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The Boston Scientific Lithotripter Compatible Basket is indicated for use in the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi. The Lithotripter Compatible Basket should not be used for any purpose other than its intended application.

The Boston Scientific Lithotripter Compatible Basket is a stone retrieval and lithotripter compatible basket used for calculi crushing and biliary stone retrieval.

This document is a 510(k) summary for a medical device called the Trapezoid™ RX Lithotripter Compatible Basket. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and study details:

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

Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, specific flexibility range) and corresponding reported device performance values are not explicitly stated. The document focuses on demonstrating "substantial equivalence" through comparison to a predicate device and general functional testing.

Instead of a table of specific criteria, the document states:

Explanation: The document emphasizes "substantial equivalence" as the primary "acceptance criterion" in the context of a 510(k) submission. This means the new device performs as safely and effectively as a legally marketed predicate device. The performance data section vaguely mentions "physical comparison and functional testing" which "support a determination of substantial equivalence," implying these tests confirmed the device's performance aligned with the predicate. However, detailed quantifiable results or specific acceptance thresholds are not provided.

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

The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). It generally refers to "functional testing."

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)

The document does not mention the involvement of external experts to establish a "ground truth" for a test set. This type of device (a mechanical basket) does not typically utilize expert-reviewed imaging or diagnostic data in the same way an AI diagnostic tool would. The "ground truth" for this device would be its mechanical and functional performance, which is presumably evaluated through engineering tests rather than expert interpretation.

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

The document does not describe any adjudication method for a test set. As noted above, the evaluation seems to focus on engineering and functional testing rather than subjective human interpretation needing adjudication.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical surgical tool, not an AI diagnostic system.

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

Not applicable. This device is a mechanical instrument, not an algorithm, so "standalone" algorithm performance is not a concept that applies here. The performance is inherently "human-in-the-loop" as it is operated by a clinician.

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

The "ground truth" for this device's evaluation is implied to be its functional performance and mechanical properties when compared to the predicate device. This would likely involve:

• Engineering specifications and measurements: Comparing dimensions, material properties, and mechanical characteristics against the predicate.
• Functional testing: Evaluating its ability to retrieve stones and perform lithotripsy in a simulated or benchtop environment, similar to how the predicate device performs.
• Biocompatibility testing: Ensuring the materials are safe for internal use.

It is not based on expert consensus on images, pathology, or clinical outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

Not applicable. This device is a mechanical surgical instrument, not an AI model. 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 an AI model, the concept of establishing ground truth for it does not apply to this device.

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The Lithotripter-Compatible Basket is indicated for the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi. The Lithotripter-Compatible Basket should not be used for any purpose other than its intended application.

Not Found

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It's a 510(k) premarket notification for a medical device (Lithotripter-Compatible Basket) seeking substantial equivalence to existing devices, not a clinical study report.

Here's a breakdown based on the information available and what is missing:

The document states: "Boston Scientific Corporation believes that Lithotripter-Compatible Basket is substantially equivalent to its currently-marketed Monolith Mechanical Lithotripter and Biliary Helical and Mini-Helical Baskets. ... Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Lithotripter-Compatible Basket will meet the minimum requirements that are considered acceptable for its intended use."

This indicates that substantial equivalence is the primary "acceptance criterion" in this context, rather than specific performance thresholds from a clinical trial. The "study" proving this is primarily the comparison to predicate devices and laboratory testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent:

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

2. Sample sized 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 provided. The document describes laboratory testing and a comparison to predicate devices, not a clinical trial with a "test set" of patients.
• Data Provenance: Not applicable/Not provided. The data appears to be from internal laboratory testing and comparative analysis, not patient data from a specific country or study type (retrospective/prospective).

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/Not provided. No "test set" requiring ground truth establishment by experts is described in this regulatory submission for substantial equivalence.

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

• Not applicable/Not provided. No "test set" requiring adjudication is described.

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 submission for a mechanical medical device (a lithotripter basket), not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or mentioned.

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

• No. This is a mechanical device, not an algorithm.

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

• Not applicable/Not provided. For substantial equivalence of a mechanical device, device specifications and performance data (e.g., tensile strength, flexibility, material composition, functional testing in a lab setting) are the "ground truth" for comparison against predicate devices, rather than clinical ground truth from patient data.

8. The sample size for the training set

• Not applicable/Not provided. No "training set" is described as this is not an AI/machine learning device.

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

• Not applicable/Not provided. No "training set" is described.

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