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The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.

The AirSculpt System is a surgical device designed of subcutaneous adipose tissue during liposuction procedures performed for cosmetic purposes. The AirSculpt System includes components necessary for the vacuum-suction removal of excess adipose tissue from the body, including a handpiece that accommodates the interchangeability of lipoplasty cannulae, a console for centralized control of the system, tubing to facilitate aspiration of subcutaneous adipose tissue, and a foot pedal for operation. Other elements necessary for the use of the AirSculpt System include commonly used Class I and Class II surgical devices such as lipoplasty cannula that are introduced into the patient and swept over subcutaneous adipose tissue for suction removal and a suction canister into which aspirated adipose tissue is collected. An optional use Instrument Sleeve accessory is also available for use with the AirSculpt Handpiece and its use is based purely on physician preference.

The provided document is a 510(k) summary for the AirSculpt Body Contouring System. This type of submission is for medical devices and demonstrates substantial equivalence to a legally marketed predicate device. It does not present clinical study data for AI/ML-based software or similar technologies.

Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving a device meets these criteria, specifically concerning AI/ML performance metrics, sample sizes for test sets, expert involvement in ground truthing, MRMC studies, or training set details.

The document states: "Clinical data was not required to support the substantial equivalence of the AirSculpt Body Contouring System to the predicate device." This confirms that no clinical studies as described in the prompt were conducted or submitted for this specific device.

The "Performance Data" section in the document focuses on bench testing to demonstrate conformity to specifications for a physical medical device (liposuction system), not an AI algorithm.

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The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.

The provided text is a 510(k) premarket notification for a medical device called the "intelliFat Disposable Adipose Tissue Harvesting and Transfer Kit" (and "intelliFat BOD Kit"). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical setting.

Specifically:

• No table of acceptance criteria and reported device performance is provided. The document is a regulatory filing for substantial equivalence, not a performance report.
• No sample size for a test set or data provenance is mentioned for proving clinical performance. The "nonclinical testing" section describes lab-based tests (biocompatibility, sterilization, packaging, nucleated cell viability), not clinical or performance outcome studies.
• No information about experts used for ground truth, adjudication methods, or MRMC studies is present. These are typically relevant for AI/imaging device evaluations, which this device is not.
• No standalone (algorithm-only) performance is discussed as this is a physical medical device, not an AI algorithm.
• No type of ground truth is specified for clinical performance, as no clinical performance study demonstrating efficacy is detailed.
• No training set sample size or ground truth establishment for a training set is mentioned. This information would be relevant for machine learning models, which this device is not.

The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits." This means the FDA cleared the device based on its similarity in intended use and technological characteristics to existing devices, and not on new clinical performance data from the manufacturer.

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