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The Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.

The provided text describes the 510(k) premarket notification for the BioCardia Morph DNA Steerable Introducer Sheath (K242169). This document does not include information about acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as the product is a physical medical instrument (a steerable introducer sheath), not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a machine learning model, as this content is not present in the provided document.

The document details the device's technical specifications, comparison to predicate devices, and various benchtop and simulated use tests conducted to demonstrate that modifications did not affect product specification requirements. These tests are focused on the physical and functional performance of the catheter, not on an AI's diagnostic or predictive capabilities.

Here's a breakdown of what the document does provide in relation to performance testing, which is different from an AI/ML performance study:

Device Performance Testing (Not AI/ML Study)

The document lists performance tests conducted to confirm the device meets product specifications due to modifications from predicate/reference devices.

1. Acceptance Criteria and Reported Device Performance: This section is presented as a list of tests conducted, implying that successful completion of these tests (meeting internal product specifications for each test) is the "acceptance criteria" for this type of physical device. The specific quantitative acceptance criteria values or detailed reported performance values for each test are not explicitly stated in the provided text. Instead, it indicates that the tests were conducted "to confirm that the modifications... did not affect the ability to meet all product specification requirements."

2. Sample Size Used for the Test Set and Data Provenance: Not applicable for a physical device. Testing would involve a number of manufactured units, but this is not typically referred to as a "test set" in the context of data for AI. No information on data provenance (country, retrospective/prospective) is provided as there's no data being collected for an AI model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The "ground truth" for a physical device like this is its physical and functional performance according to engineering specifications and simulated use scenarios, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set: Not applicable for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study is relevant for AI/ML diagnostic or prognostic tools that assist human readers. This is a physical medical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.

7. The Type of Ground Truth Used: For this physical device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993, ASTM standards) and internal product specifications for attributes like tip deflection, catheter diameter, material properties, and functional performance in simulated use models.

8. The Sample Size for the Training Set: Not applicable, as there is no training set for an AI model.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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The biocardia morph universal deflectable guide catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The BioCardia 8F Morph® DNA Deflectable Guide Catheter is a sterile, single use, bi-directional deflectable guide catheter. When the handle is fully actuated, the distal tip deflects to a minimum 135° arc in either of two directions with a nominal curve distance of 30 mm. The catheter tip includes a fluoroscopic marker to help visualize the tip location. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.

The BioCardia 8F Morph DNA Deflectable Guide Catheter is a sterile, single-use, bi-directional deflectable guide catheter. Its intended use is to provide a pathway for medical instruments (like balloon dilatation catheters, guidewires, or other therapeutic devices) into the peripheral vasculature or chambers and coronary vasculature of the heart.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Since this is a submission for substantial equivalence to a predicate device, the acceptance criteria are largely demonstrated by ensuring the new device's performance is comparable to the predicate and meets relevant safety standards. The document doesn't explicitly list numerical 'acceptance criteria' in the traditional sense with specific thresholds. Instead, it lists various tests conducted to confirm that modifications did not negatively impact performance. The "Reported Device Performance" for each test is that the device "did not affect the ability to meet all product specification requirements," implying successful adherence to the established performance characteristics for guide catheters.

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

• Sample Size for Test Set: Not explicitly stated for each test. For in-vivo testing, it was a "Single Swine Model." For benchtop and package integrity tests, it's typically a statistically significant number of units, but the exact count is not provided in this summary.
• Data Provenance: The studies were conducted by BioCardia, Inc. as part of their 510(k) submission. These are internal validation studies, not indicating specific country of origin or whether they were retrospective or prospective beyond the stated testing methods. Benchtop and package integrity tests are inherently prospective, as is the single swine model.

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

Not applicable. This is a medical device for providing access, not a diagnostic device that requires expert interpretation for a "ground truth" establishment in the traditional sense (e.g., for image analysis). The "ground truth" for this device's performance relates to its physical and functional specifications meeting engineering standards and biological safety. The "experts" involved would be the engineers, toxicologists, and biologists conducting and evaluating the studies against established ISO and ASTM standards and FDA guidance. Their qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable in the context of diagnostic interpretation, as this is a medical device. Performance is evaluated against objective engineering specifications and biological safety standards.

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-assisted diagnostic device, nor does it involve "human readers" in its intended use.

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 a software algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Engineering Specifications: Successful adherence to predefined dimensions, force tolerances, deflection angles, and functional requirements.
• Relevant ISO and ASTM Standards: Compliance with recognized international and national standards for medical devices, biocompatibility, sterilization, and packaging.
• FDA Guidance: Adherence to FDA's recommendations for medical device evaluation.
• Biological Response: Demonstrated safety and compatibility in in-vitro and in-vivo (swine model) biological tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

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The BioCardia 8.5 F Avance™ Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The BioCardia 8.5 F Avance™ Steerable Introducer (Avance) is a sterile, single use, bidirectional introducer. When the handle is fully actuated, the distal tip deflects to a nominal 180° arc in either of two directions with a nominal curve distance as indicated by the product label. The introducer tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Avance handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.

Avance includes a dilator with a pre-curved, tapered tip which extends up to 2.5 cm beyond Avance to facilitate transseptal placement. The dilator hub snaps into the Avance hemostasis valve and can accommodate a guidewire diameter of up to .038".

This document is a 510(k) premarket notification for a medical device called the BioCardia 8.5 F Avance™ Steerable Introducer. It aims to prove the device's substantial equivalence to a predicate device (St. Jude Agilis™ Steerable Introducer, K042623). However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device with acceptance criteria for classification performance (e.g., accuracy, sensitivity, specificity).

Instead, it pertains to an interventional medical device (a catheter introducer) and its performance is evaluated against engineering and biological criteria, not diagnostic accuracy. Therefore, most of the requested information regarding AI/ML device performance (like MRMC study, standalone performance, training/test set ground truth, number of experts, etc.) is not applicable to this document.

I will attempt to extract what is relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical, interventional medical device based on the provided text.

Here's an interpretation based on the information provided, recognizing that the context is a physical device and not an AI/ML algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. The "acceptance criteria" are implied by the nature of these tests, which confirm the device meets "all product performance requirements." The "reported device performance" is a statement that these tests were "conducted to confirm that the design of the Avance meets all product performance requirements." Specific numerical results for each test are not provided in this summary; rather, it states that the device successfully met these requirements.

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

• Sample Size:
  • For in-vitro bench testing, no specific numerical sample sizes are given for each test (e.g., number of devices tested for deflection, fatigue, etc.).
  • For in-vivo simulated use testing, it explicitly states: "Single Swine Model". This indicates a sample size of 1 animal.
• Data Provenance: The tests are described as "In-Vitro Bench Top Testing" and "In-Vivo Simulated Use Testing (Single Swine Model)". Since this is a premarket notification, these are prospective tests conducted specifically for this submission. The origin (country/location of testing) is not specified, but it would have been performed by or on behalf of the manufacturer, BioCardia, Inc., San Carlos, CA.

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

This concept is not applicable to this type of device and study. The "ground truth" for a physical device's performance is established by engineering measurements, physical properties, and physiological outcomes in a simulated use environment, not by expert interpretation of images or data.

4. Adjudication method for the test set

This concept is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. For a physical device, performance is measured against quantifiable engineering standards or observed physical functionality.

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 concept is not applicable. An MRMC study pertains to evaluating diagnostic performance, often with AI assistance for human readers. This document is about the physical performance and safety of an interventional introducer device.

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

This concept is not applicable. This refers to the standalone performance of an AI algorithm. The device in question is a physical catheter introducer.

7. The type of ground truth used

The "ground truth" (or basis for evaluation) for this device includes:

• Engineering specifications and measurements (e.g., deflection angles, dimensions, forces, resistance to leakage, fatigue limits).
• Compliance with recognized standards (e.g., ASTM, ISO 10993-1, TIR 28:2009).
• Direct observation of functionality in a simulated physiological environment (e.g., in the swine model, observing navigation, deflection, brake mechanism, compatibility).

8. The sample size for the training set

This concept is not applicable. There is no "training set" in the context of validating a physical medical device. The device design is developed through engineering processes, not by training an algorithm on a dataset.

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

This concept is not applicable. See point 8.

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The BioCardia Morph® Sheath Guide is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature.

The BioCardia Morph® Sheath Guide is a single lumen steerable catheter introducer. It is designed to be delivered percutaneously with the use of an internal dilator and advanced to a desired location within the vasculature to facilitate delivery of therapeutic catheters. Steering of the device is accomplished by rotation of a knob on the handle which deflects the distal tip of the catheter shaft. The BioCardia Morph Sheath Guide is supplied with a dilator and includes a hemostasis valve through which the dilator, guidewires, and devices may be passed while minimizing blood loss.

The provided text describes a 510(k) premarket notification for the BioCardia Morph® Sheath Guide. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on:

• Device Description: What the BioCardia Morph® Sheath Guide is.
• Intended Use: What it's designed to do.
• Equivalent Devices: Other similar devices on the market.
• Test Results (High-level): Mentions "in-vitro and animal testing" and "biocompatibility" but provides no specific acceptance criteria or detailed study results.
• Regulatory Communication: FDA's confirmation of substantial equivalence.

Therefore, I cannot populate the table or answer most of your detailed questions. The document explicitly states: "{1}------------------------------------------------ #### Test Results: #### Performance Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use." This is a summary statement, not a presentation of detailed acceptance criteria or study results.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study Details

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The BioCardia Morph Universal Deflectable Guide Catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

Not Found

This device, the BioCardia Morph Universal Deflectable Guide Catheter, is a medical device and not an AI/ML product. Therefore, the questions related to AI/ML product evaluation (such as acceptance criteria for AI performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and standalone performance) are not applicable.

The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria in the way an AI/ML product would.

Here’s the information gleaned from the provided text, focusing on the equivalence determination for a medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device 510(k), specific numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are typically not established in the same way as for an AI/ML device. Instead, the performance is demonstrated through comparison to a predicate device and adherence to recognized standards.

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

• The document mentions "in-vitro and animal testing."
• Sample Size: Specific numbers for samples used in in-vitro or animal testing are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.

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

• This is not applicable as there is no mention of human expert-based ground truth establishment for this type of medical device evaluation. Performance is assessed through engineering tests and animal studies.

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

• Not applicable for the evaluation of this traditional medical device.

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.

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.):

• The "ground truth" for this medical device would be based on engineering measurements for in-vitro performance (e.g., deflection force, torque transmission, guidewire passage) and physiological/anatomical observations and safety assessments in animal models. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in the AI/ML sense.

8. The sample size for the training set:

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

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

• Not applicable. There is no "training set" or corresponding ground truth for this traditional medical device.

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The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the heart and coronary vasculature of the heart.

BioCardia Universal Deflectable Guide Catheter

The provided text describes the 510(k) premarket notification for the BioCardia Universal Deflectable Guide Catheter, submitted in 2001. The information focuses on demonstrating substantial equivalence to existing devices rather than a detailed study with acceptance criteria and device performance metrics in the way a modern AI/ML device submission would.

Therefore, many of the requested fields cannot be directly populated from the provided text. I will fill in what is available and indicate when information is not present.

Acceptance Criteria and Study Details for BioCardia Universal Deflectable Guide Catheter

This submission demonstrates substantial equivalence of the BioCardia Universal Deflectable Guide Catheter to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "acceptance criteria" can be inferred as meeting the safety and effectiveness requirements for its intended use, as demonstrated through in-vitro and animal testing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document mentions "in-vitro and animal testing," but doesn't provide the number of samples or animals used.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The nature of "in-vitro and animal testing" suggests controlled lab environments.

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

• Not applicable/Not specified. The assessment appears to be based on physical testing and material compliance rather than expert image interpretation or clinical consensus.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. This type of adjudication is typically for clinical or image-based studies where expert consensus on a diagnosis is required.

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.

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. The "standalone" performance here relates to the physical and functional testing of the catheter itself, as indicated by "in-vitro and animal testing."

7. The Type of Ground Truth Used:

• For Performance and Safety: Results from "in-vitro and animal testing." This would typically involve objective measurements of device function, durability, and biological response.
• For Biocompatibility: Compliance with ISO 10993-1 standards, likely through laboratory tests and material composition analysis.

8. The Sample Size for the Training Set:

• Not applicable in the context of this device. This is a traditional medical device, not an AI/ML product that utilizes a "training set."

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

• Not applicable.

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