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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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REVOLVE ENVI™ 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

REVOLVE ENVI™ 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040. Suction Lipoplasty System. and assigned product code MUU. The subject device should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe.

The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system:

• Canister (including mesh filter)
• Syringe Adapter
• Temperature Strip
• Lactated Ringer's Tubing Set
• Vacuum Tubing Set

The device is offered in a single size, is packaged in a thermoformed tray and Tyvek® lidding and is sterilized via gamma irradiation. The device is a single-use device to be used in a healthcare facility.

Here's an analysis of the provided text regarding the REVOLVE ENVI 600 Advanced Adipose System, structured according to your request. However, it's important to note that this document is a 510(k) summary for a medical device and not a detailed study report for an AI/ML powered device. Therefore, many of your requested criteria, particularly those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, and standalone performance metrics), are unlikely to be found. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

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

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative targets for each test in a table format. Instead, it states that the tests were performed "to support substantial equivalence" and that "data demonstrate that the device is biocompatible" and "is comparable to the predicate REVOLVE System in product performance characteristics relevant to the intended use of the device."

Below is a table summarizing the types of performance tests conducted. The specific quantitative results or acceptance thresholds for each test are not provided in this summary.

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

This information is not provided in the 510(k) summary. The document describes bench testing, which typically uses laboratory samples or device units, not patient data in the context of AI.

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/provided. The performance evaluation described is for a physical medical device (lipoplasty system) through bench testing and biocompatibility assessments, not an AI/ML algorithm that requires expert-established ground truth from images or clinical data.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI algorithms, which is not the focus of the performance tests described 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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. This 510(k) is for a physical surgical system for adipose tissue processing and does not involve AI assistance for human readers.

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

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

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

This information is not applicable/provided. The ground truth for this device would be established through engineering specifications, material properties, and standardized test methods (e.g., ISO standards for hose collapse, implosion, and sterilization).

8. The sample size for the training set

This information is not applicable/provided as the device is not an AI/ML algorithm.

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

This information is not applicable/provided as the device is not an AI/ML algorithm.

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The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating 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 Dermapose Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use.

The Dermapose™ Refresh is comprised of the following:

1. 50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe
2. Two 30 mL syringes
3. Three luer caps
4. Luer-to-luer adapter

The Dermapose™ Refresh is also intended to be used with Lactated Ringer's solution, injection syringes (1 or 3 mL recommended), injection cannulas (18-21G recommended), and luer-lock harvest cannula (14G recommended) which are provided by the user. Dermapose™ Refresh should be used in conjunction with the 510(k)-exempt Dermapose TM Refresh Stand.

The provided text describes a 510(k) premarket notification for the Dermapose Refresh device. It indicates that performance and biocompatibility testing were conducted, but it does not provide detailed acceptance criteria, reported performance values, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) for the performance testing.

Here's an analysis based on the information available:

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

The document states: "The Dermapose™ Refresh was tested in accordance with established protocols and met the acceptance criteria for all tests performed." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the tests mentioned.

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

• Sample Size for Test Set: Not provided. The document lists types of performance tests (Nucleated Cell Viability, Tissue Composition, System Leak, Mechanical Test), but does not specify the number of samples or runs for any of these tests.
• Data Provenance: Not provided. The document does not specify the origin of the data (e.g., country) or whether the studies were retrospective or prospective.

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 as the described tests (cell viability, tissue composition, leak, mechanical) are objective laboratory or engineering tests, not studies requiring expert interpretation of images or patient data to establish ground truth.

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

This information is not applicable as there were no subjective assessments requiring adjudication described in the provided text.

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. The device, Dermapose Refresh, is a medical device for processing adipose tissue, not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

For the described performance tests:

• Nucleated Cell Viability: The ground truth would be established by the measurements from the Luna-Stem Automated Fluorescence Cell Counter.
• Tissue Composition: The ground truth would be established by analytical methods for assessing adipose tissue layers.
• System Leak: The ground truth would be established by quantitative measurements of vacuum retention.
• Mechanical Test: The ground truth would be established by engineering specifications and measurements of mechanical connections.

These are objective measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. The Dermapose Refresh is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable due to the nature of the device as explained in point 8.

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The JTL Tissue Processing Device is a sterile medical device intended for the processing of lipoaspirate tissue 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: orthroscopic 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 re-implanted, the harvested fat is only to be used without any additional manipulation.

The JTL-250-01 Tissue Processing Device is a centrifuge tube for processing lipoaspirate fat tissue that is intended for autologous homofunctional implant (lipofilling). The device is a pre-assembled, single-use centrifuge tube composed of a collection upper chamber, intermediate chamber, and a lower chamber. The diameter of the JTL Tissue Processing Device is 4.2 inches at the top ring and 3.6 inches in the main body. It stands 4 inches tall. The device weighs less than 1 pound. The components of the device are made of biocompatible materials. The device is sterilized by radiation and is intended for single use only. The JTL Tissue Processing Device is to be used in a healthcare facility. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

The provided text is a 510(k) summary for the JTL-250-01 Tissue Processing Device. This document focuses on demonstrating substantial equivalence to a predicate device (LipoGems System K161636) and does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of analytical or clinical performance of an AI/ML algorithm.

Therefore, many of the requested fields cannot be extracted from this document as they are typically associated with performance studies of diagnostic or prognostic devices, especially those involving AI/ML.

However, I can extract the information related to the device's characteristics and the general performance testing conducted to support its safety and effectiveness.

Here’s what can be extracted based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria for device performance in the context of an AI/ML algorithm's output (e.g., sensitivity, specificity, accuracy). Instead, it lists general performance testing categories.

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 provided in the document. The document refers to "mechanical testing" but does not specify the sample size of devices or the nature of the data (e.g., patient samples) used in these tests, nor their provenance.

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 to the type of device and study described. There is no mention of expert ground truth establishment for a test set, as this is not an AI/ML diagnostic or prognostic device requiring such a process.

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

This information is not applicable. No adjudication method is mentioned as there is no test set involving human interpretation needing adjudication for ground truth.

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. No MRMC study was done, as this is not an AI-assisted diagnostic device.

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

This information is not applicable. This device does not involve an algorithm.

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

For mechanical testing, the "ground truth" would likely be based on established engineering specifications, material science standards, and functional performance benchmarks (e.g., expected fat graft volume, oil separation efficiency). The document indicates "Verification testing of the functional design outputs for the device" and "Performance assessment... with respect to production of fat tissue that is viable and able to be administered". This suggests functional benchmarks were used, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is not an AI/ML device.

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

This information is not applicable. There is no training set for an AI/ML algorithm.

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The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

Not Found

This document is a 510(k) clearance letter for a medical device (Progenikine Concentrating System). It does not contain any information about acceptance criteria, device performance data, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It primarily addresses regulatory aspects such as registration, listing, labeling, manufacturing practices, and adverse event reporting.

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, etc.) from the provided text. This document is a regulatory approval notice, not a study report.

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The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.

The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,

The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge

The KTA Adipose Treatment Kit is a medical device intended for autologous fat grafting procedures. The provided text describes the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" alongside specific performance metrics in a pass/fail format for each criterion. Instead, it lists the types of performance tests conducted and generally states that "All testing met their predetermined acceptance criteria."

However, based on the "Performance Data" and "Performance Testing" sections, we can infer the categories of acceptance criteria and the generalized reported performance:

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

• Test Set Sample Size: The document does not specify the sample sizes used for each individual performance test (e.g., how many cannulas were tested for pressure resistance, how many kits for usability). It refers generally to "bench testing."
• Data Provenance: The studies were non-clinical bench tests performed in vitro "in accordance with ISO/IEC standards and/or internal procedures / European standards." There is no mention of country of origin for the data other than the manufacturer being Stemcis S.A.S. based in France. These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This question is not applicable to the provided information. The studies described are non-clinical bench tests (e.g., material testing, mechanical testing) and not human reader studies or studies requiring expert clinical judgment to establish "ground truth." The "ground truth" for these tests is based on objective measurements against engineering and biological standards (e.g., ISO 10993 for biocompatibility, specified pressure limits for cannulas).

4. Adjudication Method for the Test Set:

• This question is not applicable as the studies are non-clinical bench tests and do not involve human adjudication of results in the traditional sense of clinical studies. Performance is measured against objective, predetermined technical specifications and standards.

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 question is not applicable. The KTA Adipose Treatment Kit is a physical medical device (kit for fat grafting), not an AI algorithm or an imaging device requiring interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable. As stated above, the KTA Adipose Treatment Kit is a physical medical device, not an algorithm. Its performance is evaluated through bench testing of its components and overall function, not through standalone algorithm performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• For the non-clinical performance tests, the "ground truth" is based on:
  • International Standards: e.g., ISO 10993-1 for biocompatibility.
  • Internal Procedures/European Standards: for various mechanical and functional tests.
  • Predetermined Acceptance Criteria: specific numerical or qualitative targets defined for each test (e.g., 3.2 bars air pressure resistance for cannulas, specific cell viability percentages).
  • Objective Measurements: Results are compared against these established standards and criteria.

8. The Sample Size for the Training Set:

• This question is not applicable. The device is not an AI model or algorithm that requires a "training set." The tests performed are to validate the physical device's performance against established safety and efficacy standards.

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

• This question is not applicable for the same reason as point 8.

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The A123 is used for aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation.

The A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use.

The A123 consists of the following components:

• Collection chamber
• Collection mesh basket
• Concentration chamber with fluid-absorbing pads
• AuraClens™ powder packets
• Outlet tube and drain valve with tube clamp
• Mixing spatula

The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.

The provided text describes the 510(k) summary for the AuraGen 123™ Suction Lipoplasty System (A123). This device is a Class II medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The summary details bench testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

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

The document mentions that "The A123 meets the acceptance criteria for all tests," but it does not provide a table detailing the specific acceptance criteria for each test nor the quantitative reported device performance values. It lists the bench tests performed but not the specific thresholds for "meeting" the criteria.

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

The document mentions "A123 units were tested" for various bench tests, but it does not specify the sample size (number of units) used for each test.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's bench testing on manufactured units, rather than a prospective clinical trial.

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 to this type of submission. The ground truth for bench testing of a lipoplasty system involves quantifiable physical measurements and material properties, rather than expert interpretation of medical images or conditions.

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

This is not applicable. Adjudication methods are typically used in studies involving subjective human interpretation (e.g., reading medical images) to resolve discrepancies. For bench testing, the results are typically objective measurements.

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 is not applicable. This submission is for a medical device used for tissue processing, not an AI-assisted diagnostic tool that supports human readers/interpreters.

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

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

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

The "ground truth" for this device's performance evaluation is based on objective, quantitative measurements obtained through standardized bench testing methods (e.g., centrifugation for fat volume, time measurement for TTG, force measurement for tensile strength, and established ISO standards for sterility, biocompatibility, implosion, collapse, and leak tests).

8. The sample size for the training set:

This is not applicable. The device is a physical product and not an AI algorithm that requires a training set.

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

This is not applicable. As stated above, the device is not an AI algorithm.

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The Automatic Tissue Processing Unit is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The Automatic Tissue Processing Unit is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Automatic Tissue Processing Unit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

• Neurosurgery Gastrointestinal Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Arthoscopic 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 etc. In addition, the harvested fat tissues are not homogenous and contain uneven fibrotic tissues. So, for the purpose of in autologous fat transfer surgical technique. ACPU kit is designed and developed for harvest of the fine homologous adipose tissue in a sterile and closed way. ACPU needs to be centrifuged by using exclusive centrifuge (ACS Combo-A-Centrifuge/Product code: JQC) and the kits are single-use only.

Here's an analysis of the provided FDA 510(k) summary regarding the Automatic Tissue Processing Unit, structuring the information according to your requested points:

Device: Automatic Tissue Processing Unit (ACPU-100/ACPU-200)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful results of the specified tests, indicating that the device meets predetermined standards for each parameter. The "Requirements" column serves as the acceptance criteria.

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

The document does not explicitly state the sample size for the "bench tests." The tests listed are primarily physical, chemical, and biological characterization tests performed on the device itself or its materials, rather than a clinical human subject test set. The data provenance is not specified, but these are laboratory tests rather than patient data.

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

Since the tests performed are bench tests (biocompatibility, mechanical, sterility, extraction, cell counts/viability), the concept of "ground truth" established by human experts in a diagnostic or clinical context is not applicable. The ground truth for these tests is based on objective laboratory measurements and established scientific standards (e.g., ISO guidelines, ASTM standards, chemical analysis techniques).

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where human interpretation of medical images or outcomes needs consensus. For the bench tests described, adjudication is not applicable. The "results" are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document describes bench testing to demonstrate functionality and substantial equivalence to a predicate device, not a human reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an Automatic Tissue Processing Unit, a mechanical/biological processing system, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance data in this submission consists of:

• Objective physical measurements: Dimensions, leakage, adhesive strength.
• Chemical analysis results: Residuals of cleaning liquid, pH, KMnO4 reducing agents, evaporating residue, heavy metals, UV-vis spectrum.
• Biological assay results: Nucleated cell count and viability.
• Standardized biological test outcomes: Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis) performed according to ISO standards, where "Pass" is the objective outcome based on the standard's criteria.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The data presented is for validation and verification of the physical device's performance.

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

Not applicable, as there is no training set for this type of device.

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