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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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