(78 days)
The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.
2Fr, 8.3 mm Stone Dislodger Basket, Helical Design
This is a 510(k) summary for a medical device (a Stone Dislodger Basket) from 1997. The information provided in the summary is typical for submissions of that era, and focuses on substantial equivalence to predicate devices rather than clinical performance studies with specific acceptance criteria as would be expected for AI/ML-based medical devices or more recent submissions.
Therefore, many of the requested categories are not applicable or cannot be answered from the provided text.
Here's a breakdown of what can and cannot be derived from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document describes a new version of a physical medical device (stone dislodger basket) and not an AI/ML-based algorithm. The evaluation focuses on "Substantial Equivalence" to predicate devices, meaning it performs similarly and has similar safety and effectiveness profiles. There are no performance metrics or explicit acceptance criteria like sensitivity, specificity, or accuracy that would be associated with an AI/ML device.
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 / Not Provided. This is a physical device, and the "testing" refers to product testing to demonstrate substantial equivalence, not a clinical study on a test set of data. The document mentions "Product Testing" and comparison to predicate devices, but doesn't specify sample sizes in a clinical sense or data provenance.
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 / Not Provided. Ground truth and expert consensus are concepts typically applied to AI/ML device evaluation, not the kind of physical device described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. See point 3.
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 / Not Provided. This device is a surgical instrument, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. See point 3.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no AI model or training set involved in this medical device submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no AI model or training set involved in this medical device submission.
In summary of what is available from the document:
The provided document describes a medical device (a Stone Dislodger Basket) and its submission for FDA 510(k) clearance in 1997. The primary "study" mentioned is "product testing" to demonstrate substantial equivalence to four predicate devices (K871777, K871779, K925495, K951309). The document states that "The results indicate that the proposed devices are 'Substantially Equivalent' to the predicate devices in terms of performance characteristics tested." This means the device met the implicit acceptance criterion of being as safe and effective as existing legally marketed devices. However, the specific details of these "performance characteristics tested" or the quantitative results are not provided in this summary.
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.