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The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized 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 the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

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

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

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 for the same reason as point 8.

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Ophthalmology

The EXCELSIOR Software is intended for use in importing, processing, measurement, and analysis of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials.

Radiology

Excelsior is a software solution intended to be used for viewing, manipulation, annotation, and ysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images, functional data such as PET as well as anatomical datasets, such as CT or MR. Excelsior is a software only medical device to be deployed through a cloud-based computerized network via web applications and customized user interfaces for use in the analysis of images and data obtained in clinical trials. Excelsior enables visualization of information that would otherwise have to be visually compared disjointedly. Excelsior provides and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Excelsior supports the interpretation and evaluations and follow-up documentation of findings for radiologic oncology imaging and data obtained in clinical trials.

The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.

Note: The medical professional retains the ultimate responsibility for making the pertinent observations based on their standard practices and established practices related to clinical trial outcomes. Excelsior is a complement to these standard procedures. Excelsior is not to be used in mammography.

The EXCELSIOR software is a cloud-based software that provides a central reading platform integrating remote data collection, quantitative analysis and measurement, storage, and management of ophthalmic and radiological data from DICOM images for clinical trials. The software does not use artificial intelligence or machine learning algorithms.

The provided text is a 510(k) summary for the EXCELSIOR software. It describes the device's intended use, classification, predicate devices, and the rationale for substantial equivalence. However, it does not include the specific details required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:

• "Software validation and verification testing was performed which showed that the software performs as intended supporting substantial equivalence."
• "The methodology used to validate and verify that the software performs as intended was used to confirm performance of the additional tools and features."

These statements confirm that testing was done, but they do not provide the raw data, acceptance criteria, study design details, or expert qualifications that you've asked for.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not provided. The text implies the device is a workflow tool, not an AI for diagnosis, making MRMC less likely to be the primary evaluation method for diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The text states "The software does not use artificial intelligence or machine learning algorithms," implying it's a tool for human use, not a standalone diagnostic algorithm.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable, as the document explicitly states: "The software does not use artificial intelligence or machine learning algorithms." Therefore, there is no training set as understood in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable for the reason above.

In summary, the document states that validation and verification testing was performed and supports substantial equivalence, but it does not disclose the specifics of these tests, including acceptance criteria, performance metrics, or study design details.

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Stryker Neurovascular's Excelsior XT -17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neuro vasculature.

Stryker Neurovascular Excelsior® XT-17™ Microcatheters are single lumen devices designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Stryker Neurovascular hydrophilically coated Excelsior XT-17 Microcatheters are coated on the outer surface with Hydrolene® Coating that reduces friction during manipulation in the vessel. The Excelsior XT-17 Microcatheter is a single use device made of polymers, stainless steel, and Hydrolene® Coating, sterilized with Ethylene Oxide (EO) gas. Patient contact duration is less than 24 hours, and patient contact materials are polymers and Hydrolene® Coating. The Excelsior XT-17 Microcatheter is used in health care facility/hospital by physicians trained in performing endovascular procedures.

This document is a 510(k) summary for the Stryker Neurovascular Excelsior XT-17 Microcatheter, indicating its substantial equivalence to a predicate device. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or a deep learning algorithm validation study would. Instead, it describes a product and compares it to a previously cleared product to show substantial equivalence.

Therefore, many of the requested categories (like sample size for test set, data provenance, ground truth establishment for training, MRMC studies, and standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance data presented, which essentially serves as the "study" demonstrating the device meets the acceptance criteria of being substantially equivalent to the predicate device.

Here's a breakdown of the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance:

The "acceptance criteria" here is that the modified device, the Excelsior XT-17 Microcatheter, has a safety and effectiveness profile similar to the predicate device (Tracker-17 Microcatheter) and raises no new questions of safety or effectiveness. The device performance is demonstrated through various verification tests.

Here's how the other requested points align with the provided document:

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

   • Sample Size: Not specified in this document. The "test set" here refers to the samples of the device undergoing verification testing. The exact number of microcatheters tested for each functional, biocompatibility, and shelf-life test is not detailed.
   • Data Provenance: Not specified. This is an internal regulatory submission by Stryker Neurovascular (Fremont, CA, USA). The testing would typically be performed internally or by contracted labs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as this is a medical device performance and safety verification, not an AI or diagnostic imaging study requiring expert ground truth consensus. The "ground truth" is established by adherence to established engineering, biocompatibility, and regulatory standards.

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

   • Not applicable. Adjudication methods are typically for clinical outcome or diagnostic performance studies, not for physical 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, an MRMC study was not done. This is a microcatheter, not a diagnostic or AI-assisted device.

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

   • No, this is a physical medical device, not an algorithm.

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

   • The "ground truth" for this type of submission is adherence to established, recognized standards for medical device design, manufacturing, and performance (e.g., ISO standards for biocompatibility, material properties, and functional performance) and comparison to the predicate device's established safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. This is not an AI/machine learning device.

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The EXCELSIOR Software is intended for use in importing, processing, measurement, analysis and storage of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials.

The EXCELSIOR software is a cloud-based software that provides a grading platform integrating remote data collection, quantitative analysis and measurement, storage and management of ophthalmic data and images for clinical trials.

EXCELSIOR provides secure access through user authentication and role authorization, and is adherent to HIPAA and CFR 21 part 11 requirements for clinical investigations. EXCELSIOR user accounts can only be initiated by EXCELSIOR administrators or project managers: administrators or project managers enter in user information, and the user is prompted by email to setup his own user name and password. Once setup, the user access is defined by its role associated with a particular trial. EXCELSIOR provides 128-bit secure network encryption and audit trail logging to ensure that changes to the data are retraceable and re-constructible.

Here's a breakdown of the acceptance criteria and study information for the EyeKor EXCELSIOR Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the EXCELSIOR Software as an "image management system," primarily focusing on its functional equivalence to predicate devices (Topcon Medical Systems Synergy and Carl Zeiss Meditec Forum) rather than a diagnostic device with specific performance metrics like sensitivity or specificity.

Therefore, the "acceptance criteria" discussed are related to its intended use and technological characteristics rather than direct performance in a diagnostic task. The document asserts that the device meets these criteria by being substantially equivalent to the predicates.

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

The provided text does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "Performance Data" section primarily mentions compliance with DICOM and general software validation/verification, but not a clinical performance test set.

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

This information is not provided in the document as there's no mention of a clinical test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers with and without AI assistance. This device is an image management system, not a diagnostic AI.

6. Standalone Performance Study (Algorithm Only)

The document does not describe a standalone performance study in the context of a diagnostic algorithm's performance. The "performance data" refers to compliance with standards and general software functionality testing.

7. Type of Ground Truth Used

Since a clinical performance evaluation with a test set is not described, the concept of "ground truth" in terms of pathology, expert consensus, or outcomes data is not applicable in the provided text. The "ground truth" for the software validation would be adherence to functional specifications and standards like DICOM.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size, as it describes an image management system rather than a machine learning-based diagnostic algorithm that would typically require a training set.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

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The Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non- liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior® XT-27™ Microcatheter is a sterile, single lumen 0.027 in ID device with one tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization. The Excelsior XT-27 Microcatheter is coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior XT-27 Microcatheters are available in effective lengths of both 135cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and Pre-Shaped versions are available.

This document describes the Stryker Neurovascular Excelsior® XT-27™ Microcatheter and its 510(k) submission for market clearance. The submission relies on demonstrating substantial equivalence to predicate devices through a series of bench tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Excelsior XT-27 Microcatheter are largely based on demonstrating equivalence to the predicate devices (K000177, Renegade™ Hi-Flo™ Microcatheter and K042568, Excelsior® SL-10 Pre-Shaped Microcatheter). The "Result" column explicitly states "Met same criteria as predicate," indicating that the performance of the Excelsior XT-27 Microcatheter was found to be comparable to or better than the predicate devices for these specific tests.

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

The document does not explicitly state the sample sizes used for each of the bench tests. It also does not provide information about data provenance in terms of country of origin or whether the tests were retrospective or prospective. Given the nature of bench testing for a medical device, it is typically prospective, with samples of the device being manufactured and then tested in controlled laboratory environments.

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

This information is not provided in the document. For bench testing, "ground truth" is typically established through adherence to test methodologies and specifications, often informed by engineering standards and regulatory guidance, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not provided. As mentioned above, bench testing relies on objective measurements and predefined acceptance criteria rather than expert adjudication in the way clinical studies might.

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

This information is not applicable and not provided. The Excelsior XT-27 Microcatheter is a physical medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to its evaluation.

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

This information is not applicable and not provided. As it is a physical medical device, there is no "algorithm only" performance to be evaluated in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for most of these tests is established by:

• Engineering Specifications and Design Requirements: For dimensional measurements, kink radius, advancement/retraction force.
• Established Biomedical Test Standards: For biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization, hemocompatibility, pyrogenicity, USP impurities, latex). These standards define the methods and acceptance criteria for classifying a material as non-toxic, non-irritating, etc.
• Comparison to Predicate Device Performance: For many performance characteristics (e.g., visual inspection, simulated use), the "ground truth" for the new device is that its performance must be equivalent or superior to the already legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering iterations, but this is distinct from an algorithmic training process.

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

This information is not applicable and not provided for the same reasons as point 8.

In Summary:

The document focuses on demonstrating substantial equivalence of the Excelsior® XT-27™ Microcatheter to its predicate devices through comprehensive bench testing. The acceptance criteria for most tests are implicitly or explicitly that the new device must perform comparably to (or better than) the predicate devices, or meet established safety and performance standards (especially for biocompatibility). The study design is largely a series of controlled laboratory tests performed on samples of the device. Aspects related to AI, human readers, or large-scale data training sets are not relevant to this type of device submission and therefore not included.

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Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.

The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are intended to assist the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are packaged individually with a variety of Pre-Shaped tips.

This document describes the 510(k) summary for the Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheters. The core of the submission is to demonstrate substantial equivalence to predicate devices, where the primary modification is the pre-shaped tips for ease of use.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific percentage accuracy or precision). Instead, the acceptance criteria are implicitly that the modified devices (with pre-shaped tips) retain the same performance characteristics and safety profile as the predicate devices. The study performed is a "testing in support of substantial equivalence determination."

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The document refers to "in-vitro testing" but does not detail the number of units tested for each characteristic.
• Data Provenance: The data appears to be prospective as it involves "in-vitro testing" conducted specifically for this 510(k) submission. No information is given about the country of origin of the data beyond "Boston Scientific" which is a US-based company, suggesting the testing was likely conducted in the US or by a US-affiliated entity.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission is for a medical device (microcatheter) and relies on engineering and biocompatibility testing, not on expert interpretations of medical images or clinical data to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this isn't a study involving human interpretation of data where adjudication would be necessary.

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

No. This type of study is typically performed for diagnostic devices where the performance of human readers, with and without AI assistance, is evaluated. This submission is for a microcatheter, which is an interventional device, not a diagnostic one.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical microcatheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on engineering specifications, material science, and established safety standards for medical devices (e.g., biocompatibility standards, mechanical testing standards for catheters). The predicate devices serve as the reference point for equivalence.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML-driven device.

9. How Ground Truth for the Training Set was Established

Not applicable, for the same reason as point 8.

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The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Not Found

This document is a 510(k) clearance letter for a blood glucose test strip, which falls under IVD (In Vitro Diagnostic) devices. For IVD devices, the acceptance criteria and study details are typically presented differently than for AI/ML-based diagnostic software. Instead of metrics like sensitivity, specificity, AUC, or reader studies, IVD device performance is usually evaluated based on accuracy against a reference method (e.g., laboratory analyzer), precision (repeatability, reproducibility), and interference studies.

Based on the provided text, there is no detailed information on acceptance criteria and a study report in the format typically requested for AI/ML devices. The document is primarily an FDA clearance letter and an "Indications For Use" statement. It confirms that the device is "substantially equivalent" to a legally marketed predicate device.

Therefore, many of the requested points for describing acceptance criteria and a study cannot be directly extracted from this document because it is not a study report.

However, I can infer some information based on the context of 510(k) submissions for IVD devices and the provided text:

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

This information isn't explicitly in the provided text. For blood glucose meters and strips, typical acceptance criteria would involve accuracy metrics (e.g., certain percentage of results falling within specific ranges compared to a lab reference, or mean absolute relative difference - MARD), precision (coefficients of variation), and linearity. The "substantially equivalent" determination implies that the device met performance standards comparable to the predicate device.

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

Not provided in this document. Studies for blood glucose meters typically involve a diverse set of patient samples with varying glucose levels.

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

For blood glucose meters, the "ground truth" is typically established by measurements from a central laboratory's reference analyzer, not by expert interpretation.

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

Not applicable for this type of IVD device where ground truth is machine-determined (reference lab).

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, and there are no "human readers" interpreting results in the way an AI would assist a radiologist.

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

The device (test strips) essentially operates in a "standalone" manner in that the chemical reaction on the strip and the meter's reading algorithm directly provide a result. There isn't an AI "human-in-the-loop" component in the traditional sense for this type of device.

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

For blood glucose test strips, the ground truth is established by a laboratory reference method, typically a clinical chemistry analyzer with high accuracy and precision, such as a YSI glucose analyzer.

8. The sample size for the training set:

Not applicable in the context of AI/ML training. For IVD devices, development involves analytical studies (e.g., accuracy, precision, interference) and clinical studies. The "training set" concept doesn't directly apply in the same way.

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

Not applicable as there isn't a "training set" in the AI/ML sense. Ground truth for performance evaluation samples would be established via a laboratory reference method.

Summary based on the document:

The provided document is a 510(k) clearance letter for a medical device (blood glucose test strips). It attests to the device's "substantial equivalence" to a legally marketed predicate device. This implies that the device demonstrated comparable performance to the predicate through studies (not detailed in this letter), likely including accuracy against a reference method, precision, and interference studies. However, the specific acceptance criteria, study methodologies, and performance results are not included in the provided text.

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The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters. Excelsior test strips, when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters, quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.

The provided document is an FDA 510(k) clearance letter for a medical device (Excelsior Blood Glucose Test Strips). It states that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

FDA 510(k) clearance letters primarily focus on the determination of substantial equivalence, not a detailed breakdown of clinical study results or technical performance metrics used in the study submitted to support the 510(k). The detailed performance data would typically be found within the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide the requested information based on the given text.

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The Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.

This submission describes the Excelsior™ SL-10 Microcatheter. The manufacturer is seeking substantial equivalence to existing predicate devices based on in vitro performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of acceptance criteria with specific thresholds. Instead, it states that "All testing indicates that the device is safe and performs according to its intended use." This is common for predicate device comparisons where the performance is expected to be at least equivalent to the predicate, rather than meeting a specific numerical benchmark.

However, based on the testing mentioned, we can infer the performance aspects evaluated:

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

The document does not specify the sample sizes used for the in vitro performance tests. The data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin mentioned. However, since these are in vitro performance tests, they are typically conducted in a laboratory setting by the manufacturer.

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

Not applicable. The ground truth for this device is established through objective in vitro measurements and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards (like ISO-10993) and comparison to predicate devices, not subjective expert reviews requiring adjudication.

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 medical device (microcatheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Objective Measurements: Results of the in vitro performance tests (dimensional, tensile, burst, flow rate, withdrawal force).
• Established Standards: Biocompatibility verified according to ISO-10993.
• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is substantial equivalence to the legally marketed predicate devices (Tracker-10 Microcatheter and Excelsior 1018 Microcatheter) in terms of functionality, intended use, design, materials, and method of operation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

The Excelsior 1018 Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged with a steam shaping mandrel accessory.

The provided text describes a 510(k) submission for the Excelsior™ 1018 Microcatheter, focusing on its substantial equivalence to a predicate device, the TurboTracker-18 Infusion Catheter. The submission primarily details performance testing and biocompatibility to support this claim, rather than a clinical study with traditional acceptance criteria for a new AI/software device.

Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, sample sizes for test/training sets, data provenance, and adjudication methods) are not applicable to this 510(k) summary, as it pertains to a physical medical device.

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

Since this is a submission for a physical microcatheter, the "acceptance criteria" are related to established engineering and biocompatibility standards rather than clinical performance metrics typical of an AI device. The document states that "performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence."

While specific numerical acceptance criteria and reported performance values for each of these tests are not provided in the given text, the submission states that the results "demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device." This implies that the Excelsior 1018 Microcatheter met the necessary performance and safety standards to be considered equivalent to the predicate device.

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

Not applicable to this type of device submission. Performance testing usually involves a defined number of units per test, but these are engineering tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance would be from internal lab testing at Boston Scientific.

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. Ground truth in this context refers to established engineering specifications and biocompatibility standards, not expert assessments of clinical data for AI performance.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for AI, to resolve discrepancies in ground truth labeling. This submission relies on objective engineering measurements and standard biocompatibility assessments.

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 device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance testing is based on established engineering specifications, industry standards (e.g., for biocompatibility), and comparison to the predicate device's characteristics. For coil compatibility, the "ground truth" is whether the microcatheter can successfully deliver the specified GDC coils.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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