(63 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, etc.) are not explicitly stated in the provided document. | The document broadly states that "The Sherlock™ Tip Location System (TLS) met all the performance criteria of the tests performed." No specific performance metrics or their values are provided. The device aims to provide "rapid feedback on catheter tip location" and quickly locate and confirm position. |
| Compliance with FDA guidance and ISO standards (e.g., Coronary and Cerebrovascular Guidewire FDA Guidance, ISO 11070:1998, AAMI/ANSI/ISO 11135:1994, AAMI/ANSI/ISO 10993-1:1997) | "All test results confirm that the modified device is substantially equivalent to the predicate devices." |
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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).