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The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.

The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.

The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.

The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.

The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.

The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within <95 days.

The provided FDA 510(k) clearance letter and summary for the ARCHIMEDES™ Biodegradable Pancreatic Stent do not contain the specific acceptance criteria and detailed performance results for the device. While it states that "All tests met required acceptance criteria," the actual criteria and reported numerical performance are not explicitly listed.

Furthermore, the document alludes to "eight clinical studies" but provides no details whatsoever about their methodology, sample sizes, data provenance, expert qualifications, adjudication methods, or specific outcomes. It's a high-level statement without any actionable data.

Therefore, many of your requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the input:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the eight clinical studies mentioned.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective is only generally mentioned as "various settings, including single-center and multicenter, prospective and retrospective, randomized and non-randomized designs" for the collection of 8 studies, but not for any specific study or a "test set").

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 specified. The document only mentions "eight clinical studies" but no details on expert involvement for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 device is a physical medical stent, not an AI or imaging diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers and AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable, as this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the ground truth is based on the specified acceptance criteria for each test (e.g., ISO standards, FDA guidance documents).
• For the clinical studies, the document vaguely states they evaluated "safety, efficacy, clinical performance, degradation profile, and technical success," implying outcomes data would be the primary ground truth. However, no specifics are provided.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set. If the question implicitly refers to pre-clinical testing or animal studies that might inform design, no specific "training set" size is provided in the document.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the context of this device.

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