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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

Stone Extraction Balloon is composed of balloon, radiopaque marker, catheter, handle, standard connector, two-way valve, support wire and inflators. Stone Extraction Balloon is operated by the inflation and deflation of balloon, as well as liquid is injection port to assist in imaging or flushing, and complete the removal of biliary calculus the endoscopic channel. The Stone Extraction Balloon is classified to different specifications according to the diameter of balloon and the liquid outlet. There are a total of 12 models, the largest balloon diameter is 20mm, the smallest balloon diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device meets the criteria. The provided document is a 510(k) summary for a medical device (Stone Extraction Balloon) and does not contain any information about acceptance criteria or a study that uses AI or involves human readers.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It clearly states:

• "No clinical study is included in this submission." on page 6.
• The performance data section lists various non-clinical bench tests (e.g., stone capture, tensile strength, dimension test, Luer connector test, X-ray development test, rated burst pressure test, flowrate test) and concludes that the device meets "performance criteria required to fulfill the intended use" and "design specification". However, it does not specify the quantitative acceptance criteria for these tests or provide details of a study with human readers or AI.

Therefore, I cannot extract the requested information from the provided text.

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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

The subject Stone Retrieval Balloon is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some models, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some models, the balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters, or 13mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with a outer diameter of 2.4mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. EO Sterilization and use for single use only.

The provided document is a 510(k) Premarket Notification for a Stone Retrieval Balloon. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML device performance. The performance data provided is related to bench testing to demonstrate substantial equivalence to a predicate device, not, for example, the performance of an AI algorithm in image interpretation.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device described is a physical medical instrument (a stone retrieval balloon) used for endoscopic removal of biliary stones. There is no mention of any artificial intelligence, machine learning, or software component that would involve image analysis, diagnostic capabilities, or human-AI interaction.
• Focus on Substantial Equivalence: The entire 510(k) submission is built around demonstrating that the "Stone Retrieval Balloon" is substantially equivalent to existing predicate devices (Tri-Ex Extraction Balloon and 3-Lumen Extraction Balloon). This involves comparing technical characteristics, materials, and bench performance, not the diagnostic accuracy or efficacy of an AI system.
• Performance Data: The "Performance Data" section (5.8) explicitly states: "The Stone Retrieval Balloon meets all design specifications and medical for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to physical and material properties, not AI performance metrics.
• No Clinical Test: Section 5.9 explicitly states: "No Clinical test is included in this submission." This further reinforces that there isn't a study proving a specific performance metric against a clinical outcome or ground truth in the way an AI/ML device would be evaluated.

In summary, the provided document does not describe the acceptance criteria or a study that proves an AI/ML device meets those criteria, as the device in question is a physical medical instrument without an AI/ML component.

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