(28 days)
The Extractor™ Pro Retrieval Balloon Catheters are indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval. The catheter may be placed with or without the aid of a guidewire. The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire. Injection ports for contrast are set either below or above the retrieval balloon.
The document is a 510(k) Premarket Notification for the Extractor™ Pro Retrieval Balloon Catheters. This notification is for a medical device, specifically a catheter for retrieving biliary stones, and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to performance testing and demonstrating substantial equivalence to a predicate device, rather than clinical efficacy studies in the same way one might describe for a diagnostic AI device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet required specifications for components, subassemblies, and/or full devices. | All components, subassemblies, and/or full devices met the required specifications. |
| Substantial equivalence to predicate devices in design, materials, and manufacturing processes. | The proposed Extractor™ Pro Retrieval Balloon Catheters are similar in design, materials, and manufacturing processes to the predicate devices. |
| Intended Use | Matches the predicate devices: Endoscopically remove stones from the biliary system, or facilitate contrast injection while occluding the duct. |
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 for Test Set: The document states "In-vitro testing has been performed." It does not specify the sample size for this testing.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of "in-vitro testing," it refers to laboratory bench testing rather than patient data.
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)
This section is Not Applicable in the context of this 510(k) submission. The "ground truth" here is based on engineering specifications and physical performance measurements (in-vitro testing) rather than expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert assessments, which is not what was performed for this device's submission. The "test set" here refers to physical devices undergoing in-vitro performance testing.
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
This section is Not Applicable. An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation of medical images. This 510(k) is for a physical medical device (a retrieval balloon catheter) and does not involve AI or human readers for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of this device is based on engineering specifications and measurable physical properties tested through in-vitro methods. For example, balloon inflation pressures, catheter flexibility, guidewire compatibility, and material strength would be measured against predefined specifications.
8. The sample size for the training set
This section is Not Applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
This section is Not Applicable. As stated above, this device is not an AI algorithm.
§ 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.