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The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.

NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible. The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components: - A double loop ureteral stent - A steerable pusher, packed separately Also contained in some kits: - -An Orchestra® Hydrophilic guidewire, packed separately The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.

The document provided is a 510(k) summary for the NovoFlow™ Reinforced Ureteral Stent, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not include information about AI/ML device performance, ground truth, or human reader studies. The "study" mentioned refers to non-clinical bench testing to demonstrate physical properties and biocompatibility.

Here's a breakdown based on the information provided, and where information is not provided:

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

The document lists mechanical tests that were performed, but does not provide a table with specific acceptance criteria (e.g., minimum flow rate, tensile strength) or the reported values for the NovoFlow™ Reinforced Ureteral Stent for each test. It states that "Mechanical testing was completed using the FDA guidance document 'Guidance for the content of premarket notifications for ureteral stents' for reference." This implies that the tests and criteria were based on FDA recommendations for ureteral stents in general. The document also mentions "Biocompatibility testing was conducted based upon ISO 10993-1 (2018)" and sterilization and packaging tests.

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

This information is not provided. The "test set" in this context would refer to the physical devices tested for mechanical properties, biocompatibility, etc. The document does not specify the number of stents or accessories tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for physical device testing.

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 information is not applicable. The device is a physical ureteral stent, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. The "ground truth" for the performance of this device would be its adherence to established engineering and biocompatibility standards.

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

This information is not applicable, as it pertains to AI/ML performance evaluation through expert review, which is not relevant for this device.

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

No such study was done. This is not an AI/ML device.

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

No such study was done. This is not an AI/ML device.

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

The "ground truth" for this medical device's performance is compliance with established physical, mechanical, chemical (biocompatibility), and sterility standards derived from FDA guidance documents and international standards (like ISO 10993-1). No expert consensus, pathology, or outcomes data were used to establish "ground truth" for the performance tests conducted for this 510(k). The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no training set in that context.

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

This information is not applicable. This is not an AI/ML device.

Summary of "Acceptance Criteria" and "Study" for the NovoFlow™ Reinforced Ureteral Stent (based on the provided document):

Study: The substantial equivalence determination for the NovoFlow™ Reinforced Ureteral Stent was supported by non-clinical performance data, including:

• Biocompatibility Testing: Conducted based on ISO 10993-1 (2018) and relevant FDA guidance.
• Mechanical Testing: Based on FDA's "Guidance for the content of premarket notifications for ureteral stents." Specific tests included:
  • Visual Inspection
  • Dimensional Testing (Diameter, Length)
  • Flow Rate
  • Elongation/Yield and Tensile Strength
  • Loop/Curl strength
  • Guidewire compatibility
  • Radiopacity
  • Magnetic resonance compatibility
  • Shelf Life/Expiration Date
• Sterilization Testing: Validated using ethylene oxide to achieve a sterility assurance level of 10-6.
• Packaging and Distribution Testing: To ensure product integrity and sterility throughout its life.

Acceptance Criteria & Reported Performance:

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