(137 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Puregraft 50) | Related Predicate Device Performance (Puregraft 250) | Correlation to Predicate |
|---|---|---|---|
| Lipolysis (fold change) within limits | PASS | PASS | Substantially Equivalent |
| Wetness (% of control) within limits | PASS | PASS | Substantially Equivalent |
| Lipid Content (% of control) within limits | PASS | PASS | Substantially Equivalent |
| RBC (% of control) within limits | PASS | PASS | Substantially Equivalent |
| WBC (% of control) within limits | PASS | PASS | Substantially Equivalent |
| Integrity Testing (e.g., tensile strength, pressure, drop testing) within limits | PASS | PASS | Substantially Equivalent |
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.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.