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The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use (19 cm, 23 cm, 37 cm, 31 cm, 35 cm and 55 cm (tip to cuff lengths) is a dual lumen, symmetric tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038" guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field.

The provided text is a 510(k) summary for the Marvao NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use. This document describes the device, its intended use, and argues for its substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is typically found in detailed clinical trial reports or performance study reports, which are not present in this 510(k) summary.

A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria for a novel device. The document states that clinical studies were not deemed necessary because in vivo and in vitro testing were sufficient to demonstrate safety and effectiveness by comparison to a legally marketed predicate device.

Therefore,Based on the provided text, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets those criteria.

Here's why and what can be inferred:

• No specific acceptance criteria or study proving they are met are explicitly detailed. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving a novel device meets specific acceptance criteria through a full-scale clinical trial.
• The document states: "In vitro testing was performed on the NexSite HD, Hemodialysis Symmetric Tip Catheter to assure reliable design and performance in accordance with ISO 10555-1:2013." and "The non-clinical tests performed include visual and dimensional of the catheter, DISC and stylet, stylet joint strength, priming volume, catheter leakage, catheter pressure, catheter flow rate testing, catheter recirculation testing and mechanical hemolysis. The test results demonstrate that the NexSite™ HD, Hemodialysis Symmetric Tip Catheter meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate devices."
• It also mentions: "In vivo implantation studies were also performed to demonstrate that the device would perform as intended."
• Crucially, it states: "Clinical studies were not deemed necessary since in vivo and in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device."

This means that while performance testing and in vivo implantation studies were conducted, they were done primarily to establish substantial equivalence to existing devices, usually by showing the new device performs at least as well as the predicate device on the relevant metrics, rather than proving it meets pre-defined acceptance criteria for a novel functionality.

Therefore, I cannot populate the table or answer most of your questions as the document does not contain this level of detail about a dedicated study proving specific acceptance criteria.

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The NexSite™ HD, Hemodialysis Step Tip Catheter for long term use (60cm) is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

NexSite™ HD Hemodialysis Step Tip Catheter for Long Term Use (60cm)

I apologize, but the provided text focuses on the FDA's 510(k) clearance letter for the "NexSite™ HD Hemodialysis Step Tip Catheter for Long Term Use (60cm)." This document confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.

However, the document does NOT contain information about:

• Acceptance criteria for a study proving device performance. The FDA letter is a regulatory clearance, not a study report.
• Device performance data (sensitivity, specificity, accuracy, etc.).
• Details about a test set (sample size, provenance).
• Information on experts establishing ground truth or adjudication methods.
• Whether an MRMC or standalone study was done.
• The type of ground truth used.
• Training set details (sample size, ground truth establishment).

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about study design and results using only the information from the provided text. The document refers to a medical catheter, not an AI/software device that would typically undergo the kind of performance studies you're asking about (e.g., for sensitivity, specificity).

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The NexSite HD Hemodialysis Step Tip Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

The proposed device, the NexSite HD Hemodialysis Step Tip Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The proposed device is available in the following models below and has a Dacron cuff distal to the bifurcation hub.

Models:

NexSite HD Hemodialysis Step Tip Catheter for long term use (24cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (28cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (32cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (36cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (40cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (55cm)

A Dermal Ingrowth Support Collar (DISC), manufactured from polyurethane and Dacron®. and supplied with the Catheter, is implanted subcutaneously, and is intended to assist with the direction of the catheter. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, and Luer Caps) that are used to facilitate catheter placement.

The NexSite HD Hemodialysis Step Tip Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. It is a blood contact device with greater than 30 days of exposure.

The provided text describes a 510(k) premarket notification for a medical device, the NexSite™ HD Hemodialysis Step Tip Catheter. It outlines the device, its intended use, comparison to predicate devices, and performance data. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the format typically used for AI-driven software or diagnostic tests.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a combination of in vitro and in vivo testing. The acceptance criteria mentioned are general, pertaining to the requirements in applicable standards and specifications for the catheter's physical and functional properties, rather than performance metrics related to an algorithm's output.

Here's an attempt to answer your questions based on the provided text, recognizing that it's for a physical device, not an AI or diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria and reported numerical device performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC with associated thresholds). Instead, it states that the device "meets the requirements in the applicable standards and specifications."

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

• Sample Size: Not explicitly stated for specific tests. The document mentions "finished proposed NexSite™ HD Step Tip catheters" were used for comparative performance testing, and "in vivo implantation studies were also performed." The exact number of catheters or animal subjects is not provided.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing ("In vitro testing was performed on the NexSite HD Hemodialysis Step Tip Catheter"). The in vivo studies were also performed to demonstrate the device would perform as intended, but details on their nature (e.g., animal or human, retrospective or prospective) are lacking, though the context suggests animal models for a physical device before human use. Given it's a 510(k) for a physical device, no "data provenance" in the clinical data sense is typically required beyond the testing performed to demonstrate substantial equivalence.

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

This question is not applicable to the provided document. The "ground truth" for this medical device (a catheter) is based on engineering specifications, material properties, and biological compatibility standards, not on expert interpretations of data like in an AI diagnostic. The safety and effectiveness are evaluated against these standards and through performance testing, not through expert consensus on diagnostic labels.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described as would be for a diagnostic or AI system. The tests are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device for diagnostic interpretation. It is a physical medical device (catheter).

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters — Part 1: General requirements).
• Adherence to internal specifications derived from the design and intended use of the catheter, and comparison to legally marketed predicate devices.
• Results from in vitro and in vivo studies demonstrating functional performance and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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The NexSite HD, Hemodialysis Split Tip Catheter for long term use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

NexSite™ HD, Hemodialysis Split Tip Catheter for long term use

The provided document is a 510(k) Pre-Market Notification from the FDA regarding Marvao Medical Devices, Ltd.'s NexSite™ HD Hemodialysis Split Tip Catheter. It confirms substantial equivalence to a predicate device and provides indications for use.

However, the document does not contain any information about acceptance criteria, device performance testing results, sample sizes, ground truth establishment, or any studies (standalone, MRMC, or otherwise) that would prove the device meets specific acceptance criteria related to its performance.

The letter is primarily a regulatory communication confirming substantial equivalence for marketing purposes, not a detailed report of clinical or technical performance testing data.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them, as it is not present in the provided text.

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The NexSite™ HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm long are intended for femoral vein insertion.

The NexSite HD (55 cm), Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The NexSite HD, Hemodialysis Catheter for long term use is available in a range of lengths up to 55cm. The NexSite HD (55cm) Hemodialysis Catheter is manufactured from polyurethane and has a Dacron cuff distal to the bifurcation junction. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are provided with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

This document describes the premarket notification for the NexSite™ HD, Hemodialysis Catheter for long term use. The notification focuses on establishing substantial equivalence to previously marketed devices. No AI device or associated study is described within this document. Therefore, I cannot provide acceptance criteria and study details related to an AI device.

The document discusses performance data for the NexSite™ HD catheter, which includes:

• In vitro testing to assure reliable design and performance in accordance with ISO 10555-1:2004. This testing for the 55cm catheter included visual and dimensional analysis, priming volume, and catheter pressure vs. flow testing.
• In vivo implantation studies to demonstrate that the device would perform as intended.

The submission concludes that the NexSite™ HD (55cm) Hemodialysis Catheter for long term use is substantially equivalent to predicate products, with identical or substantially equivalent indications for use, methods of operation, design, and materials.

Based on the provided text, there is no mention of an AI device, acceptance criteria specifically for an AI device, or a study that evaluates the performance of an AI device.

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Indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The Modified NexSite HD Hemodialysis Catheter for long term use is intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane catheter has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to assist with the direction of the catheter. The catheter is provided in three catheter lengths (32cm, 36cm and 40cm). The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement.

The Modified NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The Modified NexSite HD Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Marvao Modified NexSite™ HD Hemodialysis Catheter:

Important Note: The provided text describes a Special 510(k) Premarket Notification. This type of submission is used when a manufacturer is making a modification to their own legally marketed device and the modification does not affect the device's fundamental scientific technology or principles of operation. As such, the testing approach is different from a de novo submission or a traditional 510(k) for a truly novel device. The focus here is on demonstrating that the modifications do not negatively impact performance compared to the predicate, and that the modified device remains substantially equivalent. Therefore, a "study" in the sense of a clinical trial or a deep algorithmic performance evaluation (like for AI/ML) is not present.

Acceptance Criteria and Reported Device Performance

Given the nature of the Special 510(k) for a modified hemodialysis catheter, the "acceptance criteria" are implied by the comparison testing to the predicate device and the adherence to relevant standards. The "study" largely consists of direct comparison testing of predefined characteristics.

Further Information (Based on provided text):

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

   • Sample Size: Not explicitly stated. The text mentions "proposed finished NexSite™ HD devices and commercial predicate devices (K121933)" were used for comparison testing. However, the number of units tested for visual, dimensional, and pressure/flow analysis is not provided.
   • Data Provenance: Not explicitly stated, but assumed to be from Marvao Medical Devices, Ltd. in Galway, Ireland, where the devices are manufactured. The testing is laboratory-based performance testing of the physical device. The data is prospective for this submission as the testing was done on the "proposed finished" modified devices.

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

   • This is not applicable to the type of device and submission. "Ground truth" in this context refers to engineering specifications and performance standards (like ISO 10555-1), not expert interpretation of medical images or outcomes.

3. Adjudication method for the test set:

   • Not applicable. Performance testing against engineering specifications does not typically involve expert adjudication in the same way clinical or image-based studies do.

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:

   • Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

5. 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.

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

   • The "ground truth" for this device's performance testing is its engineering specifications and international performance standards (e.g., ISO 10555-1) and the performance characteristics of the legally marketed predicate device (K121933).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "design" and "materials" from the predicate device serve as the foundational "knowledge base," but this isn't a training set in the AI sense.

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

   • Not applicable. See point 7. The underlying principles for hemodialysis catheters, materials science, and manufacturing processes, which were established for the predicate device, form the basis for the modified device.

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The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

The provided text describes a medical device, the NexSite™ HD Hemodialysis Catheter, and its 510(k) submission for regulatory clearance. It details the device's intended use, comparison to predicate devices, and the testing performed. However, it does not contain the kind of information typically associated with acceptance criteria and study results for an AI/device performance study as described in your request.

The document pertains to a physical medical device (catheter) and focuses on demonstrating substantial equivalence to already marketed devices through in vitro and in vivo (animal, not human clinical) testing, rather than a study evaluating the performance of an AI algorithm or digital medical device.

Therefore, many of the requested fields cannot be filled. I will fill in what information is available based on the provided text, and explicitly state when information is not present.

Acceptance Criteria and Study for NexSite™ HD Hemodialysis Catheter

The document describes the testing performed for the NexSite™ HD Hemodialysis Catheter to demonstrate its safety and effectiveness for substantial equivalence, rather than setting distinct acceptance criteria for an AI algorithm's performance. The "acceptance criteria" here are implied by meeting the requirements of applicable standards and demonstrating substantial equivalence to predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as numerical sample sizes for each test in the provided text. The document refers to "finished NexSite™ HD devices" and "commercial predicate devices" being tested.
• Data Provenance: The "in vivo implantation studies" suggest animal studies, not human data. The in vitro testing was performed on the device itself. Specific country of origin for the data is not mentioned beyond the manufacturing location (Ireland) and the regulatory submission to the FDA (USA). The studies were conducted specifically for the purpose of this 510(k) submission (prospective, in the context of device development and regulatory clearance).

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

• Not applicable/Not mentioned. This device does not involve expert-established ground truth in the context of diagnostic AI. The "ground truth" for its performance is determined by physical and biological testing against established standards and predicate device performance.

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

• Not applicable/Not mentioned. This concept is not relevant to the type of device testing described.

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

• Not applicable. This is not an AI or imaging device that would involve human readers.

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. The testing described is "standalone" in the sense that it evaluates the physical performance of the device without human interaction in the performance metrics, but it is not an algorithm.

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

• The "ground truth" for this device is based on engineering standards (ISO 10555-1:2004) for in vitro tests, and biological/physiological performance in animal models for in vivo tests, demonstrating the device performs "as intended" and is substantially equivalent to predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not applicable. No training set for an AI model.

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The NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated for long-term access to the Central Venous System. It is designed for administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300psi.

The NexSite 9Fr Dual Lumen Catheter is a long-term central venous catheter. The polyurethane Catheter is 55.5cm in length, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Port supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and Port are packaged with accessories that are used to facilitate Catheter and Port insertion.

The provided text describes the 510(k) summary for the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter.

Acceptance Criteria and Device Performance

The acceptance criteria for the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter were established based on ISO 10555-1 and ISO 10555-3 standards and by demonstrating substantial equivalence to legally marketed predicate devices.

Study Details:

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

   • The document primarily describes in vitro testing. No specific sample sizes for each test are provided, but the testing was conducted on samples of the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter.
   • Data Provenance: The testing was performed by Marvao Medical Devices, Ltd. in Ireland (GMIT Innovation in Business Centre, Dublin Road Galway, Ireland), indicating the data is from the manufacturer's internal testing program. The document does not explicitly state if it's retrospective or prospective for the in vitro tests but implies prospective testing conducted for the 510(k) submission.

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

   • This information is not applicable as the studies described are primarily in vitro performance tests (e.g., strength, leakage, radiopacity) against engineering standards (ISO 10555-1 and ISO 10555-3) rather than clinical studies requiring expert ground truth for patient outcomes or diagnoses. The "ground truth" for these tests would be the established benchmark values from the relevant ISO standards.

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

   • This information is not applicable as the studies are engineering performance tests, not clinical studies requiring human adjudication of outcomes or diagnoses.

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 comparative effectiveness study was not performed, nor is it relevant to this medical device submission. The device is a physical central venous catheter, not an AI-powered diagnostic or assistive tool.

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

   • No, a standalone algorithm performance study was not performed, nor is it relevant. The device is a physical central venous catheter.

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

   • For the in vitro tests, the "ground truth" or acceptance criteria are derived from international standards (ISO 10555-1 and ISO 10555-3) and comparison to the performance of legally marketed predicate devices.
   • For the in vivo testing, the "ground truth" was a demonstration that the "device would perform as intended," which implies meeting functional objectives in a living system (likely animal models, though not explicitly stated). No clinical outcomes data or pathology was used as "ground truth" for this submission as clinical studies were not deemed necessary.

7. The sample size for the training set:

   • This information is not applicable as this submission is for a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

   • This information is not applicable as this submission is for a physical medical device, not an AI/machine learning algorithm.

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