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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 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam).

Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes.

The following accessories are packaged with the MENTOR ™ PliaForm™ Breast Tissue Expander w/ Suture Tabs:

• Centerscope™ 2.0 Magnetic Injection Port Finder
• Winged Infusion Set (21G)

The provided text is a 510(k) clearance letter for the MENTOR™ PliaForm™ Breast Tissue Expander. It describes the device, its intended use, a comparison to a predicate device, and the performance data used to demonstrate substantial equivalence.

However, it does not contain any information about a study involving an AI/software device or human-in-the-loop performance. The "performance data" section exclusively details biocompatibility and mechanical testing of the physical breast tissue expander, along with MR/CT/RT qualification studies for the expander's physical properties when exposed to these imaging modalities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/software device or human reader performance, as this information is absent from the provided document.

The document discusses acceptance criteria and study results for the physical device's performance, which are summarized below, but these are not related to AI or human-in-the-loop studies.

Summary of Device Performance and Acceptance Criteria (for the physical device from the provided text):

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

2. Sample Size Used for the Test Set and Data Provenance:

• The document refers to "samples" used for various biocompatibility and mechanical tests, but does not specify the exact sample sizes for each test. It states, "All mechanical performance testing results met their pre-determined acceptance criteria."
• The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. It is implied to be laboratory testing of manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable as no human-in-the-loop or AI study is described. The ground truth for the physical device performance is established through standardized engineering and materials science testing methods (e.g., ASTM standards) and comparisons to established safe profiles for biocompatibility.

4. Adjudication Method:

• Not applicable as no human-in-the-loop or AI study is described.

5. MRMC Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done, as this is a physical medical device, not an AI or imaging diagnostic tool.

6. Standalone Performance (Algorithm Only):

• Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• For biocompatibility: Analytical characterization and comparison to established safe materials and predicate device.
• For mechanical testing: Engineering specifications, ASTM standards (e.g., ASTM F1441-03), and internal "pre-determined acceptance criteria."
• For MR/CT/RT qualification: Physical measurements (induced force, torque, heating), post-exposure device integrity checks against ASTM standards, and dosimetry measurements in a preclinical phantom model compared to sham controls.

8. Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not an AI system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as this is a physical medical device, not an AI system.

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Aesthetic body contouring

The MicroAire PAL® Aspiration System provides an adjustable vacuum source that drives the suction of tissue during suction-assisted aesthetic body contouring procedures. The PAL Aspiration System features a modular style PAL® Aspiration Pump (ASP-PUMP-120/240) unit with a separate, stackable PAL® Aspiration Pump Console (ASP-UI) which provides organizational modularity and ease of transport within the medical facility. Communication between the units is achieved via the Aspiration Pump Cable (ASP-CBL). The PAL Aspiration Pump utilizes a dual-piston pump as a vacuum source that delivers 0-29 inHg and drives the suction of tissue. The PAL Aspiration Pump also features a multi-socket outlet (MSO) to provide power to up to four devices using the AC Power Cord Jumper Cable (ASP-CORD), eliminating extra power cords for better cable organization. The PAL Aspiration Pump Console is an electronic control system which allows the operator to digitally set and visualize the vacuum level. It also provides the status of basic pump operations, sends the Pump's ON/OFF signal, and provides receptacles for the connection of the Aspiration Pump Cable and optional accessories. The Aspiration Foot Switch (ASP-FOOT) and the 5020 to Aspiration Pump Cable (5020-ASP) are optional accessories which provide the operator with additional Aspiration Pump ON/OFF control options. The PAL Aspiration Pump requires a Biofilter (ASP-FLTR2), which prevents the ingress of vapor particulate into the motor. The Biofilter is a non-sterile filter assembly with vacuum tubing placed on the vacuum inlet. Connection to a system of generic collection canisters (sold separately) is expected for the PAL Aspiration System to function as intended. Additional Vacuum Tubing (ASP-TUBING) can be used to replace existing Biofilter tubing as needed.

The provided text is a 510(k) summary for the MicroAire PAL® Aspiration System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would for AI/ML devices.

Therefore, much of the requested information cannot be found in this type of regulatory submission. The device is a physical suction system, not an AI/ML device, which explains the absence of data related to AI/ML specific criteria.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance in a quantitative manner for specific benchmarks. Instead, it states that "The PAL Aspiration System passed all non-clinical bench testing, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."

It lists several voluntary consensus standards and FDA Guidance documents that the device complies with, which implicitly define the acceptance criteria for various aspects:

Note on "Maximum Vacuum" and "Maximum Flow Rate": While these are reported as characteristics in Table A, they are presented as comparative figures to the predicate device, not necessarily as acceptance criteria that were quantitatively "met" against a pre-defined threshold.

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

This information is not applicable and not provided. The testing described is non-clinical bench testing of a physical device, not a study involving patient data or a "test set" in the context of AI/ML or clinical trials.

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)

This information is not applicable and not provided. As above, there is no "test set" requiring expert-established ground truth in the context of this device's non-clinical bench testing.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. The device is a suction lipoplasty system, not an AI-assisted diagnostic or treatment system.

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

This information is not applicable and not provided. The device is a physical system, not an algorithm.

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

This information is not applicable and not provided. For non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications and international standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for this type of device.

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

This information is not applicable and not provided.

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The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.

The AirSculpt System is a surgical device designed of subcutaneous adipose tissue during liposuction procedures performed for cosmetic purposes. The AirSculpt System includes components necessary for the vacuum-suction removal of excess adipose tissue from the body, including a handpiece that accommodates the interchangeability of lipoplasty cannulae, a console for centralized control of the system, tubing to facilitate aspiration of subcutaneous adipose tissue, and a foot pedal for operation. Other elements necessary for the use of the AirSculpt System include commonly used Class I and Class II surgical devices such as lipoplasty cannula that are introduced into the patient and swept over subcutaneous adipose tissue for suction removal and a suction canister into which aspirated adipose tissue is collected. An optional use Instrument Sleeve accessory is also available for use with the AirSculpt Handpiece and its use is based purely on physician preference.

The provided document is a 510(k) summary for the AirSculpt Body Contouring System. This type of submission is for medical devices and demonstrates substantial equivalence to a legally marketed predicate device. It does not present clinical study data for AI/ML-based software or similar technologies.

Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving a device meets these criteria, specifically concerning AI/ML performance metrics, sample sizes for test sets, expert involvement in ground truthing, MRMC studies, or training set details.

The document states: "Clinical data was not required to support the substantial equivalence of the AirSculpt Body Contouring System to the predicate device." This confirms that no clinical studies as described in the prompt were conducted or submitted for this specific device.

The "Performance Data" section in the document focuses on bench testing to demonstrate conformity to specifications for a physical medical device (liposuction system), not an AI algorithm.

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Aesthetic Body Contouring

The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.

The provided FDA 510(k) summary for the Vitruvian Liposaber pertains to a suction lipoplasty system, which is a physical device used for aesthetic body contouring. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and comparison of technical specifications, rather than clinical studies involving human patients or AI performance metrics.

Therefore, the requested information regarding AI acceptance criteria, specific study designs (MRMC, standalone), human reader performance improvement, multi-expert ground truth establishment, training and test set sample sizes for AI, and adjudication methods is not applicable to this device and its 510(k) submission.

The document explicitly states: "No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non-clinical testing details in this submission support the substantial equivalence of the device." This confirms that the approval is based on equivalence to existing, commonly understood devices, not on novel AI performance.

Below is a summary of the acceptance criteria and device performance as demonstrated in this 510(k) in the context of the device's technical specifications and non-clinical testing.

Acceptance Criteria and Reported Device Performance (Non-Clinical) for Vitruvian Liposaber™

The Vitruvian Liposaber™ is a physical medical device (suction lipoplasty system). Its acceptance criteria and performance are demonstrated through comparison to a predicate device and non-clinical testing, as opposed to AI performance metrics.

1. Table of Acceptance Criteria (as implied by comparison to predicate and non-clinical testing) and the Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of an AI test set. Performance was demonstrated through non-clinical engineering tests of the device prototypes, material testing, and comparative analysis to a predicate device.
• Data Provenance: The data arises from in-house engineering testing, bench testing, and laboratory studies conducted by the manufacturer, Black & Black Surgical, Inc. This is inherent to hardware device approval processes. No patient data (retrospective or prospective) was used for performance validation as no clinical study was conducted. The country of origin of the data is implicitly the USA, where the company is based and the testing would likely have occurred or been commissioned.

3. Number of Experts Used and Qualifications for Ground Truth and 4. Adjudication Method:

• Not applicable. This device is not an AI/software product requiring expert ground truth or adjudication for image interpretation or diagnosis. The "ground truth" for this device's performance is objective measurements from engineering tests (e.g., motor speed, temperature, dimensions, electrical safety compliance) and comparison to established predicate device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• Not applicable. MRMC studies are specific to evaluating AI in diagnostic imaging where human readers interpret cases with and without AI assistance. This device is a surgical instrument.

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

• Not applicable. This is not an AI algorithm. Its "performance" is its mechanical and electrical function.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's approval is based on engineering specifications, compliance with recognized electrical and safety standards (e.g., IEC 60601-1, ISO 10993-1), and documented performance of a legally marketed predicate device. It relies on objective physical measurements and adherence to established regulatory and engineering principles.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are iterative, informed by design inputs and testing, rather than a data-driven training paradigm.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. There is no training set or ground truth in the AI sense for this device. The design and validation are based on engineering principles, material science, and safety standards.

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LipoSaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. LipoSaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:

• Plastic and Reconstruction Surgery
• Orthopedic Surgery

LS-1000/LS-2000 is an ultrasonic surgical unit which uses ultrasound frequency vibration to fragment, emulsify subcutaneous fatty tissues. The PZT ceramic crystals in handpiece of LS-1000/LS-2000 transforms electrical signal into ultrasonic vibrations, and these vibrations transmit to the probe of LS-1000/LS-2000 which performs the function of fragmenting and emulsifying the subcutaneous fatty tissues. The LS-1000/LS-2000 is able to adjust the operating features such as vibration amplitude and frequency, and provides two modes as follows:

• N mode (continuous mode)
• Z mode (pulsed mode)

This document does not describe acceptance criteria for an AI/ML device, nor does it detail a study that proves a device meets such criteria.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called "LipoSaver™". This device is a suction lipoplasty system, which is a physical device used in surgery to fragment and emulsify subcutaneous fatty tissues. It is an ultrasonic surgical unit that uses PZT ceramic crystals to generate ultrasonic vibrations.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (electrical safety, biocompatibility) and a comparison of physical and functional characteristics. It does not involve AI/ML performance evaluation.

Therefore, the requested information regarding acceptance criteria for an AI/ML device and a study proving it meets those criteria cannot be extracted from this document.

The document details:

• Device Name: LipoSaver™
• Regulation Number/Name: 21 CFR 878.5040, Suction Lipoplasty System
• Regulatory Class: Class II
• Product Code: MUU
• Predicate Device: K190551, VASERlipo System
• Non-clinical tests performed: Biocompatibility (ISO 10993-5, -10, -11, USP 43 <151>), Electrical safety (IEC 60601-1), Electromagnetic Compatibility (EN 60601-1-2). These tests are typically for physical medical devices to ensure they are safe and perform as intended, not for AI/ML performance.
• Comparison of technological characteristics: Operating frequency, cannula dimensions, and primary function are compared to the predicate.

None of the information requested in points 1-9 pertains to an AI/ML device or its performance study.

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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 <151>.
  • 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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For aesthetic body contouring

The MicroAire® Power Assisted Liposuction (PAL) System is a medical device intended to be used for the aspiration of autologous adipose tissue in lipoplasty procedures. The PAL system consists of three components: electric instrument console, handpiece, and cable. The PAL-650 handpiece is powered by the MicroAire 5020 Electric Instrument Control console via the 5006 PAL cable and connected to an independent aspiration source. The PAL-650 handpiece reciprocates a cannula used in liposuction procedures for aspiration of fat tissue.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification for a medical device called the "PAL System" (Power Assisted Liposuction System) manufactured by MicroAire Surgical Instruments, LLC. It details the device's substantial equivalence to a predicate device, the Vibrasat® Power, for the indication of aesthetic body contouring.

The information provided focuses on:

• Regulatory information: FDA clearance, product codes, regulation numbers.
• Device description: Components (console, handpiece, cable), mechanism of action, physical characteristics.
• Comparison to a predicate device: Highlighting similarities and differences in intended use, technology, user, physical characteristics, performance (e.g., strokes/min), electrical safety, and reuse (cleaning/sterilization).
• Non-clinical performance data: Listing various bench tests performed (biocompatibility, electrical safety, EMD, software verification/validation, mechanical tensile testing, sterilization validation, transportation testing).
• Clinical performance data: Stating that no human clinical testing was required because the indications for use are equivalent to the predicate device and the device type has a long history of safe and effective use.

Therefore, the document does not include:

1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
2. Sample sizes or provenance of a test set for AI/ML.
3. Information about experts establishing ground truth for AI/ML.
4. Adjudication methods for AI/ML test sets.
5. MRMC studies for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth (beyond "proven safety and efficacy" for a mechanical device).
8. Sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.

The document describes the regulatory pathway for a conventional medical device, not an AI/ML model.

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MicroAire® PAL® Single-Use Cannulas are 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® PAL liposuction family of instruments is intended to be used 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® PAL Single-Use Cannulas consists of stainless-steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for a standard vacuum (suction) tubing. The MicroAire® Single-Use Cannulas are supplied sterile by the manufacturer through a validated gamma irradiation process. The Single-Use Cannula are offered in various diameters (2.4, 3.0, 4 and 5.0mm diameters), lengths (15, 22, and 30 cm) and with various types of distal fenestrations (Single Port, Mercedes, Bent Flared Mercedes, Double Mercedes, Bent Mercedes, Tri-Port III, Helixed Tri-Port III, Spatula, Multi-Hole, Del Vecchio Track-12).

The provided text is a 510(k) Summary for a medical device (PAL Single-Use Cannulas) and does not describe acceptance criteria, a study proving the device meets those criteria, or any information related to AI/ML performance.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Indications for Use
• Principles of Operation
• Technological Characteristics
• Performance Testing (non-clinical)

Therefore, I cannot provide the requested information. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm only) performance data.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Performance Data" section (point 9 in the K192694 summary) lists various engineering and biocompatibility tests performed (e.g., Sterilization validation, Biocompatibility testing, Mechanical Tensile Testing, Air leakage and tubing connection force test, Vacuum pressure testing, Transportation Testing). These tests have "specifications" or demonstrate compliance (e.g., "Met specifications," "PASSED," "demonstrates SAL of 10^-6"), but these are not the "acceptance criteria" for an AI/ML system's diagnostic performance as implied by your request. They are engineering and safety performance criteria for a physical medical device.

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The Dermapose Access fat harvest system is intended for use in aesthetic body contouring.

The Dermapose™ Access is a pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.

The following are provided sterile with the Dermapose™ Access:

• A pre-assembled polycarbonate housing with a linear needle guidance system and a 12G x ● 51 mm lancet point needle to allow passage of a 14G cannula through the bore;
• A 14G x 150 mm Harvesting/Tumescent Cannula; and
• A silicone tube set with regulator valve, which connects to a user-provided vacuum source o

The Dermapose™ Access is also intended to be used with a user-provided vacuum pump capable of at least 18 inHg (60 kPa) of vacuum in order to lift the patient's skin into the guide cavity. The pump should have a standard barb fitting of approximately 1/4 inch. The use of a collection canister is recommended but is not necessary as fluid should not enter the tubing. To protect the pump from possible fluid ingress, the Dermapose™ Access includes a protective filter.

The provided document is a 510(k) Summary for the Dermapose™ Access device, which is a fat harvest system. It discusses the device's substantial equivalence to a predicate device, st'rim. However, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific performance criteria in the format typically used for AI/ML device evaluations.

Instead, it lists performance testing categories and states that the device "met the acceptance criteria for all tests performed." It does not provide the quantitative acceptance criteria themselves or the detailed results of the tests.

Therefore, I cannot directly extract the comprehensive information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies for this medical device.

What can be extracted or inferred from the document:

The performance testing mentioned are:

• Skin Puncture Test: Evaluated the ability to penetrate skin.
• Reliability Test: Evaluated the reliability of the device.
• Skin Hold and Needle Depth Analysis: Evaluated the performance of the device to hold and puncture skin.
• Cannula Analysis: Evaluated the laboratory testing of the cannula provided.
• Biocompatibility testing: Performed according to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Pyrogen Testing, Determination of Extractable Elements).
• Human Factors and Usability Engineering.
• Sterilization validation: According to ISO 11135:2014/Amd.1:2018.
• Shelf life testing: Based on accelerated aging and ISTA 2A ship testing, resulting in a 24-month expiry date.

The document states that the Dermapose™ Access "met the acceptance criteria for all tests performed" and "was found to be safe and effective for the intended users, uses, and use environments."

Limitations of the provided text for your request:

• Acceptance Criteria & Reported Performance: Not explicitly stated with quantitative values.
• Sample Sizes: Not mentioned for any of the performance tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Number/Qualifications of Experts: Not mentioned as these tests are likely laboratory or engineering tests, not expert-read image analysis.
• Adjudication Method: Not applicable for the types of tests described.
• MRMC Comparative Effectiveness Study: Not conducted or mentioned, as this is a physical medical device, not an AI/ML algorithm requiring human reader comparison.
• Standalone Performance: Not explicitly detailed, but the performance tests listed are likely for the device in isolation or as intended for use by a single operator.
• Type of Ground Truth: Not applicable in the context of AI/ML, as these are engineering and biocompatibility tests.
• Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/ML algorithm.

In summary, the provided FDA 510(k) summary confirms that performance testing was conducted for the Dermapose™ Access device and the results met the acceptance criteria. However, it does not provide the specific quantitative acceptance criteria or detailed results required to complete your requested table and study description for an AI/ML device. The device described is a physical surgical tool, not an AI/ML software.

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