(257 days)
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.
The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.
The provided text is a 510(k) summary for an "Introducer Needle" device. It outlines the device's comparison to a predicate device and the performance data submitted to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
The performance data section (9. Performance Data) details physical and chemical performance testing, biocompatibility testing, and packaging/shelf-life testing, which are standard for medical devices like introducer needles. These tests are to demonstrate the device meets design requirements and performs as intended, but they do not involve acceptance criteria related to algorithmic performance, expert image interpretation, or human reader improvement with AI assistance.
Therefore, I cannot provide the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device, as this document pertains to a physical medical device.
Here's what I can extract from the provided text regarding the physical device's "acceptance criteria" and "performance data" if interpreted broadly:
Acceptance Criteria and Reported Device Performance (Physical Device)
The document doesn't explicitly list "acceptance criteria" in a table format with specific quantitative thresholds that need to be met for each test for the "Introducer Needle." Instead, it states that "Performance testing was performed in accordance with applicable clauses in ISO 9626-2016 and ISO 7864-2016" and that the testing was "to demonstrate that the Introducer Needle met applicable design requirements." The conclusion then states, "The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended."
However, based on the performance tests listed, we can infer the "acceptance criteria" are implied by meeting the standards of ISO 9626-2016 (presumably for stainless steel needle tubing for the manufacture of medical devices) and ISO 7864-2016 (likely for sterile hypodermic needles for single use).
Here's a representation of the implied acceptance criteria based on the testing performed, and the "reported performance" is that the device met these criteria.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility: | |
| No Skin Sensitization (ISO 10993-1) | Met (passed testing) |
| No Intracutaneous Reactivity (ISO 10993-1) | Met (passed testing) |
| No Acute Systemic Toxicity (ISO 10993-1) | Met (passed testing) |
| Apyrogenicity (ISO 10993-1) | Met (passed testing) |
| Physical & Chemical Performance (ISO 9626-2016, ISO 7864-2016): | |
| Adequate Flow Rate | Met (passed flow test) |
| Appropriate Penetration Force | Met (passed penetration force test) |
| Sufficient Stiffness | Met (passed stiffness test) |
| Resistance to Breakage | Met (passed resistance to breakage test) |
| Secure Bond between Hub and Needle Tube | Met (passed bond test) |
| Ultrasound Detectability (if specified) | Met (passed ultrasound detection test) |
| Resistance to Corrosion | Met (passed corrosion test) |
| Packaging & Shelf-life: | |
| Maintenance of Sterility | Met (passed sterilization packaging test) |
| Maintenance of Performance over Shelf-life (2 years) | Met (passed shelf-life test for 2 years) |
Other Requested Information (Not Applicable to this Document as it's not an AI/ML Device)
The following points are not applicable to the provided document, as it describes a physical medical device (introducer needle) and not an AI/Machine Learning device. Therefore, information regarding AI/ML-specific testing is absent.
- Sample sizes used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. The "test set" here refers to physical units subjected to tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to engineering specifications and performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For this physical device, the ground truth is established by the specified engineering standards (ISO 9626-2016, ISO 7864-2016) and biocompatibility standards (ISO 10993 series).
- The sample size for the training set: Not applicable (no ML training).
- How the ground truth for the training set was established: Not applicable (no ML training).
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