Search Results

The Lipose Fat Transfer System is intended to be used in the aspiration, harvesting, filtering and reinjecting of autologous fat.

The Lipose Fat Transfer System is a single-use disposable kit used in aspiration, harvesting, filtering, and transferring of autologus fat. The Lipose Fat Transfer System simplifies the collection and transfer autologous fat used in body contouring. The materials that comprise the Lipose Fat Transfer System are used routinely in similar devices and the predicate devices.

The provided text is a 510(k) summary for the Lipose Fat Transfer System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text. The document states that the device is "substantially equivalent in intended use/technological characteristics and/or method of operation" to listed predicate devices.

Here's a breakdown of why the information is not present in the provided text:

• No Acceptance Criteria or Performance Study: A 510(k) submission primarily establishes that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically require a new clinical or performance study with defined acceptance criteria for the new device itself, unless the technological characteristics or intended use are significantly different from the predicate.
• Focus on Substantial Equivalence: The summary explicitly states: "Based on the intended use, materials, and technological characteristics information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." This means the basis for market clearance is similarity to existing devices, not a new performance evaluation against predefined metrics.
• No Mention of Data Provenance, Experts, Ground Truth, or Sample Sizes for Performance: Since no specific performance study is detailed, there's no mention of sample sizes for test sets, data provenance, the number or qualifications of experts establishing ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the questions related to acceptance criteria and a performance study.

Ask a specific question about this device