(47 days)
The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.
The provided text is a 510(k) summary for the ConMed Axcess Papillotome, which describes a medical device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested elements for a study on acceptance criteria and device performance cannot be extracted directly from this document.
However, I can extract information related to what was provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | The Axcess Papillotome meets electrical safety standards. |
| In-vitro Performance | In-vitro testing was conducted which demonstrated that the device meets its performance specifications. |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document mentions "in-vitro testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not stated. This information is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.
4. Adjudication method for the test set
- Not applicable/Not stated. This detail is usually found in studies involving human readers or expert consensus on interpretations.
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
- No. This is a medical device clearance document, not a clinical study involving AI or MRMC.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device described is a physical medical instrument (papillotome), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For electrical safety, the ground truth would be compliance with established electrical safety standards.
- For in-vitro performance, the ground truth would be pre-defined performance specifications for the device's mechanical and functional characteristics.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is relevant to this device's clearance.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes performance testing which included:
- Electrical safety standards compliance.
- In-vitro testing to demonstrate the device meets its performance specifications.
The exact details of these tests (e.g., specific protocols, number of samples tested, specific "performance specifications") are not elaborated in this 510(k) summary but would have been part of the more extensive 510(k) submission to the FDA. The basis for clearance is substantial equivalence to predicate devices (Bard Apollo Papillotome K982557 and Boston Scientific Corporation Autotome K013153), rather than extensive clinical efficacy trials typically associated with AI or novel therapeutic devices. The document explicitly states: "The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications." and "The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate."
§ 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).