(192 days)
The MicroAire® PAD™ System is indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
The MicroAire® PAD™ System consists of two primary components: a pneumatic or electric reciprocating handpiece and a disposable cannula with attached suction tubing. The disposable cannula with attached suction tubing connects to an external suction sources that is not part of the PAD™ System. A disposable cannula with attached tubing is also available with a syringe to facilitate manual suction.
The pneumatic reciprocating handpieces operate with an air or nitrogen power supply. The handpieces are capable of driving the cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. The electric reciprocating handpiece is capable of driving a cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. The electric handpiece is powered and controlled by the MicroAire® Smartdrive™ electric console.
The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe. The cannula internal diameter is approximately 3mm and ranges from 26-33cm in overall length. Fluid and tissue is aspirated through windows located near the tip of the cannula when the tubing is connected to a suction source. The number of windows varies between 3-6 openings with window lengths from 7-10mm at 2mm in width.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroAire® PAD™ System, structured according to your request.
Please note: The provided document is a 510(k) summary and FDA clearance letter for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study report typical of a clinical trial for a novel AI/software as a medical device (SaMD) product. Therefore, much of the requested information (especially regarding AI-specific criteria, human readers, ground truth establishment for training, etc.) is not present in this historical regulatory submission for a physical surgical device. I will extract what is available and note what is not.
Description of Acceptance Criteria and Study for MicroAire® PAD™ System
The MicroAire® PAD™ System is a surgical aspiration device indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring. Its regulatory clearance (K981922) was based on demonstrating substantial equivalence to a legally marketed predicate device, with its performance affirmed through nonclinical evaluations and compliance with voluntary standards.
The document does not specify explicit "acceptance criteria" in a quantitative, pre-defined manner for device performance, as would be common for new AI/SaMD devices. Instead, it relies on demonstrating that the device functions as intended and safely, primarily through engineering specifications and in-vitro testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a mechanical surgical tool) and the document (510(k) summary), the "acceptance criteria" are implied by the performance specifications provided and tested.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Reciprocating Action: | |
| Pneumatic Handpieces: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. |
| Electric Handpiece: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. |
| Tissue Penetration Force Reduction: | Reciprocating cannula reduced the magnitude of penetration force by approximately 70% compared to non-reciprocating cannulae in successive trials of in vitro animal experiments. |
| Aspiration Performance: | Demonstrated ability to aspirate physiological saline and a viscous wound cleansing solution (consistency similar to synovial fluid or mucus) with a vacuum pressure of 20 cm Hg for ten seconds. The reciprocating cannula did not affect the rate of aspiration. Specific volume measurements were taken (details in Appendix F, which is not provided). |
| Sterilization Efficacy (Multiple-Use Instruments): | Gravity Discharge: 35 minutes @ 270°F (132°C) with an 8-minute drying cycle. |
| Prevaccum System: 4 minutes @ 270°F (132°C) with an 8-minute drying cycle. (This demonstrates the ability to achieve sterility per AAMI's Good Hospital Practice). | |
| Sterilization Efficacy (Disposable Components): | Pre-sterilized at 25-40 kiloGray according to ANSI/AAMI/ISO 11137-1994 (Radiation Sterilization). |
| Electrical Safety (Electric Console): | Designed to meet the electrical safety requirements of UL-544 and IEC-601-1. |
| Biocompatibility/Material Safety: | Components comprised of materials with a long history of safety when incorporated in medical devices. |
| Compliance with Special Controls for Suction Lipoplasty: | The device "complies with appropriate voluntary standards designated as special controls to assure safety and effectiveness of the device in accordance with the requirements of 21 CFR §878.5040." (While stated, specific details of these "voluntary standards" beyond the mentioned sterility and electrical safety ones are not fully enumerated here, but are implied to be met to ensure substantial equivalence for a suction lipoplasty system). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in the context of a clinical study or a large dataset for algorithmic evaluation. The performance metrics reported (e.g., 70% force reduction, aspiration rates) are derived from "successive trials of in vitro animal experiments" and "laboratory tests" measuring aspirated fluid volume. The exact number of trials or animal subjects is not detailed in the summary.
- Data Provenance: The testing appears to be prospective, in-vitro laboratory testing and animal experiments conducted by MicroAire® Surgical Instruments. Country of origin for data is implicitly the USA, where MicroAire® is located. This is not a study involving human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a summary for a mechanical device, not an AI/SaMD requiring ground truth established by medical experts on diagnostic images or patient data. The "ground truth" for the performance tests would be the measured physical properties (e.g., force, volume, stroke rate) as determined by engineering and laboratory testing protocols.
4. Adjudication Method for the Test Set
- Not Applicable. There was no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance was measured objectively in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/SaMD product. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an electro-mechanical surgical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply. The device's performance characteristics (e.g., stroke rate, force reduction) are inherent to its mechanical design.
7. The Type of Ground Truth Used
- The ground truth for the performance evaluation was based on objective physical measurements from laboratory and in-vitro animal experiments (e.g., force transducers for penetration force, volume measurements for aspiration, RPM/stroke counters for mechanical rates).
- For safety, ground truth was established by adherence to recognized voluntary standards (e.g., AAMI for sterility, UL/IEC for electrical safety) and material biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML system and does not involve a "training set" in that context. The device design and engineering are based on principles of mechanics and fluid dynamics, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth for it. The "truth" informing the device's design would be engineering principles, material science, and the clinical understanding of surgical aspiration.
§ 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.