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These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.

The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed guidewire lumen, and the subject device consists of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.

The provided text describes a 510(k) premarket notification for a medical device called the "Single Use Balloon Dilator V (with Knife)". The document focuses on demonstrating substantial equivalence to predicate devices and provides a summary of non-clinical testing performed.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of statistical performance metrics, such as sensitivity, specificity, accuracy, or other commonly used metrics for evaluating AI/algorithm performance. It is a regulatory submission for a physical medical device.

Therefore, I cannot provide the requested information from the given text. The document details engineering and performance tests relevant to the physical characteristics and safety of a medical device, not the performance of an AI or algorithm in the way your prompt specifies (e.g., "human readers improve with AI vs without AI assistance").

If this were an AI/algorithm-based device, the 510(k) summary would typically include detailed clinical study results with statistical endpoints to demonstrate effectiveness and safety, and direct comparisons to human readers or ground truth established by experts.

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The TRUEtome™ Sphincterotome devices are indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to cannulate and inject contrast medium.

TRUEtome™ Sphincterotome when connected to a monopolar current may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The TRUEtome™ Sphincterotome is a 200 cm, triple lumen sphincterotome that tapers from 7 Fr (2.3 mm) to 5.5 Fr (1.8 mm) with an atraumatic tip. The catheter is capable of accepting a 0.035 in (0.89 mm) Boston Scientific Guidewire and a 0.025 in (0.64 mm) Boston Scientific Guidewire, while injecting and/or cutting using other lumens. The sphincterotome may be placed with or without the aid of a guidewire. When connected to a monopolar current, the sphincterotome may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8 mm and larger.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TRUEtome™ Sphincterotome:

It's important to note that this document is a 510(k) summary, which is a premarket notification for a medical device. For devices seeking substantial equivalence to a predicate device, the regulatory focus is often on demonstrating that the new device is as safe and effective as the legally marketed predicate, rather than proving efficacy from scratch with extensive clinical trials. Therefore, the "study" described here is primarily a set of performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each in-vitro test. It mentions that "all components, subassemblies, and/or full devices" were tested.

The data provenance is in-vitro (laboratory) testing. There is no mention of human subject data, animal data, or data from specific countries of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for these engineering and biocompatibility tests is based on established scientific principles, industry standards (e.g., AAMI/ANSI/ISO 10993-1, IEC 60601-1), and the manufacturer's internal specifications, not expert interpretation of complex clinical data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for these performance tests is based on objective measurements against predefined specifications, not on expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through non-clinical performance data (in-vitro testing) and comparison of technological characteristics to predicate devices. It does not involve human readers evaluating images or clinical outcomes that would necessitate an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a medical instrument (sphincterotome), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

The ground truth used for the performance tests is based on:

• Industry Standards: Such as AAMI/ANSVISO 10993-1, AAMI/ANSI/ISO 10993-7, and IEC 60601-1.
• Manufacturer's Required Specifications: Internal design and performance specifications for the device and its components.
• Engineering Principles: Applied to evaluate physical properties, electrical safety, and functional parameters.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm. 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, as there is no training set for this type of device.

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The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.

The provided text is a 510(k) summary for the ConMed Axcess Papillotome, which describes a medical device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested elements for a study on acceptance criteria and device performance cannot be extracted directly from this document.

However, I can extract information related to what was provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated. The document mentions "in-vitro testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

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

• Not applicable/Not stated. This information is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

4. Adjudication method for the test set

• Not applicable/Not stated. This detail is usually found in studies involving human readers or expert consensus on interpretations.

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. This is a medical device clearance document, not a clinical study involving AI or MRMC.

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

• Not applicable. The device described is a physical medical instrument (papillotome), not an algorithm or AI system.

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

• For electrical safety, the ground truth would be compliance with established electrical safety standards.
• For in-vitro performance, the ground truth would be pre-defined performance specifications for the device's mechanical and functional characteristics.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is relevant to this device's clearance.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes performance testing which included:

• Electrical safety standards compliance.
• In-vitro testing to demonstrate the device meets its performance specifications.

The exact details of these tests (e.g., specific protocols, number of samples tested, specific "performance specifications") are not elaborated in this 510(k) summary but would have been part of the more extensive 510(k) submission to the FDA. The basis for clearance is substantial equivalence to predicate devices (Bard Apollo Papillotome K982557 and Boston Scientific Corporation Autotome K013153), rather than extensive clinical efficacy trials typically associated with AI or novel therapeutic devices. The document explicitly states: "The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications." and "The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate."

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