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The Disposable Hemostatic Clips is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
1.Endoscopic marking
2. Hemostasis for:
Mucosal/sub-mucosal defects

The Disposable Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they 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, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for a medical imaging or AI-driven diagnostic device.

The document is an FDA 510(k) clearance letter for a Disposable Hemostatic Clips device (K232450) manufactured by Zhejiang Soudon Medical Technology Co.,Ltd. It primarily discusses the device's substantial equivalence to a predicate device, its indications for use, and manufacturing/regulatory compliance.

Here's why the requested information cannot be extracted:

• Device Type: The device is a physical medical instrument (hemostatic clips), not an AI algorithm, medical imaging device, or diagnostic tool that would typically have performance criteria like sensitivity, specificity, or AUC based on a test set and ground truth established by experts.
• Study Type: The document explicitly states under "6. Clinical Test Data" that "No Clinical Study is included in this submission." The non-clinical performance data section ("5. Non-clinical Performance Data") lists bench tests (e.g., appearance, dimensional verification, force tests) which are relevant to the physical and mechanical properties of the clips, not their diagnostic accuracy or performance in a clinical setting compared to human readers.
• Absence of AI/Diagnostic Metrics: There is no mention of sensitivity, specificity, accuracy, expert readers, ground truth establishment, or any other metrics common to the type of studies you're asking about for AI or imaging devices.

Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria, AI performance, test set details, expert qualifications, or adjudication methods based on the provided text.

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Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

The provided text is a 510(k) summary for the Disposable Endoscope Injection Needles. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Device Description: What the device is made of and its configurations.
• Intended Use: How the device is meant to be used.
• Comparison of Technological Characteristics: A table comparing features of the proposed device to a predicate device.
• Non-clinical Performance Data: Mentions conformity to ISO standards for biocompatibility and sterilization, and some bench tests (appearance, physical properties) that "passed."
• Clinical Test Data: Explicitly states, "No Clinical Study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these aspects are relevant to AI/ML device evaluations and are not present in this 510(k) for a conventional medical device.

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The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.

The Disposable Sphincterotome described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for novel acceptance criteria.

Based on the provided text, the "acceptance criteria" for the Disposable Sphincterotome are primarily established by its similarity to the predicate device (Hangzhou AGS MedTech Co., Ltd.'s Sphincterotome, K201121) and compliance with relevant consensus standards.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one might see for a novel AI algorithm or a device with new performance claims. Instead, the performance is demonstrated by showing the proposed device is substantially equivalent to the predicate device and meets established safety and performance standards.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document describes bench testing for physical properties ("Appearance, Physical properties") and compliance with standards (e.g., sterilization, biocompatibility). It does not specify the exact number of units tested for these bench tests.
• Data Provenance: The tests are non-clinical (bench tests) conducted by the manufacturer, Zhejiang Soudon Medical Technology Co.,Ltd. The country of origin of the device is China. The data is prospective in the sense that the manufacturer performed these tests specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided as this submission relies on engineering and manufacturing standards verification as opposed to clinical expert assessment of a diagnostic outcome. For bench testing, ground truth is typically defined by engineering specifications and standard test methods.

4. Adjudication method for the test set:

• This is not applicable as the document describes bench testing against predefined engineering specifications and compliance with international standards, rather than expert-adjudicated clinical outcomes.

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, an MRMC study was not done. This device is a Disposable Sphincterotome, which is an electrosurgical accessory used by a clinician, not an AI-assisted diagnostic tool for "human readers." Therefore, this type of study is irrelevant for this device.

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

• No, this is an electrosurgical medical device, not an algorithm or software requiring standalone performance testing in that context.

7. The type of ground truth used:

• For the non-clinical performance data, the ground truth is based on:
  • Engineering specifications and design requirements for "Appearance" and "Physical properties."
  • International Consensus Standards such as ISO 10993-1 (Biocompatibility), ISO 11135-1 (EO Sterilization), and ISO 10993-7 (Ethylene Oxide Sterilization Residuals).
  • Substantial Equivalence to the legally marketed predicate device (K201121) in terms of indications for use, technological characteristics, and safety/performance profiles.

8. The sample size for the training set:

• This is not applicable. This submission is for a physical medical device, not an AI algorithm, and therefore there is no "training set" in the context of machine learning.

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

• Not applicable for the same reason as point 8.

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