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

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated or implied)
Functional Equivalence: Device performs the same intended functions (aspiration, harvesting, filtering, transferring autologous tissue) as legally marketed predicate devices.	The Cytori AFT System is designed for and intended for use in the aspiration, harvesting, filtering and transferring of autologous tissue, mirroring the function of predicate devices like Shippert Medical Tissu-Trans, MacroPore Puricel Lipoplasty System, Exel International Disposable Syringe, and Genesis Biosystems Lipivage.
Safety Equivalence: Device presents no new questions of safety or effectiveness compared to predicate devices. This includes material biocompatibility, sterility, and mechanical integrity.	Components in patient contact are surgical stainless steel. The device is sterilized by EtO gas, which is a common and accepted sterilization method. Mechanical testing confirmed substantial equivalence to predicate devices. There is no information suggesting new safety concerns compared to predicate devices.
Technological Characteristics Equivalence: Device shares similar design principles, materials, and operating mechanisms with predicate devices.	The Cytori AFT System's design (collection canister with filter, cannula, connection tubing, delivery syringe) and materials (polycarbonate, stainless steel, polypropylene, PVC) are stated to be substantially equivalent to the predicate devices. It uses house vacuum and manual operation, similar to the cited predicates. Key shared characteristics include the use of a polycarbonate tissue collection canister with flexible tubing, a stainless steel cannula, a filtering mechanism, and connection ports for suction and waste.
Intended Use Equivalence: The device has the same intended use as predicate devices.	The Cytori AFT System and the predicate devices "are substantially equivalent with respect to their indications for use, as they are all indicated for the same surgical procedures of aspirating, harvesting, filtering, and transferring autologous tissues." The specific surgical specialties are also listed as being covered.

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.

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.
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.
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.
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.
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.
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).
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.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

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