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510(k) Data Aggregation
(45 days)
Zimmon Needle Knife Papillotome
These devices are used for accessing the duct when standard methods of cannulation have been exhausted.
The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.
This document is a 510(k) premarket notification for a medical device called the Zimmon Needle Knife Papillotome. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries for software/AI-based medical devices.
The product referenced is an electrosurgical accessory, not a software or AI-driven diagnostic or therapeutic device. The "performance data" mentioned in the document refers to standard medical device testing such as sterilization, shelf-life, biocompatibility, and non-clinical bench testing. These types of tests have different "acceptance criteria" than those requested for an AI/software device.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance related to AI/software, nor can I answer questions about sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies, as these are not relevant to the type of device and submission described in the provided text.
Based on the provided text, here's what can be extracted regarding "performance data" and "acceptance criteria" in the context of this traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization | Device must be sterile. | Meets performance requirements. |
| Shelf Life | Device maintains functionality and sterility over a specified period. | Meets performance requirements. |
| Biocompatibility | Device materials must be safe for human contact (e.g., non-toxic, non-irritating). | Meets performance requirements. |
| Non-clinical Bench Testing | Device meets specified functional parameters (e.g., electrical safety, cutting performance, mechanical integrity appropriate for its intended use). | Meets performance requirements. |
Explanation for Table: The document states, "Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Zimmon Needle Knife Papillotome meets the performance requirements to fulfill the intended use of the device." This indicates that these tests were performed and the device passed, meaning it met their respective acceptance criteria. The specific numerical or qualitative acceptance criteria are not detailed in this FDA clearance letter or 510(k) summary, as these documents typically summarize results rather than provide raw data or full test protocols.
The remaining requested information (2-9) is not applicable or cannot be extracted from this document, as it pertains to AI/software-driven devices or clinical trials, which are not the focus of this 510(k) submission for a physical surgical accessory.
- Sample sized used for the test set and the data provenance: Not applicable in this context. Bench testing typically uses samples per batch or engineering specifications, not "test sets" in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for a needle knife papillotome's performance (e.g., cutting ability, electrical safety) is typically established by engineering standards and objective measurements, not expert consensus on medical images.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for reader performance improvement with AI, not a surgical tool.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth for bench testing would be based on objective physical measurements, material properties, and electrical safety standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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