Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device