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The Lipose Disposable Cannula is intended for use in aesthetic body contouring.

The Lipose Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock connector or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites pre-lipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Lipose Disposable Cannulas are single-use disposables, supplied sterile (gamma radiation), packaged in a PETG tray sealed with a labeled or pre-printed Tyvek lid.

This document is a 510(k) summary for the Lipose Disposable Cannula, which is a medical device used for aesthetic body contouring. The document does not describe a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like sensitivity, specificity, or improvement with AI assistance).

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. The primary "acceptance criterion" in this context is showing that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided document:

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

The document does not provide a table of quantitative acceptance criteria and device performance metrics in the way typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are demonstrating substantial equivalence in terms of:

• Indications for Use: The Lipose Disposable Cannula is "intended for use in aesthetic body contouring." This is identical to the predicate device's intended use.
• Technological Characteristics: The document states: "The design, use, and materials of the Lipose Disposable Cannulas and their predicate device are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Lipose Cannulas are all provided with a hydrophilic coating with lubricious properties as well, as are the Tulip Disposable Cannulas. No new technology or change in indications for use have been introduced by Lipose Corp. in the manufacture of the Disposable Cannulas."

Therefore, the "reported device performance" is essentially that its characteristics (design, materials, intended use, lubricious coating) are equivalent to the predicate device, thereby inferring equivalent safety and effectiveness.

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

There is no "test set" in the traditional sense of a study evaluating performance against ground truth. The submission relies on comparative data and descriptions against a predicate device. Therefore, no information on sample size or data provenance is provided.

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

Not applicable. This is not a study requiring expert consensus for ground truth establishment. The evaluation is based on comparing the device's characteristics and intended use to a legally marketed predicate device.

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

Not applicable. No test set requiring adjudication.

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 device is a surgical instrument (cannula), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

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

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

The "ground truth" in this context is the safety and effectiveness profile of the predicate device, the Tulip Disposable Cannula (K060089), which has already been cleared by the FDA. The submission argues that the Lipose Disposable Cannulas are substantially equivalent to this established device.

8. The sample size for the training set

Not applicable. No training set for an algorithm.

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

Not applicable. No training set.

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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.

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