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Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement.

The provided text is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance tests for the device, specifically focusing on "Ship Testing" and "Tip Tracking Testing."

• Visual inspection of components.
• Visual inspection of trays. | "The verification method for ship testing was executed in accordance with ISO 11607-1:2006... All testing passed the predetermined acceptance criteria." |
  | Tip Tracking Testing | - Normal: $\overline{x} + k * s \le 1 \text{ cm or } 10^\circ$
• Non-Normal: $Ppk \ge k/3$ | "The Tip Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance criteria." |

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

The document does not specify the sample size used for either the "Ship Testing" or "Tip Tracking Testing." It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "internal test methods and protocols" were used.

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

The document does not mention the use of experts or any process for establishing ground truth for the test set in the context of human-centric evaluation. The tests described are primarily device performance (engineering) verification tests.

4. Adjudication Method for the Test Set:

Not applicable, as the tests described are engineering verification tests, not clinical studies requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, an MRMC comparative effectiveness study was not mentioned or implied. The focus of this 510(k) submission is on demonstrating substantial equivalence through technical and performance testing of the device itself, not on evaluating human reader performance with or without AI assistance.

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

The device described, the Sherlock 3CG® Tip Positioning System (TPS) Stylet, is a physical medical device (a stylet with integrated technology for tip confirmation). It is not an "algorithm" in the sense of an AI/ML software. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply in the typical AI/ML context. The "Tip Tracking Testing" would be considered the standalone performance of the device's ability to track the tip.

7. The Type of Ground Truth Used:

For "Tip Tracking Testing," the ground truth would likely be established by a precisely measured, known physical position and orientation of the stylet tip. This is a technical (engineering) ground truth, not a clinical ground truth like pathology or outcome data. For "Ship Testing," the ground truth is simply meeting the defined visual and integrity criteria.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a training set.

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

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

Summary of Study Proof:

The document indicates that the Sherlock 3CG® TPS Stylet underwent verification testing to demonstrate its performance and substantial equivalence to a predicate device. The key tests reported are:

• Ship Testing: Evaluated the packaging integrity and component visual quality after simulated shipping. This was done in accordance with ISO 11607-1:2006.
• Tip Tracking Testing: Assessed the device's ability to accurately track the tip's location and orientation. This was conducted using internal test methods and protocols.

For both types of tests, the document explicitly states that "All testing passed the predetermined acceptance criteria." This statement is the proof that the device meets its established acceptance criteria. However, detailed data (e.g., specific values for mean, standard deviation, Ppk, or raw pass/fail rates beyond "all testing passed") and the sample sizes used for these tests are not provided in this summary. The ground truth for these tests is based on engineering measurements and established physical standards rather than clinical expert consensus or patient outcomes.

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Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.

The provided document is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It outlines the intended use, technological characteristics, and safety and performance tests. However, it does not contain the detailed acceptance criteria and study results in the format requested.

The document indicates that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30" and that "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not explicitly state what those predetermined acceptance criteria were, nor does it provide specific reported device performance metrics against them.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document states that the devices met predetermined acceptance criteria, but it does not list these criteria or specific performance values. Instead, it lists technical standards and guidance documents (e.g., BS/EN/ISO 10555-1: 1997, ISO 594-2: 1998, AAMI/ANSI/ISO 11135-1:2007) that were used to determine appropriate methods for evaluating performance. It also mentions risk management according to ISO 14971:2012.

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

• Cannot be provided. The document mentions "Verification and validation tests" but provides no details on sample size, data provenance, or whether the study was retrospective or prospective.

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/Cannot be provided. This device is a stylet for a catheter tip positioning system, which uses passive magnets and cardiac electrical signal detection for feedback on catheter tip location. The ground truth for such a device would likely involve direct physical measurement or imaging confirmation (e.g., X-ray) of the catheter tip, not expert review of images for diagnosis. The document does not describe the establishment of a ground truth by experts in this context.

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

• Not applicable/Cannot be provided. As above, the nature of the device and the information provided do not suggest an adjudication method for a test set, which is typically relevant for interpretative tasks often involving human expert readers.

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

• Cannot be provided. The document does not mention an MRMC study. This device is an accessory to a positioning system, which is a tool to aid in placement, not an AI for interpretation that would typically require an MRMC study to evaluate reader improvement.

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

• Cannot be directly answered. The device is described as a "stylet" that "provides the placer rapid feedback." This implies it works with human-in-the-loop (the placer). The document doesn't detail the performance of the "Sherlock 3CG® Tip Confirmation System (TCS)" itself, only the stylet which is an accessory to it. The stylet's function is to provide internal reinforcement and, when used with the TCS, enables the system to provide tip location feedback.

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

• Cannot be determined from the text. The document does not specify how the accuracy of the catheter tip location detected by the Sherlock 3CG® TCS (when used with the stylet) was validated or what "ground truth" method was employed for this validation.

8. The sample size for the training set

• Not applicable/Cannot be provided. As this is not an AI/machine learning device in the context of image interpretation or diagnosis (it's a physical medical device accessory), the concept of a "training set" is not relevant in the sense of data used to train an algorithm.

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

• Not applicable/Cannot be provided. For the same reason as above.

In summary, the provided document is a regulatory submission summary focusing on the equivalence of the device to a predicate based on technological characteristics and general safety/performance testing protocols. It does not contain the detailed study results or acceptance criteria in the requested format.

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Sherlock 3CG™ Tip Positioning System Sensor: The Sherlock 3CG™ Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG™ TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.

Sherlock 3CG™ Tip Positioning System Stylet: Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG™ Tip Positioning System (TPS), the Sherlock 3CG™ TPS stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

The Sherlock 3CG™ Tip Positioning System (TPS) consists of a sensor, stylet, and connection assembly. The system is designed to aid in central venous catheter tip positioning through magnet tracking and ECG signal information. The Sherlock 3CG™ TPS System detects and displays the position of the magnet-tipped stylet relative to the sensor. In addition, the Sherlock 3CG™ TPS System detects and displays a cardiac electrical signal from the three ECG electrodes, including the Sherlock 3CG™ TPS Stylet and two body electrodes, which provide catheter tip positioning information.

The provided document is a 510(k) summary for the Sherlock 3CG™ Tip Positioning System. However, it does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria.

The document states:

• "Performance standards have not been established by the FDA under §514 of the Federal Food, Drug and Cosmetic Act."
• "Verification and validation tests have been performed in accordance with Design Controls per 21 CFR §820.30."
• "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Sherlock 3CG™ TPS System... met the minimum requirements that are considered adequate for its intended use and are substantially equivalent in design, materials, sterilization, principles of operation and indications for use to the current commercially available Sherlock™ II Tip Location System... and the FlowPICC™ System..."

This indicates that while safety and performance testing was conducted, the detailed results, acceptance criteria, or a specific study designed to prove these criteria were met are not provided in the given text. The primary argument for clearance is substantial equivalence to predicate devices, rather than meeting specific quantitive performance standards.

Therefore, I cannot provide the requested information from the given text as it is not present.

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