clinical data for this 510(k) submission. For the non-clinical performance tests, specific sample sizes are not explicitly stated in the summary, but standard engineering and quality control practices would apply to each test (e.g., number of units tested for bending strength, fatigue, etc.).
• Data provenance: Not explicitly stated for each non-clinical test, but implied to be internal laboratory testing performed by MicroAire Surgical Instruments, LLC.

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

• Not applicable. This device is not an AI/ML diagnostic device requiring expert interpretation of results. The "ground truth" for the non-clinical tests is established by engineering specifications and objective measurements against those specifications.

4. Adjudication method for the test set:

• Not applicable. (See #3)

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. This is not an AI-assisted device.

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

• No. This is not an AI/ML device.

7. The type of ground truth used:

• For the non-clinical performance data, the ground truth is based on engineering specifications, material science properties, and adherence to recognized national and international standards related to medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, AAMI standards for sterilization).

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set for this device.

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

• Not applicable. (See #8)

Summary on Substantial Equivalence Justification:

The core of this 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices (MicroAire® PAD System Cannula, K981922, and Black&Black Surgical Inc., Aspiration and Infiltration Cannulas, K113795). The applicant asserts that the device has the same intended use, similar technological characteristics, and that the non-clinical testing confirms it does not raise any new safety or effectiveness concerns compared to the predicates. The FDA concurred with this assessment in the 510(k) clearance letter. This approach is standard for many traditional medical devices.

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