Search Results

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Compatibility Table

Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm.

The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws.

The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.

All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.

The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are:

• Minimum Zirconia Wall Thickness – 0.5 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia)
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician.

The overall design parameters for the Titanium Blank customized abutments are:

• Minimum Wall Thickness – 0.75 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations.

Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration.

All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The provided FDA 510(k) Clearance Letter for Sherlock Dental Implant Abutment does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical data reviewed by the FDA for clearance. However, it does not detail specific acceptance criteria or an associated study demonstrating compliance with those criteria.

The "Performance Data" section lists several types of non-clinical data submitted, such as static and fatigue testing according to ISO 14801, a reverse engineering study, biocompatibility testing, cleaning and sterilization validation, and an MRI review. These are the studies performed to support the substantial equivalence claim, but the FDA letter does not specify quantitative acceptance criteria for these tests nor does it report specific performance outcomes that directly address such criteria.

Therefore, I cannot populate the requested table or provide details for points 1-9 based solely on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study against predefined acceptance criteria.

Ask a specific question about this device

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/T-Lock Assembly 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/T-Lock Assembly 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/T-Lock Assembly 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/T-Lock Assembly may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.

I am sorry, but the provided documentation does not contain details about acceptance criteria, device performance, or specific study results for the Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly.

The document is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to a predicate device (K142267). It lists various performance tests conducted (e.g., Clamp/Flow rate Test, Leak/Pressure Test, Reseal Test, Stylet Removal Force, Joint Tensile, Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking), along with the test methods (BD Internal Test Method or ISO 594-2). However, it does not disclose the specific acceptance criteria for these tests or the reported results that would allow for a comparison.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or other details regarding a study that proves the device meets acceptance criteria.

Ask a specific question about this device

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Sherlock is a dental implant abutment system that is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile.

In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center.

All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.

All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.

The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are:

Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30°

The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

This document is an FDA 510(k) clearance letter for the Sherlock dental implant abutment system. It outlines the device's intended use, technological characteristics, and a comparison to predicate and reference devices to demonstrate substantial equivalence.

Based on the provided text, the "device" in question is a dental implant abutment. The approval is based on a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical study proving new performance claims. Therefore, the typical structure of acceptance criteria and a study proving those criteria for a novel device, especially an AI/ML system, is not directly applicable here.

However, I can extract information related to the non-clinical performance data used to support the substantial equivalence claim, which serves as a form of "acceptance criteria" for this type of submission.

Here's a breakdown of the information requested, adapted to what is available in the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the "acceptance criteria" are implied by the regulatory requirements for demonstrating substantial equivalence for dental implant abutments, primarily relying on non-clinical testing and comparison to predicate devices, rather than specific performance metrics from a human-in-the-loop or standalone AI study.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not applicable in the context of human data for an AI/ML system. The "test set" here refers to physical devices and materials subjected to non-clinical testing. The text refers to "worst-case constructs" for mechanical testing, but does not provide specific sample numbers for these tests.
• Data Provenance: The data provenance for this submission is primarily non-clinical bench testing (static and fatigue testing, biocompatibility, cleaning, sterilization, MRI review) and comparison to previously approved devices (leveraging data from K193335 and K212664). No human clinical data was included in this premarket notification. The tests are general, and therefore, "country of origin" of data or "retrospective/prospective" does not directly apply to the non-clinical tests themselves, although the regulatory submission is for the U.S. market.

3. Number of Experts for Ground Truth and Qualifications:

• Not applicable. This submission does not involve an AI/ML system that requires expert human annotation for ground truth establishment for a diagnostic or similar task. The ground truth for the device's performance is established through established engineering standards (ISO, AAMI) and material science principles, confirmed via laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human reading or diagnostic task involved that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements from bench testing.

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

• Not applicable. This device is a physical dental implant abutment, not an AI/ML software for data interpretation or diagnosis. Therefore, no MRMC study was performed or required.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Engineering Standards and Bench Test Results: The "ground truth" for this device's safety and effectiveness is based on compliance with established international standards (e.g., ISO 14801, ISO 10993-5, ISO 13356, ISO 14937, AAMI TIR30) demonstrated through physical and chemical testing. "Reverse engineering studies" are also mentioned, implying a comparison against the physical characteristics of existing OEM implant systems.

8. Sample Size for the Training Set:

• Not applicable. There is no AI/ML system involved that would require a "training set." The CAD/CAM customizations refer to design parameters for manufacturing, not a machine learning training process.

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

• Not applicable. As no AI/ML training set is used, this question is not relevant.

In summary: This FDA 510(k) clearance is for a physical medical device (dental implant abutment) and relies on demonstration of substantial equivalence through non-clinical bench testing and comparison to existing predicate devices. It does not involve AI/ML technology, human readers, or clinical data that would necessitate the types of "acceptance criteria" and "study proofs" typically associated with AI/ML-driven diagnostic devices.

Ask a specific question about this device

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Sherlock is a dental implant abutment system that includes four (4) abutment designs compatible with three (3) OEM implant systems. The Subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: Titanium blank, multi-unit angled 17°, and multiunit angled 30°. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided nonsterile to the end user. All digitally designed customized Titanium Blank abutments are to an Open Implants-validated milling center for manufacture.

The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness – 0.41 to 1.6 mm (varies by implant line); Minimum post height for single-unit restoration - 4.0 mm; Maximum Correction Angle - 30°; Minimum gingival height - 0.5 mm to 0.8 mm (varies by implant line); Maximum gingival height - 5 mm.

The provided document is a 510(k) summary for a dental implant abutment system named "Sherlock" (K212664). It details the device's technical specifications and compares it to predicate and reference devices to demonstrate substantial equivalence.

However, the document does NOT contain information about an AI/ML-based device or a study proving its performance against acceptance criteria using clinical data, reader studies, ground truth establishment, or sample sizes for AI training/testing. The "Performance Data" section explicitly states: "No animal or clinical data is included in this premarket notification." The tests performed are non-clinical, focusing on biocompatibility, reverse engineering for compatibility, and static compression fatigue.

Therefore, I cannot provide the requested information for an AI/ML device study. The content of the document pertains to the regulatory clearance of a physical medical device (dental abutments) based on substantial equivalence to existing devices, primarily through non-clinical performance data.

Ask a specific question about this device

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Compatibility Table

                        | 4.3, 5.0                   | 3.9 (RP)

Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP).

The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user.

Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment.

The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture.

The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.

The provided document describes a 510(k) premarket notification for a dental implant abutment called "Sherlock." It does not contain information about a study with acceptance criteria and device performance in the context of a diagnostic AI device or a comparative effectiveness study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.

Therefore, many of the requested items related to acceptance criteria for a study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of FDA submission.

However, I can extract the information available from the document that relates to the device's characteristics and the non-clinical performance data used to support its substantial equivalence.

Here's a summary based on the provided text, addressing the points where information is available and indicating where it is not:

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

The document does not present acceptance criteria for a study in terms of metrics like sensitivity, specificity, or accuracy, nor does it report device performance against such criteria. Instead, it discusses "performance testing" to validate differences in design parameters for demonstrating substantial equivalence. The specific acceptance criteria for these non-clinical tests (e.g., fatigue testing, biocompatibility) are not explicitly detailed in a table format with corresponding results, beyond stating that they were performed according to specific ISO standards.

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. The document focuses on non-clinical performance data, not a clinical 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)

Not applicable. The document describes non-clinical performance testing and substantial equivalence, not a study requiring expert ground truth for a test set.

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

Not applicable. There is no mention of an adjudication process as no clinical test set requiring ground truth adjudication is described.

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

Not applicable. This is a 510(k) submission for a dental implant abutment, not an AI or diagnostic device that would typically undergo an MRMC study.

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

Not applicable. The device is a physical dental abutment, not an algorithm.

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

Not applicable. For the non-clinical performance data, the "ground truth" would be the engineering specifications, material properties, and performance limits defined by the relevant ISO standards (e.g., successful sterilization, biocompatible materials, passing fatigue tests).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Ask a specific question about this device

The Sherlock 3CG+™ Tip Confirmation System (TCS) is indicated for navgationing of central venous access devices (CVADs) of at least 2 Fr in size. The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava.

In adult patients and in adolescents (greater than 12 through 21 years of age), the Sherlock 3CG+™ TCS can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), in infants (greater than 1 month to 2 years of age), and in neonates (from birth to 1 month of age), the Sherlock 3CG+™ TCS can be used with centrally inserted central catheters (CICCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.

Limiting but not contraindicated situations for this method are in patients where alterations of cardiac the presentation of the P-wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm catheter tip location.

The SHERLOCK 3CG+™ Tip Confirmation System (TCS) is designed to aid in central venous access device (CVAD) tip positioning through real-time navigation and electrocardiogram (ECG) technology. The SHERLOCK 3CG+™ TCS provides:

• Real-time catheter navigation information to the clinician via either: 1) ECG-based . Computed R-Peak Navigation, or 2) Sherlock™ Magnet, a technology for tracking passive magnets (when used with SHERLOCK 3CG™ TPS Stylets); and
• . Catheter tip placement confirmation via the patient's cardiac electrical activity, based upon identification of a maximum P-wave in the patient's intravascular ECG signal, with available catheter tip placement visual cues.

The subject device, SHERLOCK 3CG+™ TCS incorporates features from both of its predicate devices under a single tip confirmation system. The subject SHERLOCK 3CG+T™ TCS differs from the primary predicate device (K141634) because it incorporates features from the secondary predicate device (K140345):

• Provides real-time catheter navigation information to the clinician via Sherlock™ . Magnet Tracking, a technology for tracking passive magnets (when used with SHERLOCK 3CG™ TPS Stylets); and
• Includes optional catheter tip placement visual cues. .

The subject SHERLOCK 3CG+T™ TCS differs from the secondary predicate device (K140345) because it incorporates features from the primary predicate device (K141634):

• . Provides real-time catheter navigation information to the clinician via ECG-based Computed R-Peak Navigation; and
• . Includes optional R-wave highlighting.

The SHERLOCK 3CG+T™ TCS includes the following components:

• SHERLOCK 3CG™ TCS Sensor .
• Computing Platform .
• SHERLOCK 3CG+™ TCS Mobile Medical Application running on a computing platform .

The SHERLOCK 3CG+™ TCS also operates with the following legally-marketed accessories:

• . NAUTILUS DELTA™ E Electrical Adaptor
• SHERLOCK 3CG™ ECG Leads (Fin Assembly) ●
• SHERLOCK 3CG™ TPS Stylet .
• . Remote
• Optional Printer(s) ●
• Sensor Holster (a reusable holster to hold the SHERLOCK 3CG™ TCS Sensor between uses)
• . Remote Control Holder (a sterile, single use sheath to cover the Remote Control during a procedure)
• . Sensor Holder (a sterile, single use sheath to cover the SHERLOCK 3CG™ TCS Sensor during a procedure)

The Bard Access Systems, Inc. Sherlock 3CG+ Tip Confirmation System (TCS) (K180560) is indicated for navigation and positioning of central venous access devices (CVADs). The system uses real-time catheter tip location information by combining catheter navigation technology with the patient's cardiac electrical activity. It is indicated as an alternative to chest X-ray and fluoroscopy for CVAD tip placement confirmation from the superior vena cava.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria and reported device performance in terms of clinical accuracy (e.g., percentage of correct tip placements). Instead, it states that "the subject device, SHERLOCK 3CG+™ TCS, met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited primary and secondary predicate devices."

The acceptance criteria are implicitly linked to the successful completion of various non-clinical tests and the comparison to predicate devices, focusing on areas like:

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

The document explicitly states: "No new human clinical data was provided to support substantial equivalence."

This indicates that new clinical test data (and thus, a test set and its sample size) for the Sherlock 3CG+ TCS itself was not used to demonstrate performance. The performance claims rely on the substantial equivalence to predicate devices and non-clinical (engineering) verification testing of new features or modified aspects.

The provenance of any data from the predicate devices (K141634 and K140345) is not detailed in this specific 510(k) summary, as it refers to "Design validation data supporting device performance was provided under K141634 and K140345." To understand the sample size and data provenance for the clinical performance, one would need to review the 510(k) submissions for those predicate devices.

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

Given that "No new human clinical data was provided," there was no new clinical test set for which ground truth needed to be established by experts for this particular 510(k) submission. Any expert involvement would have been part of the predicate device submissions (K141634 and K140345), details of which are not in this document.

4. Adjudication Method for the Test Set

As no new clinical test set was used for this submission, there was no adjudication method applied to such a set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done for this submission, as indicated by the statement "No new human clinical data was provided." The device's clinical performance relies on the substantial equivalence to predicate devices, which were previously cleared.

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

The document refers to "Sherlock 3CG TCS Standalone Software Verification" and "Magnet Tracking Accuracy" as non-clinical tests. These indicate that the software and its specific functionalities (like magnetic tracking accuracy) were evaluated in a standalone manner (without a human user in a clinical setting) as part of the engineering verification testing for the changes and combined features. However, this is not a "standalone performance study" in the clinical sense of assessing diagnostic accuracy of the algorithm itself in clinical cases. The device is intended to be used with a human in the loop (clinician interpreting the cues).

7. The Type of Ground Truth Used

For the non-clinical verification tests conducted for this submission (e.g., software verification, electromagnetic compatibility, temperature/humidity, magnet tracking accuracy), the "ground truth" would be defined by the technical specifications, engineering measurements, and established standards against which the device's performance was measured. For example, for "Magnet Tracking Accuracy," the ground truth would be the known, precise position of the magnetic components as measured by a high-precision reference system.

For the claim of "substantial equivalence" regarding clinical performance, the implicit ground truth would be derived from the clinical studies and data submitted for the predicate devices (K141634 and K140345). The specific types of ground truth used in those predicate studies (e.g., chest X-ray, fluoroscopy, direct visualization, catheter tip measurement by pathology if removed) are not detailed here but would depend on the nature of those original clinical validations. This submission relies on the established safety and effectiveness of the predicates.

8. The Sample Size for the Training Set

The document does not mention a training set, as it does not describe a new clinical study involving machine learning or AI algorithm development that would typically require a training set. The device appears to be based on established physiological principles (ECG signal analysis) and magnetic tracking, rather than a machine learning model requiring a large training dataset as understood in many AI/ML device submissions. The non-clinical testing focused on verification of engineering requirements and software function.

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

As no training set is mentioned or implied for a new algorithm in this submission, this question is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm PICC tip location.

The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CGTM TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CGTM TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.

The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guiding and positioning Peripherally Inserted Central Catheters (PICCs) by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the ECG signal, it provides an alternative to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

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

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., a specific accuracy percentage for tip placement). Instead, it states that the device "met all pre-determined acceptance criteria" and "demonstrated substantial equivalence as compared to the predicate device." The overall conclusion from the testing is that the subject device "is as safe, as effective, and performs as well as or better than the predicate device."

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "verification and validation activities" and "in-house protocols" for determining the appropriate methods for evaluating performance.

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device itself and its equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

The information suggests that a standalone performance evaluation of the algorithm and device without a human-in-the-loop was conducted. The "verification and validation activities" and the statement that the device "met all pre-determined acceptance criteria" imply testing of the device's functionality and accuracy on its own. The primary claim is about the device's ability to locate the PICC tip, rather than its enhancement of human interpretation.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the provided text. However, given the device's function of confirming PICC tip location as an alternative to chest X-ray and fluoroscopy, it is highly probable that the ground truth for tip location was established using imaging methods like X-ray or fluoroscopy, which are considered the conventional and definitive methods for confirming PICC tip placement at the time of the submission. It could also potentially involve direct visualization or measurement during a medical procedure.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The submission focuses on verification and validation testing for market clearance, not on the development or training of an AI model in detail.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not detail the development or training phases of the device.

Ask a specific question about this device

The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm PICC tip location.

The Sherlock 3CG* TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CG* TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CG* TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CG* TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.

The provided text does not contain information on specific acceptance criteria and detailed study results with quantitative performance metrics for the Sherlock 3CG* Tip Confirmation System. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full clinical trial report with detailed performance data against predefined acceptance criteria.

However, based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states:

• "Verification and validation activities were designed and performed to demonstrate that the subject Sherlock 3CG* TCS met predetermined performance specifications."
• "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."

While these statements confirm that acceptance criteria existed and were met, the actual criteria (e.g., accuracy percentages, specificity, sensitivity, failure rates for specific outcomes) and the corresponding reported performance values are not detailed.

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

This information is not provided in the document. The 510(k) summary does not include details about the clinical study design, patient numbers, or data collection methodology (retrospective/prospective, country of origin) that would typically be found in a full study report.

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

This information is not provided in the document. Details on how ground truth was established, including the number and qualifications of experts, are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1, none) for the test set is not described.

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

This information is not provided in the document. The Sherlock 3CG* TCS is a device that provides real-time tip location using magnetic tracking and ECG, functioning as an alternative to chest X-ray/fluoroscopy for PICC tip confirmation; it is not presented as an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable in this context based on the device description.

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

The device itself is a "Tip Confirmation System" that "provides real-time PICC tip location information" and "displays the location... using a magnetic stylet and magnetic sensors" and "displays ECG waveforms." The phrasing suggests that the device provides direct information, and its performance would inherently be "standalone" in generating tip location guidance. However, the document does not present a specific "standalone study" with detailed results. The device's "without human-in-the-loop performance" could be inferred from its function as a direct measurement and display system, but no data is presented to quantify this.

7. The Type of Ground Truth Used

While not explicitly stated for the "test set," the device's indications for use state that "When relying on the patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients." This strongly implies that chest X-ray and/or fluoroscopy would be the ground truth comparators for confirming PICC tip placement in any validation studies. However, the specific method used for establishing ground truth in the actual performance studies is not detailed.

8. The Sample Size for the Training Set

This information is not provided in the document. The 510(k) summary does not mention a "training set" or "validation set" in the context of device development or performance testing, as it is primarily focused on demonstrating substantial equivalence rather than detailing an AI/machine learning model's development.

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

This information is not applicable/not provided as there is no mention of a "training set" in the context of device development in the provided document.

Ask a specific question about this device