(47 days)
The LS Liposuction Aspirator is for aesthetic body contouring.
The LS Liposuction Aspirator is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/ adipose (Suction Lipoplasty), soft tissue, and general surgical waste.
This document is a 510(k) premarket notification for a medical device called the "LS Liposuction Aspirator Pump" (later referred to as "Power Aspirator, Model Ls2 Or Ls2dp"). The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no specific study that proves the device meets detailed acceptance criteria in terms of performance metrics. The 510(k) submission process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive performance studies with specific acceptance criteria that would typically be seen for novel AI/software devices. However, we can infer some aspects relevant to device performance and regulatory approval:
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Inferred from 510(k) Submission) |
|---|---|
| Intended Use Equivalence: The device's intended use should be similar to that of legally marketed predicate devices. | Intended Use: Aesthetic Body Contouring (stated in document). This matches or is substantially equivalent to predicate devices. |
| Design Equivalence: The fundamental design and operating principles should be similar to predicate devices. | Design & Operating Principles: "a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/ adipose (Suction Lipoplasty), soft tissue, and general surgical waste." This design is considered substantially equivalent to predicate devices (M.D. Resource: K854844, Byron Medical: K980392, Byron Medical: K981215, HK: K032802). |
| Material Equivalence: Materials used should be similar or demonstrably safe and effective as predicate devices. | Materials: Stated as having similar materials to predicate devices. (Specific materials are not detailed in this summary). |
| Performance Equivalence: The device should perform in a manner similar to predicate devices for its intended use. | Performance: Expected to provide similar suction capabilities for lipoplasty, soft tissue, and general surgical waste removal as predicate devices. (No specific quantitative performance metrics are provided in this summary, but the claim of substantial equivalence implies acceptable performance). |
| Safety: Device components and operation should meet general safety standards. | This is generally assumed for any medical device seeking FDA clearance. No specific safety tests are described in this summary, but the clearance implies safety has been addressed in the full 510(k) submission. |
| Effectiveness: Device should be effective for its intended use. | Effectiveness is implied by substantial equivalence to devices already on the market and cleared for the same indications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document is a 510(k) clearance letter and a summary of the 510(k) submission. For mechanical devices like a liposuction aspirator pump, the "test set" and "data provenance" as you might understand them for AI/software are not applicable in the same way.
- Sample Size for Test Set: Not applicable. Performance testing for such devices typically involves engineering tests (e.g., vacuum pressure, flow rates, durability) rather than clinical studies with "test sets" of patients in the context of an AI device.
- Data Provenance: Not applicable. The 510(k) relies on comparison to predicate devices, not on a dataset of patient outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of information would be relevant for devices that interpret medical images or signals and require expert consensus for ground truth. This is a mechanical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 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
Not applicable. This is not an AI-assisted device, nor does it involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. It's a powered suction pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its ability to generate and maintain a negative pressure and safely remove substances as intended, typically verified through engineering performance specifications and safety testing, not clinical ground truth in the AI sense.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.