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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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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:

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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 ), 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 .
  • 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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The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.

The provided text is a 510(k) premarket notification for a medical device called the "intelliFat Disposable Adipose Tissue Harvesting and Transfer Kit" (and "intelliFat BOD Kit"). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical setting.

Specifically:

• No table of acceptance criteria and reported device performance is provided. The document is a regulatory filing for substantial equivalence, not a performance report.
• No sample size for a test set or data provenance is mentioned for proving clinical performance. The "nonclinical testing" section describes lab-based tests (biocompatibility, sterilization, packaging, nucleated cell viability), not clinical or performance outcome studies.
• No information about experts used for ground truth, adjudication methods, or MRMC studies is present. These are typically relevant for AI/imaging device evaluations, which this device is not.
• No standalone (algorithm-only) performance is discussed as this is a physical medical device, not an AI algorithm.
• No type of ground truth is specified for clinical performance, as no clinical performance study demonstrating efficacy is detailed.
• No training set sample size or ground truth establishment for a training set is mentioned. This information would be relevant for machine learning models, which this device is not.

The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits." This means the FDA cleared the device based on its similarity in intended use and technological characteristics to existing devices, and not on new clinical performance data from the manufacturer.

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The SyntrFuge™ System is a sterile medical device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system.

The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal, urological surgery, general surgery, gynecological surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired.

Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The SyntrFuge System is a sterile single use disposable medical device, comprised of three AdipoSets. Each AdipoSet is comprised of two AdipoChambers and one AdipoChip, two AdipoChambers attach to the AdipoChip by luer connectors.

The SyntrFuge™ System concentrates lipoaspirate, following a syringe vacuum liposuction method.

The SyntrFuge System is utilized in medical procedures where reinjection of adipose tissue into the same individual during the same surgical procedure is needed.

This document is a 510(k) Pre-market Notification for the SyntrFuge System, a medical device used for processing autologous adipose tissue. The information provided outlines the system's design, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic AI device.

Therefore, many of the requested elements for an AI device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, effect size for human readers) are not applicable to this type of device and submission.

However, based on the provided text, I can infer and extract the relevant information for the acceptance criteria and the type of "study" (which is more accurately described as "performance testing" and "comparison") that proves the device meets those criteria, specifically concerning the Nucleated Cell Viability.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

The core performance metric mentioned for the device's function is centered around the viability of the concentrated adipose tissue.

Additional Information Not Applicable to an AI Device (as requested, but noting their irrelevance here):

2. Sample size used for the test set and the data provenance: Not specified for "cell viability" or other performance tests, as this is a mechanical device rather than an AI model. This is physical product testing, not a data-driven study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for cell viability would be established through laboratory assays, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to laboratory performance testing of a physical 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: Not applicable, as this is not an AI device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Cell Viability," the ground truth would be established through laboratory-based cell counting and viability assays (e.g., trypan blue exclusion, flow cytometry). For other performance tests, it would be engineering specifications and validated test methods.
8. The sample size for the training set: Not applicable, as this is not an AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device requiring a training set or ground truth in that context.

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The Smart Kit is disposable and is indicated for autologous fat transfer is also technically called as autologous fat grafting or reinjection of concentrated adipose-tissue into the recipient body areas. The Smart kit can be used for concentration and transfer of homogenous adipose tissues with legally marketed lipoplasty system when the concentrated and homogenous fat tissue is re-injected into the recipient body areas of the same patient autologously. This device is intended for autologous fat transfer. The Smart Kit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery / Gastrointestinal Surgery / General surgery / Orthopedic Surgery / Gynecological Surgery / Thoracic Surgery / Laparoscopic Surgery / Arthroscopic Surgery / Plastic and reconstructive surgery

The fat harvested by liposuction, called as lipoaspirates, contains fat tissues, bloody impurities and tumescent solution. The harvested lipoaspirates are not appropriate for autologous fat transfer without removal of the bloody impurities and tumescent solution containing anesthetic agent, anti-coagulant agent, antibiotics and etc. In addition, the harvested fat tissues are not homogeneous and contain bigger fibrotic tissues. Smart kit is designed and developed for harvest of a variety of sizes of homogeneous adipose tissues in a closed sterile way for autologous fat transfer surgical technique. Using a separate cannula, Manual handheld suction unit, and plunger, aspirate the adipose tissue or fill the syringe with adipose tissue and centrifuge with the cap in front of the syringe. Centrifuged adipose tissue is divided into blood and fluid layer, adipose tissue layer, and free oil layer. Those are located at the bottom of the piston. After centrifugation, the plunger is pushed unlocked to the piston and free oil is drained to the outside of the syringe as the free oil moves to the top of the piston through the hole at the front of the piston. Open the cap in front of the syringe, lock the plunger completely and push it, the blood and fluid layers at the bottom of the adipose tissue will be drained and only the adipose tissue will remain inside the syringe. Depending on the syringe capacity, there are three types of piston: 10ml, 20ml, 60ml. The built-in filter adapter consists of a filter for separating the fiber and adipose tissue to facilitate movement through needles of lumpy adipose tissues and a body for receiving it. Connect the syringe containing the adipose tissue and the empty syringe to the connection parts at both ends of the built-in filter adapter and push the plunger of the syringe containing the adipose tissue to allow the adipose tissue to pass through the filter. Fiber and adipose tissues larger than the pore size is filtered, and adipose tissue smaller than the pore size of the filter is passed through to separate adipose tissue.

The provided text describes a medical device called "Smart Kit" and its performance testing for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device. However, the document does not contain details of a study proving the device meets acceptance criteria related to a specific AI algorithm or its performance in a clinical setting.

The "Performance Testing" section focuses on physical and chemical properties of the device itself (e.g., appearance, water tightness, material compatibility, sterilization). The "Cell Viability Test" is the most relevant performance metric that could be interpreted as a clinical outcome, but it is a general statement about maintaining cell viability for autologous fat transfer.

Therefore, most of the requested information about AI model performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone AI performance cannot be extracted from this document, as it describes a physical medical device, not an AI algorithm.

Below is a table of acceptance criteria and reported device performance from the document. The remaining requested information is largely not applicable or not provided in the context of this device's clearance.

Acceptance Criteria and Reported Device Performance (Smart Kit)

Study Details (Information Not Provided or Not Applicable to AI Performance)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • Not provided. The document describes performance testing for a physical device, not an AI algorithm evaluated on a clinical test set.
2. 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 is relevant for AI validation studies involving expert annotations, which is not the subject of this document. The 'Cell Viability Test' implies a laboratory-based assessment, not expert interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not applicable/Not provided. This pertains to expert review in AI studies.
4. 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:
   • No. This is not a study about AI assistance or human reader performance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable. The "Smart Kit" is a physical device for autologous fat transfer, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • For the performance tests listed, the "ground truth" would be established by laboratory measurements, physicochemical standards, and biological assays (e.g., cell viability assays). It is not expert consensus, pathology, or outcomes data in the typical sense of AI/clinical studies.
7. The sample size for the training set:
   • Not applicable/Not provided. The document describes a physical medical device. There is no mention of an AI algorithm requiring a training set.
8. How the ground truth for the training set was established:
   • Not applicable/Not provided. No training set is mentioned as there is no AI algorithm being validated.

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