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The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy.

An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly).

A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s).

The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

This document, a 510(k) Summary for the RadialSeal™ Introducer Kit (K181855), focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria specific to algorithm performance. Therefore, many of the requested categories related to AI model evaluation will not be applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabular format for each test, nor does it provide specific numerical results for the RadialSeal™ Introducer Kit for most tests. Instead, it generally states that "results indicated that no new issues of safety and effectiveness were raised and the results were within the predetermined acceptance criteria" and that "The devices performed equivalently."

However, it does list the types of performance tests conducted and the standards they followed. A summary of the reported performance is general equivalency to the predicate device.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench or animal test. It mentions that "side by side testing between the predicate device and RadialSeal was performed" and implicitly suggests multiple units were tested to demonstrate equivalency.
• Data Provenance: The bench testing refers to compliance with ISO standards and internal standards. The animal study was a "GLP Acute Animal Porcine study" conducted at "American Preclinical Services." This implies the animal data is from a controlled, prospective animal study conducted in the USA (presumably, given "American Preclinical Services"). All data appears to be prospective as it was generated to support the 510(k) submission.

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

This is not applicable as this is a medical device (introducer kit) and not an AI/software device that requires ground truth derived from expert consensus for performance evaluation. The "ground truth" for this type of device is defined by passing established physical, chemical, and biological performance standards and demonstrating equivalence to a predicate device.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. The "adjudication" is compliance with international and internal standards, and comparison to a predicate device's performance.

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

This is not applicable as this is a physical medical device, not an AI or software device.

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

This is not applicable as this is a physical medical device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by:

• Compliance with established international and national standards (e.g., ISO 11070, ISO 10993-1, ISO 594-1, ISO 594-2, ASTM, USP).
• Demonstrating functional equivalence to a legally marketed predicate device (Terumo Glidesheath Slender® K142183) through direct comparative testing.
• The safety and effectiveness of the device as assessed through non-clinical (bench) and pre-clinical (animal) testing to ensure it raises no new issues compared to the predicate.

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device and not an AI/software device that requires a training set. The "training" in manufacturing would relate to process validation and quality control, not data training.

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

Not applicable as this is a physical medical device and not an AI/software device.

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The MobiCath Transseptal Needle is used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needles consist of a thin-walled stainless steel cannula bonded to an ergonomic handle and stopcock, and a removable stylet. The cannula is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with an introducer or catheter. The handle is integrated with a pointer to show the orientation of the curve. The two-way stopcock facilitates air aspiration, fluid infusion, blood sampling, and pressure monitoring. The stylet attaches to the proximal end of the needle assembly.

Here's an analysis of the provided text regarding the MobiCath Transseptal Needle, focusing on the acceptance criteria and the study that proves the device meets them.

This document describes a 510(k) submission for a modified medical device, specifically stating "Greatbatch Medical proposes using an alternate stopcock for the MobiCath Trasseptal Needles. The current stopcock has been discontinued by the supplier. A similar stopcock has been tested as a replacement. A few minor design changes are required for the stopcock to interface with the handle components. In addition, a few manufacturing improvements have been proposed." This means the studies are not for a novel device but to demonstrate substantial equivalence of the modified device to a previously cleared predicate device (MobiCath Transseptal Needle K111644).

Therefore, the "acceptance criteria" here are to demonstrate that the changes have not introduced new safety or efficacy issues and that the device performs equivalently to the predicate. The "study" refers to a battery of non-clinical tests.

Acceptance Criteria and Device Performance

The provided document doesn't explicitly list "acceptance criteria" with numerical thresholds in a table format for each test. Instead, it describes a series of tests performed to ensure the modified device (with a new stopcock) maintains the same performance and safety profile as the predicate device. The implied acceptance criterion for each test is that the modified device performs comparably to the predicate or within established engineering specifications for the original device.

Since specific numerical thresholds for acceptance are not provided, the "Reported Device Performance" is generally stated as "risks have been mitigated and that no new safety or efficacy issues were raised," implying successful completion of the tests.

Study Details

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

   • The document does not specify sample sizes for any of the non-clinical tests.
   • The data provenance is not explicitly stated in terms of country of origin, but it is clear these are retrospective tests conducted by Greatbatch Medical to support the 510(k) submission for a device modification. They are lab-based tests, not clinical studies involving patient data.

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

   • This question is not applicable here. These are non-clinical engineering and biological tests conducted in a laboratory setting, not studies involving human interpretation of medical data (like radiology images). "Ground truth" in this context would refer to established engineering specifications or industry standards, which are not set by human experts in the sense implied by the question.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies where multiple readers interpret complex data. These are objective non-clinical tests with predefined pass/fail criteria.

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:

   • This is not applicable. This submission is for a physical medical device (transseptal needle) and does not involve AI, image interpretation, or human readers in an MRMC study.

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

   • This is not applicable. This is not an algorithmic or AI-based device.

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

   • For the non-clinical tests performed, the "ground truth" refers to predefined engineering specifications, material properties standards, and biocompatibility standards. For example, for "Air and liquid leakage," the ground truth is an established standard for permissible leakage, or zero leakage. For "Tensile" testing, it would be a specified tensile strength range.

7. The sample size for the training set:

   • This is not applicable. This is not a machine learning or AI device that requires a training set.

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

   • This is not applicable. As above, there is no training set for this type of device submission.

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The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.

The provided text describes the Z°Flex-270™ Steerable Sheath, a medical device, and its safety and substantial equivalence to a predicate device. This document is a 510(k) summary submitted to the FDA. It outlines the device's description, indications for use, and a comparison to a predicate device, focusing on technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't present explicit "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it states that the device "met all specifications per functional and performance requirements" without detailing those specifications.

However, based on the performance (bench) testing listed, we can infer the categories of acceptance:

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

• Sample size: The document states that "representative finished, sterilized samples of the subject device underwent the following testing" but does not specify the exact number of samples used for any of the individual tests. This information is typically detailed in the full test reports, not usually in a 510(k) summary.
• Data provenance: The testing performed is described as "Performance (bench) testing" and "biocompatibility testing." This indicates the data provenance is from laboratory bench testing and in-vitro/in-vivo animal studies (for biocompatibility), not human clinical trials. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are usually applicable to clinical studies.

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

• This question is not applicable to the described study. The study involves bench and biocompatibility testing of a medical device, not a diagnostic or AI device that requires expert interpretation to establish "ground truth." The "ground truth" for these tests would be the established scientific and engineering standards and methods against which the device's physical and biological properties are measured.

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

• This question is not applicable to the described study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where multiple human readers or experts provide independent assessments, and a method is needed to resolve discrepancies. The provided document describes laboratory testing where results are typically objectively measured and compared against predefined specifications.

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:

• This question is not applicable to the described study. An MRMC study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance. The Z°Flex-270™ Steerable Sheath is an interventional medical device, not a diagnostic AI system. The study described focuses on the device's physical and biological performance characteristics.

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

• This question is not applicable to the described study for the same reasons as above. This refers to the standalone performance of an AI algorithm, which is not what is being evaluated here.

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

• For the mechanical performance tests, the "ground truth" (or reference) would be engineering specifications, industry standards (e.g., ISO 11070), and functional requirements defined by the manufacturer. These are objective, measurable criteria.
• For the biocompatibility tests, the "ground truth" refers to established biological safety criteria and test methodologies (e.g., ISO 10993 series, though not explicitly cited beyond specific biological tests). The results are compared against acceptable levels of biological response.

8. The sample size for the training set:

• This question is not applicable. The device is an interventional medical catheter, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process would involve internal testing and validation, but not in the sense of a machine learning training set.

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

• This question is not applicable, as there is no training set for this type of medical device.

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The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.

The RadialSource™ Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a vessel dilator, a mini-guidewire, and an IV catheter (consisting of an IV cannula and a needle). The CSI is intended to facilitate percutaneous introduction of intravascular devices in arterial or venous procedures through, but not limited to, a radial approach. The vessel dilator and mini-guidewire are used in conjunction with the CSI to gain access to the vasculature. The CSI and vessel dilator contain a lubricious coating intended to reduce friction during insertion into the vessel. The CSI contains a hemostasis valve at the proximal end which minimizes blood loss and air intake to the vasculature. A sideport infusion line extends from the CSI proximal hub and terminates at a 3-way stopcock with a standard luer fitting for flushing/infusion. The CSI and dilator contain radiopaque material for visualization under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RadialSource™ Transradial Access Kit:

Given the provided text is for a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone de novo approval with novel performance criteria, the information will be structured based on what's available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific thresholds for each test. Instead, it states that the device "passed all verification specification criteria" and "performs as intended without raising new questions of safety and efficacy." The table below will list the tests performed, and the "Reported Device Performance" will reflect the general statement of compliance.

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

The document explicitly states: "no pre-clinical (animal) or clinical study was necessary." Therefore, there is:

• No specific test set or sample size dedicated to a clinical study.
• The data provenance for the non-clinical tests (biocompatibility, performance bench testing, etc.) would be from internal Greatbatch Medical testing laboratories or contracted labs. Specific country of origin is not mentioned but typically these are conducted in the country of manufacture or a recognized testing facility. The nature of these tests is by definition retrospective relative to the design and manufacturing of the device for the purpose of regulatory submission.
• For the "Thrombosis (In-vivo)" test, 2 dogs were used for a 4-hour contact. This is the only direct mention of an in-vivo sample size.

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

• Since no clinical study was performed, there was no test set requiring expert ground truth establishment in the conventional sense of a clinical trial (e.g., radiologists interpreting images).
• For the non-clinical tests, the "ground truth" is established by the scientific and technical standards recognized in the industry (e.g., ISO standards for biocompatibility) and the expertise of the test engineers and scientists performing and evaluating the results of these bench and in-vitro tests at Greatbatch Medical or contracted labs. No specific number or qualifications of these individuals are stated.

4. Adjudication Method for the Test Set

• None applicable in the context of a clinical test set with human readers, as no such study was conducted.
• For the non-clinical tests, compliance to specifications would be determined by standard laboratory protocols and quality control measures, but not an "adjudication method" in the sense of expert consensus on ambiguous findings.

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 MRMC study was done. This device is a physical medical device (introducer sheath kit), not an AI/software-as-a-medical-device (SaMD) that would assist human readers with interpretations. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

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

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

• For the non-clinical tests, the "ground truth" for evaluating performance criteria is based on pre-defined engineering specifications, international standards (e.g., ISO, USP), and established scientific principles for device function, material properties, and biological interaction. For example, for biocompatibility, the ground truth is whether the material elicits a toxic response as per ISO 10993. For dimensional checks, the ground truth is adherence to design drawings.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

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

• Not applicable. There is no training set for this device.

Summary of Study Type:

The submission relies on non-clinical (bench and in-vitro) testing and biocompatibility testing to demonstrate substantial equivalence to legally marketed predicate devices. The core argument for acceptance is that the RadialSource™ Transradial Access Kit performs as intended, has similar technological characteristics, and does not raise new questions of safety or efficacy compared to its predicates, thus negating the need for pre-clinical animal or clinical studies.

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The MobiCath™ Transseptal Needle is used to create the primary puncture in the inter-atrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needle consists of a thin-walled stainless steel cannula which is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with a transseptal catheter or introducer. The proximal end of the needle is bonded to an ergonomic handle with an integrated pointer to show the orientation of the curve section and a two-way stopcock to facilitate air aspiration, fluid infusion, blood sampling, and pressure monitoring. The Transseptal Needle includes a stylet with an over-molded hub designed to attach to the proximal end of the needle assembly.

This is a Premarket Notification (510(k)) for the MobiCath Transseptal Needle, a medical device for creating punctures in the inter-atrial septum. The provided document describes the device, its indications for use, comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, the acceptance criteria are implicit in the performance of the predicate devices and the successful completion of a battery of non-clinical tests. The stated objective is to demonstrate that the device "performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."

The reported device performance is that it "passed all verification specification criteria." This indicates that the device met internal design and functional requirements, which were presumably benchmarked against the predicate devices.

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

• Sample Size: The document does not specify the exact sample size for each bench test conducted. It states "Performance (bench) testing... were performed." For sterilization, shelf life, and biocompatibility, standard protocols according to the cited ISO standards would have been followed, which inherently involve specific sample sizes. However, these are not quantified in the summary.
• Data Provenance: The testing described is pre-clinical bench testing. There is no mention of human subject data, animal data (beyond specific biocompatibility tests like "Rabbit Pyrogen"), or retrospective/prospective clinical data for the performance evaluation. It's all laboratory-based, controlled testing of the physical device.

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

• This question is not applicable in the context of this 510(k) submission. This is a pre-clinical performance study of a physical medical device, not an AI or diagnostic imaging device that requires expert-established ground truth for a test set. The "ground truth" for the performance tests would be the established engineering specifications and industry standards (e.g., ISO, internal design requirements) that the device must meet.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., image interpretation) to resolve discrepancies in ground truth establishment. The tests performed here are objective bench tests with pass/fail criteria based on specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools or image analysis, which this device is not. The MobiCath Transseptal Needle is a physical surgical tool.

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

• This question is not applicable. The device is a physical, manually operated transseptal needle and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation in this 510(k) is based on engineering specifications, industry standards (e.g., ISO 11135-1, ISO 10993-1), and the performance characteristics of the predicate devices. The device had to pass "verification specification criteria" in various bench tests. This is a form of "established scientific principles and objective measurements" as ground truth.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

• This question is not applicable as there is no training set.

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The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The MobiCath™ Bidirectional Guiding Sheath is an 8.5 French, flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry that allows deflection of the distal portion of the device bi-directionally 150°. This feature provides steerability to facilitate the delivery of therapeutic devices into the heart including the left atrium, using minimally invasive techniques. The sheath is fitted with a hemostatic valve which minimizes blood loss and air intake by providing hemostasis sealing to venous pressures as well as reduce dilator insertion and removal force. The sheath is also equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath and dilator contain radiopaque material for visualization under fluoroscopy.

The provided text describes a 510(k) premarket notification for the MobiCath™ Bi-Directional Guiding Sheath, a medical device. The submission explicitly states that no animal or clinical study was deemed necessary for this device. Instead, substantial equivalence to previously cleared predicate devices was demonstrated through functional, dimensional, and material testing.

Therefore, the requested information regarding acceptance criteria derived from clinical studies, comparative effectiveness, standalone performance, ground truth establishment for test/training sets, and expert involvement is not applicable in this context.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. Performance verified through engineering and material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by medical experts for device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.

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 not an AI-assisted diagnostic tool, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance was established through engineering specifications and industry standards for mechanical, material, and biocompatibility testing.

8. The sample size for the training set: Not applicable. No training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. No training set.

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The PTFE Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical PTFE Peelable Introducer Kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire. The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.

The Greatbatch Medical PTFE Peelable Introducer underwent performance testing to establish substantial equivalence to a predicate device (K093023).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical or percentage terms in the provided document. Instead, the document indicates that the device must "Pass" a series of functional and dimensional tests to verify that it "continues to function in a safe and effective manner" and "performs per specification requirements." The reported device performance for all tested parameters was "Pass."

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for each test. It mentions that "Testing for this device was performed," but provides no details on the number of units tested. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This is a medical device (introducer) and the study involved performance testing against engineering specifications, not clinical assessment or interpretation. Therefore, no experts were used to establish ground truth in the context of clinical accuracy or interpretation.

4. Adjudication Method

Not applicable. As noted above, this study involved performance testing against engineering specifications, not expert review of clinical cases.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is not an AI-assisted diagnostic tool, but rather a physical medical introducer. The study focused on its functional and dimensional characteristics.

6. Standalone Performance (Algorithm Only)

No, standalone performance was not assessed in the context of an algorithm. This device is a physical medical device. The tests performed are described as "functional and dimensional testing" to ensure the device performs "per specification requirements."

7. Type of Ground Truth Used

The ground truth used was engineering specifications and established performance requirements for medical introducers, based on the predicate device. The tests were designed to verify that the device meets these pre-defined standards for functionality and dimensions.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve a training set as would be used for an AI/ML algorithm. The performance testing was to demonstrate substantial equivalence to a predicate device, not to train a model.

9. How Ground Truth for the Training Set was Established

Not applicable, as there was no training set. The "ground truth" equivalent for the testing was the established performance standards and specifications derived from the predicate device and general medical device requirements, which were used to evaluate the manufactured PTFE Peelable Introducer.

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The OptiSeal™ Valved PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, available in non-sideport and sideport configurations, is a small diameter tubular shaped device with integrated proximal handles. Both configurations of the OptiSeal Valved PTFE Peelable Introducer are designed to provide a relatively atraumatic method for insertion of catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. Both introducer configurations peel away after use allowing the user to remove the introducer without removing the inserted catheter or pacing lead. The sideport configuration of the OptiSeal Valved Peelable Introducer is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The OptiSeal Valved PTFE Peelable Introducer is packaged in sterile convenience kits containing a Valved PTFE Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The convenience kits are packaged five (5) per box.

The provided text describes a 510(k) summary for the Greatbatch Medical OptiSeal™ Valved PTFE Peelable Introducer. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI device.

Therefore, many of the requested sections related to AI device performance, sample sizes for test/training sets, expert ground truth adjudication, and MRMC studies are not applicable to this submission.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the verification specifications for the physical product. The document states that the device passed all these criteria, implying successful performance. Specific quantitative criteria and results are not detailed.

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

Not applicable. This device is a medical introducer, not an AI/software device that uses data for testing. The "test set" here refers to physical product units tested against design specifications. The sample sizes for these engineering tests are not provided in this summary.

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

Not applicable. Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., imaging AI). For this physical medical device, "ground truth" refers to engineering specifications met through laboratory testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are for resolving discrepancies in expert interpretations, which is not relevant for the engineering tests performed on this device.

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

No, an MRMC study was not done. These studies are typically performed for devices (often AI-powered) that assist human readers in tasks like image interpretation. This device is a physical introducer for catheters and leads. The summary explicitly states: "Given the limited scope of the modifications incorporated to create the OptiSeal Valved PTFE Peelable Introducer and identical intended use, no animal or clinical data was deemed necessary."

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

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

7. The Type of Ground Truth Used

For this device, the "ground truth" would be established by the engineering specifications and design requirements for each of the test categories (dimensional, strength, functional, etc.). The device's performance was compared against these pre-defined, objective criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

Not applicable. No training set was used for this physical medical device.

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The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire. The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.

Here's a breakdown of the acceptance criteria and study information for the Greatbatch Medical PTFE Peelable Introducer, as derived from the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • The document does not specify a separate "test set" in the context of clinical or image-based studies.
   • The "Performance Testing" section states, "The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner." This refers to non-clinical, in-vitro testing rather than human or animal studies.
   • Data Provenance: Not applicable as no human or image data was used. The testing described is non-clinical/in-vitro.

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 this device's performance was established through engineering specifications and non-clinical functional testing rather than expert review of clinical cases.

3. Adjudication method for the test set:

   • Not applicable. There was no clinical test set requiring adjudication.

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. This is a medical device (introducer), not an AI-powered diagnostic or image analysis system. Therefore, an MRMC study related to AI assistance is not relevant.

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

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

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

   • Engineering specifications and functional performance metrics. The ground truth for proving the device's efficacy and safety relies on meeting pre-defined physical and functional requirements established through non-clinical testing.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

   • Not applicable, as there is no training set.

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