(328 days)
The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.
The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Absolute® Pro .035 Biliary Self-Expanding Stent System:
Summary of Acceptance Criteria and Device Performance for Absolute® Pro .035 Biliary Self-Expanding Stent System
This 510(k) submission (K072708) relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria for a novel AI device. The "device performance" reported is that the new device is equivalent to its predicates based on various tests.
| Acceptance Criteria Category | Acceptance Criteria (based on predicate equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | The device must be intended for the same use as the predicate devices: palliation of malignant strictures in the biliary tree. | The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree, matching the predicate. |
| Technological Characteristics | The technological characteristics (e.g., self-expanding nickel titanium stent, pre-mounted delivery system, radiopaque markers, 0.035" guide wire compatibility, catheter components) must be sufficiently similar to the predicate devices to demonstrate equivalence. | A comparison of technological characteristics was performed, and the results demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is equivalent to the predicate devices. |
| Performance (In Vitro Bench Tests/Analyses) | The device must perform comparably to the predicate devices in relevant in vitro bench tests and analyses to ensure similar safety and effectiveness. (Specific performance metrics are not detailed in this summary, but implied to be sufficient for equivalence). The document explicitly states that the device's safety and effectiveness for use in the vascular system have not been established. | The results of the in vitro bench tests and analyses demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent in performance to the Absolute® .035 Biliary Self-Expanding Stent System (one of the predicates). |
Study Information (Based on the provided text):
The provided text describes a 510(k) submission for a medical device (a biliary stent system), not an AI/ML diagnostic or prognostic device. Therefore, many of the typical AI study parameters (sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.
Here's an attempt to address the points based on what's available and an understanding of traditional medical device submissions:
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A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are effectively the demonstration of substantial equivalence to the predicate devices based on intended use, technological characteristics, and performance data (primarily in vitro).
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the AI sense. This submission is for a physical medical device. The "test set" would be the units of the device subjected to in vitro bench testing. The text does not specify the number of samples used for these bench tests.
- Data Provenance: The data would be derived from internal laboratory testing conducted by Abbott Vascular. The country of origin for the data is implicitly the USA (Abbott Vascular, Santa Clara, CA). This is generally prospective testing of the manufactured device.
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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 in the AI sense. For a physical device like a stent, "ground truth" is established through engineering specifications, material science standards, and established medical device testing methodologies. The "experts" would be the R&D engineers, metallurgists, and quality control professionals who design and test the device against these standards. Their qualifications are not specified but are presumed to be appropriate for medical device engineering and testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the AI sense. The "adjudication method" for traditional device testing involves adherence to predefined test protocols, acceptance limits, and quality control procedures. It's not a consensus-based review by experts of clinical cases.
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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. This is a physical device, not an AI diagnostic tool. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro performance data, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices, as well as relevant industry standards and design requirements for biliary stents (e.g., radial force, fatigue resistance, deployment accuracy, material biocompatibility, etc., though not detailed in this summary). The goal is to demonstrate that the new device meets or exceeds these established performance benchmarks found in the predicates.
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The sample size for the training set:
- Not applicable in the AI sense. There is no "training set" for a physical device in this context. The design and manufacturing process would involve extensive engineering studies and prototypes, but not a "training set" like that used for machine learning.
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How the ground truth for the training set was established:
- Not applicable in the AI sense. See point 8.
§ 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.