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Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Tissu Trans Filtron Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.

Tissue Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

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

Shippert Medical's Tissu Trans Filtron Syringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, K092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.

Here's a breakdown of the acceptance criteria and the study details for the Tissu Trans Filtron Syringe Fill, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for Test Set and Data Provenance:

   • Sample Size: Not explicitly stated, though referred to as "clinical testing."
   • Data Provenance: Prospective (clinical testing was "conducted by Ronald D. Shippert, M.D. to validate and verify that the proposed device met all design specifications"). No country of origin is specified beyond it being a U.S. 510(k) submission, implying U.S. based.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Number of Experts: One, Ronald D. Shippert, M.D.
   • Qualifications: "Ronald D. Shippert, M.D." (presumably a medical doctor, likely a surgeon given the device's application). No specific years of experience are listed.

3. Adjudication Method for the Test Set:

   • Method: Not applicable. The "clinical testing" was conducted by a single physician without mention of additional adjudicators.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done?: No. The summary describes a single-operator clinical evaluation without a comparative effectiveness study involving multiple readers (human readers with/without AI assistance).
   • Effect Size: Not applicable.

5. Standalone (Algorithm Only) Performance Study:

   • Was it done?: Not applicable. This device is a physical medical instrument (suction lipoplasty system accessory) and does not involve an algorithm or AI.

6. Type of Ground Truth Used:

   • Type: Clinical assessment/expert judgment. The ground truth was established by Ronald D. Shippert, M.D.'s clinical evaluation, where he determined if the device performed as desired, was safe and effective, and met design specifications.

7. Sample Size for the Training Set:

   • Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "clinical testing" referenced serves as the performance evaluation for the device itself.

8. How the Ground Truth for the Training Set Was Established:

   • Method: Not applicable, as there is no training set for an AI/ML algorithm.

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The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,

Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

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

The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister.

The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.

The provided text is a 510(k) summary for the Shippert Medical Technologies Tissu Trans Filtron, a suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them as would be seen in a clinical trial for a new therapeutic device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "reported device performance" is summarized as being "safe and effective," and performing "as desired," implying it met the functional expectations for a device of its type and was comparable to the predicates in terms of safety and efficacy.

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Ask a specific question about this device