Search Results

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

Device function: 1. Contains port interfaces between: Canister to tubing & aspirator to canister. 2. Sterile tubing to connect the interfaces 3. Funnel to interface port to tubing. 4. Syringe to collect fat.
Device design: 1. Contents subjected to sterility
Material used: Plastic Canister, Syringe, silicone tubing
Physical properties: Plastic & Silicone

This document is a 510(k) premarket notification for the "LipiSystems AquaVage" sterile canister system, a device intended for aspirating subcutaneous fatty tissue, including autologous fat collection. It seeks to demonstrate substantial equivalence to a predicate device, the "LS Liposuction Aspirator" (K081593).

Regarding the device's acceptance criteria and studies, the provided text contains very limited information on performance evaluation beyond the claim of substantial equivalence to a predicate device.

Here's an attempt to structure the available information per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or specific physical performance metrics with numerical targets). Instead, it relies on demonstrating substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified.
• Data Provenance: The document states that the determination of substantial equivalence was based on "non-clinical data." No further details are provided regarding the origin (country, retrospective/prospective) of this data. Given the "non-clinical" description and the nature of the device (a sterile canister system for fluid collection), it's highly probable that this data pertains to bench testing, material compatibility, and sterilization validation, rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The substantial equivalence claim is based on "non-clinical data," implying that expert consensus or clinical ground truth as typically understood for diagnostic or image-based AI devices would not be applicable here.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device and the reliance on "non-clinical data," a formal adjudication method by experts for a test set (as would be seen in human-in-the-loop or standalone AI performance studies) is unlikely to have been performed or required for this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. The LipiSystems AquaVage is a sterile canister system; therefore, an MRMC study would not be applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not conducted or reported. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The document mentions "non-clinical data" as the basis for substantial equivalence. For a sterile canister system, this would typically involve:

• Engineering/Performance Specifications: Verifying that the device meets physical dimensions, material properties, flow rates, vacuum integrity (if applicable), and connection compatibility.
• Sterilization Validation: Demonstrating that the sterilization process achieves the required sterility assurance level (SAL).
• Biocompatibility Testing: Ensuring materials are safe for patient contact.

These types of "ground truth" are established through standardized testing protocols against pre-defined engineering and regulatory standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The LipiSystems AquaVage is a physical medical device (sterile canister system), not a software or AI-driven device that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided as there is no "training set" for this type of device.

Ask a specific question about this device

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

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.

Ask a specific question about this device