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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.

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.

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:

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.

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The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump.

Device Functionality: The KleinTouch Pump is an electrically or battery operated, manually controlled, peristaltic pump using three rollers to create pumping action in a section of sterile tubing.
Scientific Concept(s): The KTP is designed to specifically function with sterile single use only Klein Touch Tubing (KT20). Tubing must be primed before use. Please refer to the KT20 Instructions for Use for further details.
Physical And Performance Characteristics: Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs.
Components Used: Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted
Physical Properties: The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set specifically designed for the KleinTouch Pump

The provided text describes the 510(k) Notification for the HK Surgical KleinTouch Pump and Tubing Set. However, it does not contain specific acceptance criteria tables or detailed study results that typically outline performance metrics for AI/ML-based medical devices. The document focuses on regulatory compliance, intended use, and general safety testing for an infusion pump, which is a physical device, not an AI/ML algorithm.

Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML, as the document describes a traditional medical device (an infiltration pump).

Here's an analysis of what can be extracted and why other parts of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document lists general performance testing categories (UL Standards, EMC, Biocompatibility, Sterilization, Human Factors) but does not provide specific quantitative acceptance criteria or reported performance values for these tests. For example, it states "Performance testing demonstrates the KleinTouch Pump meets the specifications" but doesn't detail what those specifications are or the exact results obtained.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. This information is relevant for studies involving data-driven devices or algorithms. The KleinTouch Pump is a physical device, and its testing involves physical and electrical safety standards, biocompatibility, and human factors, not data samples in the context of AI/ML.

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):

• Cannot be provided. "Ground truth" in the context of expert consensus is typically for evaluating diagnostic or predictive AI/ML models. For a physical pump, testing involves adherence to engineering standards and safety protocols by qualified testing labs (MET LABS is mentioned), not expert consensus on medical image interpretation or similar. The "Human Factors evaluation" implies expert observation, but no specific numbers or qualifications are given for that.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. Adjudication methods are specific to scenarios where multiple experts might disagree on ground truth, which is not applicable to the testing described for this device.

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:

• Cannot be provided. MRMC studies are for evaluating diagnostic accuracy, particularly with AI assistance, which is not relevant to a physical infiltration pump.

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

• Cannot be provided. This device is a physical pump, not an algorithm. Therefore, "standalone" performance in the AI/ML sense is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be provided. The "ground truth" for this device's performance is adherence to established international and national safety and performance standards (e.g., UL 2601-1, IEC/EN 60601-1, ISO10993-1, ISO11135). The testing verifies that the device meets these engineering and safety requirements.

8. The sample size for the training set:

• Cannot be provided. The device is not an AI/ML model, so there is no "training set."

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

• Cannot be provided. As there is no training set, this question is not applicable.

In summary: The provided text is a 510(k) summary for a physical medical device (an infiltration pump) and details its design, intended use, and compliance with various established safety and performance standards. It does not describe an AI/ML device or studies involving data-driven performance metrics, ground truth establishment, or human-AI interaction.

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The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.

The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

The provided 510(k) summary for the Infiltration Pump (K050324) states that the device's substantial equivalence is based on the "principles of operation and technology incorporated" being equivalent to existing peristaltic infiltration/irrigation devices.

Therefore, this submission is a traditional 510(k) submission based on substantial equivalence to predicate devices, and not a de novo submission requiring clinical performance studies and defined acceptance criteria.

As such, the document does not contain information on:

• Acceptance criteria or reported device performance for a study.
• Sample size, data provenance, or ground truth for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) beyond conceptual equivalence.
• Sample size for a training set.
• How ground truth for a training set was established.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which means demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. This typically involves comparing technological characteristics, indications for use, and performance claims to the listed predicates (PSI-TEC Peristaltic Infiltration Pump K040149 and Klein Surgical Infiltration Pump, Model KIP-II K031432).

To fulfill the request, a clinical study with detailed acceptance criteria and performance metrics would be required, which is beyond the scope of this 510(k) summary.

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The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.

The Veinnovations Infiltration System consists of the Infiltration Pump and proprietary, sterile, single use Veinnovations Y Infiltration Set.

The provided document is a 510(k) premarket notification determination letter for the "Veiinnovations Infiltration System." This type of document establishes substantial equivalence to a predicate device for marketing purposes and does not contain detailed study results or acceptance criteria in the manner requested for AI/ML device performance.

Therefore, I cannot provide the requested information as the document does not describe acceptance criteria or a study proving device conformance to such criteria. The document focuses on regulatory approval based on substantial equivalence, not detailed performance studies with acceptance criteria, sample sizes for test sets or training sets, ground truth establishment, or expert evaluations.

Here's why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only mentions that the device is "substantially equivalent" to a predicate device based on indications for use, design, materials, and operational characteristics. No specific performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided. This is typical for a 510(k) summary focused on substantial equivalence rather than a clinical trial report.
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): Not applicable, as no test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is described.
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. The device is an "infiltration pump system," a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, MRMC studies or AI assistance are irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical pump system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is discussed for this type of device.
8. The sample size for the training set: Not applicable, as no AI/ML model or training set is involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter for a medical device (an infiltration pump) based on substantial equivalence, not a scientific publication detailing performance studies for an AI/ML product.

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