(58 days)
The MicroAire LipoFilter System is used in the aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted fat is only to be used without any additional manipulation.
The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system comprised of a medical grade canister, vacuum port, collection port, tissue port and lid intended to be used with a standard liposuction aspiration system pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing a valve. This process leaves fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.
The provided text describes the MicroAire LipoFilter System, a device for aspirating, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The document is a 510(k) premarket notification from the FDA, aiming to establish substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or target performance metric format with corresponding reported values. Instead, it describes various tests and validations that demonstrate the device meets certain standards. These can be inferred as the "acceptance criteria" for demonstrating substantial equivalence.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Sterility | Complies with ISO 11137-1:2006 and ISO 11137-2:2006 for gamma radiation validation. Sterility Assurance Level (SAL) of $10^{-6}$. |
| Shelf Life | Validated for a 2-year shelf life. Complies with ISO 11607-1:2006 and ISO 11607-2:2006 regarding packaging. |
| Biocompatibility | Made from medical grade biocompatible materials. Complies with ISO 10993-1:2009. |
| Performance/Functionality | Tested in accordance with predetermined specifications on file at MicroAire, which includes: |
- Functionality testing
- ISO 10079-1 testing
- Tubing connection strength testing
- Vacuum leak testing
- Adipocyte viability testing
- Aging Studies |
| Volume Range | Up to 2500mL (compared to predicate devices of up to 2000mL; deemed "insignificant"). |
| Separation Method | Uses decantation to separate tissue (same method as predicate devices). |
| Intended Use | Has no new intended uses compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the tests conducted (e.g., how many units were tested for sterility, shelf life, or biocompatibility). It only states that various tests were performed.
The data provenance is not explicitly mentioned in terms of country of origin or whether the studies were retrospective or prospective. All testing appears to be pre-clinical (bench testing, lab validation), not involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described (sterility, shelf life, biocompatibility, performance) are objective validations against international standards (ISO) and internal specifications. They do not typically involve experts establishing a "ground truth" in the way a clinical study might for diagnostic accuracy, where interpretations are made.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging, pathology) by multiple reviewers to resolve discrepancies and establish a consensus "ground truth." Since the studies described are pre-clinical validation tests (sterility, shelf life, biocompatibility, mechanical performance), an adjudication method is not applicable and therefore not mentioned.
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 MRMC comparative effectiveness study was done or is applicable. This device is a surgical instrument system for fat processing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human readers, AI, or effect sizes related to AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study was done or is applicable. As mentioned, this is a physical medical device, not a software algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the pre-clinical tests, the "ground truth" is established by:
- International Standards: e.g., ISO 11137-1:2006, ISO 11137-2:2006 for sterility; ISO 11607-1:2006, ISO 11607-2:2006 for packaging/shelf life; ISO 10993-1:2009 for biocompatibility; ISO 10079-1 for specific performance aspects.
- Predetermined Internal Specifications: "MicroAire LipoFilter System was tested for performance in accordance with its predetermined specifications on file at MicroAire."
- Direct Measurement/Observation for Functionality: Testing for tubing connection strength, vacuum leaks, and adipocyte viability would involve direct objective measurements against predefined pass/fail criteria.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these pre-clinical validations.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
§ 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.