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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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PreXion 3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital X-ray images of the dental (oral), maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

PreXion 3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

The provided text is a 510(k) Summary for the PreXion 3D Excelsior device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI-driven diagnostic aid.

Specifically, the document discusses:

• Device Description: The PreXion 3D Excelsior is a dental cone-beam computed tomography (CT) device.
• Modifications from Predicate: The subject device adds a "CT-panoramic" mode (reconstructing panoramic images from CT raw data) and an "Airway measurement function" (calculates volume and cross-section area of airways).
• Non-Clinical Performance Data: Conformance to various harmonized standards (e.g., IEC 60601-1, ISO 14971) and specific testing for 3D imaging performance (MTF for three image orientations).
• Software Quality Activities: Compliance with software moderate level concern based on risk management and usability evaluation, including bench tests and user evaluations.
• Conclusion: The device is substantially equivalent to the predicate device.

However, the document does NOT provide the requested information regarding acceptance criteria related to AI/Machine Learning performance (e.g., sensitivity, specificity, AUC) or a clinical study proving AI-driven diagnostic aid performance. The "Airway measurement function" is described as an additional supplemental function, but no performance metrics for this automated measurement function are presented, nor is it explicitly stated to be an AI-driven diagnostic aid in the sense of pattern recognition or disease detection.

Therefore, I cannot extract the information required to formulate the table and answer the detailed questions about acceptance criteria for an AI device and the study proving it meets those criteria. The provided submission is for a medical imaging device (CT scanner) and its software, not an AI diagnostic software that requires assessment of diagnostic accuracy.

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PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

The provided text describes a 510(k) premarket notification for the PreXion3D Excelsior device, a dental Cone-beam Computed Tomography (CT) system. The submission aims to establish substantial equivalence to a predicate device (K161881). The key modification is the addition of a "Complete mode" for CT scans, which simulatively creates a wider Field of View (FOV) by extending the FOV height.

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

1. Table of Acceptance Criteria and Reported Device Performance

Assessment: The document states that the 3D MTF results for the Complete mode met the predicate device criteria, implying that the spatial resolution in the extended FOV is comparable. However, no specific numerical acceptance threshold or performance value for 3D MTF is provided in the document. The general acceptance criteria are implicit: the modified device should perform as well as the predicate device in relevant aspects.

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

The document does not explicitly state the sample size used for the performance testing.

• It mentions "the stitching area of the volume data of Complete mode" was assessed, but the number of cases or images is not quantified.
• Data Provenance: Not specified. It can be inferred that the testing was performed by the manufacturer, PreXion Corporation, likely in Japan, given their address. There is no information on whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The assessment appears to be a technical measurement (3D MTF) rather than relying on expert radiographic interpretation as ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since the primary performance testing mentioned is a technical measurement (3D MTF), an adjudication method by experts would not be applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on technical equivalence and performance of the device itself, not on human reader performance with or without AI assistance.

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

The performance testing mentioned ("assessment of 3D MTF") is inherently a standalone (algorithm only) evaluation, as it objectively measures image quality characteristics of the device's output without human intervention for interpretation.

7. The Type of Ground Truth Used

The ground truth for the performance testing (3D MTF) appears to be based on technical standards and predicate device criteria for image quality measurements. It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This device is a CT imaging system (hardware and associated software for image reconstruction), not an AI/ML algorithm that typically requires a separate training set. The "software modifications" refer to changes that allow for the expanded FOV and reconstruction, not necessarily a machine learning model that needs a training set for diagnostic tasks.

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

Since there is no mention of a training set for an AI/ML algorithm, this information is not applicable/not provided. The "ground truth" concerning the device's functionality and image reconstruction capabilities would have been established through engineering design, simulations, and empirical testing against known physical phantoms or established imaging standards.

In summary:

This 510(k) submission primarily focuses on demonstrating technical equivalence for a modification to an existing CT device. The performance testing described is a technical assessment of image quality (3D MTF) in the newly introduced "Complete mode" to ensure it meets established (predicate device) criteria. It does not involve diagnostic performance studies with human readers, expert consensus on images, or AI/ML training data.

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PreXion3D Excelsior is intended to produce two dimensional digital panoranic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand wrist to obtain carpus innages for growth and maturity assessment.

PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

The provided text describes the PreXion3D Excelsior, a dental cone-beam computed tomography device, and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those specified acceptance criteria in the way requested by your prompt.

Specifically, the document states:

• Non-clinical performance data: Conformance to harmonized standards (listed in section 5.7), testing for 3D imaging performance to assess MTF (Modulation Transfer Function) for three image orientations (x, y, z) for 3D modes, and non-clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."
• Clinical performance data: Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" were performed by qualified clinical assessors.

However, the document lacks specific quantitative acceptance criteria (e.g., minimum MTF values, specific accuracy thresholds for diagnostic tasks) and detailed results from a study that would demonstrate the device met those specific criteria. The evaluation focuses on substantial equivalence based on conformance to standards and general considerations rather than a detailed performance study with defined acceptance criteria and statistical analysis.

Therefore, I cannot populate the table and answer the following questions with the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists standards it conforms to but does not quantify specific acceptance criteria (e.g., for image quality, diagnostic accuracy) with corresponding performance values.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. It mentions "qualified clinical assessors" for clinical considerations but no further detail.
4. Adjudication method: Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance study: Not mentioned. The device is a hardware imaging system, not an AI algorithm in the typical sense for standalone performance.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable as this is a hardware device submission, not an AI algorithm requiring a training set in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to establish substantial equivalence based on technological characteristics and general safety/effectiveness considerations, not to provide a detailed performance study against specific, quantified acceptance criteria for a novel diagnostic algorithm.

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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.

• Tip Shape Retention
• Tip steam shape shrinkage
• Flexibility of the Distal Shaft
• Softness of the Distal Tip
• Tip shape retention (only applicable to Preshaped catheters)
• Surface defects along effective length
• Surface extraneous matter along effective length
• Static Rupture / Leakage under High Static Pressure
• Dynamic Burst
• Tensile Strength
• Catheter Hub
• Compatibility with DMSO
• Compatibility with Peel-away introducer sheath
• Proximal Fluoro-saver marker visibility |
  | Biological Safety | Biocompatibility testing performed according to EN ISO10993-1:2009 + AC: 2010, comprising:
• Cytotoxicity
• Hemolysis
• Physiochemical Test
• FTIR
• Latex |
  | Shelf Life and Packaging Integrity | Shelf life testing (Product and Packaging) conducted.
  Distribution/shipping Challenge Conditioning and Testing performed.
  Packaging Verification Testing performed. |
  | Risk Assessment | Risk assessment conducted in accordance with EN ISO 14971:2012 (Design and Use FMEAs). Conclusion: Modifications "raise no new questions of safety or effectiveness." |
  | Technological Characteristics | Product feature comparison table shows most characteristics are "Same as predicate" or variations that do not alter safety/effectiveness (e.g., smaller hub, smaller distal OD, material without colorant). |

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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