Search Results

The GuardianTM burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) burr hole cover for the skull. It can also be used to secure a lead with a 1.29-mm (0.051-in) or 1.39-mm (0.055-in) diameter

The GuardianTM burr hole cover system is used to close a cranial burr hole and secure an implanted, compatible lead, when applicable. The burr hole cover system is nonpyrogenic and has three main features: base, clip, and cover. The base is intended for burr holes with a 14-mm (0.55-in) diameter. It contains two grooved slots to hold a lead in place. The clip fits into the base to hold the lead. The locking mechanism temporarily holds a lead in place before the burr hole cover is secured. The cover snaps onto the base, closing the burr hole and locking a lead in place.

The document describes a 510(k) premarket notification for a modification to the Guardian™ Burr Hole Cover System to include an "MR Conditional" statement in the labeling. The acceptance criteria and the study that proves the device meets them are related to this MR Conditional status.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of medical imaging or diagnostic device performance evaluation. Instead, the testing was for the "MR Conditional" status. This typically involves physical testing of the device itself according to specific MR safety standards. Therefore, the "sample size" would refer to the number of physical devices tested to assess their behavior in an MR environment. The document does not specify the exact number of units tested.

• Data Provenance: The testing was conducted "following the FDA Guidance, 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment'." This implies a laboratory or testing facility setting, rather than clinical patient data. The country of origin of the data is not specified, but the submission is to the US FDA.

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

This question is not directly applicable to this type of submission. Establishing "MR Conditional" status for a passive implant primarily involves engineering and physics expertise for conducting MR safety tests and interpreting their results according to established international standards (e.g., ASTM F2052, F2119, F2182). It does not typically involve a panel of medical experts establishing "ground truth" on patient images or outcomes. The "ground truth" in this context is the objective measurement of MR-related effects (e.g., heating, artifact, force).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. MR safety testing data is typically objective and quantitative, and does not require adjudication by medical experts in the way clinical diagnostic study results might.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a burr hole cover system (a passive implant), not a diagnostic imaging AI algorithm.

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

Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's inherent physical properties and behavior in an MR environment.

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

The "ground truth" for determining MR Conditional status is based on objective, quantifiable measurements from MR safety testing protocols defined in recognized standards (e.g., SAR measurements, temperature rise, displacement force, torque, image artifact assessment). This is not derived from expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in one size (18F) and two lengths (30cm and 50cm).

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the length and packaging of the current device. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a 510(k) premarket notification for a medical device called the Nanostim Introducer Kit. This document is a submission to the FDA seeking to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, torsional, simulated use/kink). It generally refers to "Design verification testing."

• Test Set Sample Size: Not specified for individual tests.
• Data Provenance: The study is reported as "Design verification testing," which implies it was conducted by the manufacturer (St. Jude Medical, Inc.) to verify their modified product. The origin of the data (e.g., country) is not specified beyond being generated by the applicant. It is a retrospective study in the sense that the testing was performed on the manufactured device, not as part of a prospective clinical trial.

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

This information is not applicable to this submission. The tests conducted are non-clinical, design verification tests, not clinical evaluations relying on expert interpretation of medical data (like imaging or pathology). The "ground truth" for these engineering tests would be established by objective measurements and defined specifications, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are non-clinical, objective measurements against pre-defined specifications determine success or failure. There is no human variability in interpreting results that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation is not required for this device." This type of study is typically performed for AI/image analysis devices where human reader performance is a key metric.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an introducer kit), not an AI algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on engineering specifications and industry standards for medical device performance. For example:

• Visual test: Conformance to manufacturing standards, absence of defects.
• Dimensional measurement test: Conformance to specified dimensions (e.g., diameter, length).
• Torsional Strength: Ability to withstand a specified torsional force without breaking or deforming.
• Simulated use/kink test: Ability to perform as intended under simulated use conditions without kinking or failure.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and prior iterations, not trained on a dataset.

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

This information is not applicable for the same reason as point 8. There is no training set for this device.

Ask a specific question about this device

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.

Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.

Here's the information extracted from the document that is relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes for the non-clinical (design verification) tests. These are typically engineering tests performed on a limited number of devices, not clinical subject data.
The data provenance is from internal testing conducted by St. Jude Medical, Inc. It is non-clinical/engineering test data, not patient data (retrospective or prospective).

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

Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., expert consensus on images, pathology results) is not relevant for these engineering verification tests. The "ground truth" here is the adherence to design specifications and performance standards as determined by engineers and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable. As these are engineering verification tests, "adjudication" in the sense of resolving discrepancies between expert readings is not relevant. The results of the tests were compared against pre-determined acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done, and is not applicable for this type of device (an introducer kit) seeking 510(k) clearance based on substantial equivalence to a predicate, especially when focused on engineering design changes. This device is not an AI or diagnostic imaging device; it's an interventional accessory.

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

Not applicable. This device is an introducer kit, not an algorithm.

7. The type of ground truth used

For the non-clinical (engineering) testing, the "ground truth" would be the established engineering specifications and performance standards for the device. For biocompatibility, the ground truth is adherence to the ISO 10993-1:2009 standard.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set. The "ground truth" for the non-clinical tests was established by predefined engineering specifications and international standards (ISO 10993-1:2009).

Ask a specific question about this device

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.

The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.

The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads.

Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting.

The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable.

Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables

Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161.

Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.

The provided document, K101982, describes the premarket notification for the Merlin™ PSA Patient Cable EX3150 and Merlin™ PSA Patient Cable Adapters EX3170 and EX3180. This submission focuses on demonstrating substantial equivalence to predicate devices for these accessories to a Pacemaker System Analyzer (PSA). As such, the studies described are primarily engineering verification and validation tests rather than clinical studies involving human readers, ground truth establishment, or comparative effectiveness with AI.

Therefore, many of the requested categories related to clinical studies and AI performance are not applicable to this 510(k) summary. I will answer the applicable questions based on the provided text.

Acceptance Criteria and Device Performance

The acceptance criteria are generally implied by the successful completion of the various verification and validation activities listed. The device performance is deemed acceptable if these tests pass, demonstrating the device's fitness for its intended use and substantial equivalence to predicate devices.

Additional Information:

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

   • The document does not provide specific numerical sample sizes for each test listed (e.g., how many cables were tested for biocompatibility, or how many packages for shipping). It generally states that "All units tested passed the acceptance criteria" or that tests "were carried out and are reported."
   • Data provenance is not specified. The tests are engineering or laboratory-based verification and validation activities.

2. 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. This is a medical device accessory 510(k) focusing on physical and electrical performance, sterility, and biocompatibility, not on diagnostic accuracy based on expert interpretation. The "ground truth" for these tests would be established by objective measurements against predefined specifications (e.g., sterility level, material properties, electrical continuity, packaging integrity).

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

   • Not applicable for the reasons stated above.

4. 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 not an AI-enabled device and no MRMC studies were conducted.

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

   • Not applicable. This is not an AI-enabled device. The "standalone" performance refers to the device's functional and safety performance as an accessory to the Merlin PSA system.

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

   • Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established through:
     • Standardized Test Methods and Specifications: e.g., electrical resistance measurements, material composition analysis, sterility assurance level (SAL) requirements, packaging integrity standards (ISTA 3A), and biocompatibility standards.
     • Industry Standards and Regulations: Conformance to relevant national and international standards for medical devices and their accessories.

7. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable.

Ask a specific question about this device