(90 days)
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.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.