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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 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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