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For aesthetic body contouring.

The Liposat Basic infiltration pump is one of the components that make up the Möller Medical Lipoplasty System. Like the original Liposat infiltration pump, the Liposat Basic is an electrically powered infiltration/peristaltic pump.

The provided document is a 510(k) summary for the Moeller Medical Liposat Basic infiltration pump, which is part of a Suction Lipoplasty System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a de novo or PMA submission might.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or specific study types (MRMC, standalone).

Here's why the requested information is absent and what the document does provide:

1. Acceptance Criteria and Reported Device Performance: Not applicable for a 510(k) submission focused on substantial equivalence. The document asserts that the modified Liposat Basic infiltration pump is "substantially equivalent to the original Liposat infusion pump in terms of intended use, design, operating principles, and materials." There are no quantitative performance metrics (like sensitivity, specificity, accuracy, etc.) or acceptance criteria reported.

2. Sample Size for Test Set and Data Provenance: Not applicable. No clinical test set data is presented. The submission relies on a comparison to a predicate device (K053451) rather than a new clinical study to establish performance.

3. Number of Experts and Qualifications: Not applicable. The document does not describe a study involving experts to establish ground truth for a test set.

4. Adjudication Method: Not applicable. No test set requiring adjudication is described.

5. MRMC Comparative Effectiveness Study: Not applicable. This is not a study comparing human readers with and without AI assistance.

6. Standalone Performance Study: Not applicable. The document does not present a standalone performance study for the device. Its focus is on asserting equivalence to a previously cleared device.

7. Type of Ground Truth Used: Not applicable. No ground truth is established in the context of a performance study for the Liposat Basic as presented here.

8. Sample Size for Training Set: Not applicable. The device is a medical pump, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established: Not applicable, as no training set is relevant for this device.

What the document does indicate about the device:

• Device Name: Suction Lipoplasty System (containing the Liposat Basic infiltration pump)
• Proprietary Name: Liposat® Basic (infiltration pump), model # 92 007 688
• Intended Use: Aesthetic Body Contouring
• Regulatory Class: Class II
• Product Code: MUU (initially), later updated to QPB
• Predicate Device: K053451 (containing the original Liposat infiltration pump)
• Reason for Submission: The original Liposat infiltration pump was modified to make it easier to use.
• Claim of Substantial Equivalence: The modified Liposat Basic infiltration pump is substantially equivalent to the original Liposat infusion pump in terms of intended use, design, operating principles, and materials.

In summary, this 510(k) notification is for an administrative change/update of a product code and a minor modification to an existing device, asserting substantial equivalence based on design and operating principles to a predicate device, rather than providing data from a new clinical performance study as would be required for novel devices or those seeking clinical claims.

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For aesthetic body contouring.

The Moller Medical Lipoplasty System is an electrically powered infiltration/peristalitic pump combined with an aspiration/vacuum pump and manual or vibrating cannula hand-piece, tubing sets and waste containers for the removal of fat tissue and general surgical waste.

The provided text is a 510(k) summary for the Moeller Medical Suction Lipoplasty System. It is a regulatory submission to the FDA for market clearance, stating that the device is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about specific acceptance criteria, device performance studies, or clinical trial data in the way you've requested.

The document focuses on establishing substantial equivalence based on intended use, design, operating principles, and materials compared to existing devices. It does not include a study proving the device meets specific performance acceptance criteria with detailed statistical analysis, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot populate the requested table and answer the questions related to detailed study methodologies, sample sizes, expert qualifications, and ground truth types based on the information provided in this 510(k) summary.

Here's what I can extract from the provided text, and why I cannot answer your specific questions:

1. Table of acceptance criteria and reported device performance:

• Cannot provide. This information is not present in the 510(k) summary. A 510(k) does not typically include a table of specific, quantifiable acceptance criteria (e.g., flow rates, vacuum pressure thresholds) and the device's measured performance against them. It focuses on the equivalence of the general operational principles.

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

• Cannot provide. No test set or study data is described in this regulatory summary.

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

• Cannot provide. No test set or ground truth establishment process is described.

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

• Cannot provide. No test set or adjudication method is described.

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:

• Cannot provide. The device described (Suction Lipoplasty System) is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant to this type of device.

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

• Cannot provide. As above, this is a physical surgical device, not an algorithm. Standalone performance as described is not applicable.

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

• Cannot provide. No study or ground truth establishment is described.

8. The sample size for the training set:

• Cannot provide. No training set is applicable or described for this type of device.

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

• Cannot provide. As above, no training set or ground truth establishment is applicable or described.

What the document does provide pertinent to regulatory approval:

• Device Name: Suction Lipoplasty System
• Proprietary Names: Liposat® (infiltration pump), Vacusat® (aspiration/suction pump), Vibrasat® (vibration handpiece)
• Intended Use: Aesthetic Body Contouring (Page 3, 4)
• Regulation Number: 21 CFR 878.5040 (Suction lipoplasty system) (Page 1, 4)
• Regulatory Class: Class II (Page 1, 4)
• Product Code: MUU (Page 1, 5)
• Predicate Devices (for substantial equivalence):
  • HK Surgical, Inc. (K032802)
  • Byron Medical, Inc. (K981172, K001803)
  • MicroAire Surgical Instruments (K981922)
    (Page 5)

This 510(k) submission successfully argued for substantial equivalence, which means the FDA determined it was as safe and effective as legally marketed devices, implying that any necessary performance data would have been deemed sufficient for this assertion, but the specifics are not included in this summary.

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