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The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.

The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.

Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.

The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.

Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.

This document, a 510(k) Premarket Notification for the Olympus Single Use Retrieval Basket V (K243807), details the device's substantial equivalence to a predicate device. However, it does not contain the specific information required to address your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human comparative effectiveness study.

The provided text focuses on the device's mechanical, material, and operational equivalence to a previously cleared device. It outlines:

• Device Description: Single-use retrieval baskets for stones in the biliary tract.
• Performance Data: Biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135), packaging validation (ISO 11607-1, ASTM F1980-21), and mechanical testing (Insertion/Withdrawal, Open/Close Basket, Dimensional verification, Grasping Basket Effective Test, Attachment/Detachment of Hook, Injecting Fluid, Strength of Junction).
• Conclusion: The device is substantially equivalent to the predicate based on these non-clinical tests.

Crucially, the document explicitly states:

• "Animal study data and clinical study data were not required to demonstrate substantial equivalence."

This indicates that a study involving human subjects or AI-assisted performance, which would typically contain the data you're requesting, was not part of this 510(k) submission. The acceptance criteria described are for the physical and material properties of the basket, not for diagnostic performance or human-AI interaction.

Therefore, I cannot provide the requested information from this document. The device in question is a medical instrument (a retrieval basket), not an AI/software as a medical device (SaMD) that would have diagnostic performance metrics, ground truth establishment, or multi-reader studies.

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This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.

The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope.

The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.

The provided text is a 510(k) summary for a medical device called "Extraction Basket". It describes the device, its intended use, and comparison to a predicate device, along with performance data. However, this document does not describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic or AI-driven performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, which involves:

• Biocompatibility testing: To ensure the materials are safe for use in the human body.
• Performance testing: To confirm the mechanical functionality and intended operation of the physical device.
• Shelf-life and packaging integrity testing: To ensure the device remains sterile and functional over time.
• Sterilization validation: To confirm the sterilization process is effective.

Therefore, the information required to answer your request (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document.

The "Performance Data" section lists various types of tests conducted, such as "Dimension Testing," "Connection Force Testing," "Simulated-Use Testing," and "Stone Capture and Durability Testing," but it does not provide specific acceptance criteria or quantitative results of these tests.

The document explicitly states:

• No animal study is included in this submission.
• No clinical study is included in this submission.

The question you've posed is typically relevant for AI/ML-driven diagnostic devices or devices where performance is measured against a clinical outcome or diagnostic accuracy. This document describes a physical medical tool (an extraction basket) for removing stones/foreign bodies, and its clearance is based on demonstrating mechanical and material safety and effectiveness, not diagnostic performance.

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The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.

The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Single-use Extraction Baskets." This type of document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing. It is not a document that details the rigorous clinical validation of an AI-powered diagnostic device, which is what your request implies by asking about acceptance criteria, ground truth, training sets, and MRMC studies.

Therefore, most of the information you requested regarding acceptance criteria and a study proving device performance (especially for an AI device) cannot be found in this document because the device in question is a mechanical medical device (extraction baskets), not an AI diagnostic tool, and the review process outlined here focuses on substantial equivalence through non-clinical and mechanical performance testing.

However, I can extract information related to what was used to demonstrate the device's performance for this specific 510(k) submission:

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

The document does not provide a formal table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of performance tests conducted and states that the "test results demonstrated that the subject device complies with the standard requirements." "Compliance with standard requirements" is the implicit acceptance criterion for these non-clinical tests.

• Dimensions Testing
• Tensile Pull Testing
• Simulated-Use Functionality & Durability Testing
• Stone Capture Testing
• Deflection Testing | Demonstrates basic performance and performs as intended. | Confirmed that the subject device performs as intended. |
  | Comparative Testing | Performance comparable to the predicate device (K203322). | Demonstrated that the subject is as safe and effective as the predicate. |

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

• Sample Size for Test Set: Not specified in terms of numbers of devices or specific test runs for each mechanical test. The document states "The following performance data were provided..." without quantifying the test samples.
• Data Provenance: Not explicitly stated, given that these are non-clinical bench tests rather than patient data. These tests would typically be performed in a lab setting by the manufacturer.

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

• This information is not applicable and not provided in this document. Since the device is a mechanical extraction basket, there is no "ground truth" in the diagnostic sense or expert interpretation required for these performance tests. The ground truth for mechanical performance is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for human expert review processes, typically in clinical studies or for establishing ground truth in diagnostic AI datasets. This document describes non-clinical engineering and performance tests.

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 specifically for evaluating the impact of AI on human reader performance, usually in image-based diagnostics. This document is for a mechanical medical device, not an AI diagnostic tool.
• The document explicitly states: "The clinical data is not applicable."

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

• No, this is not applicable. The device is a "Single-use Extraction Basket," a physical tool, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The type of ground truth used

• For mechanical performance tests: The "ground truth" is established by engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM). For example, "Dimensions Testing" would verify that the device's dimensions meet pre-defined specifications. "Stone Capture Testing" would evaluate the basket's ability to capture stones under simulated conditions, with the "truth" being whether it successfully performed the action based on defined criteria.
• Not applicable for clinical or diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data, as this is not an AI diagnostic device.

8. The sample size for the training set

• Not applicable. This device is a mechanical one and does not involve AI or machine learning that requires a "training set."

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

• Not applicable. As a mechanical device, there is no AI training set.

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Endoscopic removal of stones in the biliary system and foreign bodies.

The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm).

Diameters of Outer Tube of the device are 1.8mm and 2.3mm, working lengths are 700mm,200mm and 2300mm, and open widths are 10mm, 15mm, 20mm,35mm,40mm, and the devices have eight types of baskets and two kinds of handles (single hand type and two hands type).

It is comprised of guiding head (stainless steel/nitinol), pulling wire (stainless steel), outer tube(PTFE) and handle components (ABS, stainless steel and etc.). Basket is advanced out of and retracted into the polytetrafluoroethylene outer tube using the handle. The device is not compatible with any mechanical lithotripter.

This document is a 510(k) summary for a medical device called "Stone Extraction Baskets." It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for FDA clearance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it lists the types of non-clinical bench tests performed and concludes that the device "meets the performance criteria required to fulfill the intended use of the device."

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

The document does not provide details on sample sizes used for the non-clinical bench tests. It only lists the types of tests performed. There is no information about data provenance (country of origin, retrospective/prospective) because this document describes a pre-market submission, not a clinical study involving patient data. The tests are bench tests performed on the device itself.

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

This information is not applicable to the provided document. The tests described are non-clinical bench tests and do not involve human expert interpretation of data or images to establish a "ground truth" in the same way a clinical diagnostic study would. The performance is assessed against engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are physical and functional assessments of the device.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on establishing substantial equivalence through bench testing, not on comparing human reader performance with and without AI assistance. This device is a manual tool (stone extraction basket), not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its operation inherently involves a human operator (a clinician).

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not directly applicable to the bench tests described. For these engineering and functional tests, the "ground truth" is typically defined by:

• Engineering specifications: (e.g., dimensions, tensile strength).
• Functional requirements: (e.g., successful capture of a simulated stone, ability to pass through an endoscope).
• Regulatory standards: (e.g., biocompatibility testing according to ISO standards, sterility assurance level).

8. The Sample Size for the Training Set

There is no mention of a training set sample size because this device is not an AI/ML algorithm that requires training data.

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

This question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth.

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The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.

The SpyGlass Discover Retrieval Basket is designed to be used with the SpyGlass Discover Digital Catheter (K200483), which is a single-use endoscope. The SpyGlass Discover Retrieval Basket is a self-expanding nitinol wire basket that is housed within a flexible sheath. The basket is extended from the sheath (opened) and retracted into the sheath (closed) using a thumb slide on the proximal handle. The basket cage is made of four nitinol wire legs. The basket wires are looped at the distal end featuring a tipless design with no exposed wire ends.

The provided text is a 510(k) summary for the Boston Scientific SpyGlass™ Discover Retrieval Basket. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on demonstrating equivalence through comparison of technical characteristics and performance data, rather than detailing a clinical study with human subjects, acceptance criteria for an AI/algorithm, or MRMC studies that would be typical for an AI-powered diagnostic device.

Therefore, the information requested in your prompt regarding acceptance criteria for an algorithm, study design elements like sample size for training/test sets, expert adjudication, or MRMC studies, and ground truth establishment is not present in this document. This document describes a physical medical device (a retrieval basket), not a software or AI-based diagnostic tool.

However, I can extract the acceptance criteria and performance data for the physical device's bench testing, as described in Section 7, "Performance Data."

Here's a breakdown based on the information available:

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

The document describes various bench tests conducted to evaluate the device. The specific acceptance criteria values and the quantitative results are not explicitly stated in a table format with numerical values within this summary. However, the types of tests and the implicit acceptance criteria (that the device performs acceptably for its intended use and is comparable to the predicate) are listed.

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

• Sample Size: Not specified for individual bench tests. The document generically states "Testing includes:" and then lists the tests.
• Data Provenance: The testing was "Non-clinical performance bench testing and simulated use testing" performed by Boston Scientific Corporation. This is laboratory bench data, not human patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the context of human data studies.

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

• This information is not applicable as this document solely describes bench testing of a physical device. There is no concept of "ground truth" derived from expert interpretation in this context, nor human subject data requiring expert review.

4. Adjudication method for the test set:

• Not applicable, as there are no human interpretations or judgments to adjudicate in bench testing.

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 is not an AI/software device, nor is it a diagnostic device that would involve human "readers" interpreting images.

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

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

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

• Not applicable. For bench testing of a physical device, "ground truth" refers to the engineering specifications and measurable physical properties of the device, assessed through specific testing methodologies (e.g., measuring dimensions, tensile strength, successful stone capture in a simulated environment). This is not equivalent to clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.

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The device is used for the endoscopic removal of biliary stones and foreign bodies.

The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.

The provided text is a 510(k) summary for the Disposable Stone Extraction Basket. It describes the device, its intended use, and compares it to a predicate device. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria, especially not in the context of an AI/ML powered device.

The document discusses performance data broadly in Section 5.8: "The Disposable Stone Extraction Basket meets all device standards for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to general device safety and functionality standards, not specific performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be typical for an AI/ML powered medical device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving its performance for an AI/ML powered device based on the given text. The device described is a physical medical device (stone extraction basket), not an AI/ML algorithm.

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The Stonetome Stone Removal Device is indicated for use in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP), transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

The Stonetome Stone Removal Device is a 200 cm tapered 7F (2.3 mm) to 5.5F (1.8 mm) triple lumen catheter that incorporates a sphincterotome with a latex retrieval balloon. The Stonetome Stone Removal Device is available in several configurations: (1) with the latex balloon mounted distal or proximal to the cutting wire, (2) with a 20- or 30-mm wire, and (3) with a 5 mm or 20 mm distal tip.

This FDA 510(k) clearance summary for the Stonetome Stone Removal Device (K191789) does not describe a study involving an AI/Machine Learning device. Instead, it focuses on the substantial equivalence of a modified medical device (a catheter for stone removal) to a predicate device.

Therefore, many of the requested criteria related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.

The document discusses performance data in the context of bench testing for a physical medical device, not a software algorithm.

Here's an attempt to answer the questions based only on the provided document, highlighting what is present and what is absent for this type of medical device clearance:

Acceptance Criteria and Study for the Stonetome Stone Removal Device (K191789)

This document pertains to the clearance of a physical medical device, not an AI/Machine Learning algorithm. Therefore, the "acceptance criteria" and "study" described here relate to the device's physical and functional performance, as well as its safety and biocompatibility, as compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Non-clinical testing was successfully performed" and "Performance testing (bench) was successfully completed to establish substantial equivalence" for the listed tests. For Biocompatibility, it explicitly states "All acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For bench testing of a physical device, "sample size" would refer to the number of device units tested. The document does not specify this, nor does it specify the provenance of data as it's not a clinical study on human subjects or a dataset for AI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is not an AI/ML device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is its ability to meet engineering specifications and safety standards during bench testing.

4. Adjudication Method for the Test Set:
Not applicable. This is not an AI/ML device requiring human adjudication of results. Testing involved objective engineering measurements and biocompatibility evaluations.

5. Was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study 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 physical catheter, not an AI-assisted diagnostic or therapeutic tool for which human reader performance with and without AI assistance would be relevant.

6. Was a standalone (i.e., algorithm only without human-in-the-loop performance) study done?
Not applicable. This is a physical device, not a standalone algorithm. The performance described is of the device itself through bench testing.

7. The Type of Ground Truth Used:
The 'ground truth' for this device's acceptance is based on engineering specifications and pre-defined performance standards met during non-clinical (bench) testing, and compliance with biocompatibility standards (ISO 10993-1). It is not based on expert consensus, pathology, or outcomes data in the typical sense for AI/ML or clinical trials.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.

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Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.

This document describes a 510(k) premarket notification for a medical device called the "Wilson-Cook Mini Basket Extraction Basket" (K182381). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the information provided in this document is not a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based device. Instead, it demonstrates the device's technical performance and equivalence to a predicate device.

Given this context, I will address your request by interpreting "acceptance criteria" as the performance tests conducted to establish equivalence and "proof" as the results of those non-clinical tests. Since this is a physical medical device and not an AI or algorithm-based product, many of your specific questions regarding AI-related performance measures (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies) are not applicable.

Here's an adaptation of your requested information based on the provided document:

Device Name: Wilson-Cook Mini Basket Extraction Basket
FDA 510(k) Number: K182381
Device Type: Biliary Catheter and Accessories (Physical Medical Device, not AI/Algorithm)

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, "acceptance criteria" are implied by the successful completion of the listed performance tests, which are standard for such devices to demonstrate functionality and safety in comparison to a predicate. The document states that these tests "confirmed that the subject device performs as intended."

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of stones tested) for each non-clinical test. This level of detail is typically found within the full 510(k) submission, not the summary letter.
• Data Provenance: The studies were conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. These are non-clinical (benchtop/laboratory) tests, not human studies. The data provenance is internal to the manufacturer's testing facilities. It is inherently "retrospective" in the sense that the testing was completed before the submission.

3. Number of Experts and Qualifications for Ground Truth

• This question is not applicable as this is a physical medical device submission, not an AI/algorithm device requiring expert human readers to establish ground truth for image interpretation or similar AI-specific performance metrics. Performance was assessed through engineering and material science tests.

4. Adjudication Method for the Test Set

• This question is not applicable as this is a physical medical device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus on challenging cases, primarily in clinical studies involving interpretation (e.g., radiology for AI). The tests performed here are objective engineering tests.

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

• Not applicable. MRMC studies are used to evaluate the comparative effectiveness of different diagnostic methods, typically involving human readers interpreting images, possibly with AI assistance. This submission is for a physical device used for stone extraction, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance

• Not applicable. This section relates to AI/algorithm performance. The Wilson-Cook Mini Basket is a physical device that is used by a human endoscopist. There is no "algorithm only" performance for this type of product.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical tests would be defined by engineering specifications, material properties, and physical standards for stone capture, tensile strength, and functional operation. For example, a successful "stone capture" test would be defined by the physical retention of the stone within the basket under specified conditions, rather than a clinical outcome or expert diagnosis. Biocompatibility used established ISO standards.

8. Sample Size for the Training Set

• Not applicable. This question pertains to AI/machine learning models which require training data. This is a physical medical device. Manufacturing processes and design iterations occur, but there isn't a "training set" in the AI sense.

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

• Not applicable. As above, this pertains to AI/machine learning. For a physical device, functional parameters and material specifications are validated through established engineering and quality control procedures during design and manufacturing.

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Endoscopic removal of stones in the biliary system and foreign bodies.

The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.

This is a 510(k) premarket notification for a medical device called the "Non-Lithotripsy Extraction Basket," which is used for the endoscopic removal of stones and foreign bodies in the biliary system. The document states that performance testing, consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing, demonstrates that the device meets the performance criteria.

However, the provided text does not include acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria. The performance data section is very high-level and only lists the types of tests conducted:

• Stone and Foreign Body Capture Testing
• Tensile Testing
• Flexibility Testing
• Post-Aging Functional Testing

Therefore, I cannot provide the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document.

To answer your request, here's what the document does provide in relation to a study, but falls short of a comprehensive answer to your questions:

1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The document only lists types of tests performed, not the specific criteria or results.

2. Sample sized used for the test set and the data provenance:
Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a physical device testing, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method for the test set:
Not applicable/not provided.

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 is a physical medical device, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For the physical tests listed (Stone and Foreign Body Capture, Tensile, Flexibility, Post-Aging Functional), the "ground truth" would be the measurable physical properties and functional performance of the device against pre-defined engineering specifications. The document does not detail these specifications.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided 510(k) notification states that non-clinical bench testing was performed and that the device meets the performance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, sample sizes, or detailed methodologies of these tests.

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The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.

The provided text describes a 510(k) premarket notification for a medical device called the "Nathanson Transcystic Bile Duct Stone Exploration Pack". The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a comparative effectiveness study involving AI or human readers.

Therefore, the requested information about acceptance criteria, study design for proving device performance (especially for AI/human reader studies), sample sizes for test/training sets, expert involvement, and ground truth establishment, cannot be found or inferred from the provided document as it relates to a traditional premarket notification for a mechanical medical device, not an AI/ML software.

However, I can extract the acceptance criteria and performance as presented for the mechanical and biocompatibility testing of the device, which is relevant to a non-AI medical device.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Reported Device Performance (for a Traditional Medical Device)

The document outlines acceptance criteria and corresponding test results for various components and aspects of the Nathanson Transcystic Bile Duct Stone Exploration Pack.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes for the physical and biocompatibility tests. It refers to "test articles" but does not quantify them.
• The only reference to a "study" is a retrospective clinical study from 2007 (Taylor et al, 2007).
  • Sample Size: 160 consecutive patients.
  • Data Provenance: Not explicitly stated (e.g., country of origin), only that it's a "retrospective study."

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

• This information is not applicable and not provided for this type of device submission. The test results are based on engineering specifications and laboratory testing, not expert interpretation of medical images or data.
• The clinical study mentioned is a retrospective review of patient outcomes, not an expert panel establishing ground truth for a new device's performance.

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

• This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies where human assessment or interpretation is involved in determining an outcome, which is not the primary focus of this 510(k) submission's testing section.

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 is a mechanical medical device, not an AI-powered diagnostic tool. The document focuses on physical and chemical properties and a retrospective clinical review of outcomes.

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

• No, this is not applicable. There is no algorithm or AI component in this device.

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

• For the physical tests: The "ground truth" is defined by engineering specifications and pre-determined acceptance criteria based on established standards (e.g., ISO 10993-1, force measurements in Newtons, length in mm).
• For the clinical study mentioned: The "ground truth" is patient outcomes data (e.g., successful common bile duct exploration, need for additional intervention, major morbidity, biliary leak, stricture).

8. The sample size for the training set:

• Not applicable. This document describes a mechanical medical device, not an AI/ML algorithm requiring training data.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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