(59 days)
The Microvasive® Needle Knife Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive Needle Knife can also be used to cannulate and inject contrast medium.
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This document is a 510(k) summary for the Microvasive® Needle Knife Sphincterotome. It outlines the manufacturer's claim of substantial equivalence to previously marketed devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner requested by the prompt.
Therefore, much of the requested information regarding "acceptance criteria" and "study data" for an AI/device performance evaluation is not applicable here because this document describes a traditional medical device (a sphincterotome) undergoing a 510(k) clearance process, not an AI or software as a medical device (SaMD).
However, I can extract the relevant information from the document that touches upon performance and equivalence.
Here's the breakdown of what can be extracted and what information is not present based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (from document) |
|---|---|
| Safety: Biocompatibility | Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. |
| Safety: Sterilization | Sterilized using ethylene oxide gas using the AAMI protocol. |
| Safety: Pyrogenicity | Pyrogenicity testing performed periodically to monitor bacterial endotoxin levels. |
| Performance: Functional Equivalence | Laboratory testing performed to verify safety and performance. Believed to be substantially equivalent in design and materials to predicate devices. |
| Intended Use: As specified | Indicated for transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. Can also be used to cannulate and inject contrast medium. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes "laboratory testing" and a "biocompatibility assessment," but it does not specify a "test set" in the context of clinical trial or AI model validation. It's a medical device clearance, not a data-driven performance study in the way the prompt implies.
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. This is not an AI or diagnostic device where expert ground truth for a test set is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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 is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's clearance would be its compliance with material standards, sterilization protocols, and functional performance in laboratory settings, as well as its similarity to previously cleared predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of what the document does provide regarding device performance:
The document focuses on establishing substantial equivalence to existing legally marketed devices (Microvasive® Rapid Exchange Sphincterotome and Ultratome XL™ Triple Lumen Sphincterotome).
Key points from the document regarding performance:
- Laboratory testing: Stated that "Laboratory testing regarding characteristics was performed on the Microvasive® Needle Knife Sphincterotome to verify its safety and performance." However, no specific performance metrics or detailed results from this testing are provided in the summary.
- Biocompatibility: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Microvasive® Needle Knife Sphincterotome with satisfactory results."
- Sterilization: The device "will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization."
- Pyrogenicity: "Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels."
- Conclusion: The manufacturer "believes that Microvasive® Needle Knife Sphincterotome is substantially equivalent... A comparison of the descriptive characteristics of these products demonstrate the Microvasive® Needle Knife Sphincterotome is equivalent in its indications for use, while being very similar in design and materials."
In essence, this 510(k) summary asserts that the new device is safe and effective by demonstrating its similarities to already approved devices and by confirming basic safety aspects through laboratory tests, rather than providing a detailed study with specific performance metrics against a defined acceptance criterion.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).