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The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures.

The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidwire can be locked and will not be moved, so the convenience of the operation can be improved.

The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge.

This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy.

There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope.

The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 6 months.

The provided document, K220247, describes a 510(k) premarket notification for a medical device called the "Guidewire Locking Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials for software performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device. The device in question is a physical accessory used during ERCP procedures, and its performance evaluation involves engineering and biocompatibility testing, not an AI performance study with human readers or standalone algorithm analysis.

Here's why the requested information is absent:

• Device Type: The "Guidewire Locking Device" is a physical accessory to be used with endoscopic biliary devices to lock guidewires. It is a mechanical device, not an AI/software device that requires performance metrics like sensitivity, specificity, or reader studies.
• 510(k) Premarket Notification: This regulatory pathway (510(k)) is for demonstrating "substantial equivalence" to a predicate device. It typically relies on comparing technological characteristics and non-clinical performance data (e.g., bench testing, biocompatibility, sterilization) rather than novel clinical performance studies or AI validation studies.
• Performance Data Provided: Section 8, "Performance Data," lists several engineering tests (e.g., Slide Block Flexibility Test, Locking Retention Performance Test, Friction Resistance Test, Sealability Test, Wire Locking Force Test, Brush and Squeegee Performance Test, Connection Force Test). It also mentions shelf-life, sterilization validation, and biocompatibility testing. None of these are related to AI performance.
• Absence of Clinical/Animal Studies: Sections 9 and 10 explicitly state "No animal study is included in this submission" and "No clinical study is included in this submission," further confirming that this is not an AI or software-as-a-medical-device (SaMD) submission that would involve the type of performance evaluation requested.

In summary, the questions posed (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the type of device and regulatory submission described in the provided document.

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The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.

The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap. The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged. The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel. The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.

The provided text describes the "CleverLock Guidewire Locking Device and Biopsy Cap" and its substantial equivalence to a predicate device. It includes information on non-clinical testing, but it does not contain the specific details required to fully address your request, particularly regarding clinical studies, acceptance criteria for performance metrics, sample sizes for test and training sets for an AI/algorithm, expert qualifications, or multi-reader multi-case studies.

The device described is a physical medical device, not an AI/algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable.

Below is an attempt to answer the relevant parts based on the provided text, and I will explicitly state when the information is unavailable.

Acceptance Criteria and Study for CleverLock Guidewire Locking Device and Biopsy Cap

The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe an AI/algorithm, therefore, many of the typical acceptance criteria and study details for AI-powered devices are not present.

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

The document details various bench tests performed, but it does not explicitly state specific numerical acceptance criteria or reported performance values for each test. The "Conclusion" section only broadly states that the device is "substantially equivalent" and "presents no new questions of safety or effectiveness," implying that the device met internal performance specifications without providing the quantitative details.

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

This information is not provided in the document. The testing described is primarily non-clinical bench testing. Details on the number of samples tested for each bench test, or any "data provenance" in the sense of patient data, are not disclosed.

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)

This information is not applicable as the device is a physical medical device, not an AI/algorithm that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing standards.

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

This information is not applicable as the described testing does not involve human interpretation or adjudication in the context of an AI/algorithm's output.

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

This information is not applicable as the device is a physical medical device, not an AI system designed to assist human readers.

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

This information is not applicable as the device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and manufacturing, validated through bench testing.

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

For the biological aspects (biocompatibility, sterilization), the "ground truth" is defined by compliance with established international standards (ISO, USP, ANSI/AAMI/ISO). For the mechanical/performance tests, the "ground truth" would be the device meeting pre-defined engineering specifications and functional requirements as determined by the manufacturer's design verification process. No "expert consensus," "pathology," or "outcomes data" in the clinical sense is mentioned for the evaluation of this specific device's performance.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

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

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

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