(37 days)
The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.
The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only.
The provided text is a 510(k) summary for a medical device (Tri-Ex Extraction Balloon) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a typical AI/software device submission would. This document is for a physical medical device, not a software or AI product.
Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details," are not applicable and are not present in the provided text.
The device's performance is assessed through substantial equivalence to a predicate device, meaning it is considered equally safe and effective based on similar design, materials, and intended use, rather than meeting specific quantifiable performance metrics through a clinical study.
Here's a breakdown of what can be extracted or inferred based on the document's content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K953951) | Believed to be substantially equivalent. |
| Safe and effective for intended use | Believed to be substantially equivalent in terms of Intended Use, performance characteristics tested, and biocompatibility. |
| Use for endoscopic removal of stones in the biliary system | Intended use: endoscopic removal of stones in the biliary system. |
| Use for contrast injection | Intended use: contrast injection. |
| Sterility | Supplied sterile. |
| Single use only | Intended for single use only. |
Explanation: The "acceptance criteria" for this type of device (a Class II medical device cleared via 510(k)) primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as the predicate. The performance data section broadly states that the device is believed to be substantially equivalent in terms of "Intended Use, performance characteristics tested and biocompatibility." No specific numerical performance metrics (e.g., success rate, complication rate) are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable / Not mentioned. This submission relies on substantial equivalence to a predicate device, not a new clinical trial with a "test set" in the context of AI/software.
- Data Provenance: Not applicable / Not mentioned.
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)
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable.
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
- MRMC study: No, this is not an AI/software device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable in the context of an AI/software device. For this physical device, the "ground truth" concept aligns with established performance and safety of the predicate device, validated through various non-clinical (e.g., bench testing, biocompatibility) and potentially some clinical safety data (though not detailed here as a study).
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable. This is not an AI/software device.
In summary: The document describes a traditional medical device cleared via the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a new clinical study with specific performance metrics and ground truth establishment, as would be common for AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" and "study details" is not present or relevant in the context of this 510(k) summary for a physical extraction balloon.
§ 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.