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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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It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.

The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.

This document details the FDA's 510(k) clearance for the VedDilator™ 3-Stage Balloon Dilation Catheter. It does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, the requested information regarding acceptance criteria and performance of an AI/ML-based device cannot be extracted from this document.

The document focuses on the substantial equivalence of this medical device (a physical catheter) to a predicate device based on non-clinical performance testing and biocompatibility.

Here's why the requested information cannot be provided from this document:

• No AI/Machine Learning: The device is a physical catheter, not a software or AI-based diagnostic tool.
• No Diagnostic Performance Study: The document lists non-clinical bench testing for physical characteristics (e.g., burst pressure, maneuverability, sterility) and biocompatibility, not diagnostic performance metrics like accuracy, sensitivity, or specificity.
• No Human Reader Study: Since it's a physical device, there's no concept of human readers or MRMC studies.
• No Ground Truth Establishment: The "ground truth" in this context refers to the physical properties of the device, measured through standard engineering tests, not a clinical diagnosis established by experts.

Summary of available information (not directly addressing the prompt's request for AI/ML device performance):

• Device: VedDilator™ 3-Stage Balloon Dilation Catheter
• Purpose: To endoscopically dilate strictures of the alimentary tract.
• Study Type: Non-clinical bench testing and biocompatibility testing for substantial equivalence to a predicate device (K112994).
• No Clinical Study: Section 7 explicitly states, "No clinical study is included in this submission."
• Test Performed (Non-Clinical): Rated burst pressure test, Balloon tightness test, Connection firmness test, Maneuverability test, X-ray development performance test, Sterility test, Residual amount of ethylene oxide Test, Balloon fatigue Test, Burst Test of Guidewire, Bend Test of Guidewire, Connection Strength Test of Guidewire, Corrosion resistance Test of Guidewire.
• Biocompatibility Tests: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material mediated pyrogenicity.
• Conclusion: The device meets design specifications and demonstrates substantial equivalence to the predicate device based on these non-clinical tests.

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It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/ sub-mucosal defects

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.

The provided text describes a 510(k) submission for a Disposable Endoscopic Hemoclip (K222146) and compares it to a predicate device (K182556). The submission focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical trials or AI/algorithm performance. Therefore, many of the requested details about acceptance criteria, clinical studies, and AI performance cannot be found in the provided document.

Here's a breakdown of the available information:

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

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it lists the results of various non-clinical (bench) tests and biological evaluations, aiming to show compliance with standards and equivalence to the predicate. The "performance" is generally described as "passed" or "complies with standards."

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

The document explicitly states: "No clinical study is included in this submission." All tests described are non-clinical (bench tests, biocompatibility, sterilization, packaging, MR safety). Therefore, there is no "test set" in the context of clinical data, sample size for clinical evaluation, or data provenance from a retrospective or prospective study.

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, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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

Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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 device (hemoclip), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" would be the specific requirements and specifications defined by the relevant ISO and ASTM standards. For example, for a tensile strength test, the "ground truth" is a defined force threshold that the device must withstand. For sterilization, it's achieving a SAL of 10^-6. These are objective measures against predefined engineering and biological standards.

8. The sample size for the training set

Not applicable, as no clinical studies or AI/algorithm development (with a training set) were conducted or reported.

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

Not applicable, as no clinical studies or AI/algorithm development were conducted or reported.

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The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.

The provided text is a 510(k) summary for a medical device (Disposable Polyp Snare) and does not contain information about software as a medical device (SaMD) or an AI/ML device. Therefore, it does not describe acceptance criteria, the study that proves a device meets those criteria, or the other specific details requested in the prompt related to AI/ML or SaMD performance.

The document pertains to a physical medical device and its substantial equivalence to a predicate device based on non-clinical performance testing. The "510(k) Summary," specifically section 8 "Summary of non-clinical testing," outlines the tests conducted to support its marketing claims and confirm safety and effectiveness.

Based on the provided text, I cannot provide the requested information for the following reasons:

• Device Type: The device is a "Disposable Polyp Snare," which is a physical endoscopic accessory, not an AI/ML or software device.
• Study Type: The document explicitly states "No clinical tests were performed" (Section 9). The "non-clinical testing" summarized in Section 8 refers to physical performance tests (e.g., strength, maneuverability, cutting ability), sterilization, shelf-life, biocompatibility, and electrical safety, not the performance of an AI algorithm.
• Ground Truth/Experts/Sample Size (for AI): Since this is not an AI/ML device, there is no mention of training sets, test sets for AI performance, expert consensus for ground truth, or adjudication methods for AI performance evaluation.

In summary, the provided document does not contain the type of information needed to answer your detailed questions about acceptance criteria and study data for an AI/ML or SaMD product.

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The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.

The provided text is a 510(k) summary for an Injection Needle, a medical device used with an endoscope for various injections in the GI tract. It does not describe an AI/ML-enabled device nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the new Injection Needle to a predicate device (Single Use Injector NM600/610) based on non-clinical tests (biocompatibility, sterility, package integrity, etc.) and direct comparison of design and intended use specifications, as is common for traditional medical devices in a 510(k) submission. No clinical study was performed.

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