(44 days)
The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center 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.
The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:
- Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
- Suction Jar without Luer Lock extension 1,500 and 2,500 ml
- Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection
The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.
The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance in the specific format you've outlined.
The document is a 510(k) premarket notification for "MMT Autoclavable Suction Jars and Lids." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed study with acceptance criteria for a novel device's performance characteristics in the way you've described for AI/algorithm-based studies.
Here's why I cannot fulfill your request based on the provided text:
- No specific acceptance criteria or performance metrics are provided for the device itself. The document mentions "Performance testing has demonstrated that the products' efficacy and effectiveness is substantially equivalent to the predicate device," but it does not quantify this efficacy or effectiveness with specific numerical targets.
- The device is a physical medical device (suction jars and lids), not an AI algorithm. Therefore, concepts like "test set," "training set," "ground truth established by experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance" are not applicable in this context.
- The "studies" mentioned are nonclinical tests related to biocompatibility, leakage, sterilization validation, and cleaning validation, which are standard for physical medical devices but are not performance studies in the sense of accuracy, sensitivity, or specificity that would have acceptance criteria for an AI diagnostic tool.
- No human readers or experts were involved in establishing ground truth for a diagnostic outcome, as this is a device for collecting fat, not for making a diagnosis.
The information available regarding studies is:
- Nonclinical Tests:
- Biocompatibility tests: ISO MEM Elution, ISO Intracutaneous Irritation Test, ISO Acute Systemic Injection Test, ISO Guinea Pig Maximization Sensitization Test.
- Leakage and compatibility of Collection Jars with Lids and Liners.
- Accuracy comparison of MMT Fat Collection and Transfer Devices to the comparative predicate device (no specific metrics or methodology provided).
- Gamma Irradiation Sterilization Validation (ISO 11137-1:2006; Amd. 1, 2013).
- Cleaning Validation (AAMI O TIR30:2011 Guidance document).
- Sterilization Validation for a gravity autoclave (TIR N0. 12-2004 and ISO 17665-1:2006/(R) 2013).
- Clinical Tests: "Not applicable."
- Conclusion: "Performance testing has demonstrated the product's efficacy." and "The MMT Fat Collection and Transfer Devices have been demonstrated to be substantially equivalent to the predicate device."
Without a document describing a performance study with defined acceptance criteria and specific outcomes (like sensitivity, specificity, AUC, etc.) for a diagnostic or AI-driven device, I cannot generate the table or answer the specific questions you've posed.
§ 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.