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The Articulating Needle Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Articulating Needle Knife is not intended for use in the central nervous system or in the central circulatory system.

The Ethicon Endo Surgery® (EES) Articulating Needle Knife is an endoscopic instrument intended for cutting, dissecting and cauterizing tissue via highfrequency electrical current waveform. The device consists of a flexible wire cable and needle knife electrode, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. When connected to an electrosurgical generator and activated, the Needle Knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 3.2 mm or larger working channels. This device is supplied sterile for single-patient use.

The provided text describes a 510(k) premarket notification for the "Ethicon Endo Surgery Articulating Needle Knife". This device is an electrosurgical instrument. The information given focuses on bench testing and compliance with electrical safety standards, rather than a clinical study involving human readers or sophisticated AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The "test set" here refers to the device itself being tested in a benchtop environment, not a dataset of patient images or information.
• Data Provenance: Not applicable. The performance data is derived from direct electrical and material testing of the manufactured device.

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

Not applicable. "Ground truth" in this context would typically refer to expert annotations on medical images or clinical outcomes. For this device, the "ground truth" for its performance is established by objective engineering standards and direct physical/electrical measurements, not human expert interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation or uncertain clinical outcomes. The performance of this device is assessed against objective engineering standards.

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. This document describes a medical device clearance for an electrosurgical instrument, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

Not applicable. This device is an electrosurgical instrument, not a standalone algorithm. Its performance is always predicated on human use connected to an electrosurgical generator.

7. The type of ground truth used

The "ground truth" for the device's performance is compliance with established electrical safety standards (AAMI / ANSI HF 18:2001, IEC/EN 60601-2-2:2000, IEC/EN 60601-2-18:1996) and biocompatibility standard (ISO 10993-1). Additionally, bench testing demonstrated the device performs its intended functions (cutting, dissecting, cauterizing).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

Not applicable, as there is no training set for this device.

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The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.

The proposed Autotome™ RX is a triple lumen sphincterotome with controlled orientation and rotation features. It is compatible with the Boston Scientific Microvasive® Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .035" guidewire while allowing simultaneous injection through an adjacent lumen.

The provided document is a 510(k) summary for the Autotome™ RX device, which is a sphincterotome. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for novel AI/machine learning devices.

Therefore, much of the requested information cannot be extracted from this specific document, as it describes a traditional medical device submission based on predicate device comparison.

Here's an attempt to answer the questions based on the available information and highlighting what is not present:

1. 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)

This information is not provided in the 510(k) summary. The submission focuses on device comparison rather than a clinical study requiring a specific test set.

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/provided. Ground truth establishment by experts for a test set is typically relevant for studies validating diagnostic or AI devices, which is not the nature of this submission.

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

This information is not applicable/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

This information is not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

This information is not applicable. This is not an algorithmic/AI device.

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

This information is not applicable/provided. The evaluation is based on "performance characteristics tested and biocompatibility" compared to a predicate device, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set

This information is not applicable/provided. This is not an AI/machine learning device that would require a training set.

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

This information is not applicable/provided.

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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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