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The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The hardware and software components of the SurgiVision ClearPoint System. The hardware and software components of the SurgiVision ClearPoint System 37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality. The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following: ClearPoint Workstation Software (for trajectory planning and . monitoring) Laptop Computer . The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.

Here's an analysis of the provided text regarding the SurgiVision ClearPoint System 3T, focusing on the acceptance criteria and the study proving it meets those criteria:

The K111073 submission for the ClearPoint System 3T is a 510(k) to expand the indications for use of the previously cleared ClearPoint System (K100836) to include 3.0 Tesla MRI scanners. Therefore, the primary "acceptance criterion" being evaluated is the device's performance and safety within the 3T MRI environment, specifically demonstrating it is substantially equivalent to the predicate device operating in a 1.5T environment.

Acceptance Criteria and Reported Device Performance

Details of the Study

1. Sample Size used for the test set and the data provenance:

   • The document does not specify a "sample size" in terms of number of patients or cases. The testing described is bench testing only.
   • Data Provenance: Not applicable in the context of patient data, as the tests were bench tests.

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

   • Not applicable. The ground truth for bench testing is typically based on engineering specifications and metrology, not expert clinical consensus from patient data.

3. Adjudication method for the test set:

   • Not applicable, as this was bench testing against engineering standards, not a clinical study requiring adjudication of expert interpretations.

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:

   • No MRMC or comparative effectiveness study was performed. The device, a neurological stereotaxic instrument, is a guidance system, not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in the way described.

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

   • The "testing" described is inherently standalone in nature, as it's bench testing of the system alone for its physical and functional characteristics (force, torque, heating, accuracy, etc.) within the 3T MRI environment. While the system is used with a human in the loop during surgery, the specific tests mentioned here evaluate the device's technical performance.

6. The type of ground truth used:

   • Bench Test Ground Truth: Engineering specifications, physical measurements, and established safety standards for medical devices in an MRI environment (e.g., limits for heating, artifact generation, and system accuracy specifications from the predicate device).

7. The sample size for the training set:

   • Not applicable. This device is a sterotactic guidance system; there is no mention of a machine learning component requiring a "training set" of data.

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

   • Not applicable, as there is no training set mentioned or implied for this device.

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The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T Philips MRI system.

The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy, This product is to be used with a 1.5T Philips MRI system. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.

The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with a 1.5T Philips MRI system.

The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.

This 510(k) summary describes a device that is essentially an accessory to an MRI system (internal MR coils). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating that the new device (Philips compatible version of existing coils) is substantially equivalent to legally marketed predicate devices, particularly regarding safety and compatibility with the new MRI system.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

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The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T MRI machine.

The Intercept™ Esophageal Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophaqus. The single use, disposable coil is designed for insertion into the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with Siemens 1.5T MRI systems.

The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with Siemens 1.5T MRI systems. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.

The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with Siemens 1.5T MRI systems.

The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.

The provided document is a 510(k) summary for the Intercept™ Esophageal, Urethral, and Vascular Internal MR Coils. It focuses on demonstrating substantial equivalence to previously cleared predicate devices for use with Siemens 1.5T MRI systems. This type of submission generally emphasizes safety and functional equivalence rather than extensive clinical comparative effectiveness studies found in other regulatory pathways.

Therefore, the information typically requested in your prompt regarding acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not extensively detailed. The performance data presented primarily addresses safety and a qualitative assessment of imaging performance.

Here's an attempt to extract and describe the information based on the provided text:

Acceptance Criteria and Device Performance

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The Intercept-Urethral Microcoil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with a 1.5T GE Signa MRI machine. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.

The Intercept-Urethral Microcoil (IUMC) is an intracavitary specialty coil for use in MRI imaging of the anatomical regions surrounding the urethra. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The imaging coil and the coaxial cable are completely sealed inside the insulating sleeve. This device is advanced into the subject's urethra and positioned in the region of interest. The balancing and decoupling circuit is located outside the body.

The provided text is a 510(k) summary for the Intercept-Urethral Microcoil (IUMC). It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria, numeric performance metrics (sensitivity, specificity, AUC), or a detailed study description with a test set, ground truth experts, or training set information as requested in the prompt.

The document states that the imaging performance was evaluated and that "The imaging performance was evaluated in the male and female urethra. These images are shown in Exhibit 7." However, Exhibit 7 is not provided in the given text, and therefore, no quantitative performance metrics for imaging performance are available to construct the acceptance criteria table.

Based on the provided text, I can extract the following information about the studies performed, but without the specific numerical acceptance criteria or performance results:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the types of tests performed and their general outcomes ("no excess heating," "no possibility of increased susceptibility," "imaging performance was evaluated," "met performance specifications"), but it does not provide specific, quantifiable acceptance criteria or numerical performance results (e.g., a specific temperature threshold, a specific imaging quality score, or mechanical specifications). Therefore, this table is based on the qualitative outcomes described.

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

• Test Set Sample Size: Not explicitly stated for imaging performance. For RF heating, a "phantom that is representative of worst case clinical conditions" was used. For mechanical testing, individual components underwent testing.
• Data Provenance: Not explicitly stated. The studies appear to be laboratory-based and phantom-based for heating and mechanical testing. Imaging performance evaluation was done on "male and female urethra," implying human subjects, but details are not provided. Origin (e.g., country) is not mentioned.
• Retrospective/Prospective: Not specified.

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

• Not specified. The document does not describe a ground truth establishment process involving experts for the tests mentioned. For imaging performance, it only states that images were evaluated and shown in an exhibit.

4. Adjudication Method for the Test Set

• Not specified. No mention of an adjudication process.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes tests related to safety (heating, nerve stimulation, mechanical) and general imaging performance, not a comparison of human readers with and without AI assistance.

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

• This is not applicable as the device described (Intercept-Urethral Microcoil) is an accessory to an MRI system designed to improve image quality, not an AI algorithm. Its "standalone" performance refers to its physical and electrical properties, not an algorithmic output.

7. Type of Ground Truth Used for the Test Set

• For RF Heating and Nerve Stimulation: Calculated values and phantom measurements, comparing with and without the coil.
• For Mechanical Testing: Performance specifications (presumably engineering standards and internal benchmarks).
• For Imaging Performance: "Evaluated in the male and female urethra" - the specific ground truth (e.g., clinical diagnosis, pathology) is not described, nor is how the "evaluation" was performed (e.g., by experts, objectively).

8. Sample Size for the Training Set

• Not applicable. The device is a physical medical device (a coil), not a software algorithm that requires a training set.

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

• Not applicable, as this is a physical device and not an AI algorithm.

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The Surgi-Vision Esophageal Stylet Coil is recommended for highresolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.

The Surgi-Vision Esophageal Stylet Coil is a specialty coil for use in MRI imaging of the anatomical regions surrounding the esophagus. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for GE MRI systems. The coil and cable are completely sealed inside the insulating layer.

The provided document is a 510(k) summary for the Surgi-Vision Esophageal Stylet Coil, indicating that it is a medical device submission to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria in the way AI/ML devices typically would.

Therefore, much of the requested information (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from this type of regulatory document.

However, I can organize the available information into the requested format where possible.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes phantom testing for safety and performance, not a clinical test set with human subject data. Therefore, concepts like "sample size for the test set" and "data provenance" (country/retrospective/prospective) are not applicable in their usual clinical study context.

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 safety and performance testing involved physical measurements (heating, current leakage) and imaging performance in a phantom. There is no mention of expert consensus for ground truth on a clinical test set.

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

Not applicable, as no human-read test set data 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 medical device for improved MRI imaging quality, not an AI/ML diagnostic tool.

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

Not applicable. This is a passive MRI coil, not an algorithm. The "standalone" performance here refers to the coil's physical properties.

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

For safety criteria (RF heating, nerve stimulation), the ground truth was based on physical measurements and established scientific thresholds/limits (e.g., 4 W/kg SAR limit).
For imaging performance, the ground truth for "enhanced resolution" would likely be based on objective image quality metrics in the phantom, possibly compared to images acquired without the device, though the document does not specify these metrics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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The Surgi-Vision Endo-Esophageal MRI Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The one-time use, disposable Endo-Esophageal MRI Coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.

The Surgi-Vision Endo-Esophageal MRI Coil is a specialty coil for use in MRI imaging of the anatomical regions surrounding the esophagus. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for GE MRI systems. The coil and cable are completely sealed inside a standard nasogastric tube.

Here's an analysis of the provided text regarding the Surgi-Vision Endo-Esophageal MRI Coil, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for the test set. It mentions "experiments" for heating and "calculations and experiments" for nerve stimulation, and "imaging performance," but no details on the number of subjects (human or phantom) or cases used.

The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing likely occurred in a controlled lab or internal facility given the nature of premarket submissions.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct measurements and observations during testing (e.g., temperature changes, current leakage, visual assessment of image resolution).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the study does not describe a scenario where multiple readers or assessors would be making subjective evaluations that require adjudication. The testing seems to be based on objective physical measurements and direct observation of imaging output.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on the device's technical performance and safety compared to the predicate device's function, not on comparing human reader performance with and without AI assistance. The device itself is a passive imaging coil, not an AI-powered diagnostic tool.

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

This question is not applicable in the context of this device. The Surgi-Vision Endo-Esophageal MRI Coil is a hardware accessory for an MRI machine, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted or relevant. The "performance" described refers to the coil's ability to produce clear images.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance appears to be based on:

• Direct Physical Measurements (quantitative): For heating (temperature change) and nerve stimulation (current leakage calculations and experiments).
• Direct Visual Assessment (qualitative/semi-quantitative): For imaging performance, where "enhanced resolution of aortic regions visualized from the esophagus" implies a visual comparison of image quality.

It does not utilize expert consensus, pathology, or outcomes data as "ground truth" in the way an AI diagnostic tool would.

8. The Sample Size for the Training Set

This device does not involve a training set. As a hardware device, it is not "trained" in the manner of machine learning algorithms.

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

This question is not applicable, as there is no training set for this hardware device.

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