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The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.

The provided text is a 510(k) premarket notification for a medical device called the "Multi-Link X2 ECG Cable and Lead Wire System." This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It covers the device's indications for use, technological characteristics, and performance data, primarily focusing on compliance with established medical device standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the device performance is demonstrated through adherence to recognized medical device standards. The "Performance Data" section lists the standards the device was tested against and states that the tests were performed to support substantial equivalence.

The document states, "Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness." This indicates that the device met the requirements of the listed standards, and this compliance serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of device (ECG cables and lead wires).

For a device like an ECG cable and lead wire system, performance is primarily assessed through its ability to safely and effectively transmit ECG signals, which is verified through compliance with electrical safety, biocompatibility, and functional standards, rather than diagnostic accuracy metrics typically associated with AI-driven diagnostic devices.

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

The document does not specify a "test set" in the context of clinical data, as it describes a hardware device that transmits signals rather than a diagnostic algorithm. The testing described refers to engineering verification and validation of the device's physical and electrical characteristics against recognized safety and performance standards. Therefore, information about "sample size" for a clinical test set or "data provenance" (country of origin, retrospective/prospective) is not applicable here. The testing would involve a sufficient number of device units or components to demonstrate compliance with the specified standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to the presented device and study. The "ground truth" for an ECG cable and lead wire system is its adherence to electrical and material safety standards, which is assessed through laboratory testing and engineering analysis, not through expert clinical consensus on diagnostic findings.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often with AI systems. The studies here involve objective measurements against technical 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:

This information is not applicable. The device is an ECG cable and lead wire system, which are hardware accessories for patient monitoring. It does not incorporate AI technology, nor is it a diagnostic tool that assists human readers in interpreting results. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant.

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

This information is not applicable. The device is a hardware component; it is not an algorithm and does not operate in a standalone algorithmic capacity.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is compliance with established international and national medical device standards for electrical safety, biocompatibility, and functional performance (e.g., "60601-2-27:2011," "EC53:2013," "AAMI ANSI ISO 10993"). This is determined through objective engineering tests and material analyses.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an ECG cable and lead wire system, which undergoes engineering verification and validation. It is not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no "training set" for this hardware device.

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Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments:

Based on the provided 510(k) Summary (K151036), this document describes a medical device modification (design change from single-piece to take-apart) rather than an AI/algorithm-based product. Therefore, many of the requested points related to AI/algorithm studies (like human-in-the-loop performance, training sets, etc.) are not applicable to this submission.

The acceptance criteria and supporting study are focused on ensuring the modified physical device maintains its safety and effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes (e.g., number of instruments tested) for each non-clinical performance test. It only states that the tests were conducted and the device "PASSED" the criteria.

Data provenance: Not explicitly stated, but these are typically retrospective non-clinical engineering and laboratory tests conducted by the manufacturer, CareFusion 2200 Inc. The country of origin of the data would likely be the location where CareFusion performs its product testing, which can be global, but typically for FDA submissions, the testing adheres to international (ISO) and US (AAMI, ANSI) standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable. The "ground truth" for physical device performance tests like strength, pull, force, reliability, cleaning validation, and biocompatibility is established by engineering specifications, recognized national and international standards (e.g., AAMI, ANSI, ISO), and regulatory requirements, not by expert medical opinion in the same way an AI model's diagnostic accuracy might be judged. These tests are objective measurements against defined thresholds.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's ambiguity in classifying clinical data for ground truth establishment. For the objective non-clinical performance tests mentioned, the results are typically quantitative measurements that either meet or fail pre-defined acceptance limits based on standards and engineering requirements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "N/A - No clinical tests were conducted for this submission." MRMC studies are typically for evaluating diagnostic accuracy or clinical effectiveness, often involving human readers and AI assistance, neither of which is present in this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (referring to an algorithm's performance) was not done. This submission is for a physical surgical instrument, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests undertaken are:

• Engineering Specifications and Design Requirements: For parameters like instrument strength, inadvertent disassembly, ease of disassembly/reassembly, handle reusability, and handle compatibility. These are defined by the manufacturer based on expected operational loads and user interaction.
• National and International Standards: For aspects like cleanability and sterilizability (e.g., AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) and biocompatibility (ISO 10993). These standards provide objective criteria and methodologies for testing.

8. Sample Size for the Training Set

This question is not applicable. There is no AI/algorithm, so there is no training set for an algorithm.

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

This question is not applicable, as there is no AI/algorithm and thus no training set.

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The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and filling them with carbon dioxide gas.

The V. Mueller® Uterine Cannula devices are constructed with a stopcock, finger ring control, an elongate shaft and a distal end with a rubber acorn.

The provided text describes the 510(k) summary for Uterine Cannulas, focusing on demonstrating substantial equivalence to a predicate device due to a "material modification". This submission is for a medical device, not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable.

However, I can extract the relevant acceptance criteria and study information provided for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission concerns a physical medical device (Uterine Cannula) and its material modification, not an AI/ML algorithm requiring a test set of data. The performance evaluations are based on non-clinical tests (biocompatibility and functionality).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth as typically understood for AI/ML device evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by adherence to recognized standards for biocompatibility and engineering analysis for functionality.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring adjudication of results from a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established international standards for biocompatibility (ISO 10993-1:2009 / AC 2010) and engineering analysis (Plating Thickness Analysis) for functionality.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. There is no training set for this physical medical device.

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