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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

The provided text describes a 510(k) premarket notification for a medical device called the "Tri-Ex Extraction Balloon with Multiple Sizing." This device is used for endoscopic removal of biliary stones and for contrast injection. The submission seeks to demonstrate substantial equivalence to a predicate device (Tri-Ex Extraction Balloon K170292).

However, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI device performance. It is a regulatory submission for a physical medical device, not an AI-powered one. Therefore, I cannotExtract the requested information about AI device acceptance criteria and study details from this document.

The document only states the following regarding performance:

• Performance Data: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended."
• Summary of non-clinical testing:
  • Functional Testing/ Design Verification Testing
  • Biocompatibility Assessment
  • Fluoroscopic Visibility

This information indicates that bench testing was performed to demonstrate that the device meets its intended performance, but no specifics on "acceptance criteria" or detailed study results are provided, nor is there any mention of AI elements.

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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

Here's a breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for clinical performance that the device must meet (e.g., a specific success rate for stone removal). Instead, it focuses on demonstrating that the modified device performs as intended and is as safe and effective as its predicate.

The reported device performance is presented as a summary of non-clinical testing results.

2. Sample Size for Test Set and Data Provenance

The document describes non-clinical (bench) testing and does not include any human clinical "test set" data. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable, as no human clinical test set data is presented. The "ground truth" for the non-clinical tests would be defined by engineering specifications and recognized testing standards.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set data is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or reported in this document. The device is a physical medical device (an extraction balloon), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by engineering specifications, design requirements, and recognized testing standards (e.g., ISO 10993-1 for biocompatibility).

8. Sample Size for the Training Set

Not applicable. As a physical medical device undergoing non-clinical validation, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device validation.

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The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.

The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only.

The provided text is a 510(k) summary for a medical device (Tri-Ex Extraction Balloon) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a typical AI/software device submission would. This document is for a physical medical device, not a software or AI product.

Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details," are not applicable and are not present in the provided text.

The device's performance is assessed through substantial equivalence to a predicate device, meaning it is considered equally safe and effective based on similar design, materials, and intended use, rather than meeting specific quantifiable performance metrics through a clinical study.

Here's a breakdown of what can be extracted or inferred based on the document's content:

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

Explanation: The "acceptance criteria" for this type of device (a Class II medical device cleared via 510(k)) primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as the predicate. The performance data section broadly states that the device is believed to be substantially equivalent in terms of "Intended Use, performance characteristics tested and biocompatibility." No specific numerical performance metrics (e.g., success rate, complication rate) are provided in this summary.

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

• Sample Size: Not applicable / Not mentioned. This submission relies on substantial equivalence to a predicate device, not a new clinical trial with a "test set" in the context of AI/software.
• Data Provenance: Not applicable / Not mentioned.

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)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC study: No, this is not an AI/software device.
• Effect size: Not applicable.

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

• Standalone performance: No, this is not an AI/software device.

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

• Type of ground truth: Not applicable in the context of an AI/software device. For this physical device, the "ground truth" concept aligns with established performance and safety of the predicate device, validated through various non-clinical (e.g., bench testing, biocompatibility) and potentially some clinical safety data (though not detailed here as a study).

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/software device.

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

• How ground truth was established: Not applicable. This is not an AI/software device.

In summary: The document describes a traditional medical device cleared via the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a new clinical study with specific performance metrics and ground truth establishment, as would be common for AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" and "study details" is not present or relevant in the context of this 510(k) summary for a physical extraction balloon.

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