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The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

The device under consideration is the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter.

Based on the provided text, the device's acceptance criteria are addressed through a series of Functional/Safety Testing and Animal Testing. The manufacturer, Transit Scientific, LLC, states that "All data met pre-determined acceptance criteria" for these tests and that the device is "substantially equivalent to the cited predicate device."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets predefined acceptance criteria, but it does not explicitly state specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it broadly states that "All data met pre-determined acceptance criteria."

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

The document does not specify the sample sizes used for any of the tests (biocompatibility, performance bench testing, or animal testing).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing by Transit Scientific, LLC.

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

This information is not provided in the document. The document describes engineering and biological testing, not clinical studies involving expert interpretation of data.

4. Adjudication method for the test set

This information is not applicable/provided. The tests described are laboratory and animal studies, not clinical trials requiring adjudication of expert interpretations.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a physical medical device (catheter), not an AI/software device that would involve human readers interpreting AI output.

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

This information is not applicable/provided. The device is a physical medical device, not an algorithm.

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

For the biocompatibility and design verification (performance bench testing), the "ground truth" would be the established international standards (ISO 10993-1) and internal design specifications and requirements, as well as the performance of the predicate device (K221986).
For animal testing, the "ground truth" for safety, usability, and scoring performance would be observed physiological responses, usability metrics, and observable effects on the treated vessels within the animal models. No mention of expert consensus, pathology, or outcomes data specifically as "ground truth" is made for the animal study.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable/provided for the same reason as point 8.

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The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.

The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

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

The document describes bench testing and biocompatibility testing rather than a "test set" of patient data for an algorithm. Therefore, "sample size" here refers to the number of devices or materials tested. The exact sample sizes for each bench test are not specified in this summary.

• Data Provenance: The testing was conducted by Transit Scientific, LLC, to support a 510(k) submission to the FDA. This implicitly means the testing was performed in a controlled laboratory environment, likely in the US, and is prospective in the sense that the testing was specifically designed and executed to gather data for this submission.

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

This question is not applicable to this document. The submission is for a physical medical device (microcatheter), not an AI/software device that requires expert ground truth labeling of patient data. The "ground truth" for this device's performance is established through adherence to engineering specifications, recognized standards, and direct comparison to a predicate device's established performance characteristics via bench testing.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers are evaluating and labeling data (e.g., radiology images) to establish a consensus "ground truth" for a dataset. This document concerns a physical device's performance through bench testing, not human interpretation of data.

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

This question is not applicable. An MRMC study is relevant for AI/software devices where human readers' performance with and without AI assistance is being evaluated. This document is for a physical microcatheter and does not involve AI or human image interpretation studies.

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

This question is not applicable. This submission is for a physical medical device, not a standalone algorithm.

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

For this type of device, the "ground truth" is established by:

• Adherence to engineering specifications and design requirements.
• Compliance with recognized industry standards (e.g., ISO 10993-1 for biocompatibility).
• Performance characteristics demonstrated through rigorous bench testing that simulate clinical use conditions and measure physical properties (e.g., flow rate, pressure resistance, kink resistance).
• Comparison to the established performance profile of the predicate device. The predicate device itself serves as a benchmark of "safe and effective."

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There is no "training set."

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The XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Score LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score LP catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in the one catheter length (150 cm), and longitudinal scoring element length (23cm).

The provided text is a 510(k) summary for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter. It focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional/safety testing, rather than an AI-driven medical device requiring a study with acceptance criteria for a new clinical indication or improved diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic context, a study proving the device meets that criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.

The "acceptance criteria" referred to in the document are for bench testing to validate and verify that the device is substantially equivalent to a predicate device, focusing on physical and functional characteristics of the catheter. This is different from the type of acceptance criteria and study design you're asking for, which typically apply to AI/software as a medical device (SaMD) or diagnostic devices that provide clinical information or assist human readers.

To be specific, the document explicitly states:
"The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria."
The listed tests are all bench tests (e.g., Biocompatibility, Kink Radius, Tensile Testing, Retrieval Force Testing, Device Recovery, Accessory PTA Balloon Catheter burst pressure, Torque, Cycling, Scoring Capability Assessment).

In summary, the provided text does not describe the type of study and acceptance criteria you've requested for an AI-driven or diagnostic device.

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The XO Cross Coronary is a support catheter intended to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross Coronary Support Catheter is a single-lumen support catheter designed to support a guidewire during access of the peripheral or coronary vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross Coronary Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 175cm), with a diameter of 2 Fr (0.7 mm) and with a tapered polymer tip at its distal end.

The provided text describes a medical device, the XO Cross Coronary Support Catheter, and its 510(k) submission to the FDA for substantial equivalence. However, the document does not contain information about:

• Acceptance criteria for an AI/ML powered device. The device described is a physical catheter, not an AI/ML software.
• A study proving the device meets AI/ML specific acceptance criteria.
• Sample size for test sets or data provenance (these are relevant for AI/ML validation).
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Stand-alone performance of an algorithm.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

The document details the following for the physical catheter device:

Device Performance and Testing:

The document focuses on demonstrating substantial equivalence to a predicate device (Quick Cross Extreme Support Catheter, K092396) and a reference device (XO Cross Support Catheter, K210322). The "performance" assessment is based on functional and safety testing of the catheter, not on specific output metrics typically associated with AI/ML systems (like accuracy, sensitivity, specificity, etc.).

Biocompatibility Testing:

• Tests performed and passed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Endotoxin LAL, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Blood Platelet and Leukocyte Count.
• Method: In accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (≤ 24hrs) to circulating blood. The device used the same materials and processes as the reference device, with an additional assessment for a new black polymer outer layer.

Design Verification (Performance Bench Testing):

• Tests performed or fulfilled: Tip ID Testing, Tip Tensile Testing, Distal Shaft Kink Testing, Simulated Use.
• Purpose: To ensure the catheter met applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence.

Comparative Analysis (Substantial Equivalence):

The document presents a comparison (Table 2) between the subject device, the predicate device, and the reference device across various attributes like:

• Intended Use
• Indications for Use
• Classification Name
• Single Use
• Fundamental Scientific Technology
• Prescription (Rx Only)
• Anatomical Access
• Design
• Effective Length (cm)
• Distal Tip/Crossing Profile
• Shaft Outer Diameter
• Visibility
• Guidewire Compatibility
• Sheath / Introducer Compatibility
• Max Infusion Pressure
• Sterility
• Biocompatibility

Conclusion:

The submission concludes that the XO Cross Coronary Support Catheter is substantially equivalent in safety and effectiveness to the legally marketed predicate and reference devices. The minor design differences (longer tapered tip, modified strain relief, outer polymer layer color change, minimum kink specifications, minimum tip ID and tensile specifications) were assessed and determined to "raise no additional or different questions of safety or effectiveness."

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (catheter), not an AI/ML-powered device. Therefore, it does not contain the specific information requested regarding AI/ML acceptance criteria and validation studies.

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The XO Cross is a support catheter intended to guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross Support Catheter is identical to the predicate device in that it is a single-lumen support catheter designed to support a guidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 15cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.

The provided text describes the submission for a 510(k) premarket notification for the XO Cross Support Catheter, which is a revised version of a previously cleared device. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Here's an analysis of the requested information based on the provided text:

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

The document does not present a table of specific acceptance criteria with corresponding performance statistics for the device in terms of clinical outcomes or diagnostic accuracy. Instead, it details that "Verification & Validation activities were performed on the subject XO Cross Support Catheter to demonstrate substantial equivalence to the predicate device."

The closest the document comes to "acceptance criteria" and "reported performance" is in the context of the functional/safety testing and biocompatibility testing. For these, the acceptance criteria are generally "passed" or "met/exceeded" internal requirements and ISO standards.

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

The document does not provide details on a 'test set' in the context of clinical data or patient outcomes. The testing described is primarily pre-clinical (biocompatibility, engineering design verification). Therefore, information on sample size and data provenance for a clinical test set is not available.

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

This information is not applicable to the provided document. The submission is for a medical device (support catheter), not an AI/diagnostic software. Ground truth, in the sense of expert consensus on imaging or pathology, is not part of this type of submission. The "ground truth" for the engineering and biocompatibility tests would be the established scientific methods and standards (e.g., ISO 10993-1, ISO 10555-1) and internal specifications.

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

This information is not applicable. There is no clinical 'test set' involving human interpretation or adjudication for this device submission.

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

This information is not applicable. The device is a physical support catheter and not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical support catheter, not an algorithm.

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

The "ground truth" for the evaluations performed is based on:

• International Standards: ISO 10993-1 for biocompatibility and ISO 10555-1 for catheter design verification.
• Internal Requirements: Transit Scientific's in-house specifications for design verification tests (e.g., radiopacity, tip ID, tensile, lubricity, durability, particulate, integrity, coaxial).

8. The sample size for the training set

This information is not applicable. The document does not describe the development of an AI algorithm with a training set. The descriptions relate to physical device design and manufacturing.

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

This information is not applicable. As there is no AI algorithm or training set discussed, this question is not relevant to the provided content.

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The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a 6.3 Fr (2.08 mm) diameter, single-lumen, metal alloy hypotube shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in various catheter lengths (65cm, 125cm), and longitudinal scoring element lengths (5cm, and 7cm).

The provided text describes the "XO Score Percutaneous Transluminal Angioplasty Scoring Catheter" and its substantial equivalence to predicate devices, without directly presenting acceptance criteria in a table format with reported performance. However, it does state that "All necessary verification steps met pre-determined acceptance criteria to support substantial equivalence." and "All data met pre-determined acceptance criteria." It also mentions "The XO Score catheter met all acceptance criteria to support substantial equivalence."

Based on the information provided, here's an attempt to infer and structure the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria alongside specific reported performance values for each criterion. Instead, it generally states that the device met "pre-determined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicate devices.

However, based on the "Functional Testing" and "Comparative Analysis" sections, we can infer areas where performance was assessed and accepted:

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

• Sample Size for Test Set: The document mentions "An animal study (Ovine model)" was conducted. However, the specific number of animals or anatomical sites used in this Ovine model is not provided.
• Data Provenance: The animal study data would be considered prospective data, specifically for a pre-clinical assessment in an animal model. The country of origin of the data is not specified.

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

This information is not provided in the document. The animal study would likely involve veterinary scientists or surgeons, but the specific number and qualifications of experts for establishing "ground truth" (e.g., assessing lesion scoring effectiveness or adverse events) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC study is not mentioned or implied. The device is a physical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the provided context.

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

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

7. The Type of Ground Truth Used

For the animal study:

• The "ground truth" would be established through direct observation and assessment of the anatomical effects of the catheter on the Ovine model, likely involving histological examination, imaging, and macroscopic evaluation to determine functionality, safety (e.g., lack of perforation, dissection), and performance (e.g., successful scoring of lesions). This falls under a combination of pathology and outcomes data (clinical outcomes in the animal model).

For other verification tests (biocompatibility, design verification):

• Ground truth would be established by conformance to established international standards (ISO 10993-1, ISO 10555-1) and Transit Scientific's in-house requirements.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as in point 8.

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The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross catheter is a single-lumen support catheter designed to support a quidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross catheter within the vasculature, while under fluoroscopy. It is available in various lengths (90cm, 135cm, 150cm, 175cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.

The provided text is a 510(k) summary for the XO Cross Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria, especially in the context of device performance metrics with numerical values or statistical analyses.

The document states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence" and "All data met pre-determined acceptance criteria" for functional tests, but it does not specify what those criteria are beyond general statements. It also doesn't describe the methodology of any studies that would demonstrate these criteria were met in a quantifiable way.

Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria for each functional test (e.g., maximum acceptable cytotoxicity index, specific force required for kink resistance in design verification).
• Quantitative results of the functional tests against the specific criteria.
• Any performance testing related to guidewire support strength, catheter trackability, pushability, or other in-use functional attributes beyond basic material and design verification.

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

• Missing. The document does not describe any specific "test set" in terms of patient data or clinical samples that would have a sample size or provenance. The "functional/safety testing" refers to laboratory-based verification, and no sample sizes for these tests are provided.

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

• Not applicable. This information would typically be relevant for studies involving qualitative assessments, such as image interpretation or clinical diagnosis. The described testing is primarily laboratory-based engineering and biocompatibility testing. No "ground truth" established by experts in this context is mentioned.

4. Adjudication method for the test set

• Not applicable. See point 3.

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

• Not applicable. This device is a physical medical device (support catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

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

7. The type of ground truth used

• For the functional/safety testing, the "ground truth" would be the standards and specifications (e.g., ISO 10993, ISO 10555) that the device must meet, as well as the manufacturer's own internal design requirements. These are objective engineering and biological standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth described for the tests mentioned.

8. The sample size for the training set

• Not applicable. This device is a physical medical device. There is no concept of a "training set" as there would be for AI/machine learning models.

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

• Not applicable. See point 8.

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