Search Results

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

The MacroPore Puricel Lipoplasty System is a single use, pre-assembled, manual lipoaspirate system that relies on house vacuum for its energy supply. The MacroPore Puricel Lipoplasty System consists of a cannula, connection tubing, and a waste collection container. The cannula handle is attached to the collection canister via connection tubing. The cannula is a hollow tube with a single opening near the tip to communicate house-vacuum to the tissues and subsequently fragment. emulsify, and aspirate subcutaneous fatty tissues from the patient into the waste collection canister for purposes of aesthetic body contouring. The collection canister contains various capped / sealed ports and a filter to trap large tissue masses

The Puricel Lipoplasty cannula is provided in various sizes ranging from 15cm - 36cm in length and 3.0 ~ 4.6mm in diameter with a single opening near the tip of the cannula. The tip region of the cannula may have a single or multiple openings that range in size from 4mm to length distributed uniformly or randomly throughout the end of the cannula. The handle of the device is 20mm in diameter and may be provided in diameters ranging from 20mm in diameter. The connecting tubing is provided with an inner diameter of 9.6mm (3/8"), an outer diameter of 14.3mm (9/16"), and a wall thickness of 2.2mm. The tubing that connects the cannula handle to the waste canister is provided in a length of 4 feet and may be provided in lengths ranging from 1 - 8 feet. The bottom of the waste collection container is also provided with the same 3/8" inner diameter connection tubing of various lengths. The proximal end of the exiting connection tubing may be provided with a barbed tubing connector to assist in the attachment of like-sized tubing for purposes of connecting the MacroPore Puricel Lipoplasty System to house vacuum and / or assorted waste traps. Connection tubing leading to and from the waste collection container is provided with a stepped clamp to allow the operator to seal the connection tubing on both sides of the waste container and prevent spillage of the collected fluids / tissues.

This response is based on the provided text, which details an FDA 510(k) clearance letter for the "Macropore Puricel Lipoplasty System." This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific performance metrics and acceptance criteria for the new device as would be found in a clinical trial report or a performance study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully extracted in the manner typically associated with an AI/device performance study. The document primarily describes the device and its substantial equivalence to previously cleared lipoplasty systems.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and precise performance metrics are not explicitly stated. The FDA 510(k) clearance process, as reflected here, primarily assesses "substantial equivalence" to a predicate device rather than setting new, quantitative performance benchmarks for the new device in terms of clinical outcomes or specific efficacy and safety percentages.

However, the document implies that the device "meets" its intended purpose by demonstrating substantial equivalence to predicate devices already on the market. The "performance" described is in terms of design characteristics and intended use being similar to existing cleared devices.

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

The provided document describes in vitro testing ("Mechanical testing of the MacroPore Puricel Lipoplasty System") rather than a clinical study involving a "test set" of patient data. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The testing appears to be primarily laboratory-based mechanical testing to demonstrate functional equivalence.

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

As there is no mention of a "test set" of patient data or a clinical study with human interpretation, this information is not applicable. The "ground truth" for this regulatory submission is established by demonstrating equivalence to existing, legally marketed devices.

4. Adjudication Method for the Test Set

Again, this information is not applicable as the document does not describe a clinical study requiring adjudication of a test set.

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 described is a physical medical device (lipoplasty system) and not an AI-powered diagnostic or assistive technology 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 surgical tool, not an algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" for demonstrating the safety and effectiveness of the MacroPore Puricel Lipoplasty System is its substantial equivalence to predicate devices that have already been cleared by the FDA and are legally marketed. The predicate devices identified are:

• Byron Medical Lipoplasty / Liposuction and Tumescent Infusion Cannulae and Needles (cleared under K981172)
• Sound Surgical Soundvaser System (cleared under K022051)

The grounds for equivalence are based on shared indications for use, similar design principles (hollow tubular cannulas, connection tubing, waste collection container), and comparable materials.

8. The Sample Size for the Training Set

This information is not applicable. The document describes a physical medical device, not a machine learning or AI algorithm that requires a "training set."

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

This information is not applicable as the concept of a "training set" for an algorithm is not relevant to this device's submission.

Ask a specific question about this device