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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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Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.

The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.

The provided document is a 510(k) summary for a guidewire device and specifically states that no clinical tests were performed (Section 8. Clinical Test: "It is not applicable"). Therefore, there is no study described that involves AI or human readers for diagnostic purposes. The acceptance criteria and testing detailed relate to the physical and biocompatibility performance of the guidewire itself.

Based on the provided text, here's a breakdown of the requested information, focusing on the non-clinical performance and a clear indication where information is not available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each performance test, "The predetermined acceptance criteria was met." Specific numerical thresholds for these criteria are not provided in this summary.

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

The document does not specify the exact sample sizes for each test in the acceptance criteria, nor does it detail the provenance of any data beyond indicating "in-house standard" for some tests. It mentions testing on "non-aged and aged to 3 years sample," implying samples were physical guidewire units. This is a medical device, not a diagnostic AI product, so "data provenance" as it relates to patient data is not applicable here.

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

Not applicable. This device is a physical medical instrument (guidewire) and not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of an AI study.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication described for the performance tests of the guidewire.

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. The document explicitly states "Clinical Test: It is not applicable." This is a guidewire, not an AI-assisted diagnostic tool.

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

No. This is a guidewire, not an algorithm or AI product.

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

For the physical and biological tests of the guidewire, the "ground truth" or reference points are defined by the standards themselves (e.g., ISO, ASTM, FDA guidance, USP) and "in-house" specifications. These standards provide the objective criteria against which the device performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no AI model requiring a training set.

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

Not applicable. There is no AI model requiring a training set or ground truth in that context.

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The GuideWire 0.6 Single Use is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.

It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing device (malleable, sensor within the tip).

Each device incorporates a sensor device, which is tracked by the navigation system within the low-energy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).

This document is a 510(k) summary for the Fiagon Navigation - GuideWire 0.6 Single Use. It's a special 510(k) to clear a modified version of an already cleared device, primarily changing from a reprocessed device to a sterile, single-use, disposable one. Therefore, the "study that proves the device meets the acceptance criteria" largely focuses on demonstrating that the modifications do not negatively impact the device's performance or raise new safety/effectiveness concerns compared to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing that a 510(k) summary is designed to summarize, not provide the full detail of, the underlying studies. As such, some specific details might be less granular than typically expected for AI/software device studies.

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

The document does not explicitly state numerical acceptance criteria with corresponding reported performance for the modified device in a table format. It generally states that "Testing was performed in order to determine device precision and accuracy of the modified device" and "Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system."

However, since this is a Special 510(k) for a modified version of a predicate device (Fiagon Navigation - Guidewire 0.6, K160369), the implied acceptance criterion is that the modified device's performance (precision, accuracy, functionality) must be comparable to or not worse than the predicate device. The conclusion states: "the GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device does not present any new issues of safety or effectiveness." This implies the tests successfully demonstrated this equivalency.

Therefore, we can infer the following (with details inferred or generally stated due to lack of specificity in the summary):

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

The document does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective. It generally refers to "Testing was performed."

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 section is not applicable (N/A) as the device is a stereotactic navigation guidewire, not an AI/software device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for a guidewire's precision and accuracy would typically be established through physical measurements against reference standards in a controlled test environment.

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

N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of performance testing for a physical medical device like a guidewire.

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

N/A. This is a physical medical device (guidewire) and not an AI/software device that would involve human readers or AI assistance for image interpretation.

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

N/A. This is a physical medical device, not an algorithm. The performance of the guidewire itself (precision, accuracy) would be evaluated in a standalone manner (without a human interpreting its output, but rather observing its physical performance or software-displayed position). The document states "Testing was performed in order to determine device precision and accuracy of the modified device."

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

For a device determining "precision and accuracy" of a physical instrument in navigation, the ground truth would typically be established by highly accurate physical measurement systems (e.g., optical tracking systems, mechanical fixtures with known dimensions, or other calibration tools) within a controlled laboratory setting. The document does not specify the exact methods but implies standard metrology for precision and accuracy.

8. The sample size for the training set

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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The GuideWire 0.6 is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.

It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is

• a. Navigated pointing devices (maleable, sensor within the tip)
  Each device incorporates a sensor device, which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)

The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)

The provided text describes the 510(k) premarket notification for the Fiagon Navigation – GuideWire 0.6. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for a novel AI device. Therefore, much of the requested information (like multi-reader multi-case studies, expert adjudication for ground truth, or details on a training set for an AI) is not applicable or not available in this document.

However, I can extract the available performance data and infer an acceptance criterion based on the comparison to the predicate device.

1. Table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample size (e.g., number of measurements or trials) used for the bench accuracy test for the new device or the predicate. The data provenance (country of origin, retrospective/prospective) is also not mentioned, as this is a bench test, not clinical data.

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

Not applicable. This was a bench accuracy test, not a clinical study involving expert interpretation of medical images.

4. Adjudication method for the test set

Not applicable. This was a bench test.

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 document describes a medical device (guidewire) used in image-guided surgery, not an AI or imaging diagnostic tool that would typically involve human readers.

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

Not applicable. This device is a guidewire, a physical instrument, not an algorithm.

7. The type of ground truth used

For the bench accuracy test, the 'ground truth' would be the known, precisely measured physical position or target, against which the device's measured position is compared. This is inherent to a bench accuracy test of a navigation device.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not an AI model requiring a training set.

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

Not applicable.

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The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

Not Found

The provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) clearance letter from the FDA to Oscor Inc. for a Guidewire, Pursuer Series. It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. The enclosure is an "Indications for Use Statement" which describes the intended use of the guidewire but does not include any performance metrics or study details.

Therefore, I cannot provide the requested information based on the given input.

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This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Coated guidewire. Removal of the guidewire is not necessary during sphinctecterotomy. Three guidewire configurations, straight, V taper and angled tip. These instruments have been designed to be used with the Olympus Endo-Therapy Accessories.

The provided 510(k) summary for the Accellent, Inc. Disposable Guidewire (K072354) does not contain a study that demonstrates the device meets specific acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Olympus Guidewire G-205-3545S, G205-3.545A #K021179) by comparing key features such as intended use, materials, and sterilization method. This is a common approach for Class II medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria are often not required if substantial equivalence can be shown.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets acceptance criteria, as such information is not present in the provided text.

Here's why and what information is available:

• No Acceptance Criteria or Performance Data: The document explicitly states: "When compared to the predicate device, the new device does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect the safety or effectiveness." This statement, along with the comparison table, serves as the primary "proof" for substantial equivalence rather than a detailed performance study against predefined acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on demonstrating that the Accellent Disposable Guidewire is as safe and effective as a legally marketed predicate device. This is achieved by showing similarities in design, materials, and intended use, and by asserting that there are no significant changes that would raise new questions of safety or effectiveness.

Summary of available information as per your requested points (where applicable):

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

   • Not Applicable. The submission does not define specific acceptance criteria or report performance data against them. The "performance" is implicitly deemed equivalent to the predicate device due to no significant changes.

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

   • Not Applicable. No test set or associated data is described, as the submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. No ground truth establishment for a test set is mentioned.

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

   • Not Applicable. No adjudication method is mentioned.

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 medical device (guidewire), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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. No ground truth as typically understood for diagnostic device evaluation is used. The "ground truth" for showing substantial equivalence is the predicate device itself and its established safety and effectiveness profile.

8. The sample size for the training set:

   • Not Applicable. No "training set" in the context of machine learning or complex device development is described.

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

   • Not Applicable.

What the document does provide in relation to demonstrating "performance" (via substantial equivalence):

• Predicate Device: Olympus Guidewire G-205-3545S, G205-3.545A (#K021179)
• Comparison of Features (Table 1):
  • Intended Use: Identical for both predicate and new device (guiding and exchanging endoscopic accessories for the biliary duct, including common bile, cystic, pancreatic, right and left hepatic ducts).
  • Materials:
    • Predicate: Nickel Titanium alloy, Polyurethane -coating, Hydrophilic -coating, Silicone - coating
    • New Device: Nickel Titanium alloy, Polytetrafluoroethylene PTFE, Pebax, Lubricious
    • (Note: While some materials differ in coating/polymer type, the submission implies these differences do not affect safety or effectiveness significantly enough to require new studies beyond this comparison.)
  • Sterilization Method: Identical (Ethylene Oxide).

Essentially, the "proof" for this guidewire's acceptability is its demonstrated similarity to an already legally marketed and safe device.

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The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

The provided text is a 510(k) summary for the Rocket Medical plc IR™ Guidewires, dated November 2, 2004. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.

Instead, it pertains to a physical medical device (guidewires) and focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are relevant to the evaluation of AI/machine learning devices, not a traditional physical medical device like guidewires in this context.

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These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The material of construction is stainless steel which is consistent with guidewires presently in commercial distribution. The wires are also manufactured using a PTFE coating. The wires are available straight, with "J" end, or moveable core. The wires range from .014" diameter through .065' diameter and lengths from 15cm. to 400cm.

The provided text describes a 510(k) premarket notification for Galt Medical's Guidewires, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because such a study was not performed or detailed in the provided documents. The submission relies on non-clinical testing and comparison to predicate devices, not human or animal clinical trials with specific performance metrics for acceptance.

Here's a breakdown based on the available information:

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

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

• Sample Size: Not specified. Non-clinical tests were performed, but the number of guidewires tested for each characteristic is not detailed.
• Data Provenance: Not specified. This would be non-clinical lab data, likely from in-house testing by Galt Medical Corp. in Garland, TX, USA. It is prospective testing, as it was conducted for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was a non-clinical device performance claim, not a diagnostic or clinical efficacy study requiring expert-established ground truth. The "ground truth" for non-clinical tests would be established by industry standards, design specifications, and comparison to predicate devices.

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

Not applicable. This was a non-clinical device performance claim, not a clinical study involving human judgment or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a guidewire, a physical medical device for interventional procedures, not an AI or imaging diagnostic tool that would involve human readers.

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

Not applicable. This device is a guidewire, not an algorithm. The "standalone" performance refers to the device's functional integrity as evidenced by the non-clinical tests.

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

Not applicable directly. For the non-clinical tests, the "ground truth" is implied by accepted engineering standards for tensile strength, torque, flexibility, and coating adherence for guidewires, as well as the performance characteristics of the legally marketed predicate devices. The focus is on demonstrating comparable physical and mechanical properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

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

Not applicable. As above, there is no training set for this type of device submission.

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