(156 days)
Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
Three Lumen Papillotome/Sphincterotome
Here's an analysis of the provided text regarding acceptance criteria and a device study:
Important Note: The provided documents (FDA 510(k) K992402 letter and "Indications For Use" attachment) are for a Three Lumen Papillotome/Sphincterotome, which is a medical device, not an AI/software device. The questions you've asked (e.g., about AI assistance, standalone algorithm performance, training sets, expert consensus for ground truth) are highly specific to AI/software products.
Therefore, the information you're requesting, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9 about detailed study design and acceptance criteria for an AI device, cannot be extracted from these documents. These documents confirm the device's substantial equivalence to a predicate device, which is a regulatory pathway for hardware medical devices, not a detailed performance study for an AI algorithm.
Based only on the provided documents, I can answer the following, while clarifying that AI-specific details are absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission was the demonstration of substantial equivalence to legally marketed predicate devices. The documents do not detail specific performance metrics (like sensitivity, specificity, accuracy) or associated thresholds typically seen for AI devices.
- Reported Device Performance: The documents do not report specific performance metrics for the device itself (e.g., success rates, complication rates from a clinical study). The FDA statement focuses on the determination of substantial equivalence (i.e., that it's as safe and effective as existing devices), not on a quantitative performance report.
| Criterion (Implicit for 510(k)) | Reported Device Performance (Implicit for 510(k)) |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent. |
The following points (2-9) are not applicable or cannot be answered from the provided documents as they pertain to AI device studies, which is not what this 510(k) describes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This information is not present in the 510(k) documents as it's not an AI device study requiring a "test set" in that context. The 510(k) likely relied on bench testing, biocompatibility data, and comparison to predicate device characteristics.
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 relates to AI/diagnostic imaging ground truth establishment, which is not relevant to this mechanical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This is for AI/diagnostic studies for resolving discrepancies in ground truth.
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 specific to AI-assisted reading studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no algorithm for this mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Ground truth as described is not relevant to a 510(k) submission for a mechanical device. The "truth" in this context is its safe and effective deployment based on its design and comparison to existing products.
8. The sample size for the training set
- Not Applicable: This refers to AI model training, which is not involved here.
9. How the ground truth for the training set was established
- Not Applicable: This refers to AI model training, which is not involved here.
§ 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).