(256 days)
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):
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.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.