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The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

The provided text is a 510(k) Premarket Notification for the SCOUT MD Surgical Guidance System. It aims to demonstrate substantial equivalence to a predicate device, the SAVI Scout Reflector and SAVI Scout System.

However, the document does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be described in a clinical study report for proving a device meets specific acceptance criteria. Instead, it lists the types of tests performed to support substantial equivalence.

Therefore, I cannot extract answers to many of your specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert roles, and MRMC studies, as this information is not present in the provided text.

The document implicitly "proves" the device meets acceptance criteria by stating that the results of safety and performance tests demonstrate the device is substantially equivalent to the predicate, and that any differences do not raise new questions of safety and effectiveness. This is the core argument for a 510(k) submission.

Here's an attempt to answer what can be inferred or directly stated from the provided text, with clear indications where the information is not available.

Acceptance Criteria and Device Performance (Inferred/Stated)

While explicit numerical acceptance criteria are not detailed, the summary implies that the device performance met the standards for demonstrating substantial equivalence to the predicate. The performance "tests" enumerated are implicitly the method by which acceptance was determined.

Study Details (Information from the Text):

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

   • Sample Size: Not specified. The document lists types of performance tests, but not the sample sizes used for those tests (e.g., number of devices tested, number of simulated deployments, or any human subject data).
   • Data Provenance: Not specified. The document does not mention the country of origin of any data or whether the studies were retrospective or prospective. Given the nature of the tests listed (e.g., integrity, functional, electrical safety, biocompatibility, simulated use), these are typically bench or lab-based engineering verification and validation activities, not clinical studies with human subjects in the traditional sense for AI/imaging devices.

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

   • This information is not provided. The listed tests are primarily engineering and bench testing, not clinical performance studies requiring expert ground truth establishment in the context of diagnostic accuracy. If "Simulated Use" involved expert assessment, it's not detailed.

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

   • Not applicable / Not provided. This typically refers to clinical image interpretation studies, which are not detailed here.

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 evidence of an MRMC study. This device (SCOUT MD Surgical Guidance System) is an implantable marker and a localization system. It does not appear to be an AI-powered diagnostic imaging device that would assist human readers in interpreting images. Its function is to non-imaging detect and localize an implanted reflector.

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

   • The "SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector." The functional and performance tests mentioned (deployment, detection, accuracy) would constitute standalone performance evaluation of the algorithm and system components. The specific details of how thoroughly this was tested are not explicitly described beyond listing the types of tests.

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

   • For the engineering and functional tests described (e.g., dimensional accuracy, detection range accuracy, material properties), the "ground truth" would be engineering specifications, physical measurements, and established scientific standards (e.g., ISO, ASTM standards for materials, sterilization, electrical safety). There is no mention of expert consensus, pathology, or outcomes data as ground truth, as these tests are not related to diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable / Not provided. The document describes a "Surgical Guidance System" that non-imaging detects an implanted marker. There is no indication that this system uses machine learning or requires a 'training set' in the context of AI model development. The principle of operation is described as measuring the relative strength of RF reflective energy.

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

   • Not applicable / Not provided. As there's no mention of a traditional 'training set' for an AI model, this question is not relevant to the information provided.

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Using SCOUT Bx Delivery System, the SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The SCOUT Bx Delivery System (including the SCOUT Reflector) is a sterile, single use device composed of a SCOUT Reflector preloaded in a delivery system. The SCOUT Reflector, when used in conjunction with the SCOUT Handpiece and SCOUT Console, can be used as a guide for the surgeon to follow in the excision of tissue. The SCOUT Reflector is visible using ultrasound and radiography. The SCOUT® Console, SCOUT Handpiece and SCOUT Reflector are components of the SCOUT Surgical Guidance System. The SCOUT Bx Delivery System is intended to be used with compatible Hologic® Biopsy Devices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture) and ATEC® ILS 0914-20).

The provided text is a 510(k) summary for the SCOUT Bx Delivery System. It outlines the device description, indications for use, comparison to a predicate device, and the performance testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study that proves the device meets the criteria in the context of an AI/ML medical device performance study.

The relevant sections are focused on bench testing and biocompatibility for a physical medical device (implantable marker delivery system), not on software performance, diagnostic accuracy, or human reader effectiveness with AI assistance.

Therefore, many of the requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training/test set details, are not applicable or present in this document.

Here's what can be extracted and what cannot:

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

The document mentions various bench tests and biocompatibility tests. While it states "Performance Testing-Bench" and lists categories like "Compatibility with legally marketed 3rd party Biopsy Device," "Deployment Accuracy," "Cannula Effective Length & OD," etc., it does not provide the specific quantitative acceptance criteria or the reported performance values for these tests. It only lists that these tests were conducted as part of the substantial equivalence determination.

2. Sample sizes used for the test set and the data provenance:

• Sample sizes: Not specified for any of the performance tests.
• Data provenance: Not applicable in the context of clinical data for AI testing, as this document describes bench and biocompatibility testing of a physical device.

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

• Not applicable. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert interpretation of images) is not relevant to the described physical device testing.

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

• Not applicable. No expert-based adjudication is mentioned.

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. The document explicitly states: "No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device." This confirms that no clinical studies involving human readers or AI assistance were performed.

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

• Not applicable. This is not an AI/ML device.

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

• For the physical device, ground truth would be based on engineering specifications and physical measurement standards (e.g., ISO, ASTM standards listed). Not expert consensus or pathology in the diagnostic sense.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable.

In summary:

The provided text documents the 510(k) clearance for a physical medical device (SCOUT Bx Delivery System) and outlines the bench and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device. It does not contain any information related to AI/ML device performance studies, diagnostic accuracy, or human reader interaction with AI, which are the typical contexts for the requested acceptance criteria and study details.

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The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests.

Scout Sport is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.

The device can be used for patients of all ages, from infants through adults, to include geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests.

The Scout Sport Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the Scout Sport system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters.

DPOAE I/O is a software option. The standard DPOAE test measures otoacoustic response to a series of frequencypairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The DPOAE I/O software option enables the Scout Sport device user to perform DPOAE testing at different stimulus intensities in order to obtain the DPOAE Input / Output (I/O) function for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE response.

The functionality of the Scout Sport system has been enhanced by addition of the following Scout software program modules: the Patient and Test Information database (P&TI), the BLReports application, and additional peripheral software utilities.

The Patient and Test Information database (P&TI) is used to store, display, and manage patient and test information records. The database stores the following:

• Patient demographic information such as Patient Name, . Patient ID, Doctor Information, and comments; and,
• Test demographic information such as ID. Test Dates. . and Test Results

The standalone BLReports application provides customizable reporting for Scout. The Scout application must invoke BLReports directly, passing the data necessary to create and use report templates. The report templates are made up of template components that can be added, modified or removed by the user.

The additional peripheral software utilities consist of the Feedback utility and the database Repair utility. The Feedback utility enables users to create an archive containing recent logs, databases, registry data and system information to be copied on a CD and provide to Natus Technical Support to assist in troubleshooting. The database Repair utility enables the repair and compaction of databases.

The provided text describes the "Scout Sport Otoacoustic Emissions Measurement System" but does not contain a specific section detailing acceptance criteria or a dedicated study explicitly proving the device meets said criteria with quantitative performance metrics. The document focuses on demonstrating substantial equivalence to predicate devices.

However, based on the information provided, we can infer some aspects related to validation and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity). Instead, it relies on demonstrating that the device "meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

Therefore, a table of explicit acceptance criteria with reported numerical performance values cannot be constructed from the provided text. The performance is broadly described as the device accurately performing TEOAE, DPOAE, and DPOAE I/O tests to assess cochlear function, similar to its predicates.

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

The document states: "Design verification and validation were performed to assure that the Scout Sport Otoacoustic Emissions Measurement System meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

It does not provide specific details on the sample size used for validation testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). This information is not typically included in a 510(k) summary for devices demonstrating substantial equivalence through functional and performance similarities to predicates rather than novel clinical performance claims.

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

The document does not mention the use of experts to establish a "ground truth" for a specific test set. The validation appears to be focused on meeting technical specifications and functional equivalence to predicate devices, rather than a clinical study requiring expert-derived ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a clinical test set requiring expert adjudication to establish ground truth.

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. The device is an Otoacoustic Emissions Measurement System, which assesses cochlear function directly. It's not an AI-powered diagnostic tool requiring human reader interpretation or offering "AI assistance" in the typical sense. Therefore, an MRMC study and effect size in human reader improvement are not relevant to this device.

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

The device inherently operates in a "standalone" manner in terms of its core measurement function. It delivers acoustic signals and measures emissions independently. The "pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters." This implies an algorithm-only decision for the "pass/refer" outcome. However, it's not described as a "standalone algorithm performance study" in the context of an AI-based diagnostic tool. The device assesses cochlear function and then provides a recommendation based on its measurements.

7. The Type of Ground Truth Used:

The ground truth used for validation is implicitly based on the established performance and expected physiological responses of similar predicate devices, and the device's ability to accurately measure and report these responses according to its specifications. There is no mention of external "ground truth" such as pathology, clinical outcomes, or expert consensus in the traditional sense of a diagnostic imaging study. The "ground truth" is the accurate capture of otoacoustic emissions and appropriate application of pre-defined protocols for pass/refer recommendations.

8. The Sample Size for the Training Set:

Not applicable. This device is not described as utilizing a machine learning or AI model that requires a "training set" in the context of deep learning or statistical pattern recognition. Its operation is based on established audiology principles and signal processing.

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

Not applicable, as there is no training set for a machine learning model.

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The ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the Biotronik, Inc. ScoutPro ACS CS Lead Introducer System. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use.

Crucially, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria. It is a regulatory clearance letter, not a scientific study report.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance stating that the device is "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices. The detailed performance data and acceptance criteria would have been part of the 510(k) submission that led to this clearance letter, but are not included in the letter itself.

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The ScoutPro CS Lead Introducer System facilitates lead implantation in the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. This submission is in regard to a modification in a hemostatic valve, which is an accessory component of the ScoutPro family. The hemostatic valve is included with the ScoutPro 7F kit and is also separately available. The hemostatic valve will be modified to include a 2-way spigot instead of a 3-way spigot, from a new supplier, Qosina.

This document describes a Special 510(k) for a modification to the BIOTRONIK ScoutPro Hemostatic Valve. Special 510(k)s often refer back to previously cleared predicate devices and generally focus on modifications that do not significantly alter the device's fundamental scientific technology or indications for use. Therefore, the information typically found in a full de novo 510(k) about extensive clinical studies and detailed acceptance criteria may not be present in this type of submission.

Based on the provided text, the device in question is a modified hemostatic valve, which is an accessory component of the ScoutPro 7F kit. The modification involves changing from a 3-way spigot to a 2-way spigot and sourcing the new spigot from a new supplier (Qosina). The manufacturer explicitly states that "No changes have been made to the functionality of the hemostatic valve or any other accessories included within the kit." and that "The usage of the ScoutPro hemostatic valve and ScoutPro 7F kit remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060807."

This indicates that the acceptance criteria for this Special 510(k) are primarily related to ensuring the modified component does not negatively impact the previously established performance of the overall device and retains substantial equivalence to the predicate device. The primary evidence presented for meeting these criteria is biocompatibility testing and the assertion of no functional changes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document mentions "a full battery of biocompatibility testing" for the modified hemostatic valves. However, it does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective nature). Given that it's a Special 510(k) for a component modification, the "test set" likely refers to the samples used for this specific biocompatibility testing and potentially functional verification tests in a lab, rather than a clinical study with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (experts for ground truth determination) is typically associated with studies involving diagnostic accuracy or efficacy in clinical settings. Since this submission is for a component modification based on maintaining substantial equivalence and successful biocompatibility testing, no information is provided regarding experts establishing ground truth for a test set. The "ground truth" here would be defined by established material safety standards (for biocompatibility) and engineering specifications (for functional equivalence).

4. Adjudication Method for the Test Set

Similarly, adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic accuracy studies where human interpretation of results is involved. For a component modification involving biocompatibility and functional equivalence, no adjudication method is described in the provided text. The assessment would rely on standardized laboratory test results against predefined acceptance limits.

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

No MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for evaluating the impact of AI or assisted technologies on human reader performance, which is not applicable to a modification of a mechanical hemostatic valve.

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

No standalone performance study was done or is mentioned. This section is also related to AI or diagnostic imaging devices, which is not relevant to this medical device modification.

7. Type of Ground Truth Used

For the reported performance related to the modification, the ground truth is established through:

• Biocompatibility Standards: The "full battery of biocompatibility testing" implies adherence to recognized standards (e.g., ISO 10993 series) for material safety.
• Engineering Specifications/Functional Requirements: The statement "No changes have been made to the functionality" suggests that the modified valve meets the original functional specifications of the predicate device.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This concept is primarily relevant to machine learning or AI models, not a mechanical component modification.

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

Not applicable, as there is no training set involved.

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The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.

ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: ScoutPro 7F Sheath Hook L, ScoutPro 7F Sheath Multipurpose Hook L, ScoutPro 7F Sheath Amplatz 6.0 L, ScoutPro 7F Sheath BIO2 L, ScoutPro 7F Sheath MPEP L, ScoutPro 7F Sheath Extended Hook L, ScoutPro 7F Sheath Extended Hook Right L. Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components: 1 guiding catheter, 1 (long) dilator for the guiding catheter. The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the ScoutPro 7F Long Catheters by BIOTRONIK. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way an AI diagnostic device would.

Therefore, much of the requested information (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission. The document focuses on modifications to existing predicate devices (primarily length of catheters and a modified X-ray marker) and their substantial equivalence.

Here's what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable. This submission is based on engineering design, material equivalence, and functional equivalence to predicate devices, not on a clinical test set with human subjects as would be used for an AI diagnostic device.

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

• Not applicable. This submission does not involve "ground truth" derived from expert interpretation of data. Substantial equivalence for this type of device relies on engineering specifications and comparison to existing, cleared devices.

4. Adjudication method for the test set:

• Not applicable. No test set or expert adjudication process 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 device is a guiding catheter, not an AI diagnostic device. No human reader studies or AI assistance are involved.

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

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

7. The type of ground truth used:

• Not applicable. The concept of "ground truth" as it applies to diagnostic accuracy studies is not relevant here. The "truth" for this submission revolves around demonstrating that the modified device maintains the same safety and effectiveness profile as its predicate, primarily through engineering and material comparisons.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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The ScoutPro CS Lead Introducer System facilitates lead implantation in the left of the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus.

The provided text is a 510(k) Premarket Notification for modifications to BIOTRONIK's ScoutPro accessories. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the information required to populate the acceptance criteria table and describe a study proving the device meets those criteria is not present in the provided text.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Metrics: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for a diagnostic device; durability, success rates for an interventional device). Consequently, there are no reported device performance metrics against such criteria.
• No Clinical Study Details: The document describes modifications to existing devices (ScoutPro 8F guiding catheters) and relies on the concept of "substantial equivalence" to predicate devices. It explicitly states: "The usage of the ScoutPro 8F kit as well as all the ScoutPro 8F guiding catheters remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060655, cleared on April 4, 2006." This indicates that a new clinical study to establish performance against new acceptance criteria was not conducted for this modification.
• Focus on Bench Testing and Equivalence: The mention of "a change in the tensile test procedure" suggests bench testing or non-clinical verification was performed to ensure the modifications did not negatively impact performance, but these are not clinical studies designed to meet acceptance criteria in the way you've described.

In summary, based only on the provided text, I cannot complete your request for a table of acceptance criteria and a detailed description of a study proving the device meets them because such information is not included in this type of regulatory submission for device modifications that rely on substantial equivalence.

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The ScoutPro CS Lead Introducer System facilitates lead implantation in the heart via the coronary sinus. The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus.

The provided text is a 510(k) Premarket Notification for modifications to an existing medical device, the ScoutPro accessories. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way one might expect for a novel device or software.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, nor does it include details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

This is because the submission's purpose is to:

• Identify minor modifications to existing ScoutPro 7F guiding catheters (new shaping process and additional braided tubing supplier).
• Introduce new ScoutPro 7F accessories (Extended Hook, Extended Hook Right).
• Make previously cleared components (MPEP, BIO2 guiding catheters, Guidewire) available separately.
• Make minor modifications to the ScoutPro Slitter Tool (packaging and technical manual).
• State that all accessories will use non-lingual labeling.
• Demonstrate that these modified/new components are substantially equivalent to previously cleared predicate devices (ScoutPro 8F, ScoutPro 7F, ScoutPro Slitter Tool Advanced).

The core argument for substantial equivalence is based on the assertion that "the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories." This implies that the performance of the modified devices is expected to be the same as the predicate devices, and therefore, extensive new performance studies are not typically required for this type of submission.

In summary, none of the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) is present in the provided 510(k) summary.

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The ScoutPro Slitter Tool Advanced is used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The ScoutPro Slitter Tool Advanced represents further development of the ScoutPro Slitter Tool, which is part of the ScoutPro family of coronary sinus lead delivery systems. The main difference between the modified Slitter Tool Advanced and its predecessor is a more ergonomic design of the grip in order to optimize the handling and to enable a smooth removal of the delivery system. The optimized design is achieved by fabricating the entire device out of stainless steel. The Slitter Tool Advanced can be used with all BIOTRONIK coronary sinus leads with diameters 4.1F to 7.2F. Thus the optimized Slitter Tool Advanced covers the same lead diameter range as the two preceding Slitter Tools combined. The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool. The ScoutPro Slitter Tool Advanced is a separately sold accessory that can be used in conjunction with the ScoutPro family of coronary sinus lead introducer systems.

This looks like a Special 510(k) for a modified medical device, the ScoutPro Slitter Tool Advanced. Special 510(k)s are primarily used for minor modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology or safety and effectiveness.

For such submissions, the focus of the testing and acceptance criteria is often on demonstrating that the changes to the device do not adversely affect its performance compared to the predicate, rather than establishing entirely new performance criteria. Therefore, the details you're asking for, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies, are typically not part of a Special 510(k) and are not present in the provided text.

The document states: "The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool." This indicates that the core functionality is assumed to be equivalent to the predicate, and the focus of the submission is on the design change (more ergonomic grip, stainless steel fabrication, covering a wider lead diameter range).

Here's an analysis based on the information provided, highlighting why many of your questions cannot be answered from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in quantitative terms or report specific performance metrics for the ScoutPro Slitter Tool Advanced beyond the physical characteristics changed. Instead, the submission relies on demonstrating substantial equivalence to its predicate device, the BIOTRONIK's ScoutPro 7F (#K060807, 04-24-2006).

The key "performance" aspect mentioned is the ability to work with a range of lead diameters:

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

• Not explicitly stated in the provided text. For a Special 510(k) focused on design changes and substantial equivalence, the testing often involves bench testing (e.g., mechanical strength, material compatibility, dimensional analysis) to ensure the changes don't introduce new risks or degrade performance. The specific test quantities and data provenance for such tests are not detailed here.

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

• Not applicable/Not stated. This type of information is typically reserved for studies involving subjective human assessment (like image interpretation or clinical outcomes) or establishing a complex diagnostic ground truth. For a mechanical device modification, expert "ground truth" for performance would likely be based on engineering specifications and bench test results, often reviewed by in-house experts.

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

• Not applicable/Not stated. Adjudication methods are usually relevant to studies with multiple readers or assessments that require conflict resolution regarding a 'ground truth'. For physical device testing, adjudication is less common.

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 study was not done. This is a medical device (a slitter tool), not an AI/software device that assists human readers with interpretation. Therefore, MRMC studies are not relevant to this submission.

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 is a mechanical medical device, not an algorithm.

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

• For this type of device modification, the "ground truth" would be established through engineering specifications, material science standards, and the performance characteristics of the predicate device. Testing would likely confirm that the new design meets these established engineering and safety benchmarks, and that the material change (stainless steel) is appropriate.

8. The sample size for the training set:

• Not applicable/Not stated. There is no "training set" in the context of this mechanical device modification. Training sets are relevant for machine learning or AI models.

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

• Not applicable/Not stated. As there is no training set, this question is not relevant.

Summary based on the Provided Text:

The Special 510(k) for the ScoutPro Slitter Tool Advanced is based on demonstrating substantial equivalence to its predicate by showing that:

• The device's function, indications for use, and contraindications are identical to the previous version.
• The design modifications (more ergonomic grip, stainless steel fabrication) improve handling and allow for compatibility with the combined lead diameter range of the previous two tools, without introducing new safety or effectiveness concerns.
• The primary "study" supporting this would be a comparison of the modified device to the predicate device through bench testing and potentially design verification/validation activities (e.g., material testing, dimensional checks, simulated use testing) to ensure the new design performs as intended and does not compromise safety or efficacy. The specific details of these tests (e.g., number of units tested, specific parameters measured) are not included in this high-level summary but would be part of the full 510(k) submission.

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The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.

The ScoutPro 7F delivery system is a modified version of the BIOTRONIK's current legally marketed ScoutPro delivery system (K03320, dated 11-19-2003). The ScoutPro 7F functions similarly to that of a standard introducer for pacemaker leads. It contains catheters with various distal arcs to facilitate and support the implantation of left-ventricular polyurethane leads up to 6.6 F in the coronary venous system.

For implantation of left ventricular pacing leads, the subclavian or the cephalic vein is used as a point of entry into the venous system. After gaining access to the vein, one of the braided, peel-away guiding catheters (long sheaths) used in combination with the dilator and hemostatic valve is introduced into the vein using a guide wire initially positioned in the atrium. Selection of a guiding catheter with a suitable curve (arc) allows the distal tip of the catheter to probe the coronary sinus and facilitates implantation of the lead into the coronary veins. A side access in the hemostatic valve enables the injection of irrigation solutions and contrast dyes to facilitate gaining access to the coronary sinus.

After successful placement of the hemostatic valve and the guiding catheter are removed over the lead. In this process, the pre-slitted peel-away grip, which is glued to the proximal end of the guiding catheter, is broken off. The catheter is opened along the pre-slit portion (2 cm). Then, using the slitter tool, the guiding catheter is slit from proximal to distal end.

The main difference between the predicate device ScoutPro and the ScoutPro 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Most coronary sinus leads to be implanted have a smaller diameter, for which a 7F introducer system is sufficient.

The provided text is a 510(k) premarket notification for a medical device called ScoutPro 7F. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than exhaustive new clinical studies proving performance against absolute acceptance criteria.

Therefore, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment as would be found in a study designed to prove device performance from the ground up (e.g., for a PMA submission or a novel device).

Here's an breakdown based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission is typically showing substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as the predicate, often through comparisons of technological characteristics and intended use.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, accuracy, sensitivity, specificity) are reported in a quantifiable manner for the ScoutPro 7F. The submission focuses on describing the device and its modifications relative to the predicate.

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

• Not applicable / Not provided: The document does not describe a clinical "test set" in the sense of a study testing the device's performance in patients. This is a 510(k) submission, not a clinical trial report. Data provenance, if any, for non-clinical testing is not mentioned.

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 / Not provided: As there's no described clinical "test set" with ground truth to be established, this information is not present.

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

• Not applicable / Not provided: No clinical test set means no adjudication method.

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 / Not provided: This device is a delivery system (catheter, guide wires, etc.) for coronary sinus leads, not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this product submission.

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

• Not applicable / Not provided: This refers to AI/algorithm performance. The ScoutPro 7F is a mechanical device, not an algorithm.

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

• Not applicable / Not provided: No clinical "ground truth" data is referenced in this submission. The basis for substantial equivalence is primarily comparison of technological characteristics and intended use to a previously cleared device.

8. The sample size for the training set

• Not applicable / Not provided: There is no "training set" in the context of device performance data for this submission. This term relates to machine learning models.

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

• Not applicable / Not provided: No training set or ground truth for it.

Summary based on the document:

This 510(k) submission for the ScoutPro 7F is based on demonstrating substantial equivalence to the predicate device, BIOTRONIK's ScoutPro (K033320). The modifications described are primarily the inner diameter of the guiding catheters and some accessory changes. The implicit "acceptance criteria" for this type of submission is satisfying the FDA that these modifications do not raise new questions of safety or effectiveness and that the device remains substantially equivalent to the predicate.

The document does not detail specific performance studies with quantitative data, sample sizes, or expert ground truth as would be required for novel device approval or other types of regulatory pathways.

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