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510(k) Data Aggregation
(113 days)
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.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Components in indirect patient contact meet ISO 10993 for External Communication Devices, Tissue contact, < 24 hours. | All components passed ISO 10993 testing regimen for External Communication Devices, Tissue contact, of less than 24 hours. Biocompatibility testing was performed on the sterile, finished device. |
| Sterility: Device is sterile. | The Tissu Trans Filtron is sterilized by Gamma Radiation. |
| Mechanical Performance: Device functions as intended for aspiration, harvesting, filtering, and transferring autologous tissue. | Mechanical testing demonstrates the device is substantially equivalent to the predicate device. Clinical testing performed by Ronald Shippert, M.D. demonstrated the device performed as desired and was safe and effective. |
| Safety and Effectiveness (Clinical): Device is safe and effective for its intended use (collection of aspirated fat for aesthetic body contouring; if untreated, reinjection). | Clinical testing performed by Ronald Shippert, M.D., proved to be safe and effective. The device performed as desired and was as safe and as effective as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical testing performed by Ronald Shippert, M.D." but does not specify the sample size for this clinical testing. It also does not provide information on the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "clinical testing performed by Ronald Shippert, M.D." as validating the device's performance, implying he acted as an expert. No other experts are mentioned, nor are specific qualifications beyond "M.D." provided. Given the context of a 510(k) summary for a medical device used in aesthetic procedures, Ronald Shippert, M.D., is likely a surgeon with experience in lipoplasty.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information on adjudication methods is provided in the document.
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
No MRMC comparative effectiveness study was done. This device is a physical medical device (suction lipoplasty system), not an AI-driven diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for device performance appears to be based on the subjective assessment of "safety and effectiveness" by a medical professional, Ronald Shippert, M.D., likely through observing surgical outcomes and device functionality during procedures. Given the nature of a lipoplasty system, "outcomes data" in terms of successful fat aspiration and contouring, as well as absence of adverse events, would form the practical ground truth, evaluated by the operating physician. No objective pathology or extensive outcomes data is explicitly mentioned beyond the physician's assessment.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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