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The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

The MEDRON Vessel Dilator is a dilator consisting of a radiopaque HDPE (high density polyethylene) shaft with an overmolded HDPE Hub. The dilator comes in a variety of diameters ranging from 6F to 17.5F. It is also available in two models, a straight model and a stepped model. The straight model has a consistent diameter along the length of the shaft until it tapers at the distal tip. In the stepped model, the distal segment of the dilator shaft has a smaller diameter than the proximal segment as well as a taper at the distal tip.

The provided document is a 510(k) summary for the MEDRON Vessel Dilator. It outlines an equivalency study comparing the MEDRON Vessel Dilator to a predicate device, the Medcomp Vessel Dilator (K162389). However, it does not describe a study involving an AI/Machine Learning device or its performance. Instead, it details non-clinical performance tests (biocompatibility and functional testing) for a traditional medical device (vessel dilator).

Therefore, I cannot provide information for all your requested points as they pertain to AI/ML device studies. I will address the relevant sections based on the available information for a conventional medical device.

Information based on the provided document:

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

2. 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 explicitly state the sample sizes for each non-clinical test (biocompatibility and functional testing). It refers to "test samples," "study animals," and "all test animals" without providing specific numbers. The data provenance is not specified, but these are laboratory-based non-clinical tests, not human data.

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)

This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a medical device, not an AI/ML system requiring expert-established ground truth from images or other clinical data.

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

This section is not applicable for the reasons stated above. Adjudication methods are relevant for human interpretation tasks, not laboratory device testing.

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 section is not applicable. The document describes a 510(k) submission for a physical medical device (vessel dilator) and its comparisons to a predicate device based on technological characteristics and non-clinical tests. It does not involve AI or human readers.

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

This section is not applicable as the device is not an algorithm or AI system.

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

For the biocompatibility tests, the "ground truth" is established by standard biological responses observed in laboratory models (e.g., cell cultures, animal models) under controlled conditions, and interpreted against predefined criteria (e.g., Grade 0 reactivity, no abnormal clinical signs). For functional tests, the "ground truth" is based on engineering specifications and adherence to relevant international standards (e.g., ANSI/HIMA MD70.1-1983, ISO 594-2, ISO 11070).

8. The sample size for the training set

This section is not applicable as the device is not an AI/ML system requiring a training set.

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

This section is not applicable as the device is not an AI/ML system requiring a training set.

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Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.

Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.

There are several types of dilators made from stainless steel or aluminum:

• Cooley Coronary Dilators
• Cooley Vessel Dilators
• Garrett Vascular Dilators
• Hiebert Vascular Dilators
• DeBakey Vascular Dilators
• Sarns-Style Dilators
• Myocardial Dilators

These dilators are available in a range of different length and diameters.

The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.

Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.

The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.

The provided document is a 510(k) premarket notification for a medical device: Fetzer Medical Vessel Dilators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials for new medical technologies like AI/ML devices. As such, the information you're asking for, particularly regarding acceptance criteria, study design for proving performance, and expert-driven ground truth establishment (which is typical for AI/ML diagnostic devices), is not present in this document.

The document focuses on non-clinical performance testing (reprocessing, sterilization, biocompatibility, mechanical tests) to demonstrate that the Fetzer Medical Vessel Dilators are as safe and effective as existing, legally marketed predicate devices.

Here's a breakdown of why your specific questions cannot be answered by this document and what is provided:

Why the document does not contain the requested information (related to AI/ML device performance studies):

• Device Type: The Fetzer Medical Vessel Dilators are manual surgical instruments, specifically vessel dilators. They are not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This involves comparing indications for use, technological characteristics (design, materials, performance), and demonstrating that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or conducting large-scale clinical studies with human readers, ground truth consensus, or advanced statistical analyses like MRMC studies, which are common for AI/ML-driven diagnostic devices.
• Performance Data Scope: The "performance data" mentioned in this document refers to physical testing of the device (e.g., cleanability, sterilizability, mechanical strength), not diagnostic accuracy or clinical outcomes in patients.

What the document does provide regarding "Testing":

The document details performance testing conducted to show the device's characteristics are similar to the predicate devices and that it meets relevant standards for a surgical instrument.

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

• Acceptance Criteria (Implicit): For this type of device, the "acceptance criteria" are broad and relate to meeting industry standards and demonstrating comparable performance to the predicate device in specific functional aspects.

  • Automatic Reprocessing Validation according to ANSI/AAMI ST81: The implicit acceptance criterion is that "contamination...could be removed...by the given cleaning and disinfection instructions."
  • Sterilization testing: The implicit acceptance criterion is that "the device will be adequately sterilized under the validated sterilization parameters" to achieve a SAL (Sterility Assurance Level) of 10^-6.
  • Biocompatibility testing (ISO 10993-5): The implicit acceptance criterion is that materials are "non cytotoxic for the indicated contact duration."
  • Mechanical tests: The implicit acceptance criterion is that devices "were able to withstand the required pulling force without deformation or failure."

• Reported Device Performance:

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

• Test Sets: The document refers to "worst case devices" for reprocessing validation and "test specimens" for sterilization testing. The exact number of units or biological samples tested is not specified.
• Data Provenance: This is not applicable in the context of clinical patient data. The tests are laboratory-based. No country of origin for clinical data is mentioned as no clinical studies were performed. The tests are retrospective in the sense they were done before submission.

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

• Not applicable. The "ground truth" for these tests relates to measurable physical/biological parameters (e.g., residual protein levels, bacterial reduction, material cytotoxicity, mechanical force applied), not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus building among experts for subjective interpretations, which is not relevant for the objective laboratory tests performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating observer performance, typically in diagnostic imaging. It was not conducted for this surgical instrument.

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

• Not applicable. This relates to AI/ML algorithm performance. The device is a manual surgical tool.

7. The type of ground truth used:

• Laboratory-based measurements against established standards:
  • Reprocessing: Measured contamination levels (red blood cells, residual protein, organisms, total organic carbon) against AAMI TIR 30 guidelines.
  • Sterilization: Reduction of bioindicators/challenge suspension to achieve SAL 10^-6.
  • Biocompatibility: Cytotoxicity results per ISO 10993-5.
  • Mechanical: Resistance to pulling forces.

8. The sample size for the training set:

• Not applicable. This is typically for machine learning models. No training set for an algorithm was used.

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

• Not applicable. See point 8.

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The Medcomp® Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials (polyethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.

The provided text is a 510(k) summary for the Medcomp Vessel Dilator, a medical device for percutaneous entry into a vessel to enlarge the opening for catheter placement. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study involving AI.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable or present in this document.

However, I can extract information related to the bench/performance data/non-clinical testing that demonstrates the device's substantial equivalence to its predicate and reference devices.

Here's the relevant information based on the provided text:

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

The document does not present specific acceptance criteria in a table format with corresponding reported performance values for an AI device. Instead, it states that "The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols." It also mentions "The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment."

The performance data mentioned includes:

• Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires)
• Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters - part 1: general requirements) - described as "Bench Testing"
• Compliance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices -- Part 1: evaluation and testing within a risk management process) - described as "Biocompatibility"
• Compliance with ISO 11135:2014 (Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices) - described as "Sterility"
• Compliance with AAMI / ANSI / ISO 10993-7:2008(R) 2012 (Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals) - described as "Sterility"
• Compliance with ISO 14971:2007 (Medical devices - application of risk management to medical devices)

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

This information is not provided. The document describes non-clinical performance testing and biocompatibility studies, not a test set related to AI performance.

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)

This information is not applicable as the document is not about an AI device or a study requiring expert ground truth for image interpretation.

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

This information is not applicable.

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 information is not applicable. The document is about a physical medical device (vessel dilator) and its substantial equivalence, not an AI-powered image analysis tool.

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

This information is not applicable.

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

For the non-clinical performance testing, the "ground truth" would be the established specifications and requirements outlined in the referenced ISO standards and internal test protocols. For biocompatibility, it's the biological response against predefined safety limits. This isn't "ground truth" in the context of an AI diagnostic device.

8. The sample size for the training set

This information is not applicable.

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

This information is not applicable.

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INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.

Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) submission for Instrumed Vessel Dilators. This is a traditional medical device, not an AI/ML powered device, therefore the typical AI/ML-related study criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The acceptance criteria and supporting "studies" are focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, material analysis, and existing market data, rather than clinical trials with human subjects or AI model performance metrics.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) for a physical medical device:

Acceptance Criteria and Device Performance for Instrumed Vessel Dilators

The "acceptance criteria" for the Instrumed Vessel Dilators are primarily based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device meets specific performance characteristics and safety requirements, similar to the predicate. The "reported device performance" reflects how the Instrumed Dilators met these equivalence criteria through various non-clinical tests and evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

Given this is a physical device and not an AI/ML model, the concept of a "test set" for performance evaluation is different.

• Sample Size: The document does not specify exact sample sizes for each type of bench test (e.g., how many dilators were tested for tip retention, corrosion, etc.). It generally refers to "the proposed device" or "the new devices" in plural, implying a representative number were subjected to the specified tests.
• Data Provenance:
  • Bench Testing: Performed on the proposed Instrumed Vessel Dilators. The country of origin for this testing is not explicitly stated but assumed to be under the applicant's (INSTRUMED INTERNATIONAL, INC. in Schaumburg, IL) oversight. This is prospective testing performed specifically for the 510(k) submission.
  • Clinical Evaluation: Based on "literature research" and "market surveillance information." This includes "database evaluation," "scientific literature," and "data from market experience of the same or similar devices."
  • Market Experience: Data from Instrumed International's own sales (hundreds of dilators over 5 years to non-US markets) with "no reported customer complaint or potentially reportable event." This data is retrospective from global markets (markets other than US).

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

This question is not applicable to this type of device. The "ground truth" for a physical device like a dilator is established through engineering standards, mechanical tests, material specifications, and clinical consensus on safe and effective surgical practice. There is no concept of "experts establishing ground truth for a test set" in the way it applies to diagnostic AI systems. Expert surgeons would use these devices, but their role in a 510(k) for this product is primarily related to the general acceptance and understanding of dilator function and safety, not as ground truth adjudicators for a specific performance evaluation dataset.

4. Adjudication Method (for the test set)

This question is not applicable. The "test set" here refers to the physical devices undergoing bench testing. The outcomes of these tests (e.g., measured diameter, material composition, breakage force) are objective measurements against defined specifications or standards, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially imaging-based ones) to assess how human reader performance changes with or without an AI aid. Instrumed Vessel Dilators are surgical instruments, not diagnostic tools, so an MRMC study is not relevant.

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

No, a standalone study was not done. This concept applies specifically to AI algorithms. The Instrumed Vessel Dilators are physical devices that are inherently used "with human-in-the-loop" (i.e., by a surgeon).

7. The Type of Ground Truth Used

The "ground truth" for the Instrumed Vessel Dilators is based on a combination of:

• Engineering Specifications and Standards: For dimensional accuracy, material properties (ASTM F 899-07), mechanical strength, and corrosion resistance.
• Predicate Device Performance and Safety Profile: The established safety and effectiveness of the legally marketed predicate devices (KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, K030788 AND DEBAKEY VESSEL DILATORS) serve as a de facto "ground truth" for what constitutes acceptable device performance and safety for this class of device.
• Clinical Literature and Market Surveillance: General medical understanding of appropriate indications for use and safe practices for vessel dilation.
• Biocompatibility Standards: To ensure the material is non-cytotoxic and safe for contact with human tissue.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model involved; therefore, no "training set."

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

This question is not applicable. There is no AI model involved; therefore, no "training set" ground truth to establish.

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GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

GEISTER vessel dilators

This is a 510(k) premarket notification for a medical device (GEISTER Vessel Dilators), not a study report for an AI/ML device. Therefore, the document does not contain information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI/ML study.

The document is an FDA letter stating that the GEISTER Vessel Dilators are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines the regulatory classification, product code, and indications for use of the device.

To directly answer your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not contain information relevant to an AI/ML device study. It is a 510(k) clearance letter for a Class II surgical vessel dilator and discusses substantial equivalence to predicate devices, not performance against specific acceptance criteria in a study format typically associated with AI/ML.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: Not applicable for this type of document.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The Cordis TrapEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The VisEase Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

The subject TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator most notably differs from the predicate TrapEase Permanent Vena Cava Filter and Introduction Kit with regards to the vessel dilator that is included as a component in the Introduction Kit. In addition to its original function as a vessel dilator, which was featured with the predicate Cordis TrapEase Introduction Kits, the subject VisEase Angiographic Vessel Dilator features new intended uses involving angiographic visualization and linear measurement. These new intended uses of the subject VisEase Angiographic Vessel Dilator are addressed in updated product labeling herein and are identical to the intended uses of the predicate Cordis Super Torque MB Angiographic Catheter (reference K992347, determined substantially equivalent on October 8, 1999). Besides the aforementioned changes in intended use for the VisEase Angiographic Vessel Dilator, the TrapEase Permanent Vena Cava Filter and all other components used with the subject device remain unchanged from #K000062, #K003964 and #K010083).

The provided document is a 510(k) premarket notification for the "Cordis TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator." This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or AI device might.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not typically found in this type of regulatory submission because they are not required to demonstrate substantial equivalence for this conventional medical device.

However, I can extract the information that is present and indicate what is not applicable based on the document.

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

For this device, "acceptance criteria" are primarily related to conforming to established standards and demonstrating functional performance through non-clinical testing. The document states that the safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."

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

This information is not provided in the document as it's a 510(k) summary relying on non-clinical engineering and bench testing, not human subject data for "test sets" in the typical sense. Data provenance is not specified for the non-clinical tests.

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)

This information is not applicable for this type of submission, as ground truth is not established by human experts for non-clinical bench testing.

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

This information is not applicable for this type of submission.

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

An MRMC study is not applicable to this device, as it is a physical medical device (vena cava filter and dilator), not an AI diagnostic tool or system that assists human readers.

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

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

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

Given that the testing consisted of "non-clinical design verification tests and analyses" (Visual and Dimensional Inspection, Catheter Sheath Introducer Compatibility, Flow Rate Testing, Hydrodynamic Testing, Pull Strength Testing), the "ground truth" would be established by engineering specifications, material science standards, and performance metrics defined for the device during its design and development, rather than medical ground truths like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable as this is a physical medical device and not an AI algorithm requiring a training set.

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

This information is not applicable as this is a physical medical device and not an AI algorithm.

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The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices.

The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft, a soft distal tip, and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180

The provided text describes a 510(k) premarket notification for an "Intracardiac Introducing Sheath and Accessories." This is a medical device, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices, not an AI/ML powered device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study performed based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an in vitro testing program designed to demonstrate the "substantial equivalence" of the subject device (Intracardiac Introducing Sheath and Accessories) to its predicate devices. The study involved a series of controlled laboratory tests measuring various physical, mechanical, and functional properties.

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

• Sample Size: The document does not specify the exact sample sizes used for each in vitro test. It generally refers to "manufactured sheaths and dilators" and "packaged units." For in vitro testing, this typically involves a representative number of devices to achieve statistical significance for the specific tests performed, but the exact count is not provided.
• Data Provenance: The data provenance is from laboratory testing (in vitro) conducted by Boston Scientific Corporation/EP Technologies. There is no mention of country of origin for the data (as it's in vitro testing, often performed internally or by contract labs), nor is it retrospective or prospective in the clinical sense.

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

• Number of Experts & Qualifications: Not applicable. For this type of in vitro device performance testing, "ground truth" is typically established by predefined engineering specifications, industry standards (e.g., ISO 11135 for sterilization), and comparison to the performance of predicate devices, rather than expert clinical consensus. The testing engineers and quality control personnel are the "experts" in this context, ensuring adherence to protocols and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the clinical sense. In vitro testing results are compared against predetermined acceptance criteria (e.g., a tensile strength minimum, a leak rate maximum, visual inspection criteria, or direct comparison to predicate device performance). Any discrepancies would be handled by internal quality control and engineering review processes.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This submission is for a physical medical device (an introducer sheath).

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

• Ground Truth Type: The "ground truth" or reference standard for this device's performance relies on:
  • Engineering Specifications: Predefined performance metrics (e.g., bond strength, leak rates, friction forces).
  • Industry Standards: Compliance with relevant international standards (e.g., ISO 11135 for sterilization).
  • Predicate Device Performance: Direct comparison of the subject device's performance to that of the legally marketed predicate devices, demonstrating similar safety and effectiveness.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a training set. The device itself is manufactured to specifications.

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

• Ground Truth for Training Set: Not applicable.

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The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.

The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180

The provided document is a 510(k) summary for an "Intracardiac Introducing Sheath and Accessories." This type of submission focuses on demonstrating substantial equivalence to predicate devices for medical devices, rather than establishing efficacy through clinical trials with specific performance metrics akin to software device approval.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device does not apply to this document.

Here's why and what information is available:

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

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity). The acceptance criteria for this device revolve around demonstrating substantial equivalence to predicate devices in terms of design features, materials, and in vitro performance, ensuring no new safety or effectiveness issues.
• Reported Device Performance:

  Test Type	Reported Performance
  Biocompatibility testing	Qualified the equivalence between the subject device and dilators.
  Sterilization validation	Validated per ISO 11135 guidelines.
  Reliability testing	Included shipping and accelerated aging of packaged units.
  Tensile testing	Performed on critical bond joints.
  Rotational testing	Performed on the sheath to luer bond.
  Leak, friction forces, insertion	Performed in an in vitro setup, indicating performance as well as predicate devices for these aspects.

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

• This document describes in vitro testing, not a clinical study with human subjects or a dataset for AI. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on manufactured units of the device itself.

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

• Not applicable. This is not a study requiring expert readers to establish ground truth. Device performance was assessed through engineering and laboratory tests.

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

• Not applicable. No adjudication process is relevant for this type of in vitro testing.

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 an intracardiac introducing sheath, not an AI-powered diagnostic or assistive tool.

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

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

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

• "Ground truth" in this context refers to established engineering standards, material properties requirements, and performance specifications for medical devices. For example, sterilization validation adheres to ISO 11135 guidelines, and tensile strength tests have defined pass/fail criteria based on material science and predicate device performance. The in vitro tests verify that the device meets these engineering and safety standards.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for this type of device submission.

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

• Not applicable.

Summary of available information:

The document details a 510(k) submission for a physical medical device. The "performance data" provided consists of various in vitro engineering and biocompatibility tests designed to demonstrate that the new device is substantially equivalent to existing predicate devices and does not raise new safety or effectiveness concerns. It does not involve AI or clinical studies with human subjects in the way your questions are framed.

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The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.

The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures.

Here's an analysis of the provided text regarding the Adam Spence Percutaneous Catheter Introducer, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• Many acceptance criteria are comparative against a predicate device rather than absolute quantitative standards.
• The document explicitly states that "Performance standards have not been established under Section 514 of the Food, Drug and Cosmetic Act."
• Referenced standards like "ANSI MD70.1-1983" and "ISO/DIS 11070.2" likely define specific physical and performance requirements that the tests above would then demonstrate compliance with, but the specific numerical thresholds from these standards are not detailed in the provided text.

2. Sample Sizes and Data Provenance

The provided document describes a summary of technological characteristics and performance testing for the Adam Spence Percutaneous Catheter Introducer compared to a predicate device. However, it does not provide specific details on the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The testing appears to be primarily bench testing (laboratory-based) comparing physical properties and performance aspects rather than clinical trials with patient data.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. The evaluation is based on engineering and performance testing.

4. Adjudication Method

No adjudication method is mentioned, as the evaluation is based on objective performance testing rather than expert-based assessments requiring adjudication.

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

No MRMC comparative effectiveness study was done. The device is a physical medical device (catheter introducer), not an imaging or diagnostic AI tool that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done for the Adam Spence PCI. The "Summary of Technological Characteristics" table presents the performance of the Adam Spence PCI (algorithm/device only) in various tests (e.g., tensile properties, valve/sheath leak, air aspiration, tip peelback) independent of human-in-the-loop performance, though often in direct comparison to the predicate device.

7. Type of Ground Truth Used

The "ground truth" for the performance claims appears to be established through engineering measurements, physical testing, and laboratory experiments (e.g., measuring tensile strength, observing leakage, quantifying insertion force). For biocompatibility, it's compliance with established ISO standards.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a physical medical device, not an AI/machine learning algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable for a physical medical device as there is no "training set" in the machine learning sense. The device's design and manufacturing are based on established engineering principles and materials science, with performance validated through direct testing against predetermined specifications or predicate device performance.

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To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.

The Vessel Dilator is a device used over a quide wire to dilate the opening in a vessel in preparation of percutaneous entry of a catheter. The device may be used separately or in conjunction with a sheath introducer. The device consists of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist in dilation. The hub proximal end has a female luer lock configuration An optional hub collar may be used to attach the dilator to an introducer. The device is available in sizes 4F through 15F and is supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.

The provided text is a 510(k) summary for a medical device called a "Vessel Dilator." It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The information provided focuses on:

• Biocompatibility: Stating that "Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests."
• Material Testing: "The device meets the requirements of the USP XXIII physicochemical tests for plastics."
• Tensile Strength: "Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device."

These are engineering and material compliance statements, not clinical performance acceptance criteria or studies in the way you've outlined with terms like "test set," "ground truth," "MRMC study," or "standalone performance."

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.

Here's how I can address what is available:

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

The remaining questions cannot be answered from the provided text as they relate to clinical study design and performance, which is not present in this 510(k) summary.

2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical ground truth described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this device is a physical medical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable; no clinical ground truth described.
8. The sample size for the training set: Not applicable; no training set described.
9. How the ground truth for the training set was established: Not applicable; no training set described.

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