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510(k) Data Aggregation
(57 days)
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and cannula. The handpiece is connected to the controller and to an independent aspiration source. The controller sends electronic signals to the handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the handpiece.
The provided document is a 510(k) Pre-Market Notification for the PowerX Lipo System. It claims substantial equivalence to a predicate device, K110255, also named PowerX Lipo System.
This document describes a medical device (a suction lipoplasty system) rather than an AI/ML-driven diagnostic or prognostic device. Therefore, the typical acceptance criteria and study designs involving AI performance metrics (like sensitivity, specificity, AUC, human-in-the-loop studies, multi-reader multi-case studies, expert consensus for ground truth) as outlined in the prompt are not applicable to this submission.
The "acceptance criteria" for this device are based on its substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and safety and effectiveness profiles when tested against applicable non-clinical standards.
Here's how to interpret the provided information in the context of a 510(k) for a medical device:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" here relate to the device meeting performance specifications and safety standards comparable to the predicate device. The document explicitly states:
| Characteristic | Subject Device PowerX Lipo System | Predicate K110255 |
|---|---|---|
| Intended Use | Removal of tissue or fluid from the body | Identical to subject device |
| Operating Frequency | 36kHz Nominal | Identical to subject device |
| Suction Vacuum (max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannula dimensions | 1-6 mm diameter 7-40 cm length | 2.4 -4.6 mm diameter 17 – 34 cm length |
And also lists compliance with electrical standards:
| Standard | Description | Reported Performance / Compliance |
|---|---|---|
| IEC 60601-1:2005/AM1:2012 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | Demonstrated compliance |
| ISO 10079-1:2015 | Medical suction equipment -- Part 1: Electrically powered suction equipment | Demonstrated compliance |
| Cannula deformation resistance | $20°±5°$ and straightening without the shaft exhibiting any fractures, sharp edges, or loss of suction performance | Demonstrated compliance |
| Suction Vacuum (max) | 20 inHg at 5,000 ft | Confirmed performance |
2. Sample size used for the test set and the data provenance:
For this type of device, a "test set" in the AI/ML sense (e.g., a set of medical images) is not applicable. The testing here refers to engineering and bench testing to demonstrate compliance with performance and safety standards. The document does not specify sample sizes for these tests (e.g., how many cannulas were tested for deformation resistance), but often these are done on a representative sample to ensure manufacturing quality and design verification. Data provenance is not specified as it's not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context is established by engineering specifications, international standards (IEC, ISO), and performance testing rather than expert medical interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of diagnostic findings.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., IEC 60601-1, ISO 10079-1), and the performance characteristics of the predicate device. For example, a "ground truth" for suction vacuum might be a calibrated pressure gauge reading that matches the specified 20 inHg.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a standard 510(k) submission for a traditional medical device (suction lipoplasty system). The "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device through engineering and non-clinical performance testing against established safety and performance standards. The questions related to AI/ML software performance are not relevant to this specific device submission.
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