FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.

The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
The AYON Infiltration and Aspiration Sub-System(s) are used for the infiltration and suction / aspiration of fluids and tissue during surgical procedures. Infiltration and Suction is designed to operate as a stand-alone function.

Device Description

The AYON Body Contouring System includes an Ultrasound Sub-system, an Infiltration Sub-system, and an Aspiration Sub-system. The Ultrasound Sub-system includes an ultrasound amplifier, an ultrasound handpiece, and ultrasound probes which are to be used with compatible skin ports and plugs. The Infiltration Sub-system includes a peristaltic pump and weighing scale and utilizes sterile infiltration tubing, handles and cannulas to infiltrate tissue with fluids. The Aspiration Sub-system includes two suction units that have the capability to function separately or together in series, such that it can be used as two separate suction units by two operators, or as a single suction unit (in series) by a single operator. The Aspiration Sub-system utilizes sterile suction tubing, handles and cannulas to aspirate fluids and soft tissue. The Infiltration and Aspiration Sub-systems are designed to operate independent of the Ultrasound Sub-system such that the system may be offered with only Infiltration and Aspiration to support standard suction-assisted liposuction (SAL) or with Ultrasound enabled to support ultrasound-assisted liposuction (UAL).

Apyx Medical devices/accessories for the system include the following:

Infiltration and aspiration handles
Ultrasound handpiece
Ultrasound handpiece cables
Ultrasound probes
Footswitches: Two (2) wireless footswitches to control ultrasound and infiltration
Skin ports and skin port tool
AYON Base Tower mounting poles and canister mounts
Power cords

Additional commercially available devices/accessories include the following:

Infiltration and aspiration cannulas
Aspiration filters
Sterile, single-use infiltration and aspiration tubing
Wrench
Sterilization tray and cleaning brushes
Collection canisters and liners
Infiltration fluid warming unit(s)

The AYON Body Contouring System may also accommodate other equipment, including commercially available electrosurgical generators owned by Apyx Medical, such as the Apyx One Console.

AI/ML Overview

The provided FDA 510(k) clearance letter for the AYON Body Contouring System does not contain acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/software-driven medical device for diagnosis or prognosis.

Instead, this document describes a traditional medical device clearance process for a hardware-based system (liposuction system), which relies on substantial equivalence to a predicate device rather than performance against defined metrics.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies are not applicable or cannot be extracted from this document.

However, I can still extract information related to the performance data provided, even if it's not structured around explicit acceptance criteria and corresponding performance metrics for an AI algorithm.

Non-Applicable Sections for this Device Type:

Acceptance Criteria for AI Performance: No explicit acceptance criteria (e.g., sensitivity, specificity, F1-score thresholds) for AI performance are stated because the device is not an AI/software diagnostic or prognostic tool.
Study Proving Acceptance Criteria: No such study is described.
Sample size used for the test set and the data provenance: No test set for AI/software performance is mentioned. The "testing" refers to mechanical, electrical, software, biocompatibility, and reprocessing validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI performance is established.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI performance.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Extracted Relevant Information (related to device performance and testing):

While not in the requested format of AI acceptance criteria, here's a summary of the performance testing conducted and the "reported device performance" as described in the 510(k) summary for the AYON Body Contouring System:

1. Table of "Acceptance Criteria" (interpreted as performance characteristics compared to predicate) and Reported Device Performance:

Feature/Specification	Acceptance Criteria (Predicate Device K110306)	Reported Device Performance (AYON Body Contouring System)	Comments (from document)
Intended Use (Overall System)	Fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring. Other surgical specialties.	Fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring.	Identical (for aesthetic body contouring). Subject Device not pursuing expanded indications.
Ultrasound Sub-System: Operating Frequency	36 kHz nominal	37 kHz nominal	Similar
Ultrasound Sub-System: Vibratory Power/Amplitude	Settings ranging from 10% to 100%	Low Power = 8 watts, Medium Power = 20 watts, High Power = 28 watts	Similar
Aspiration Sub-System: Suction Vacuum	20 in Hg at 5000 ft. (~25 in Hg at sea level)	27 in Hg at sea level	Similar¹ (within 0-29.9 in Hg range)
Infiltration Sub-System: Infiltration Rate	Adjustable flow rate from 50-550 mL/min	Adjustable flow rate from 40-1000 mL/min	Similar² (ranges overlap and extend)
Mechanism of Action	Ultrasonic fragmentation/emulsification, infiltration, and aspiration.	Ultrasonic fragmentation/emulsification, infiltration, and aspiration.	Identical
Electrical Safety	IEC Class I, Type BF	IEC Class I, Type BF	Identical for all sub-systems.

Notes for Table:

¹ Suction vacuum for the Subject Device falls within the vacuum range of 0 to 29.9 in Hg included in the Product Code description and falls below the maximum vacuum range for other FDA cleared devices. Vitruvian Ultimate Aspirator (K161722), PSI-TEC Aspirator (K981215).
² The infiltration flow rates for the Subject Device are identical or fall below the maximum flow rates for other FDA cleared infiltration and infusion pumps. Reference devices; Klein Surgical Infiltration pump (K031432) and the Wells Johnson Infusion pump (K991437).

2. Sample size used for the test set and the data provenance:

Test Set (for AI/software performance): Not applicable.
Data Provenance: Not applicable.

However, the document lists various non-clinical performance tests:

Mechanical and Physical Bench Testing: Each subsystem (ultrasound, infiltration, aspiration) was tested separately and as a combined system for overall performance, tip vibrational amplitude, thermal effects on tissue, voltage/current outputs, and compatibility. Aspiration testing was in accordance with ISO 10079-1 and ISO 10079-4.
Electrical Safety and EMC: Testing performed per IEC 60601-1-1, IEC 60601-1-2, and 60601-4-2. Wireless emissions testing for footswitch.
Software and Cybersecurity: Verification and Validation (V&V) performed in accordance with ISO 62304.
Biocompatibility Testing: Conducted per ISO 10993-1 on patient-contacting materials.
Reprocessing: Tested in accordance with ISO 17665.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device does not use an expert-established ground truth for performance evaluation in the context of AI. The performance is assessed through engineering and bench testing, and comparison of specifications to a predicate device.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. The device is not a diagnostic imaging or AI-assisted diagnostic tool. No clinical studies were required or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device. The product is a physical electro-mechanical system.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is derived from established engineering standards (e.g., ISO, IEC), physical measurements, and direct comparison of specifications to the legally marketed predicate device. There is no biological or expert consensus "ground truth" in the AI sense.

8. The sample size for the training set:

Not applicable. The device is a hardware system, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

Regulation Number and Section

§ 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.