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The double loop ureteral stents are used for:

• drainage of the upper urinary tract over fistulas or ureteral obstacles

• healing of the ureter

The Biosoft duo Double loop ureteral stents are flexible tubular devices designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. A withdrawal thread is attached on the proximal end to allow removal.

Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.

The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.

The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents are supplied in kits which are comprised of any of the following components depending of the reference of the kit:

• A double-loop ureteral stent equipped with a withdrawal thread ●
• A non-steerable pusher provided with a clamp, or a steerable pusher ●
• Available in certain kits: 0
  • o A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
  • A ureteric (also called ureteral) catheter о

This FDA 510(k) summary describes a submission for a ureteral stent, not an AI/ML powered device. Therefore, much of the requested information about AI model performance, sample sizes for training and testing, ground truth establishment, and expert involvement is not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format as one would expect for an AI model's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria for a medical device like a ureteral stent are typically based on demonstrating substantial equivalence to an already legally marketed predicate device. This involves showing comparable performance, indications for use, design, and materials.

The study that "proves the device meets the acceptance criteria" is the nonclinical testing (bench testing and biocompatibility testing) performed to demonstrate this substantial equivalence.

• Drainage of the upper urinary tract over fistulas or ureteral obstacles
• Healing of the ureter" |
  | - Comparable Design | "The Biosoft duo Double Loop Ureteral stents are flexible tubular devices designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization.
  ...The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents are supplied in kits..." (Implies similar design principles and components to the predicate) |
  | - Comparable Materials | Supported by nonclinical testing and the assertion of substantial equivalence in materials. |

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

• Not Applicable. This document describes nonclinical (bench and biocompatibility) testing, not a clinical study involving human data or an AI model's test set. The "test set" in this context refers to the physical devices and materials undergoing various characterization tests. The document does not specify quantities of devices tested, only that testing was performed.

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, in the context of AI/ML, refers to expert-labeled data. For a hardware medical device, "ground truth" is typically defined by established material standards, engineering specifications, and biological responses, not expert consensus on images or diagnoses.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, which is not pertinent to the evaluation of a ureteral stent through bench and biocompatibility 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

• Not Applicable. MRMC studies are specific to evaluating diagnostic imaging systems or AI-assisted diagnostic tools. This device is a therapeutic/support device, not an imaging or diagnostic aid.

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

• Not Applicable. This is not an algorithm or AI device.

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

• For this device, the "ground truth" is established by:
  • Engineering Specifications: Performance characteristics verified through bench testing (e.g., strength, flexibility, radiopacity).
  • Biocompatibility Standards: Assessment of material compatibility with living tissue, conducted according to established ISO standards.
  • Predicate Device Performance: The legally marketed predicate device itself serves as the benchmark or "ground truth" for demonstrating equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device.

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