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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 PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.

The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference.

The PAL® Infiltration System is comprised of the following components that are subject to this 510K:

• INF-PUMP PAL Infiltration Pump
• Accessories
  • o PAL-INF-1600 Infiltration Tubing
  • o PAL-INF-XXXXX Single-Use Infiltration Cannulas
  • o PAL-INF-RXXXXX Multi-Use Infiltration Cannula
  • o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable
  • o INF-FOOT-1, Infiltration Foot Switch

The provided document is a 510(k) Pre-Market Notification for a medical device (MicroAire PAL Infiltration System). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials or performance studies with acceptance criteria in the typical sense of AI/algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially related to AI/algorithms), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.

The document describes engineering and biocompatibility testing, primarily against established standards, to demonstrate that the new device performs similarly and is as safe as its predicate. It does not involve AI, image analysis, or diagnostic/prognostic output that would require the typical performance study elements you've listed.

Here's a breakdown based on the document's content, explaining why your specific questions are not directly answerable in this context:

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

• Not Applicable in the AI/algorithmic sense. The "acceptance criteria" here are met through demonstrating compliance with recognized standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety) and internal specifications for functional parameters (e.g., flow rate). The document states: "Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."
• Reported Performance (Functional, not diagnostic):
  • Infiltration Pump Flow Rate: "meets internal specifications" (No specific numerical target or range is given in the public summary, only that it passed).
  • Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity per ISO 10993-5, -10, -11, and USP .
  • Electrical Safety: Passed per IEC 60601-1.
  • Electromagnetic Disturbance (EMD) testing: Passed per IEC 60601-1-2.
  • Transportation Testing: "Demonstrates package integrity maintained" per ASTM D4169.

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

• Not Applicable. This device is a mechanical pump and associated cannulas/tubing. Performance testing refers to engineering tests on a limited number of manufactured units or materials, not a "test set" of patient data for an algorithm. There is no patient data involved in these performance tests.

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

• Not Applicable. No "ground truth" in the clinical/interpretive sense is established as there's no AI or diagnostic component.

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

• Not Applicable. No clinical/interpretive test set or adjudication is relevant here.

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 device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. No ground truth for clinical outcomes in this context. Performance is measured against engineering specifications and international standards.

8. The sample size for the training set:

• Not Applicable. No training set, as there is no AI/machine learning component.

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

• Not Applicable. No training set or associated ground truth.

In summary: The provided document is a direct FDA 510(k) submission that demonstrates substantial equivalence for a physical medical device (an infiltration pump) through engineering and biocompatibility testing against established standards, not through AI/algorithm performance studies or clinical trials involving patient data analysis. Your questions are tailored for AI/ML device submissions, which is a different regulatory pathway and type of evidence.

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The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.

The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m

The provided text is a 510(k) summary for the NOUVAG Dispenser DP 20, an infiltration pump. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the way you've outlined.

Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.

The 510(k) summary does contain the following relevant points:

1. Device Description and Intended Use: The Dispenser DP 20 is an infiltration pump intended for general surgical fluid irrigation and infiltration under physician control, using a peristaltic action. It is not for intravascular infusion.
2. Predicate Devices: The document identifies two predicate devices:
   • PSI-TEC Peristaltic Infiltration Pump (K040149)
   • Wells Johnson Infusion System, Model 20-6000-00 (K991437)
3. Substantial Equivalence Claim: The manufacturer claims substantial equivalence based on the principle of operation and technology (peristaltic action for fluid delivery) being similar to other irrigation devices previously cleared by the FDA.
4. Nonclinical Testing: A brief summary states: "The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or performance of the product." This indicates some form of testing was done to safety standards, but no specific criteria or results are provided.

In summary, this 510(k) document is a regulatory submission focused on comparing technological characteristics and intended use to existing devices, not on providing a detailed performance study with quantifiable acceptance criteria and results as typically found for novel AI/diagnostic devices.

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

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

This submission (K040149) is a 510(k) premarket notification for a medical device called "The PSI TEC III Peristaltic Infiltration Pump." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the new device as would be seen for novel technologies or higher-risk devices.

Based on the provided document, there is no information available about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested details about such a study.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This confirms that the approval was based on substantial equivalence, not on a standalone performance study with defined acceptance criteria for the new device K040149 itself.

Here's an attempt to answer the questions based on the available text, highlighting what is not present:

1. Table of acceptance criteria and the reported device performance

   • Not provided. The document does not specify performance acceptance criteria for the new device (PSI TEC III Peristaltic Infiltration Pump) or report specific performance metrics against such criteria. The submission is framed around substantial equivalence to existing devices.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary. The approval is based on substantial equivalence to predicate devices, not on a performance study of the PSI TEC III itself.

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/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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 device is an irrigation/infusion pump, not an AI-assisted diagnostic tool. No MRMC study would be relevant here.

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

   • Not applicable. This device is a pump, not an algorithm. Standalone performance for a physical device would refer to its functional specifications (e.g., flow rate accuracy, pressure), but these are not detailed as specific performance study results in this summary. The substantial equivalence argument implicitly assumes its performance is comparable to predicates.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

8. The sample size for the training set

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

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

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

Summary of available information related to equivalence:

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Predicate Devices for Substantial Equivalence Claim:

• Product: Bi-Phasic Infiltrator
  • Manufacturer: Reliance Medical
  • 510(k) Number: K012044
  • Substantial Equivalence Date: August 28th, 2001
• Product: Autofuse V Infiltration Pump
  • Manufacturer: Randolph-Austin
  • 510(k) Number: K980394
  • Substantial Equivalence Date: March 25th, 1998
• Product: Wells-Johnson Infusion System
  • Manufacturer: Wells-Johnson
  • 510(k) Number: K991437
  • Substantial Equivalence Date: August 30th, 1999

The substantial equivalence claim is based on the "principles of operation and technology incorporated" being similar to these predicates, specifically mentioning that the PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing, similar to other peristaltic irrigation systems. It also mentions that, like all peristaltic pumps, it contacts only the tubing and not the fluid, thus maintaining sterility.

In conclusion, for this specific 510(k) submission, the device did not undergo a study to meet defined acceptance criteria in the way a novel diagnostic or therapeutic device might. Its approval was based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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