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The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.

The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient. The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement.

Acceptance Criteria and Device Performance for Sherlock™ Tip Location System (TLS) Detector

1. Acceptance Criteria and Reported Device Performance

The provided document indicates the following acceptance criteria and device performance:

Note: The document only provides broad statements ("Meets accuracy claim" and "Meets requirements") rather than specific quantitative acceptance criteria or numerical performance metrics.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bench" testing.

3. Number of Experts Used and Their Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide information on human reader improvement with or without AI assistance. The device is a "Tip Location System (TLS) Detector," which sounds like a standalone device rather than an AI-assisted interpretation system for human readers.

6. Standalone (Algorithm Only) Performance

The document describes the "Sherlock™ Tip Location System (TLS) Detector" as a "battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet." This implies that the device operates as a standalone system (algorithm only) to provide rapid feedback on catheter tip location, without a human-in-the-loop for interpreting its output. The "Bench" testing for "Accuracy" and "User interface" would reflect its standalone performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the bench testing. Given that it's a "Tip Location System," the ground truth for accuracy would likely be established through precise physical measurements or imaging techniques (e.g., X-ray, fluoroscopy) to independently verify the actual position of the magnet-tipped stylet compared to the device's reading.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This suggests the device's underlying technology (passive field sensors) may not rely on machine learning or deep learning models that typically require large training datasets.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, there is no information on how its ground truth might have been established.

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Catheter stylets provide internal reinforcement to aid in catheter placement. The Sherlock™ TLS Stylet contains passive magnets that generate a magnetic field can be detected by the Sherlock™ TLS Detector to provide the placer rapid feedback on catheter tip location.

The Sherlock TLS Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally Inserted Central Catheters (PICCS) and Central Venous Catheters (CVCs) during and after initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock TLS Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.

The Sherlock Tip Location System (TLS) consists of the Sherlock TLS Detector and Sherlock TLS Stylet.

The Sherlock TLS 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 venotomy. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock TLS Detector to allow for rapid feedback of catheter tip placement. The information provided by the Sherlock TLS is not meant to replace conventional methods of catheter placement verification. Clinicians are urged to confirm correct catheter placement according to their established institutional protocol and clinical judgment.

The provided text is a 510(k) summary for the Sherlock™ TLS (Tip Location System). It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in a quantitative sense.

The document states that "The Sherlock™ Tip Location System (TLS) met all the performance criteria of the tests performed" and that "Bench testing was based on the above referenced guidance document and standards. All test results confirm that the modified device is substantially equivalent to the predicate devices." However, it does not explicitly list these "performance criteria" as acceptance metrics (e.g., accuracy +/- X mm, sensitivity, specificity, etc.) nor does it provide the detailed results of those tests.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer based on the available information, with clear indications where information is not present:

Acceptance Criteria and Study Details for Sherlock™ TLS

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document. The document refers to "Bench testing," but no details on the number of samples or tests conducted are given.
• Data Provenance: Not specified. As it refers to "Bench testing," it implies laboratory-based testing rather than clinical data from specific countries. It does not mention retrospective or prospective studies for performance evaluation beyond bench testing.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Ground Truth Establishment: Given that the testing was "bench testing," the "ground truth" would likely be established by precise measurements and engineering standards rather than expert clinical judgment (e.g., precise physical measurement of magnet location).

4. Adjudication method for the test set

• Adjudication Method: Not specified. This detail is typically relevant for studies involving human interpretation or subjective measurements, which is not clearly described here for the performance testing.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described or indicated in the provided document. The Sherlock™ TLS is a device to provide "rapid feedback on catheter tip location" and "quickly locates and confirms the position" of catheters. It is not an AI system designed to assist human readers in image interpretation.
• The document states, "The information provided by the Sherlock TLS is not meant to replace conventional methods of catheter placement verification. Clinicians are urged to confirm correct catheter placement according to their established institutional protocol and clinical judgment." This suggests the device is an aid, not a standalone diagnostic or interpretive tool that would typically be evaluated in an MRMC study regarding "human reader improvement with AI."

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

• The performance evaluation described ("Bench testing") would inherently be a standalone evaluation of the device's ability to detect and locate the magnetic tip. The document indicates the device "provides the placer rapid feedback on catheter tip location" and "quickly locates and confirms the position." The "performance criteria" that were met were for the device itself.

7. The type of ground truth used

• For the reported "Bench testing," the ground truth would likely be based on precise physical measurements of the actual magnetic tip location, using calibrated equipment. The document doesn't provide explicit details but points to engineering and biocompatibility standards.

8. The sample size for the training set

• The Sherlock™ TLS described here appears to be a hardware device (detector and stylet with magnets) based on physical principles of magnetic detection, not a software algorithm that would typically require a "training set" in the context of machine learning or AI. Therefore, this concept does not apply to the described device.

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

• As the device does not appear to be an AI/machine learning system requiring a training set, the question of establishing ground truth for a training set does not apply.

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