(78 days)
The Alma LipoFlow System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue and infiltration for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The Alma LipoFlow System is a wheeled cart (also called as console) that contains a peristaltic irrigation pump and an adjustable vacuum source. The peristaltic pump (120 VAC, 50-60 Hz and 220-230 VAC, 50-60 Hz) is intended for continuous and/or intermittent delivery of tumescent liquid into a patient's body. The vacuum source is a rocking piston oil-less pump that delivers an adjustable vacuum pressure intended for subsequent aspiration of localized subcutaneous fatty deposit.
The console has a control panel that is the user interface for operating the system. The control panel has a peristaltic knob that allows a flow-rate selection of up to 535ml/min. The control panel also has a vacuum knob that allows the delivery of vacuum pressure of up to 27 in Hq (90 kPa). The device operates using a Peristaltic Pump Mode or a Vacuum Pump Mode. Only one mode can be activated at a time using the footswitch.
The system also includes an AC Power Cord, isolation transformer, wires and connectors. Other third party components of the system include: canister-style filters, tubing, syringe for potential re-injection, infiltration cannulas, aspiration cannulas, HEPA filter tubing, tumescent tubing, suction canister holder and waste canisters,
The canister filter (fat canister) is a closed loop tissue collection system with a volume capacity of up to 2500 mL. It includes a vacuum port, tissue port, tissue port and lid. It is used with the aspiration system to separate and filter adipose tissue for possible reimplantation. The aspiration system provides the vacuum suction source to the canister. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing the valve. This process leaves the fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.
The Alma LipoFlow System is a Suction Lipoplasty System used in the aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, it is to be used without any additional manipulation.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the acceptance criteria are implicitly met by successful completion of various performance tests. The document does not provide specific numerical criteria for each test or detailed quantitative performance metrics. Instead, it states that the device "functioned as intended" or that "results were passing."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification & Validation | "demonstrated that the software performs as intended" |
| Electrical Safety (IEC 60601-1) | "testing was conducted and results were passing" |
| Electromagnetic Compatibility (IEC 60601-1-2) | "testing was conducted and results were passing" |
| Biocompatibility | "of patient-contacting components was established" |
| Sterility Validation | "was established for all required components" |
| Adipose Viability | "adipose viability testing demonstrated that fat tissue viability was maintained" |
| Bench/Laboratory Testing | "was completed to verify the functionality of the device components and combined system" |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The phrasing "adipose viability testing" and "bench/laboratory testing" suggests laboratory experiments rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the test set. The tests appear to be related to the technical and biological performance of the device rather than diagnostic accuracy or subjective interpretation.
4. Adjudication method for the test set
The document does not describe any adjudication method as it does not involve human interpretation or subjective measurements that would typically require adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Alma LipoFlow System is a medical device for fat aspiration and transfer, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI component or effect size relevant to human reader improvement discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Alma LipoFlow System. The device is a physical system with integrated software and mechanical components for a medical procedure, not a standalone algorithm. Its "performance" is based on its physical operation and biological outcome (adipose viability).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in the context of diagnostic AI algorithms is not explicitly detailed for this device. However, inferring from the tests performed:
- For software verification and validation, the ground truth would be the pre-defined functional specifications and expected outputs of the software.
- For electrical safety and electromagnetic compatibility, the ground truth would be compliance with the specified IEC standards.
- For biocompatibility, the ground truth would be the established safety profiles of the materials in contact with the patient.
- For sterility validation, the ground truth would be the absence of viable microorganisms as per defined sterility assurance levels.
- For adipose viability testing, the ground truth would be the assessment (e.g., cellular integrity, metabolic activity) of fat cells after processing by the device, likely compared to a control or accepted standard for viable adipose tissue. This would be a biological ground truth.
- For bench/laboratory testing, the ground truth would be the expected functional parameters and physical outputs of the device components and the combined system.
8. The sample size for the training set
The document does not mention a training set. The Alma LipoFlow System is a hardware device with associated software, not a machine learning model that requires a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as a training set for a machine learning model is not mentioned or relevant to this device's description.
§ 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.