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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. Adipose tissue harvested with the HydraSolve™ Lipoplasty System may be used for autologous transfer following the method provided in the manual.

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 to suction. Adipose tissue aspirated with the HydraSolve™ Lipoplasty System can be harvested for subsequent autologous transfer.

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) turnescent 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.

Acceptance Criteria and Study for HydraSolve™ Lipoplasty System (K130152)

This document details the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for an expanded indication (autologous fat transfer).

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for an extended indication and substantial equivalence based on non-clinical data), specific quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, etc.) are not explicitly stated in the provided text. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and proving the safety and effectiveness for the new indication through non-clinical testing.

The "reported device performance" in this context refers to the outcomes of the non-clinical tests that supported the substantial equivalence and the expanded indication.

Note: The FDA's 510(k) clearance (K130152) confirms that based on the provided information, the device is substantially equivalent to the predicate devices and may be marketed. This implicitly means the acceptance criteria for market clearance under the 510(k) pathway were met.

Details of the Study

The provided text describes a non-clinical study to demonstrate safety and effectiveness, especially for the expanded indication of autologous fat transfer.

• Type of Study: Non-clinical testing. The submission explicitly states: "Clinical testing was not necessary."

• Purpose: To demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for its intended use, particularly with the addition of autologous fat transfer. This was done to establish substantial equivalence to predicate devices.

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

• Sample Size for Test Set: Not specified. Non-clinical studies (e.g., in-vitro or animal studies) typically involve a different kind of "sample size" than human clinical trials. The document does not provide details on the number of samples (e.g., tissue samples, animals) used for the cell viability, survivability, and quality tests.
• Data Provenance: Not specified (e.g., country of origin, whether retrospective or prospective). Given it's a non-clinical study, "country of origin" might refer to where the lab work was conducted, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.

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

• Not applicable. As this was a non-clinical study involving laboratory and bench testing (cell viability, fat graft survivability, and quality), there was no "ground truth" established by human experts in the way it would be for diagnostic imaging or clinical assessment. The "truth" would be based on scientific measurements and established protocols for evaluating these biological parameters.

4. Adjudication Method for the Test Set

• Not applicable. There was no human expert adjudication of test results in the manner described (e.g., 2+1, 3+1). The outcomes of the non-clinical tests would typically be objectively measured and analyzed according to scientific standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical testing was not necessary," and the study described is non-clinical. Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable. This device is a medical device (a liposuction system), not an AI or algorithm-based diagnostic tool. Therefore, the concept of a "standalone algorithm-only performance" study does not apply. The device's performance is tied to its mechanical and biological effects, not an algorithm's classification or detection capabilities.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context refers to established scientific measurements and biological parameters for evaluating aspirated adipocyte cell viability, fat graft survivability, and fat graft quality. This would involve specific laboratory assays, histological assessments, or other quantifiable biological markers considered standard in the field for assessing the health and integrity of adipose tissue for autologous transfer.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable, as there is no training set for this type of medical device.

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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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The Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring.

The Phaser Lipoplasty System is indicated for use in aesthetic body contouring.

The Phaser Lipoplasty System is a surgical liposuction device that utilizes pressurized, heated and pulsed saline streams ("the Phaser stream") in conjunction with a specialized cannula to transition adipose tissue from a solid state to a liquid or gel state so as to facilitate its removal from the body. The physician can employ standard surgical liposuction techniques when using the device, the low pressure and temperature allow adipose tissue removal without burning or otherwise damaging non-target tissues within the surgical field.

This looks like a 510(k) summary for the Andrew Technologies' Phaser Lipoplasty System. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving those criteria were met in the same way a de novo or PMA submission might.

Therefore, the requested information in the form of a table of acceptance criteria and reported performance, especially regarding AI-specific elements like sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document. This device is a physical surgical liposuction system, not an AI/ML powered device, which explains the absence of such information.

However, I can extract the available performance data described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical device, typical "acceptance criteria" are not explicitly stated as they would be for an AI/ML device. Instead, the performance data focuses on demonstrating safety and comparable effects to existing devices. The primary performance assessment was based on thermal effects and histological evidence in a porcine model.

Study Proving Device Meets Performance:

The company conducted in-vivo testing in a porcine model and a simulated use study.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated (e.g., number of pigs, number of test sites). The document mentions "a porcine model."
• Data Provenance: Porcine model (animal study, in-vivo), likely conducted by the manufacturer or contracted research organization. Retrospective/prospective is not specified but animal tests are typically prospective. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Experts: Not explicitly stated. Histological examination typically involves a pathologist, but the number and qualifications are not provided.
• Qualifications: Not provided.

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

• Not applicable/Not provided.

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, an MRMC study was not done. This is a physical device, not an AI/ML system, so human reader performance with or without AI assistance is not relevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• For Thermal Damage: Histological examination (pathology).
• For User Interface: "Evaluations" of human factor considerations, which would likely be observational assessments against intended function.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set for an AI/ML algorithm.

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