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510(k) Data Aggregation
(210 days)
EUROMI SA
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.
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(148 days)
EUROMI SA
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.
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