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The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. The HydraSolve™ Lipoplasty System is Indicated for use in aesthetic body contouring.

The Andrew Technologies HydraSolve™ Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution in addition to suction.

The device includes the HydraSolve™ Console which contains within its durable case. a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) tumescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.

The provided text is a 510(k) summary for the Andrew Technologies HydraSolve™ Lipoplasty System. It is focused on demonstrating substantial equivalence to a predicate device based on non-clinical testing. Therefore, it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Specifically, the document states: "Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance testing of the new cannulae design." This indicates that the evaluation was for a physical medical device (a lipoplasty system and its cannulae), not an AI/ML device.

However, I can extract the information that is present and explain why other requested information is not available in this document.

Here's what can be addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific metrics or reported device performance in a quantitative manner. It generally states that "Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance testing of the new cannulae design." Without specific performance metrics or criteria, a table cannot be constructed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical test data" and "performance testing of the new cannulae design," but it does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data.

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)

This information is not applicable and not provided. The testing described is "non-clinical performance testing of the new cannulae design," which would typically involve engineering or laboratory tests, not expert interpretation or ground truth establishment in the context of diagnostic or prescriptive AI/ML.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As mentioned above, the testing is non-clinical performance testing, not a study involving human adjudication of results.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML devices where human readers (e.g., radiologists) interact with the AI. The HydraSolve™ Lipoplasty System is a physical medical device.

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

No, a standalone algorithm performance study was not done. The device is a physical lipoplasty system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable and not provided. "Ground truth" in this context usually refers to a confirmed diagnosis or condition used to evaluate an AI's accuracy. For performance testing of a physical device like a cannula, ground truth would relate to physical specifications (e.g., cannula bore diameter, material strength, fluid flow rates), which are not detailed here.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as the device is not an AI/ML system that requires training data.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as above.

In summary:

The provided 510(k) summary is for a physical medical device (HydraSolve™ Lipoplasty System) and discusses "non-clinical performance testing of the new cannulae design" to demonstrate substantial equivalence to a predicate device. It does not contain any information related to AI/ML device performance, acceptance criteria for AI algorithms, expert consensus, ground truth establishment, or human-in-the-loop studies that would be relevant to an AI/ML product. The request's questions are tailored for AI/ML device evaluations, which are not detailed in this document.

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