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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 | <5N |
| Exposure and retraction force | <15N |
| Detachable limit buckle | Present |
| 360° rotation in LiNA OperaScope | Confirmed |
| Distention fluid clearance | Confirmed |
| Blockage of OperaScope camera | No blockage (implied by meeting functional requirements) |
| Inability to pass needle with protective cap through OperaScope working channel | Confirmed (intentional design feature for safety) |
| Insertion and extraction force to/from OperaScope working channel | <10N |
| Other Tests | |
| Visual Inspection | Met (implied by successful testing) |
| Device Geometric Dimensions | Met (implied by successful testing and comparison to predicate) |
| Device Weight | Met (implied by successful testing and comparison to predicate) |
| Device Surface | Met (implied by successful testing) |
| Device Robustness | Met (implied by successful testing) |
| Biological Risk Assessment | Met (implied by successful biocompatibility and bioburden evaluation) |
| Bioburden Evaluation | Met |
| Endotoxin/LAL Evaluation | Met |
| Distention fluid clearance | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not specify the exact sample sizes for each functional bench test. The studies were non-clinical performance tests conducted by LiNA Medical ApS, which is based in Glostrup, Denmark. The data provenance is internal testing by the manufacturer. The tests are prospective in nature, as they are conducted on newly manufactured devices to ensure they meet specifications.
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)
Not applicable, as this is a non-AI/ML device. The "ground truth" for this device is based on engineering specifications and international standards (e.g., ISO 10993 for biocompatibility) rather than expert interpretation of medical data. The tests are objective measurements of physical properties and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling of medical images, which is not relevant here. The tests involve direct measurement and evaluation against predefined physical and performance criteria.
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
Not applicable, as this is a non-AI/ML device. MRMC studies are used for evaluating the impact of AI on human reader performance, which does not apply to a surgical needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a non-AI/ML device. "Standalone performance" refers to the performance of an AI algorithm without human involvement, which is not relevant for a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional tests, the "ground truth" is defined by the device's engineering specifications and established performance limits (e.g., insertion force <5N).
For biocompatibility, the ground truth is established by adherence to recognized international standards such as ISO 10993 and USP <151>.
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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