(77 days)
The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.
The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating. The High Flow papillotome luer fitting is PVC and the handle assembly material is ABS. The High Flow papillotome electrode assembly is similar in construction to the Bard Proforma except that the set screw is stainless steel versus nickel plated brass. The High Flow papillotome shaft is an 8 french O. D. that tapers to 5.5 french tip O. D.
The provided text is a 510(k) summary for a medical device (Bard® High Flow Papillotome) and describes a comparison to predicate devices, rather than a study with acceptance criteria and reported device performance in the way a clinical trial or AI validation study would.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable in the context of this document. This document focuses on demonstrating substantial equivalence to existing devices based on material comparisons, functional tests, and in-vitro performance, not on a new clinical study with specific acceptance criteria as you've described.
To address your request by interpreting the document as best as possible within its context:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) summary focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" refers to how the new device compares to these predicates in specific technical aspects.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Bard® High Flow Papillotome) |
|---|---|
| Movement through side viewing endoscope & guidewire movement: Equivalent to Bard ProForma Papillotome and Microvasive Sphincterotomes. | Comparative movement testing: Demonstrated substantial equivalence to predicate devices. |
| Electrical safety: Meets national/international standards for electrosurgical accessories (e.g., ANSI/AMMI HF18-1993). | Electrical testing: Confirmed the High Flow papillotome meets the requirements of the ANSI/AMMI HF18-1993 standard. |
| Biocompatibility: Materials are safe for contacting mucosa and tissue, similar to commonly used materials in medical devices (implicitly, predicate devices). | Biocompatibility testing: Confirmed the materials used for the proposed High Flow papillotome are safe for contacting mucosa and tissue. (Note: materials are described as "commonly used" in the industry, implying safety by common usage, and further confirmed by testing). |
| Flow rate: Equivalent to Microvasive® Ultratome XL sphincterotome. | In Vitro flow testing: Confirmed the device is substantially equivalent to the Microvasive® Ultratome XL sphincterotome. |
| Mechanical integrity/functionality: Adequate bow force, bow orientation, radiopacity, and joint integrity (implicitly, similar to predicate devices). | Additional tests: Bow force, bow orientation, radiopacity, and joint integrity tests were completed to confirm device safety and effectiveness. (No specific numerical results or direct comparison to predicates are given for these, but "confirmed" implies they met expectations for safety and effectiveness). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "Comparative movement testing," "Electrical testing," "Biocompatibility testing," "In Vitro flow testing," and "Bow force, bow orientation, radiopacity and joint integrity tests." These are likely benchtop or in-vitro tests, not clinical studies with human patient sample sizes. The number of samples/units tested is not provided.
- Data Provenance: The tests are in-vitro/benchtop. There is no indication of country of origin for "data" in the sense of patient data. These are laboratory tests. The document is for a device in the US market (510(k) summary).
- Retrospective/Prospective: Not applicable, as these are benchtop tests, not clinical studies involving patient data collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of this document refers to established engineering or material science standards and physical measurements, not expert clinical interpretation. The tests mentioned (e.g., electrical, flow, biocompatibility) rely on objective measurements against established specifications or predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical trials or studies where human expert interpretation is ambiguous and needs resolution. This document describes objective engineering tests.
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 document describes a physical medical device (papillotome) for an interventional procedure, not an AI-powered diagnostic tool for human readers. No MRMC study was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on engineering specifications, material science standards (e.g., biocompatibility guidance), and the measured performance of predicate devices in a laboratory setting. For instance, electrical testing uses "the requirements of the ANSI/AMMI HF18-1993 standard" as its reference. Flow testing uses the "Microvasive® Ultratome XL sphincterotome" as its comparative benchmark.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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).