(104 days)
Aesthetic body contouring
The MicroAire PAL® Aspiration System provides an adjustable vacuum source that drives the suction of tissue during suction-assisted aesthetic body contouring procedures. The PAL Aspiration System features a modular style PAL® Aspiration Pump (ASP-PUMP-120/240) unit with a separate, stackable PAL® Aspiration Pump Console (ASP-UI) which provides organizational modularity and ease of transport within the medical facility. Communication between the units is achieved via the Aspiration Pump Cable (ASP-CBL). The PAL Aspiration Pump utilizes a dual-piston pump as a vacuum source that delivers 0-29 inHg and drives the suction of tissue. The PAL Aspiration Pump also features a multi-socket outlet (MSO) to provide power to up to four devices using the AC Power Cord Jumper Cable (ASP-CORD), eliminating extra power cords for better cable organization. The PAL Aspiration Pump Console is an electronic control system which allows the operator to digitally set and visualize the vacuum level. It also provides the status of basic pump operations, sends the Pump's ON/OFF signal, and provides receptacles for the connection of the Aspiration Pump Cable and optional accessories. The Aspiration Foot Switch (ASP-FOOT) and the 5020 to Aspiration Pump Cable (5020-ASP) are optional accessories which provide the operator with additional Aspiration Pump ON/OFF control options. The PAL Aspiration Pump requires a Biofilter (ASP-FLTR2), which prevents the ingress of vapor particulate into the motor. The Biofilter is a non-sterile filter assembly with vacuum tubing placed on the vacuum inlet. Connection to a system of generic collection canisters (sold separately) is expected for the PAL Aspiration System to function as intended. Additional Vacuum Tubing (ASP-TUBING) can be used to replace existing Biofilter tubing as needed.
The provided text is a 510(k) summary for the MicroAire PAL® Aspiration System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would for AI/ML devices.
Therefore, much of the requested information cannot be found in this type of regulatory submission. The device is a physical suction system, not an AI/ML device, which explains the absence of data related to AI/ML specific criteria.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance in a quantitative manner for specific benchmarks. Instead, it states that "The PAL Aspiration System passed all non-clinical bench testing, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."
It lists several voluntary consensus standards and FDA Guidance documents that the device complies with, which implicitly define the acceptance criteria for various aspects:
| Acceptance Criteria Category (Implied by Compliance) | Reported Device Performance (Implied by "passed all tests") |
|---|---|
| Electrical safety (IEC 60601-1) | Met |
| Electromagnetic Disturbance (IEC 60601-1-2 and IEC 60601-4-2) | Met |
| Essential Performance (IEC 60601-1-6) | Met |
| Software Verification (IEC 62304) | Met |
| Usability testing (IEC 62366-1) | Met |
| Safety testing for electrically powered suction pumps (ISO 10079-1) | Met |
| Vacuum performance | Met specified requirement |
| Free air flow | Met specified requirement |
| Noise | Met specified requirement |
| Reliability | Met specified requirement |
Note on "Maximum Vacuum" and "Maximum Flow Rate": While these are reported as characteristics in Table A, they are presented as comparative figures to the predicate device, not necessarily as acceptance criteria that were quantitatively "met" against a pre-defined threshold.
| Characteristic | Predicate Device Performance | Subject Device Performance |
|---|---|---|
| Maximum Vacuum | 27.5 inHg | 29 inHg |
| Maximum Flow Rate | 6.4 cfm | 2.12 cfm (60L/min) @ 60Hz |
| 1.77 cfm (50L/min) @ 50Hz | ||
| Sound Level | 50 dB | 56.8 dBA |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is non-clinical bench testing of a physical device, not a study involving patient data or a "test set" in the context of AI/ML or clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. As above, there is no "test set" requiring expert-established ground truth in the context of this device's non-clinical bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The device is a suction lipoplasty system, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device is a physical system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications and international standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.