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The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.

This document is a 510(k) clearance letter for a medical device called the "Amulet™ Steerable Delivery Sheath." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve comprehensive clinical studies or complex AI performance evaluations.

Based on the provided text, the changes to the device are primarily related to manufacturing processes:

• "The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions."
• "Additionally, a tip bond tensile specification and in-process tensile test method are being implemented."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing designed to show that these manufacturing changes do not negatively impact the device's function or safety, and that the new device remains substantially equivalent to the predicate. There is no mention of AI, human-in-the-loop studies, multi-reader multi-case studies, or complex ground truth establishment in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text, presented in the requested format, while acknowledging the severe limitations of this specific document for an "AI" type of study.

Acceptance Criteria and Device Performance for Amulet™ Steerable Delivery Sheath

Summary of Device Modification: The primary difference between the subject device and the predicate device is the "in-process solvent used to prepare the surface of the distal tip PEBAX extrusions." Additionally, a new "tip bond tensile specification and in-process tensile test method are being implemented." The submitted 510(k) is a "Special 510(k)," which is used for modifications to a manufacturer's own legally marketed device where the modified device does not raise new questions of safety and effectiveness.

Study Type: Non-clinical (benchtop) performance testing, process qualifications, and re-evaluation of biocompatibility and sterilization profiles for substantial equivalence demonstration. This is not a clinical study involving human patients, nor an AI performance study.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Important Note: The provided document is for a medical device modification, not an AI or diagnostic device. Therefore, many of the requested bullet points regarding AI-specific evaluation are not applicable. I will address them by stating their non-applicability.

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

   • Sample Size: Not explicitly stated as a numerical value (N) for each test. For "Process Qualification," it refers to "Product performance qualification (PPQ) testing." This typically involves a defined number of units tested per batch or according to a statistical sampling plan (e.g., AQL tables), but the specific numbers are not disclosed in this summary.
   • Data Provenance: This is non-clinical benchtop testing conducted by the manufacturer, Abbott Medical, in a laboratory setting. It is not patient data; therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in their clinical sense. The testing is essentially "prospective" in that it's performed on newly manufactured samples of the modified device prior to marketing.

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

   • Not Applicable. This is non-clinical benchtop testing of a physical medical device. "Ground truth" in the context of expert review (e.g., for AI image analysis) is not relevant here. Performance is measured against engineering specifications and industry standards by qualified engineers and technicians.

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

   • Not Applicable. As this is non-clinical engineering testing, there are no human "readers" or clinical "adjudication" in the sense of consensus on medical findings. Test results are compared against predefined acceptance criteria from engineering specifications.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This document describes the clearance of a physical medical delivery sheath, not an AI-powered diagnostic device or a device intended for clinical interpretation improvement. No human reader studies or AI assistance are mentioned or relevant to this 510(k).

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

   • Not Applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

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

   • Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by predefined engineering specifications (e.g., tensile strength values, deflection angles, number of cycles) and adherence to recognized industry standards (e.g., ISO, ASTM). For biocompatibility, it's based on ISO 10993 standards and the assessment of material properties. For sterilization, it's based on ISO 11135 and a Sterility Assurance Level (SAL).

7. The sample size for the training set:

   • Not Applicable. This device is not an AI model requiring a training set. The "training" for the device's performance is its design and manufacturing process, and its "experience" is validated through the non-clinical tests described.

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

   • Not Applicable. As there is no AI training set, this question is not relevant. The device's foundational "ground truth" (its design and intended performance) is established through extensive engineering design, development, and risk assessment processes preceding this specific 510(k) modification.

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The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Arrial Appendage Occluder.

The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.

The provided text is a 510(k) summary for the Abbott Amulet™ Steerable Delivery Sheath (K232690). This document describes the device's characteristics, its comparison to a predicate device, and non-clinical performance testing conducted to demonstrate substantial equivalence.

It's crucial to understand that this document explicitly states the testing was non-clinical performance testing (Section VII). This means the study described is a benchtop simulated use model for design validation, and not a clinical study with human patients. Therefore, the questions related to human readers, experts, ground truth from pathology/outcomes, and typical clinical study elements like ROC curves, sample sizes for training/test sets based on patient data, and human adjudication methods are not applicable in the context of this specific regulatory submission.

The "study that proves the device meets the acceptance criteria" in this document refers to the Design Validation study which used a benchtop simulated use model.

Here's the information extracted from the provided text based on your request, focusing on the available non-clinical testing details:

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

The document states: "The protocol acceptance criteria were met." However, it does not provide a detailed table listing specific quantitative acceptance criteria or corresponding device performance results for the design validation study. It only lists the types of tests performed.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the benchtop simulated use model test set. It mentions "physicians who have experience with left atrial appendage devices" evaluated the performance.
• Data Provenance: This was a non-clinical benchtop simulation study, not involving human patient data. Therefore, country of origin or retrospective/prospective is not applicable in the traditional sense. The study was conducted as part of the regulatory submission by Abbott Medical, located in St. Paul, Minnesota, USA.

The sample sizes for training sets and the type of ground truth are not applicable for this type of non-clinical, benchtop study. The ground truth for this device's performance is against engineering specifications and functional objectives in a simulated environment, rather than clinical outcomes or diagnostic accuracy.

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)

• The document states "physicians who have experience with left atrial appendage devices evaluated the performance."
• Number of Experts: Not specified.
• Qualifications of Experts: "Physicians who have experience with left atrial appendage devices." No further detail (e.g., years of experience, specific specialty like interventional cardiologist etc.) is provided in this summary.
• Ground Truth Establishment: The "ground truth" for this benchtop study was the successful delivery of the Amplatzer Amulet Left Atrial Appendage Occluder within the simulated use model according to pre-defined protocol acceptance criteria related to the device's mechanical and functional performance, as evaluated by the experienced physicians.

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

• Adjudication Method: Not specified. It only states that physicians evaluated the performance. Without a specified number of physicians or a detailed methodology, an adjudication method cannot be inferred.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This is a non-clinical benchtop study for a delivery sheath, not an AI-assisted diagnostic device for human readers. Therefore, questions regarding AI assistance and improvement for human readers are not applicable.

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

• Stand-alone Performance: This is a physical medical device (delivery sheath), not an algorithm or AI. Therefore, the concept of "standalone performance" of an AI algorithm is not applicable. The device's performance was evaluated in a simulated environment, with human interaction (physicians using it).

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

• For the Design Validation study, the "ground truth" was established by pre-defined protocol acceptance criteria for successful device function in a benchtop simulated use model, as assessed by physicians experienced with the procedure. This is distinct from ground truth derived from clinical outcomes, pathology, or expert consensus on diagnostic images.

8. The sample size for the training set

• Not applicable. This section describes non-clinical testing of a physical medical device, not the development or training of an AI algorithm.

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

• Not applicable. This section describes non-clinical testing of a physical medical device, not the development or training of an AI algorithm.

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The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atral Appendage Occluder.

The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.

The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath, allowing for more accurate device placement. Additionally, a hemostasis valve and side port are integrated in the device handle to support improved procedural hemostasis control and ease of use. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35" guidewire and a 19F introducer.

This Special 510(k) is being submitted to add additional precautions and updated procedural steps to the Instructions for Use (IFU) of the Amplatzer Steerable Delivery Sheath.

This appears to be a 510(k) summary for the Amplatzer™ Steerable Delivery Sheath. Based on the provided text, the submission is a "Special 510(k)" to add additional precautions and updated procedural steps to the Instructions for Use (IFU).

Crucially, the document states: "There are no changes in technological characteristics from the predicate device." and "As there are no changes in the indication for use, intended use, technological characteristics, the Amplatzer Steerable Delivery Sheath is substantially equivalent to the primary predicate device (K212026)."

This means that the provided document does not contain the full details of the original acceptance criteria and the study that proved the device met those criteria, as it refers back to the predicate device (K212026) for the substantial equivalence. The current submission only addresses the safety and effectiveness of the updated IFU, primarily through a Human Factors evaluation.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I can only infer what kind of testing would have been done for the original clearance based on typical medical device regulations and what is mentioned about the current submission.

Here's what can be extracted and inferred from the provided text regarding this specific 510(k) submission:

Device: Amplatzer™ Steerable Delivery Sheath

Reason for this 510(k) Submission (K220340): To add additional precautions and updated procedural steps to the Instructions for Use (IFU).

Key Statement: "There are no changes in technological characteristics from the predicate device."

Acceptance Criteria and Device Performance (Based on this Special 510(k) submission)

Study Information (Based on this Special 510(k) submission):

• Sample size used for the test set and the data provenance: Not explicitly stated, but the study type is a "Human Factors evaluation." These typically involve a relatively small number of representative users performing tasks with the device and new IFU. The provenance is likely within a controlled lab environment.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For a Human Factors study, "ground truth" relates to identifying usability issues and risks. Experts might include human factors specialists, clinicians, and engineers.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. For Human Factors, this would involve systematic observation and analysis of user performance, errors, and feedback.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for this specific 510(k) submission. This is a Human Factors evaluation, not a clinical effectiveness trial for the device's diagnostic or therapeutic performance.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device. The "standalone" concept applies more to AI/software.
• The type of ground truth used: For a Human Factors study, the "ground truth" is the observed user behavior, identified use errors, and subjective feedback compared against expected safe and effective use.
• The sample size for the training set: Not applicable, as this is a Human Factors study, not an AI/ML model.
• How the ground truth for the training set was established: Not applicable.

Information that would be in the original K212026 submission:

To fully answer your request regarding the original acceptance criteria and proof of device performance (e.g., mechanical, electrical, biocompatibility, and potentially clinical performance) for the Amplatzer™ Steerable Delivery Sheath, one would need to review the predicate device's 510(k) submission (K212026). That submission would contain:

• Detailed performance testing (e.g., tensile strength, steerability, torqueability, burst pressure, fatigue, material compatibility, dimensional stability, etc.) directly linked to the device's design specifications and intended use.
• Biocompatibility testing
• Sterilization validation
• Potentially, pre-clinical (in-vitro or in-vivo) or clinical studies if substantial changes were made from its own predicate, or if it was the first of its kind. Given it's a catheter delivery system, comparative bench testing and possibly animal studies would be typical.

Conclusion:

This specific 510(k) (K220340) demonstrates continued safety and effectiveness through a Human Factors evaluation of updated Instructions for Use. It relies on the substantial equivalence to its predicate (K212026) for the fundamental performance claims of the Amplatzer™ Steerable Delivery Sheath itself. Therefore, the detailed performance data and acceptance criteria for the device proper (not just its IFU) would be found in the K212026 submission.

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The Amplatzer Talisman Delivery Sheath is indicated to provide a pathway through which an Amplatzer™ PFO Occluder is introduced for patent foramen ovale closure.

The Amplatzer Talisman Delivery Sheath is a line extension of the Amplatzer Trevisio Intravascular Delivery System. The Amplatzer Talisman Delivery Sheath is a single use sheath intended to facilitate the delivery and deployment of the Amplatzer Talisman PFO Occluder. The delivery sheath is available in 8F and 9F sizes with a 45° curve and 80 cm usable length. The sheath and dilator are radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a platinum/iridium marker band near the distal tip. The Talisman Delivery Sheath is comprised of two components: a dilator to ease penetration of tissue and minimize vessel trauma, and a sheath to provide a pathway through which an Amplatzer occluder is delivered

The provided text describes the regulatory clearance of a medical device, the Amplatzer Talisman Delivery Sheath, and references various tests and studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or detailed results of a study in a format that would allow for the direct completion of the requested table and detailed description.

The document states that "Bench testing, including shelf life testing, was conducted to demonstrate that the Amplatzer Talisman Delivery Sheath met all performance specifications" for items like "Dimensional", "System Leak", "Handoff Force", etc. It also mentions "Design Validation studies" and an "acute animal study." However, it does not provide the numerical acceptance criteria for these specifications nor the quantitative results that prove the device met them.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or expert details for the studies, as this specific information is not present in the provided text.

The document focuses on confirming that certain types of tests were performed and that the device was deemed "substantially equivalent" based on these tests, without detailing the quantitative outcomes of those tests against specific acceptance criteria.

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The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder.

The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.

The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath. Additionally, a hemostasis valve and side port are integrated in the device handle. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35″ guidewire and a 19F introducer.

The provided text describes a submission for a medical device called the Amplatzer™ Steerable Delivery Sheath, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.

The document is a 510(k) summary for a traditional medical device (a catheter delivery system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It includes information on biocompatibility, bench testing, sterilization, packaging, and a design validation study in an animal model.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or an AI/ML-specific study.

Here's why the document doesn't fit your request:

• No AI/ML Component: The Amplatzer™ Steerable Delivery Sheath is described as a physical medical device (catheter) used to deliver another device. There is no mention of any artificial intelligence or machine learning component in its design or function.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to existing predicate devices, which is a standard regulatory pathway for non-novel medical devices. This typically involves comparing design, materials, indications for use, and performance through established test methods, not AI model metrics.
• Study Types: The studies mentioned (biocompatibility, bench testing, animal model design validation, human factors) are typical for hardware medical devices and do not involve AI performance evaluation metrics (e.g., accuracy, sensitivity, specificity, AUC).

If you have a document describing an AI/ML device, I would be happy to analyze it against your criteria. This document, however, does not contain that information.

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The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) is an extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45 100cm) product family (K120120 and K083214) and is available in both a 12Fr and 14Fr sheath size.

The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths with the exception of having a shorter 80 cm length and the tip taper length of the 12Fr (80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm) dilator.

The 80 cm length is consistent with several TorqVue Delivery System products including the TorqVue™ Delivery system (ITV) cleared under submission K072313 and the TorqVue™ (TVLA) delivery sheaths cleared under submission K120120.

Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flush adapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies the following essential components:
Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip.
Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy.
Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.

The document provided is a 510(k) summary for a medical device (AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath). However, it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device. This document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for new medical devices in the US, rather than proving performance against specific acceptance criteria through a clinical or performance study with a test set, ground truth, and expert interpretations.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document as it pertains to a different type of regulatory submission.

Here's what can be gathered, largely in the context of a substantial equivalence claim:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or report specific performance metrics in the way an AI/ML device study would (e.g., sensitivity, specificity, accuracy). The "performance" demonstrated here is primarily through a comparison to a predicate device and functional/safety testing, asserting that the new device performs equivalently and safely.

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

Not applicable. This document does not describe a test set or data provenance in the context of evaluating an AI/ML algorithm. The equivalence is established through engineering and design comparisons, and prior testing of predicate devices.

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

Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is a traditional medical device submission, not an AI/ML device study.

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

Not applicable. No adjudication method is described as there isn't a test set requiring expert consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed or described.

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.)

Not applicable. This document relies on regulatory standards, engineering principles, and prior verification/validation for predicate devices, rather than a "ground truth" in a clinical study sense for a novel diagnostic or AI device.

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. This is not an AI/ML device.

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The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."

This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.

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The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°. The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length. The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the AMPLATZER® TorqVue® Delivery Sheaths.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes various functional and safety tests performed on the AMPLATZER TorqVue Delivery Sheaths to demonstrate their substantial equivalence to a predicate device. The document does not explicitly state numerical "acceptance criteria" for each test but implies that the device "conforms to the requirements for its intended use" if the tests are passed.

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

The document mentions "Bench and laboratory testing" and "Design validation testing (animal study)". However, it does not specify the sample size for the test set used for these various tests. It also does not provide data provenance (e.g., country of origin, retrospective or prospective) for any of the studies, beyond stating that they were "Bench and laboratory testing" and an "animal study."

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any of the described tests. The tests appear to be primarily engineering and animal model-based, rather than human expert-driven interpretation.

4. Adjudication Method for the Test Set:

Given the nature of the bench, laboratory, and animal studies described, an adjudication method is not mentioned and is likely not applicable in the same way it would be for studies involving human interpretation or clinical outcomes. The tests appear to have objective pass/fail criteria based on engineering specifications or physiological responses in the animal model.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench, laboratory, and animal studies to demonstrate substantial equivalence, not a clinical study involving human readers and interpretations. Therefore, no effect size for human readers improving with or without AI assistance is provided.

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

This device is a physical medical device (catheter delivery system), not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable.

7. The Type of Ground Truth Used:

The ground truth for the bench and laboratory tests would have been established by engineering specifications, material properties, and performance standards for medical devices of this type. For the "design validation testing (animal study)," the ground truth would be based on physiological responses, procedural success, and absence of adverse events observed in the animal model, as determined by veterinary experts and scientific observation.

8. The Sample Size for the Training Set:

This device is a physical medical device, and the described studies are for its functional and safety validation. There is no concept of a "training set" as would be used for machine learning or AI algorithms.

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

As there is no "training set" in the context of this device and its validation, this question is not applicable.

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The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator. The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.

The provided text describes the acceptance criteria and the results of the functional and performance testing for the Adelante® Breezeway Delivery Sheath. However, it does not describe a study involving an AI/Machine Learning device or any human-in-the-loop performance. This document is a 510(k) premarket notification for a medical device (a catheter introducer), not an AI algorithm.

Therefore, many of the requested items related to AI/ML studies are not applicable or cannot be extracted from this text.

Here's a breakdown of the information that can be extracted, along with explanations for the missing AI-specific details:

Acceptance Criteria and Device Performance

Study Details (as applicable to a medical device, not an AI study)

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

   • The document does not specify the sample sizes (number of devices tested) for the functional and performance tests. It mentions "Functional and performance testing was conducted" but provides no numerical details.
   • Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are lab/bench tests on manufactured devices, not clinical data.

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

   • Not applicable. Ground truth, in the context of device performance, is established by adherence to engineering specifications and regulatory standards, not expert consensus on interpretations. The tests appear to be physical and chemical characterizations.

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

   • Not applicable. This concept is for clinical data interpretation, not for objective physical/chemical device testing.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This device is a physical medical instrument (a delivery sheath), not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is not an algorithm.

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

   • The ground truth for this device's performance tests is based on engineering specifications, manufacturing standards, and regulatory requirements. For example, a bond must withstand a "designated pull force," and residual levels "must be within limits."

7. The sample size for the training set:

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

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

   • Not applicable.

Summary regarding AI/ML aspects:
The provided document is a 510(k) summary for a traditional medical device (Adelante® Breezeway Delivery Sheath) and details its functional and performance testing against established acceptance criteria. It does not involve any AI or Machine Learning components, therefore, questions related to AI studies, training/test sets, expert adjudication, or reader studies are not applicable to the information presented. The "study" referenced is a series of benchtop and lab tests to ensure the device meets its design specifications and safety requirements.

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The AMPLATZER TorqVue Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature. The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy. The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) summary for the AMPLATZER® TorqVue® 2 Delivery Sheath, a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling typical "acceptance criteria" and "studies" in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested points related to AI software performance (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance, provenance of data) are not applicable to this type of device and submission.

Here's an analysis based on the information provided:

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

For this device, "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm would have sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various functional and safety characteristics. The reported "performance" is that it met these criteria through bench testing.

Study Title: Not explicitly named, but referred to as "Bench testing" and "laboratory verification test."

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

• Sample Size for Test Set: Not specified. Bench testing often involves a statistically determined number of units or replicates for each test, but the exact numbers are not detailed in this summary.
• Data Provenance: The testing appears to be internal "bench testing" and "laboratory verification tests" performed by the manufacturer, AGA Medical Corporation, in Plymouth, MN, USA.
• Retrospective/Prospective: As this is bench testing of physical properties, these terms are not applicable in the typical clinical study sense. The tests are designed and executed prospectively in a lab setting.

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: This is a physical medical device (delivery sheath), not an AI algorithm requiring expert interpretation for "ground truth" on images or clinical data. The "ground truth" for its performance is derived from standardized engineering tests measuring physical properties.

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

• Not Applicable: As above, this is bench testing of a physical device. There is no "adjudication method" involving experts for a test set in the context of clinical interpretation or diagnosis. Test results are objective measurements against predetermined 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

• Not Applicable: This is a physical medical device, not an AI algorithm. Therefore, MRMC studies are not relevant.

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

• Not Applicable: As this is a physical medical device, not an algorithm, the concept of "standalone performance" for an algorithm is not relevant.

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

• Ground Truth Type: For a physical device, the "ground truth" is defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "ground truth" for tensile strength would be a defined force threshold, or for kinking, a specific angle of bend without occlusion. These are objective, measurable physical properties.

8. The sample size for the training set

• Not Applicable: This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

• Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.

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