(265 days)
The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.
The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Single-use Extraction Baskets." This type of document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing. It is not a document that details the rigorous clinical validation of an AI-powered diagnostic device, which is what your request implies by asking about acceptance criteria, ground truth, training sets, and MRMC studies.
Therefore, most of the information you requested regarding acceptance criteria and a study proving device performance (especially for an AI device) cannot be found in this document because the device in question is a mechanical medical device (extraction baskets), not an AI diagnostic tool, and the review process outlined here focuses on substantial equivalence through non-clinical and mechanical performance testing.
However, I can extract information related to what was used to demonstrate the device's performance for this specific 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of performance tests conducted and states that the "test results demonstrated that the subject device complies with the standard requirements." "Compliance with standard requirements" is the implicit acceptance criterion for these non-clinical tests.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | In accordance with ISO 10993-1, including cytotoxicity, sensitization, and irritation testing. | Complies with standard requirements; testing performed. |
| Sterilization Validation | In accordance with ISO 11135:2014 (Half-cycle approach). | Confirmed validation. |
| Shelf Life Testing | In accordance with ASTM F1980-21 (accelerated aging). | Confirmed stability (three years real-time aging test will be performed). |
| Mechanical Performance Testing |
- Dimensions Testing
- Tensile Pull Testing
- Simulated-Use Functionality & Durability Testing
- Stone Capture Testing
- Deflection Testing | Demonstrates basic performance and performs as intended. | Confirmed that the subject device performs as intended. |
| Comparative Testing | Performance comparable to the predicate device (K203322). | Demonstrated that the subject is as safe and effective as the predicate. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of numbers of devices or specific test runs for each mechanical test. The document states "The following performance data were provided..." without quantifying the test samples.
- Data Provenance: Not explicitly stated, given that these are non-clinical bench tests rather than patient data. These tests would typically be performed in a lab setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided in this document. Since the device is a mechanical extraction basket, there is no "ground truth" in the diagnostic sense or expert interpretation required for these performance tests. The ground truth for mechanical performance is typically defined by engineering specifications and objective measurements.
4. Adjudication method for the test set
- This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for human expert review processes, typically in clinical studies or for establishing ground truth in diagnostic AI datasets. This document describes non-clinical engineering and performance 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
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in image-based diagnostics. This document is for a mechanical medical device, not an AI diagnostic tool.
- The document explicitly states: "The clinical data is not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a "Single-use Extraction Basket," a physical tool, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The type of ground truth used
- For mechanical performance tests: The "ground truth" is established by engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM). For example, "Dimensions Testing" would verify that the device's dimensions meet pre-defined specifications. "Stone Capture Testing" would evaluate the basket's ability to capture stones under simulated conditions, with the "truth" being whether it successfully performed the action based on defined criteria.
- Not applicable for clinical or diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data, as this is not an AI diagnostic device.
8. The sample size for the training set
- Not applicable. This device is a mechanical one and does not involve AI or machine learning that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As a mechanical device, there is no AI training set.
§ 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.