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510(k) Data Aggregation
(142 days)
LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.
LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.
The provided text does not describe an AI/ML device, therefore, the requested information focusing on acceptance criteria and studies for such devices, including details like test set provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set specifics, is not applicable.
The document discusses the substantial equivalence of a medical device, the LiNA OperaScope™ Needle, to a predicate device (Cook Injection Needles). The acceptance criteria and supporting studies are related to the physical performance, biocompatibility, and shelf-life of this non-AI medical instrument.
Here's the relevant information based on the provided text, adapted to the context of a physical medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Bench Testing) | Reported Device Performance |
|---|---|
| Insertion in Tissue | . |
| For sterilization and shelf-life, the ground truth is established by validated scientific methods confirming sterility and stability over time. |
8. The sample size for the training set
Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for a physical medical instrument.
9. How the ground truth for the training set was established
Not applicable, as this is a non-AI/ML device.
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