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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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This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.

The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.

The provided text is a 510(k) summary for a medical device called "Locking device." It describes the device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA. However, the document does not contain information about acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.

Instead, it focuses on bench testing and biocompatibility for a physical medical accessory. Therefore, I cannot extract the requested information as it is not present in the provided text.

The information that is available includes:

• Device Name: Locking device
• Intended Use: An accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. Supplied sterile and intended for single use only.
• Predicate Device: Wilson-Cook USW Cap and Wire Lock (K040137)
• Performance Testing Mentioned:
  • Guidewire fixing force performance (for 0.025inch, 0.035inch, 0.038inch diameter guidewires)
  • Biocompatibility tests (In Vitro Cytotoxicity Test: ISO 10993-5:2009; Skin sensitization Test: ISO 10993-10:2010; Intracutaneous Reactivity Test: ISO 10993-10: 2010)
  • Manufacturing process for sterility (ISO 11135)

The document explicitly states: "No Clinical test is included in this submission."

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation as the document describes a purely mechanical medical device accessory.

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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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The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices:

The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.

The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.

The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of a sterile, single-patient use biopsy cap and a rigid plastic guidewire locking device for use with other Boston Scientific Rapid Exchange catheter devices.

This document is a 510(k) premarket notification for a medical device and therefore describes a device modification and substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in the manner of an AI/ML or diagnostic study.

Here's an analysis based on the provided text, focusing on what can be inferred about "acceptance criteria" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics for a diagnostic or AI/ML device.

Instead, the "acceptance criteria" here are framed in terms of substantial equivalence to predicate devices and meeting design specifications through verification testing.

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy or AI/ML performance. The "testing" mentioned is Design Verification testing, which typically involves engineering or bench testing to ensure the device meets its design specifications (e.g., strength, fit, function, sterility), rather than testing on patient data.

• Sample size for test set: Not applicable/Not specified in the context of diagnostic studies. Design verification testing would involve a different type of sampling (e.g., number of devices tested for mechanical properties).
• Data provenance: Not applicable. This is a physical medical device accessory, not a diagnostic or AI/ML system trained on patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of patient diagnoses or outcomes is not relevant for this type of device submission. Ground truth for design verification would be the engineering specifications themselves.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the diagnostic sense requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an accessory (locking device and biopsy cap system) for existing endoscopic procedures, not an AI or diagnostic system that would aid human readers in interpretation.

6. Standalone Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical accessory, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance. For design verification, the "ground truth" would be the engineering design specifications and requirements.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device accessory, not an AI/ML system that requires a "training set."

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

Not applicable for the same reason as above.

In Summary:

This document is a 510(k) submission for a non-diagnostic, non-AI/ML medical device accessory. The "acceptance criteria" and "study" mentioned refer to the process of demonstrating substantial equivalence to legally marketed predicate devices and confirming adherence to design controls and specifications through engineering and bench testing (Design Verification), rather than clinical performance studies for diagnostic accuracy. Therefore, most of the requested information (sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of device submission.

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The Spectranetics Lead Locking Devices, LLD™, are intended for use in patients suitable for transvernous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.013 - 0.032 inches (0.33 - 0.81 mm) and a length less than 25.6 inches (65 cm).

Lead Locking Devices are percutaneous wire stylets which are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.

The provided text is a 510(k) summary for the Spectranetics Lead Locking Device (LLD™). It describes the device, its intended use, and claims substantial equivalence to a predicate device (Wilkoff Locking Stylet, K970690).

However, the document does not contain the information requested regarding acceptance criteria and a detailed study proving the device meets those criteria. Specifically, the following information is not present:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that a "Design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints, tracking, locking and unlocking, visibility, trackability and biocompatibility. Testing performed for the Lead Locking Device provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated." This statement indicates that testing was performed, but it does not provide details on the specific acceptance criteria, test results, or study methodologies that would allow for a complete answer to your request.

Therefore, I cannot provide the requested table or detailed study information based on the input text.

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The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to an introducer in order to reduce the risk of inadvertent movement.

The USCI® Input™ Tuohy-Borst Locking Device (hereinafter referred to as the Input Lock) is comprised of a single channel (body) which at its distal segment connects to the introducer sheath hub and ends proximally with a threaded segment containing an internally seated gland. Attached to this threaded proximal segment is an end cap which when thread tightened compresses the gland and secures the indwelling catheter.

The provided text describes a medical device, the USCI® Input™ Tuohy-Borst Locking Device, and compares it to a predicate device, the USCI® Disposable Y-Connector w/Modified Tuohy-Borst Adapter.

However, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a full study report with performance metrics.

Based only on the provided text, I can infer the intended function of the device, which serves as a proxy for what would be tested, but no specific acceptance criteria or study results are explicitly stated.

Therefore, I cannot populate the requested table with "reported device performance" against "acceptance criteria" because these are not present in the provided text. I also cannot answer many of the specific questions about sample size, ground truth, expert qualifications, adjudication, or MRMC studies, as this information is not included in a 510(k) summary from 1996 for this type of device.

Here's what I can extract and infer based on your request and the provided text:

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

Reasoning for Inference: The "Description and Intended Use" sections clearly state the device's purpose: "functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to an introducer in order to reduce the risk of inadvertent movement." The similarities and differences section also discusses the "identical mechanism for reducing the risk of inadvertent catheter movement." Precautions from the predicate device (not collapsing the lumen or impairing guidewire movement) imply performance criteria related to not causing harm.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. This document is a regulatory submission, not a clinical study report. Substantial equivalence for this type of device often relies on engineering testing and comparison to predicate devices, rather than large clinical trials in this era.

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. The development and regulatory approval of a mechanical medical device like this in 1996 would not typically involve "experts establishing ground truth" in the way it's understood for AI/diagnostic studies.

4. Adjudication method for the test set

• Not applicable and 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 mechanical medical device for securing catheters, not an imaging or diagnostic AI device.

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

• Not applicable. This is a mechanical medical device.

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

• Not applicable in the context of "ground truth" as typically discussed for AI studies. For a mechanical device, performance would be assessed through engineering tests (e.g., tensile strength, leak testing, functional testing of the locking mechanism, material compatibility). The "truth" would be whether the device performed its intended mechanical function within specified parameters.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable. This device does not use a "training set."

In summary: The provided document is a 510(k) summary for a mechanical medical device from 1996. It focuses on describing the device, its intended use, and demonstrating substantial equivalence to a predicate device. It does not contain the detailed (and often proprietary) results of performance testing, much less information about AI-related metrics like training sets, ground truth establishment by experts, or MRMC studies.

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