(148 days)
The subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The subject device consists of:
- Lipomatic Control Unit
- Tubing
- Key for the Lipomatic Control Unit
- Oil
- Silicone Pipe
- Lipomatic Cannulas
- Handle with a pneumatic motor
- Collection Container
- Pedal
The handpiece is a motorized pneumatic handle with interchangeable cannulas. The motor is linear and not rotary. The subject device uses external air sources. Therefore, the user chooses the air source and filtration system from readily available sources within a hospital or clinical environment. The Lipomatic does not include an aspirator or compressor.
The subject device includes either stainless steel or Teflon coated cannulas (based on customer order) that vary in length between 150mm-350mm and vary in diameter between 2.5mm-4.5mm.
The subject device has a built in safety feature which stops the device in the event hard tissue is encountered.
The provided text is a 510(k) summary for the Euromi S.A. Lipomatic Liposuction Device. This document does not include acceptance criteria for device performance in the way a medical AI/CADe device would. Instead, it focuses on the device's substantial equivalence to predicate devices, its intended use, technological characteristics, and safety features for FDA clearance as a surgical tool.
Therefore, many of the requested categories related to medical AI/CADe device studies (e.g., sample sizes for test/training sets, expert ground truth adjudication, MRMC studies) are not applicable to this type of device and submission.
However, I can extract information relevant to the device's performance claims and the "study" mentioned for its international usage:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Claim (Implicit) | Reported Device Performance (from text) |
|---|---|
| Safety Profile (absence of adverse events) | "High success rate and no adverse events" in a clinical study by Dr. Angelo Rebelo. |
| Effectiveness (satisfactory results) | "High success rate" in a clinical study by Dr. Angelo Rebelo. "Clinical usage has found the subject device to produce satisfactory results". |
| Compliance with Biocompatibility Standards | "Components that make contact with the patient are composed of materials that meet biocompatibility requirements as found in ISO 10993." |
| Built-in Safety Feature Functionality | "The subject device has a built in security feature which stops the device when hard tissue is encountered." |
| Compliance with Quality Standards | "The subject device is compliant to European Medical Device Directives and is manufactured by an ISO 9000 certified facilities." |
2. Sample size used for the test set and the data provenance
- Sample Size: The text states, "A clinical study by Dr. Angelo Rebelo documented the use of the Lipomatic for more than 1600 liposuction/liposculpture procedures."
- Data Provenance: The study was conducted based on "international" usage, without specifying a particular country. It is a retrospective summary of accumulated clinical experience.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The text mentions a "clinical study by Dr. Angelo Rebelo." It does not specify if other experts were involved in establishing "ground truth," nor does it detail Dr. Rebelo's specific qualifications beyond being a doctor who performed procedures. For a surgical device, the "ground truth" often refers to the clinical outcomes and safety observed during actual procedures by the operating physician.
4. Adjudication method for the test set
- Not applicable in the context of this device and study. The study appears to be a review of clinical outcomes by a single physician based on their own procedures.
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
- No, this was not an MRMC comparative effectiveness study. This device is not an AI/CADe system for diagnosis or interpretation but a surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm, but a physical medical device (liposuction system). Performance is inherently linked to human operation.
7. The type of ground truth used
- The "ground truth" was based on clinical outcomes and observed safety from real-world surgical procedures ("success rate and no adverse events").
8. The sample size for the training set
- Not applicable. This is not a machine learning device with a distinct training set. The 1600+ procedures represent accumulated clinical experience, not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set in the AI sense. The clinical outcomes were observed and documented by Dr. Angelo Rebelo during the reported procedures.
§ 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.