(248 days)
The Sof-Flex Ureteral Stent Set is intended for temporary internal drainage from the ureteropelvic junction to the bladder. Sof-Flex ureteral stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques. The 3 French stents are indicated for pediatric patients.
The Sof-Flex Ureteral Stent is a single-lumen ureteral stent indicated for endoscopic, percutaneous, or open surgical techniques in order to provide temporary internal drainage from the ureteropelvic junction to the bladder. This ureteral stent is a long-term indwelling device not to exceed 6 months in the body. The Sof-Flex Ureteral Stent Set is composed of a Sof-Flex Ureteral Stent, positioner, and wire guide. The Sof-Flex Ureteral Stents may be sold in sets or as standalone devices. The Sof-Flex stent is constructed from radiopaque polyurethane and is available in multiple sizes. The stent sizes range from 3 to 12 Fr in outer diameter with a length between 4 to 32 cm. The stents are available in a specified-length or multi-length configuration. The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.
The provided text describes the 510(k) premarket notification for the Sof-Flex® Ureteral Stent Set, a medical device. It focuses on the substantial equivalence determination based on performance testing and biocompatibility. However, the document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers, AI assistance, or the establishment of ground truth for an AI model.
Therefore, most of the information requested in your prompt (especially points 2, 3, 4, 5, 6, 7, 8, and 9, which relate to AI model evaluation) cannot be extracted from this document, as it pertains to a traditional medical device (a ureteral stent) and not an AI/ML diagnostic or therapeutic system.
I can, however, provide the acceptance criteria and performance data for the physical device based on the provided text, if you'd like.
Based on the provided document, here's what can be extracted regarding the physical device's acceptance criteria and performance, not an AI/ML system:
The document describes the testing performed on the Sof-Flex® Ureteral Stent Set, a physical medical device. It does not mention any AI/ML components or studies related to AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (for physical device) | Reported Device Performance |
|---|---|---|
| Tensile Strength & Retention | Retention strength: ≥ 0.03 N but ≤ 3.9 N | The acceptance criteria were met. |
| Strength (Time Zero & Aged) | Minimum break strength: > 3.9 N | The acceptance criteria were met. |
| Flow Rate (Time Zero) | No acceptance criteria (for characterization purposes only) | Measurements performed for characterization purposes only. |
| Radiopacity (Time Zero) | Evaluated by comparative fluoroscopic evaluation (in accordance with ASTM F640-12) | The acceptance criterion was met. |
| Magnetic Resonance (MR) Imaging Safety | Performed in accordance with ASTM F2503-13, ASTM F2052-14, ASTM F2213-06(2011), and ASTM F2119-07(2013) | Testing performed. (Implicitly met, no explicit failure stated) |
| Biocompatibility | Conformance with ISO 10993-1(2009) and FDA guidance for various toxicities | Performed to ensure biocompatibility of the subject device. |
| Leachable Studies | Toxicological equivalence to reference device (Kwart Retro-Inject Ureteral Stent K162109) | Presented to support toxicological equivalence. |
Information Not Applicable to This Document (Relates to AI/ML Performance)
The following points are central to describing an AI/ML study but are not present in this documentation because the Sof-Flex® Ureteral Stent Set is a traditional physical medical device, not an AI/ML diagnostic or therapeutic system.
- 2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was on the physical stent material and design, not a dataset for an AI model.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish for an AI model in this context. Expert review would relate to clinical performance Post-market, not the manufacturing/design verification and validation described here.
- 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: Not applicable. This refers to comparing AI-assisted human performance to unassisted human performance, which is irrelevant for a physical stent.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable. There is no AI model to train.
- 9. How the ground truth for the training set was established: Not applicable.
Conclusion from document: All predetermined acceptance criteria for the physical device testing were reportedly met, supporting its intended performance and substantial equivalence to predicate devices.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).