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The Cytori Puregraft 50 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

The Puregraft 50 System is a sterile, single use, closed system intended for the preparation and delivery of autologous fat grafts back to the same patient for aesthetic body contouring in cosmetic and reconstructive surgery applications. The dual filtration bag system connects to an off the shelf sterile luer lock syringe through a swabable luer activated valves interface. The attached slider is used to facilitate the movement of liquids through the filter mesh and out of the Puregraft bag through the drain stub as waste. The Puregraft 50 System is composed of the following components: Outer Membrane (2), Filter 74 micron (1), Filter 800 micron (1), Tissue Port (1), Drain Port (1), Attached Slider (1). The Puregraft 50mL System is a sterile, single-use, 100mL capacity mixing bag measuring approximately 184 mm x 96 mm and consists of 2 filters layered between a polyvinyl chloride (PVC) outer shell and 2 ports on the bottom of the bag. Each port is labeled and designed to assure the proper connection is made with a luer fitting. The "tissue" port and the "drain" port contains a female swabable luer fitting designed to connect to a luer syringe. The "tissue" port and the "drain" port are designed as one-way valves to assure that the contents within the Puregraft 50mL Bag are not accidently spilled from the bag. The Puregraft 50mL Bag contains two (2) filters that are continuous within the bag. The first filter is a 800 micron filter mesh and the second filter is a 74 micron filter. The Puregraft 50 Bag has an attached plastic "slider" that is used to compress the Puregraft bag as a means to facilitate the movement of liquids through the filter mesh and out of the Puregraft bag to waste; through the "drain" port. All materials are medical grade and DEHP free.

This document describes the Puregraft® 50 System, a device for harvesting, filtering, and transferring autologous fat tissue for reinjection for aesthetic body contouring. The provided information focuses on demonstrating substantial equivalence to predicate devices rather than detailing independent acceptance criteria and a study dedicated solely to proving the device meets those criteria in isolation.

Here's an analysis based on the provided text, addressing your specific questions as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "PASS" outcome in the substantial equivalence testing for various parameters. The "reported device performance" is the achievement of this "PASS" status.

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

The document does not explicitly state the specific sample sizes for the "test set" for each individual parameter (Lipolysis, Wetness, etc.). It mentions that "nonclinical testing was performed" on the Puregraft 50 System and the predicate devices (Puregraft 850/PURE System and Puregraft 250/PURE System). The phrasing implies in vitro testing (bench-top testing) rather than human clinical trials.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating substantial equivalence against predicate devices.
• Data Provenance: The nature of the tests (Lipolysis, Wetness, Lipid Content, RBC, WBC, Integrity Testing) strongly suggests in vitro, laboratory-based studies. There is no indication of country of origin for the data provided, nor whether it was retrospective or prospective in a clinical sense.

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

This information is not applicable and is not provided in the document. The "ground truth" for the tests described (e.g., Lipolysis, Wetness) would be established by laboratory measurement standards and protocols, not by expert consensus in the typical sense of medical image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human assessment where disagreements need resolution. The tests described are laboratory-based.

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 Puregraft 50 System is a mechanical device for processing autologous fat tissue, not an AI or imaging diagnostic tool that would involve human readers or MRMC comparative effectiveness studies.

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

This information is not applicable. The Puregraft 50 System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the "Substantially Equivalent Testing Summary," the "ground truth" for each parameter (Lipolysis, Wetness, Lipid Content, RBC, WBC, Integrity Testing) would be quantitative laboratory measurements compared against predefined thresholds or ranges that demonstrate functional performance and safety consistent with the predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The Puregraft 50 System is a physical device, not an AI model that requires a "training set."

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

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

Summary of the Study:

The provided document describes a nonclinical, bench-top testing study designed to demonstrate the substantial equivalence of the Puregraft 50 System to its predicate devices (Puregraft 250/PURE System and Puregraft 850/PURE System). The study involved performing various tests on the Puregraft 50 System, specifically biological performance verification (Lipolysis, Wetness, Lipid Content, RBC, WBC) and bench-top engineering tests (tensile strength, pressure, and drop testing, summarized as "Integrity Testing"). The results (all "PASS") were then correlated with the performance of the predicate devices to show substantial equivalence. This approach is common for obtaining 510(k) clearance for medical devices, where direct clinical outcome studies are often not required if substantial equivalence to a legally marketed predicate can be shown.

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The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

The Puregraft® 850/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. The Puregraft 850/PURE System consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Puregraft® 850/PURE System is composed of the following components: Puregraft® 850 Bag, Puregraft® 850 Drain Bag, Tissue Access Port Adapter (TAPA), and Luer Lock Syringe Adapter. In addition to the Puregraft® Assemblies described above, the Puregran® 850/PURE System is used in combination with the following Class I hand-held manual instruments provided by Cytori Therapeutics: Easel and Slider.

This document describes the Puregraft® 850/PURE System, a device for harvesting, filtering, and transferring autologous fat tissue. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from the provided text. The document is a 510(k) summary, which typically focuses on demonstrating equivalence to a previously cleared device, not on presenting novel clinical trial results.

Here's an attempt to address your request based on the available information, with clear notations where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for a clinical study. The nonclinical testing mentioned was "bench top testing" comparing the new device to a predicate. The number of units tested for mechanical and biological verification is not specified.
• Data Provenance: The testing was "nonclinical" and involved "bench top testing." It's internal testing conducted by the manufacturer, Cytori Therapeutics, Inc., based in San Diego, California, USA. It is retrospective in the sense that it's comparing against an existing predicate, but the specific testing conducted for this submission would be prospective for the purpose of demonstrating equivalence.

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

• This information is not applicable and not provided because the study described is a nonclinical, bench-top comparison demonstrating substantial equivalence, not a clinical study involving human outcomes or expert assessment of diagnostic accuracy. There was no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method for the Test Set

• Not applicable and not provided. As it was nonclinical bench testing, there was no need for adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable and not provided. This device is a medical instrument for fat tissue processing, not an AI-powered diagnostic or decision-support system involving human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

• Not applicable and not provided. This device is a physical system, not a software algorithm.

7. The Type of Ground Truth Used

• For the nonclinical testing described, the "ground truth" would be engineering specifications and the performance of the predicate device. For example, for tensile strength, the "ground truth" would be a defined breaking point or acceptable range. For biological performance, it would be adherence to established standards or the comparable performance of the predicate device. Specific quantitative metrics for this "ground truth" against which the new device was measured are not detailed in the summary.

8. The Sample Size for the Training Set

• Not applicable and not provided. This is not an AI/ML device that requires a training set.

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

• Not applicable and not provided. This is not an AI/ML device that requires a training set or ground truth for training.

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The Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

The Cytori PureGraft 250/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly.

The Cytori PureGraft 250/PURE System is a medical device used for processing autologous fat tissue for reinjection. The provided text outlines its similarity to predicate devices rather than detailing specific performance testing with acceptance criteria.

Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed because the document focuses on demonstrating substantial equivalence to predicate devices rather than presenting explicit performance metrics and thresholds for the Cytori PureGraft 250/PURE System itself.

However, we can infer some "acceptance criteria" through the lens of substantial equivalence and outline what information regarding device performance is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not provide details on a specific "test set" with a sample size for the Cytori PureGraft 250/PURE System's performance in harvesting, filtering, and transferring fat tissue in a clinical or simulated environment.
• The primary evidence presented is a comparison to predicate devices, focusing on substantial equivalence in design, materials, and indications for use.
• The "Mechanical testing" mentioned is general and does not specify sample sizes or data provenance.

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

• This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparison to existing legally marketed devices rather than de novo clinical performance studies that require ground truth establishment by experts in the context of diagnostic or efficacy claims.

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

• This information is not provided as there is no described test set that would necessitate an adjudication method for establishing 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:

• An MRMC study is not applicable to this device. The Cytori PureGraft 250/PURE System is a medical device for processing fat tissue, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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

• This concept is not applicable to this device. The Cytori PureGraft 250/PURE System is a physical medical device.

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

• The concept of "ground truth" as typically applied to performance studies of diagnostic or image analysis systems is not directly relevant or explicitly stated for this device in the provided text.
• The "ground truth" for substantial equivalence here relies on the established safety and effectiveness of the predicate devices for their indicated uses, and ensuring the new device shares fundamental technological characteristics and indications.

8. The sample size for the training set:

• This information is not applicable as the device is 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 as the device is not an AI/machine learning model.

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Cytori AFT System is used in the aspiration, harvesting, filtering and transfering of autologous tissue.

The Cytori AFT System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Laparoscopic Surgery

The Cytori AFT System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The Cytori AFT System is provided in two packaged assemblies: 1). Cytori AFT Tissue Collection Canister and 2). Cytori AFT Delivery Syringe. The Cytori AFT Tissue Collection Canister is a single-use disposable device designed to utilize house vacuum to create suction within the hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the adipose tissue into the collection canister. The Cytori AFT Delivery Syringe is a, sterile, single-use 60cc piston syringe.

This document is a 510(k) premarket notification for the Cytori AFT System, which is a medical device. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and ground truth methodologies.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not typically part of a 510(k) summary. These summaries primarily focus on comparing the new device's indications for use, technological characteristics, and safety/effectiveness principles to those of existing predicate devices.

Here's an attempt to address your questions based on the provided text, noting where the information is not available due to the nature of a 510(k) submission:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" as a set of quantified performance metrics met by the device in a dedicated study is not presented in this 510(k) summary. Instead, the "acceptance criteria" for a 510(k) submission are largely met by demonstrating substantial equivalence to predicate devices. The performance is assessed through this equivalence, particularly in terms of indications for use, design, materials, and safety/effectiveness.

The document states:

• "Mechanical testing of the Cytori AFT System demonstrates that the device is substantially equivalent to the predicate devices."

This statement implies that the mechanical performance of the device was found to be comparable to established devices, thereby accepting its functionality. However, specific numerical benchmarks for device performance are not provided.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text in the way one might expect for a clinical trial outcome.

Study Information (Based on 510(k) Submission)

Given that this is a 510(k) submission, the "study" referred to is generally a series of tests and analyses (e.g., mechanical, materials, sterilization validation) to support substantial equivalence, rather than a clinical effectiveness study with human participants for de novo approval.

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

   • No specific sample size for a "test set" (in the context of clinical data or image-based AI studies) is provided. The document mentions "Mechanical testing of the Cytori AFT System," but does not detail the sample sizes of devices or tests performed.
   • Data Provenance: Not applicable in the context of clinical trial data. The data provenance would be from internal lab testing and comparisons to predicate device specifications/literature.

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

   • Not applicable. "Ground truth" in the sense of expert consensus on diagnostic imaging or clinical outcomes is not a component of this type of submission. The performance is established through substantial equivalence based on engineering and material comparisons, as well as adherence to recognized standards for sterility and biocompatibility.

3. Adjudication method for the test set:

   • Not applicable. No expert adjudication method is described as there isn't a clinical test set requiring ground truth establishment through human interpretation.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a suction lipoplasty system. The device does not involve "human readers" or "AI assistance" in its intended use.

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

   • No, a standalone algorithm-only performance study was not done. The Cytori AFT System is a physical medical device, not an algorithm or AI software.

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

   • Not applicable for a 510(k) submission of this type. The "truth" in this context is adherence to engineering specifications, material properties, and functionality consistent with legally marketed predicate devices, as demonstrated by mechanical testing and other validations (e.g., sterilization).

7. The sample size for the training set:

   • Not applicable. There is no training set for an AI algorithm mentioned or implied as this is a physical medical device.

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

   • Not applicable for the same reason as above.

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The Cytori Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Laparoscopic Surgery

The Cytori Lipoplasty System is indicated for use when the fragmentation, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The Celase Reagent is intended for use in the fragmentation, disaggregation, and liquefaction of soft tissues and subcutaneous fatty tissues within the Lipoplasty System's Collection Canister.

The Cytori Lipoplasty System with Celase Reagent is provided in two packaged assemblies: 1). Lipoplasty Unit and 2). Celase Reagent. The Lipoplasty Unit is a single-use disposable device designed to utilize house vacuum to create suction within the hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the adipose tissue into the collection canister. The Celase Reagent is a single-use, non-reusable reagent designed to digest the waste tissue in the collection canister as a means to allow the non-reasons rought designed the screen and mitigate down-stream clogging and blockage in the waste system.

The provided text is a 510(k) premarket notification letter and related documentation for the Cytori Lipoplasty System with Celase Reagent. It establishes substantial equivalence to existing predicate devices but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance acceptance criteria.

The document discusses the device's intended use, design characteristics, material composition, and sterility, and it details its equivalence to existing marketed products (MacroPore Lipoplasty System, Flow Laboratories Trypsin, and Oxoid USA Sputasol).

The only mention of "In Vitro Testing" states: "Mechanical testing of the Cytori Lipoplasty System with Celase Reagent demonstrates that the device is substantially equivalent to the predicate." This is a general statement and does not provide specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, or details of a study setup.

Therefore, I cannot provide the requested information.

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The Cytori Celution™ Cell Concentration Device is indicated for the collection, concentration, washing, and reinfusion of autologous cells collected intraoperatively or postoperatively to obtain concentrated blood cells for reinfusion. Such areas of application may include, but are not limited to, the following:

• · General Surgery
• · Cardiovascular Surgery
• · Orthopedic Surgery
• · Vascular Surgery
• · Plastic/Reconstructive Procedures
• Obstetric/Gynecologic Surgery
• · Neurosurgical Procedures
• · Thoracic Surgery
• · Transplantation Surgery
• · Emergency / Trauma Procedures
• Urology Procedures
• · Postoperative Treatment Areas

The Cytori Therapeutics Celution™ Cell Concentration Device consisting of a centrifuge, blood collection canister, peristaltic pumps, pinch valves, sensors, controller and associated vacuum fluorescent display. The Celution Cell Concentration Device weighs approximately 170 lbs, measures 35 inches with a height of 55 inches, and is equipped with lockable caster wheels for portability in the operating room. The Celution Cell Concentration Device is used in conjunction with a sterile disposable set that consists of a blood collection canister, a concentration chamber, a waste bag, and associated tubing. The Disposable Set for the Celution Cell Concentration Device is provided in a separate sterile package and mounted onto the device by the user at the time of use by contacting the tubing with the peristaltic pumps and pinch valves. Various washing solutions are provided by the user and connected to the single-use disposable set through the use of Spike ports attached to the tubing. The user is able to choose between large and small volume disposable sets based on the user's needs. The large volume set (190ml chamber size) is referred to as the "Macro" disposable set while the small volume set (70ml chamber size) is referred to as the "Micro" disposable set. The Macro and Micro disposable sets consists of the same essential configuration of tubing, bags, rotating seal, etc., and operate on the same essential principles of peristaltic pumping to transmit fluids, centrifugation, etc. The Macro and Micro disposable sets differ with respect to their collection chambers and continuous processing capabilities as the 190 ml chamber can only process one time and must have product removed from the chamber with a syringe and needle. The 70 ml chamber can process multiple runs and pump the cellular product to a pull/donif interface. The centrifuge of the Celution Cell Concentration Device concentrates and pellets the cells in the concentration chamber and the peristaltic pumps and associated pinch valves interact with the disposable tubing to remove the superitiation from the pelleted cells and deliver the waste to the waste bag. The Celution Cell Concentration Device then washes the cells by delivering the user-provided washing solutions to the cells through the use of the same peristaltic pumps and pinch valves. After the wash cycles, the pelleted cells are them available for use by the physician. The Celution Cell Concentration Device is operated by the user through use of a menu driven user interface. The device operates on a user interaction principle through use of the key pad by requiring the user to confirm the completion of prompted tasks. The device also comprehends timing on to the next programmed step. The device also comprehends programmed steps as there are sensors built into the device to confirm the execution of critical tasks and/or equipment error conditions.

The provided text describes a 510(k) submission for the Cytori Celution Cell Concentration Device, which is intended for the collection, concentration, washing, and re-infusion of autologous cells. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and detailed performance studies against those criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided document. The document describes "Design Verification Testing" generally, stating that performance is substantially equivalent to predicate devices with respect to "key cellular components" and that mechanical and safety testing demonstrated substantial equivalence in areas like "sterility, biocompatibility, durability, reliability, electrical safety, and software validation." However, no specific quantitative acceptance criteria or detailed study results are provided for these aspects.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

This information is not explicitly stated in the provided text. The document claims substantial equivalence in performance to predicate devices regarding "key cellular components" and in mechanical/safety aspects, but it does not provide a table with specific, quantifiable acceptance criteria and the device's measured performance against them.

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

This information is not explicitly stated in the provided text. The document mentions "Design Verification Testing" and "Test results," but it does not provide details on the sample size of the test set, the type of data (e.g., in vitro, animal, human), or its provenance (country of origin, retrospective/prospective).

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

This information is not explicitly stated in the provided text. Given that the submission focuses on substantial equivalence and general performance claims rather than a clinical efficacy study with ground truth established by experts, this detail is not provided.

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

This information is not explicitly stated 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

An MRMC study is not mentioned or implied in the provided text. This device is an "Autotransfusion Apparatus" for cell concentration, not an AI-assisted diagnostic tool that would typically involve human readers.

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

This concept is not applicable as the device is a physical cell concentration system, not an algorithm in the typical sense of AI or software-only performance. The device's "Celution firmware logic" and "user interaction principle" are mentioned, implying it operates automatically once initiated by a user, but it's not discussed in terms of standalone "algorithm performance" in the context of diagnostic algorithms or interpretations.

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

This information is not explicitly stated in the provided text. Given the nature of the device (cell concentration), "ground truth" would likely relate to quantifiable cellular parameters (e.g., cell viability, concentration, purity) rather than diagnostic outcomes. However, the document does not detail how the "key cellular components" performance was benchmarked or what "ground truth" standard was used.

8. The sample size for the training set

This information is not explicitly stated in the provided text. The phrase "training set" typically refers to machine learning. While the device contains "firmware logic" and operates on a "user interaction principle," there's no indication of a machine learning component requiring a training set in the conventional sense detailed in the document.

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

This information is not explicitly stated in the provided text, and as mentioned for point 8, the concept of a "training set" for machine learning is not discussed in this submission.

Summary of what is available regarding "acceptance criteria" and "study":

The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific, predefined acceptance criteria through a detailed performance study with explicit numerical targets.

The study described is "Design Verification Testing" which showed:

• The performance of the Cytori Celution Cell Concentration Device is substantially equivalent to the predicate device in yielding a blood product with respect to key cellular components.
• Mechanical and safety testing demonstrated substantial equivalence to the predicate device with respect to sterility, biocompatibility, durability, reliability, electrical safety, and software validation.

The document does not provide details on the methodologies, specific metrics, or quantitative results of these "Design Verification Testing" studies, nor does it list explicit predefined acceptance criteria that were met.

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