(193 days)
The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 6.0, 7.0, and 8.0 mm at stent lengths of 18, 26, 36, and 56 mm.
The provided text describes a 510(k) submission for the "LifeStent SDS Biliary Endoprosthesis." This is a medical device submission seeking clearance to market, demonstrating substantial equivalence to existing devices. It is not a study that proves the device meets acceptance criteria in the way described by the request, particularly for AI/machine learning models.
The information provided focuses on comparative technological characteristics (materials, performance properties, biocompatibility, sterilization, packaging) and in vitro tests to establish substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance based on patient outcomes or expert evaluations.
Therefore, many of the requested fields cannot be directly answered from the provided document.
Here's a breakdown of what can be inferred or directly stated, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with corresponding performance results. Instead, it states: "Orbus protocols ensure that the LifeStent SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength." This implies that the device met internal performance specifications designed to demonstrate equivalence, but the specific metrics and targets are not disclosed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was an in vitro (laboratory) testing comparison against predicate devices, not a clinical study involving a test set of 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)
Not applicable. Ground truth for clinical data is not relevant to this in vitro device comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
Not applicable. This is not an AI-assisted diagnostic device, nor was an MRMC study described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical measurements/observations during testing of the LifeStent SDS Biliary Endoprosthesis. This is not clinical ground truth.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device clearance is not based on a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be extracted based on the nature of the submission:
- Device Type: Biliary stent (LifeStent SDS Biliary Endoprosthesis) mounted on a balloon catheter.
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
- Performance Evaluation: Primarily in vitro testing.
- Comparison Basis: Substantial equivalence to predicate devices based on:
- Identical intended use.
- Identical material properties.
- Similar performance properties (deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, balloon tensile strength).
- Similar packaging and sterilization methods.
- Key Finding: The device was deemed substantially equivalent to predicate devices, allowing it to be marketed.
Conclusion: The provided document is a 510(k) clearance letter and associated summary information. It describes regulatory clearance based on substantial equivalence demonstrated through in vitro testing, not a clinical study with detailed acceptance criteria and performance data as would be typically expected for AI/ML device validation or a human clinical trial. As such, the specific metrics for patient-centric acceptance criteria, sample sizes for medical data, and expert ground truth establishment are not present in this document.
§ 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.