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For the introduction of various types of pacing or defibrillator leads and catheters.

The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short term application (

The provided document describes the Coronary Sinus Guide & Lateral Vein Introducer Kits. The study presented focuses on demonstrating the substantial equivalence of the modified device to its predicate devices through various tests.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

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ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen.

The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (

The provided document describes a medical device, the "ScoutPro Inner Catheters," and its 510(k) summary for FDA clearance. This summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than an independent clinical study proving specific acceptance criteria in the manner of a multi-reader multi-case (MRMC) or standalone algorithm study for AI.

Therefore, many of the requested sections regarding AI study design (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC study effect size, standalone algorithm performance, and training set details) are not applicable and cannot be extracted from this document. This document details engineering and bench testing to demonstrate that the device performs similarly to existing, cleared devices.

Here's an analysis based on the provided text, aligning with the sections where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for each test, indicating that the device met pre-defined internal specifications for safe and effective operation comparable to predicate devices. The document does not provide numerical thresholds for these "Pass" criteria but affirms that the device successfully met them.

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

• Sample Size: The document does not explicitly state the sample size (number of devices) used for each test. It only lists the tests performed and their outcomes ("Pass").
• Data Provenance: The tests are described as "Testing" and appear to be bench testing conducted by the manufacturer, Thomas Medical Products - A GE Healthcare Company. This implies an internal, prospective testing methodology rather than a retrospective analysis of clinical data from specific countries.

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

• Not Applicable: For this type of 510(k) submission based on bench testing for substantial equivalence, clinical expert ground truth establishment for a "test set" in the context of diagnostic performance is not relevant or described. The "ground truth" here is adherence to engineering specifications and performance in simulated scenarios, which would be assessed by engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

• Not Applicable: As this is bench testing against engineering specifications, there is no mention of an adjudication method in the sense of clinical reviewers or consensus. Each test would have pre-defined pass/fail criteria, and results would be recorded.

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 document describes a medical device (catheter) and its physical and mechanical performance, not an AI-powered diagnostic system. Therefore, an MRMC study or effect size related to AI assistance for human readers is not relevant and was not performed.

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

• Not Applicable: This document is about a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the bench and simulated use testing, the "ground truth" is based on engineering specifications and performance standards. These standards would define acceptable ranges for forces, dimensions, structural integrity, and functional performance (e.g., kink resistance, leak resistance). The predicate devices' performance would also serve as a benchmark for what constitutes an acceptable level of performance.

8. The Sample Size for the Training Set

• Not Applicable: This document does not describe the development of an AI algorithm with a training set.

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

• Not Applicable: This document does not describe the development of an AI algorithm with a training set and its ground truth establishment.

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The CSI is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

The RCIS consists of a 5-7F spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch. Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Each introducer also has a radiopaque distal tip to aid the physician is correct placement of the device. The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

The provided text does not contain information about acceptance criteria, device performance, or any studies involving test sets, training sets, or expert evaluations.

The document is a 510(k) summary for a Reinforced Catheter Introducer System (RCIS) and the FDA's clearance letter for the device. It focuses on establishing substantial equivalence to a predicate device, as required for 510(k) submissions.

Key information provided:

• Device: Reinforced Catheter Introducer System (RCIS) (5-7F)
• Manufacturer: Thomas Medical Products, Inc.
• Predicate Device: Thomas Medical Products, Inc., Reinforced Catheter Introducer System - K081341
• Comparison Basis: The submission states that the "technological characteristics of the device are identical to those of the predicate devices" and that they have "identical intended use / indications for use."
• Indications for Use: The RCIS is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
• Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill the request as the necessary data regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment are not present in the provided text. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) submission document.

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The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.

Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.

The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

This document is a 510(k) summary for the submission of a Reinforced Catheter Introducer System (RCIS) by Thomas Medical Products, Inc. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

The provided document does not outline specific numerical acceptance criteria or quantitative performance metrics typically found in a study for a diagnostic AI device. Instead, it focuses on qualitative technological characteristics and claims substantial equivalence to predicate devices based on these features. The "acceptance criteria" here are implicitly the shared technological characteristics with the predicate devices.

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

This document describes a medical device (catheter introducer system), not an AI/diagnostic software. Therefore, there is no "test set" in the context of AI performance evaluation, and thus no information on sample size, data provenance, or data type for such a test set. The evaluation is based on a comparison of device features.

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. As noted above, this submission is for a physical medical device, not an AI/diagnostic software that requires expert-established ground truth.

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

Not applicable. This submission is for a physical medical device, not an AI/diagnostic software.

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 document is for a physical medical device, not an AI product. No MRMC study or comparative effectiveness study comparing human performance with and without AI assistance would be conducted for this type of submission.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

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

Not applicable. For a physical medical device like a catheter introducer, "ground truth" would relate to its physical properties, biocompatibility, sterility, and mechanical performance, which are evaluated through engineering tests, material analysis, and pre-clinical/clinical studies (though no full clinical study report is part of this 510(k) summary). The document indicates evaluation of "similar technological characteristics, and indications for use."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no AI/machine learning aspect, there is no training set and no ground truth establishment for it.

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The Y-Glide™ Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

The Thomas Medical Products Inc. Y-Glide™ Hemostatic Valve Wye Adapter contains a hemostasis valve with a secondary locking seal, a rotating luer lock, and a sideport. The primary hemostasis seal is opened by depressing the cap thereby enabling valve flushing, and a conduit for introduction and withdrawal of diagnostic/interventional devices. When the cap is not depressed, the seal returns to the closed position to allow device positioning with minimal fluid loss. The secondary locking seal can be adjusted when the internal threads are engaged, by rotating the cap clockwise while slightly depressing it until the threads catch. Clockwise turns of the cap thereafter will close the locking seal. Rotating counterclockwise will open the locking seal. Closing the locking seal will secure the position of the inserted diagnostic/interventional device and/or permit pressure injections up to 450 psi (30.6 Atm.).

The provided text does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI/ML device.

This document is a 510(k) summary for a physical medical device, specifically a hemostatic valve wye adapter. The regulatory pathway for this type of device (Class II, 510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against predefined quantitative acceptance criteria through a clinical or algorithmic study as would be the case for an AI/ML diagnostic tool.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document because the described evaluation process is different.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not relevant:

1. Table of acceptance criteria and the reported device performance

This document does not describe quantitative acceptance criteria and reported performance in the typical sense of a study for an AI/ML diagnostic. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on a comparison of characteristics.

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. This document describes a 510(k) submission for a physical medical device, not an AI/ML diagnostic. There is no "test set" in the sense of a dataset for an algorithm. The evaluation is based on a comparison to a predicate device and engineering analyses rather than a clinical study with a patient sample.

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. No ground truth determination by experts is described for a test set in this 510(k) summary. The assessment is primarily engineering-focused and regulatory-focused, comparing the new device to a predicate.

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

• Not applicable. There is no "test set" or adjudication method described in this document.

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. This document is for a physical medical device (hemostatic valve), not an AI/ML product. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This device is a passive physical component; there is no algorithm or standalone performance in the context of AI/ML.

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

• Not applicable. For this type of device, "ground truth" as understood in AI/ML is not relevant. The "truth" for substantial equivalence lies in demonstrating that the device's characteristics, safety, and effectiveness are comparable to a legally marketed predicate device. This is typically supported by bench testing, material comparisons, and adherence to relevant standards, rather than clinical outcomes or diagnostic accuracy against a "ground truth" diagnosis.

8. The sample size for the training set

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

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

• Not applicable. There is no "training set" or ground truth establishment for it.

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For the introduction of various types of pacing or defibrillator leads and catheters. AND For the introduction of various types of catheters.

The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis. The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.

The medical device being described is a Large bore splittable introducer kit manufactured by Thomas Medical Products, Inc.

Based on the provided 510(k) summary and official letter, this submission is for establishing substantial equivalence to a previously cleared device (Thomas Medical Products, Inc., Tear-away sheath introducer kit - K934901). Substantial equivalence means that the new device has the same intended use and technological characteristics as the predicate device(s).

Crucially, the provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it focuses on demonstrating equivalence to an already marketed device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study designed to meet specific performance metrics. The information regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for these performance studies is also absent from this specific 510(k) submission document.

Summary of what can be extracted from the provided text:

• Device Name: Large bore splittable introducer kit
• Manufacturer: Thomas Medical Products, Inc.
• Intended Use: To provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads. More specifically: "For the introduction of various types of pacing or defibrillator leads and catheters." and "For the introduction of various types of catheters."
• Predicate Device: Thomas Medical Products, Inc., Tear-away sheath introducer kit (K934901).
• Basis for Clearance: Substantial equivalence to the predicate device, not performance against specific acceptance criteria. The document states: "The technological characteristics of the device are the same as those of the predicate devices." and "The Thomas Medical Products Inc. Large bore splittable introducer kit has similar general intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. Large bore splittable introducer kit is substantially equivalent to the legally marketed predicate devices."

In the context of 510(k) clearances based on substantial equivalence, specific clinical performance studies with detailed acceptance criteria and expert reviews are often not required if the new device is sufficiently similar to a legally marketed predicate device. The FDA's review in such cases focuses on comparing the new device's technological characteristics and intended use to those of the predicate device to ensure it raises no new questions of safety or effectiveness.

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For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The Thomas Medical Products Inc. Braided Guiding Introducer System(s) are designed t to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each Braided Guiding Introducer System consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Braided Guiding Introducer System.

The provided text describes a 510(k) premarket notification for a medical device, the "Braided Guiding Introducer System." However, it does not contain any information regarding acceptance criteria, device performance derived from a study, or details of a study's methodology.

The document states that the device is substantially equivalent to a legally marketed predicate device (Thomas Medical Products, Inc., 6 French Braided Guiding Introducer, K013202) because:

• Identical Intended Use/Indications for Use: The new device has the same indications for use as the predicate device, which is "For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture."
• Identical Technological Characteristics: The technological characteristics of the new device are the same as those of the predicate device.

Since this is a 510(k) submission based on substantial equivalence, the FDA typically does not require new performance studies if the device is sufficiently similar to an already cleared predicate. The focus is on demonstrating that the new device raises no new questions of safety or effectiveness compared to the predicate.

Therefore, I cannot provide the requested information, as the input text does not contain it. The sections regarding acceptance criteria, reported performance, sample size, ground truth, expert involvement, adjudication, MRMC studies, or standalone studies are not present in the provided 510(k) summary and FDA letter.

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Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

The Thomas Medical Transseptal Needle consists of a specifically curved distal portion to accommodate positioning in the cardiac anatomy when used in conjunction with a transseptal introducer. A stopcock is attached to the proximal end of the needle for air aspiration, fluid infusion, blood sampling and pressure monitoring. A pointer is included on the needle shield to show orientation of the curve.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Transseptal Needle:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text states, "All samples passed the protocol qualification testing requirements." It does not specify an explicit sample size for each test. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The text describes mechanical qualification testing, not a study involving expert assessment of a medical condition or images.

4. Adjudication Method for the Test Set

This information is not applicable as the tests conducted were mechanical qualification tests and did not involve expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not performed. The submission is for a medical device (a needle) and not an AI or diagnostic imaging device that would typically undergo such a study. The “study” described is qualification testing to ensure the device’s mechanical integrity.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the qualification testing was the pre-defined protocol qualification testing requirements. These requirements would have defined acceptable ranges or thresholds for the mechanical properties being tested (e.g., minimum pull force, maximum torque). For the overall device, the "ground truth" for its regulatory approval was its substantial equivalence to predicate devices in terms of intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable for the same reasons as #8.

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For the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum.

The Thomas Medical Products Inc. modified Transseptal Introducer Sets are designed to provide a conduit to deliver diagnostic and therapeutic catheters into the left side of the heart through the interatrial septum. Each modified Transseptal Introducer Set consists of; a sheath, a dilator, and a "J" tip guidewire.

In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Transseptal Introducer Sets as optional accessories.

The provided document is a 510(k) summary for the Thomas Medical Products, Inc. Transseptal Introducer Set. It outlines the device information, intended use, and claims of substantial equivalence to a predicate device.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, or any of the detailed study parameters requested in the prompt. The submission primarily focuses on establishing substantial equivalence based on the device's technological characteristics and intended use being the same as the predicate device.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is simply not present in the provided text.

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