(63 days)
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures. The Safety Wire Guide Introducer includes an obturator and sheath. The radiopaque polyethylene obturator is 7.0 French, 25.7 cm in length, and has a 1 cm taper along the distal tip of the device. It can be inserted through the radiopaque polyethylene introducer sheath that is 12.0 French, 22.2 cm in length, and tapers 6 mm from the distal end of the device.
The provided document is a 510(k) premarket notification for a medical device called the "Safety Wire Guide Introducer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies or defining strict performance acceptance criteria in the same way one might for an AI/ML device.
Therefore, the information required to fully answer the request (especially regarding acceptance criteria, study details, expert involvement, and comparative effectiveness studies for AI) is not present in the provided document. The device is a physical medical instrument, not an AI/ML algorithm.
However, I can extract the available performance data and how it demonstrates "acceptance" in the context of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
In a 510(k) for a physical device, "acceptance criteria" are typically the successful completion of specified engineering and biocompatibility tests in accordance with recognized standards and FDA guidance. The document states that "All predetermined acceptance criteria were met." Specific numerical criteria are not detailed in this summary, but the categories of testing performed are listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Testing | Met |
| Tensile Strength | Met |
| Assembly After Kinking Testing | Met |
| Obturator/Sheath Tip Rollback Testing | Met |
| Radiopacity Testing | Met |
| Biocompatibility Testing | Met (conforms to requirements; all evaluation criteria met for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-mediated Pyrogenicity) |
| Sterilization | Met |
| Package integrity and stability | Met |
| Shelf-life | Met |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. For engineering and biocompatibility tests, sample sizes are typically determined by relevant ISO standards or internal statistical rationale, but these details are not provided in this 510(k) summary.
- Data provenance: Not explicitly stated, but these tests would have been conducted in a controlled laboratory environment by the manufacturer (Cook Incorporated) or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not directly applicable to the testing of a physical device like a wire guide introducer. "Ground truth" in this context would refer to the physical properties measured and assessed against engineering specifications, which are determined by instrumentation and established test methods, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set:
Not applicable in the context of physical device testing. Results are typically quantitative measurements compared against predefined engineering specifications.
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. This device is a physical medical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument.
7. The type of ground truth used:
For the listed performance tests, the "ground truth" would be the objective measurement of physical properties (e.g., length, tensile strength, radiopacity, biological reaction) compared against predefined engineering specifications and biocompatibility standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in that sense.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the provided document is a 510(k) summary for a conventional, physical medical device. It details the engineering and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance characteristics of an AI/ML system.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).