(210 days)
The device is intended to be used for aesthetic body contouring.
The subject device is used in conjunction with the Lipomatic Handpiece. The Lipomatic Handpiece is a motorized pneumatic handle with interchangeable canulae. The Lipomatic handpiece can be used with readily available air sources at the hospital or clinic.
The EVA sp6 is an aspiration system that can be used with the Lipomatic handpiece for the purposes of aesthetic body contouring.
The EVA sp6 can be in continuous operation or can be controlled by a foot pedal. The device has two modes; infiltration and aspiration. Syringes are used for infiltration.
The EVA sp6 has wheels to allow it to move around the clinical or hospital as needed.
The list of accessories include:
- Pedal .
- . Hospital Grade Power Cord and Plug
- Replacement Fuses .
- Tubing (5 kits) .
- Twisted Pipe of 5 meter with one connector .
- Aspiration Jars (2 jars) .
The request is to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.
Based on the provided FDA 510(k) submission summary for the "Euromi EVA sp6 Lipoplasty Suction System" (K101413), here's the information regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Electrical | 110-120 V | 110-120 V (Implied by specification. No test result explicitly states the measured voltage, but passing electrical safety testing implies conformity.) |
| Power | 250 W | 250 W (Implied by specification. No test result explicitly states the measured power, but passing electrical safety testing implies conformity.) |
| Noise Level | 57 dB | 57 dB |
| Weight | 10 Kg | 10 Kg |
| Final Vacuum (mb relative) | -850 | -850 |
Note: The document lists "Specification" which functions as the acceptance criteria for these characteristics. The "Reported Device Performance" is implied to meet these specifications as the device passed non-clinical testing.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text indicates that non-clinical testing was performed on the subject device. For electrical safety, EMC, FCC Part 15, and accuracy testing, typically a sample size of one or a small number of devices is used to demonstrate compliance. The exact sample size is not specified in the document. The data provenance is also not specified, but given it's for an EU manufacturer (Euromi SA in Belgium) seeking US FDA clearance, the testing would generally follow internationally recognized standards (like IEC) and potentially be conducted by accredited labs. It is a prospective test in the sense that the device was specifically tested for these parameters.
- 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 device is a lipoplasty suction system, not an AI or diagnostic imaging device that requires expert-established ground truth for performance evaluation in the context of the provided document. The performance data relates to engineering specifications and safety standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As above, this is about engineering performance and safety testing, not diagnostic accuracy requiring adjudication among experts.
- 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. A MRMC comparative effectiveness study was not performed. This device is a medical instrument (lipoplasty suction system), not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance evaluation was for the standalone physical device. The device was subjected to standalone non-clinical testing for electrical safety, EMC, FCC Part 15, and accuracy.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data (electrical, power, noise, weight, vacuum), the "ground truth" is established by engineering specifications and measurements against recognized standards. For example, electrical safety is measured against IEC 60601-1. The vacuum level is a direct measurement.
- The sample size for the training set
Not applicable. This is not an AI/machine learning device. There is no training set mentioned or implied.
- How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.