(22 days)
The Stonetome Stone Removal Device is indicated for use in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP), transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
The Stonetome Stone Removal Device is a 200 cm tapered 7F (2.3 mm) to 5.5F (1.8 mm) triple lumen catheter that incorporates a sphincterotome with a latex retrieval balloon. The Stonetome Stone Removal Device is available in several configurations: (1) with the latex balloon mounted distal or proximal to the cutting wire, (2) with a 20- or 30-mm wire, and (3) with a 5 mm or 20 mm distal tip.
This FDA 510(k) clearance summary for the Stonetome Stone Removal Device (K191789) does not describe a study involving an AI/Machine Learning device. Instead, it focuses on the substantial equivalence of a modified medical device (a catheter for stone removal) to a predicate device.
Therefore, many of the requested criteria related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.
The document discusses performance data in the context of bench testing for a physical medical device, not a software algorithm.
Here's an attempt to answer the questions based only on the provided document, highlighting what is present and what is absent for this type of medical device clearance:
Acceptance Criteria and Study for the Stonetome Stone Removal Device (K191789)
This document pertains to the clearance of a physical medical device, not an AI/Machine Learning algorithm. Therefore, the "acceptance criteria" and "study" described here relate to the device's physical and functional performance, as well as its safety and biocompatibility, as compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance (Met/Not Met) |
|---|---|---|
| Performance Testing (Bench) | Balloon Inflation (OD) | Successfully completed (Met) |
| Balloon Inflation (Leakage) | Successfully completed (Met) | |
| Simulated Stone Retrieval | Successfully completed (Met) | |
| Balloon Distensibility | Successfully completed (Met) | |
| Biocompatibility | Cytotoxicity | All acceptance criteria were met (Met) |
| Irritation | All acceptance criteria were met (Met) | |
| Sensitization | All acceptance criteria were met (Met) | |
| Acute Systemic Toxicity | All acceptance criteria were met (Met) | |
| Substantial Equivalence | Design Verification | Met all acceptance criteria |
Note: The document states "Non-clinical testing was successfully performed" and "Performance testing (bench) was successfully completed to establish substantial equivalence" for the listed tests. For Biocompatibility, it explicitly states "All acceptance criteria were met."
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For bench testing of a physical device, "sample size" would refer to the number of device units tested. The document does not specify this, nor does it specify the provenance of data as it's not a clinical study on human subjects or a dataset for AI.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is not an AI/ML device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is its ability to meet engineering specifications and safety standards during bench testing.
4. Adjudication Method for the Test Set:
Not applicable. This is not an AI/ML device requiring human adjudication of results. Testing involved objective engineering measurements and biocompatibility evaluations.
5. Was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study done? If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, an MRMC study was not done. This device is a physical catheter, not an AI-assisted diagnostic or therapeutic tool for which human reader performance with and without AI assistance would be relevant.
6. Was a standalone (i.e., algorithm only without human-in-the-loop performance) study done?
Not applicable. This is a physical device, not a standalone algorithm. The performance described is of the device itself through bench testing.
7. The Type of Ground Truth Used:
The 'ground truth' for this device's acceptance is based on engineering specifications and pre-defined performance standards met during non-clinical (bench) testing, and compliance with biocompatibility standards (ISO 10993-1). It is not based on expert consensus, pathology, or outcomes data in the typical sense for AI/ML or clinical trials.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.