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The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.

The CADD® High-Volume Administration Sets with FlowStop is a modification to the current CADD® High-Volume Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The FlowStop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the "CLIP" must be removed to activate the FlowStop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the FlowStop in the open position. The Add-on Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the FlowStop.

The acceptance criteria and study proving the device meets them are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not explicitly stated as a separate "test set" in the context of typical AI/diagnostic device studies. The document refers to "in-vitro testing" for functional performance and "biocompatibility testing" for materials. The sample sizes for these specific tests are not provided.
• Data Provenance: The studies were in-vitro (laboratory-based) and focused on the device's functional mechanics and material properties. There is no mention of human data, patient data, country of origin, or retrospective/prospective nature as would be relevant for clinical performance studies.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not applicable. The ground truth for this device (a medical administration set) is based on engineering specifications for function and established standards for biocompatibility. It does not involve expert interpretation of medical images or other diagnostic data that would require a panel of medical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (Test Set):

• Adjudication Method: Not applicable. As the evaluation relies on direct functional and material testing against predefined engineering specifications and standards, there is no need for expert adjudication of results.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of complex medical data (e.g., radiologists reading images with or without AI assistance). The CADD® High-Volume Administration Set with FlowStop is an administration set, not a diagnostic device involving human readers or interpretation.
• Effect Size of Human Readers: Not applicable.

6. Standalone Performance Study:

• Standalone Study: Yes, a standalone study (algorithm-only performance) was conducted, though framed differently for a physical medical device. The "functional testing" and "biocompatibility testing" represent the standalone performance of the device itself (its physical mechanics and material properties) without human intervention in the primary function being tested (i.e., whether the FlowStop occludes, or whether the materials are biocompatible). The studies assessed how the device performed against its intended specifications.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth was based on:
  • Engineering Specifications: For the functional performance of the FlowStop (e.g., its ability to occlude the tube under defined conditions).
  • Biocompatibility Standards: Established standards and protocols for assessing the safety of materials in medical devices that come into contact with human tissue or fluids.

8. Sample Size for Training Set:

• Sample Size: Not applicable. This device is a physical medical administration set, not an AI/machine learning algorithm that requires a "training set" of data. The design and manufacturing process would involve internal testing and validation, but not in the context of an AI training set.

9. How Ground Truth for Training Set was Established:

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

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TruFlow™ Long-term Dual-lumen Hemodialysis Catheters are indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis.

TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

The catheters are long-term 12.5 French dual lumen straight polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. The catheters include a preattached in-growth cuff. Catheters will be offered in multi-unit packaging and with accessory components.

This submission is for a medical device (TruFlow™ Long-term 12.5 French Dual-lumen Dialysis Catheters), not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable.

The approval for this device is based on substantial equivalence to a legally marketed predicate device (TruFlow™ Long-term 14.5 French Dual-lumen Dialysis Catheters). The review relies on functional and biocompatibility testing, not on the performance metrics typically associated with AI/ML systems.

Here's a breakdown of the information that is relevant to this submission, framed as closely as possible to your request, but acknowledging the difference in device type:

Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided document:

• Sample sized used for the test set and the data provenance: Not relevant for a physical medical device. Functional and biocompatibility tests are conducted on device samples, not "data sets."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" in the context of AI/ML is not applicable here. Device specifications and performance are typically verified against engineering standards and material science expertise.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for a non-AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a physical device is its adherence to predefined engineering specifications, material properties, and safety standards, as verified through functional and biocompatibility testing. In this case, comparison to the predicate device's established performance also serves as a benchmark.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (as presented in the document):

The device's acceptance is based on two primary studies:

1. Functional Testing (In-vitro):

   • Description: Conducted on the TruFlow™ Dialysis Catheters.
   • Purpose: To demonstrate that the catheters perform according to their design specifications. Although specific metrics (e.g., flow rates, pressure resistance, durability) are not provided in this summary, such tests would have been performed and documented in a more detailed report.
   • Conclusion: The testing indicated that the TruFlow™ Dialysis Catheters function according to specifications.

2. Biocompatibility Testing:

   • Description: Conducted on the catheters.
   • Purpose: To ensure that the device materials are safe for human contact and do not elicit adverse biological responses.
   • Conclusion: The materials used in the device are biocompatible.

Overall Conclusion from the studies (as per the document):
The results of the testing (functional and biocompatibility) indicated that the TruFlow™ Dialysis Catheters function according to specifications, and the materials are biocompatible. Therefore, the product is considered acceptable for human use, and crucially, clinical studies were not deemed necessary due to the device's similarity in materials, design, and function to the predicate device. This approach is common for devices seeking 510(k) clearance based on substantial equivalence.

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TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute hemodialysis and apheresis.

TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

TruFlow™ Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

The catheters are long- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.

The provided document describes the 510(k) premarket notification for the TruFlow™ Dialysis Catheters. The assessment for this device relied on functional testing and comparison to predicate devices, rather than clinical studies or an AI-driven approach.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

• Sample Size: Not explicitly stated. The document mentions "In-vitro testing" and "Biocompatibility testing" but does not quantify the number of devices or data points involved in these tests.
• Data Provenance: The studies were in-vitro (laboratory testing) and biocompatibility testing. This means the data was generated in a controlled laboratory environment and not from human subjects. The country of origin for the data is not specified other than the applicant's location (St. Paul, MN, USA). The studies were likely prospective in nature within the lab.

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

• Not applicable. The ground truth for functional and biocompatibility testing is typically based on established engineering standards and laboratory protocols, not expert consensus in the way a clinical study would be.

3. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or outcomes, not for functional and biocompatibility laboratory 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 MRMC comparative effectiveness study was done. This is not an AI device. The study focused on the functional and biocompatibility performance of a physical medical device (dialysis catheter) compared to predicate devices.

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

• No standalone algorithm performance study was done. This is not an AI device.

6. The type of ground truth used:

• Functional Testing: The ground truth would be based on established engineering specifications and performance standards for dialysis catheters (e.g., flow rates, pressure resistance, structural integrity).
• Biocompatibility Testing: The ground truth would be based on international standards for biocompatibility of medical devices (e.g., ISO 10993 series), which define acceptable biological responses to materials in contact with the body.

7. The sample size for the training set:

• Not applicable. This device is a physical medical catheter, not an AI model requiring a training set.

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

• Not applicable for the same reason as above.

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The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.

The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump.

The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.

The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.

The provided text is for a 510(k) premarket notification for the Deltec Cozmo™ Insulin Infusion Pump and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and detailed study performance as would be seen in a clinical trial or a novel device submission. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating functional similarity and safety through various types of testing, but it does not present a table of quantitative acceptance criteria for device performance (e.g., accuracy of insulin delivery within specific tolerances) and then report measured performance against those criteria.

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

• Test Set Description: The document refers to "Functional Testing" which included "software validation, verification of software controlled programming functions, and software related to proper pump operation" for the pump and the PC Communications System, along with "In-vitro testing and biocompatibility testing" for the 3-ml Cartridge.
• Sample Size: The specific sample sizes for these tests are not disclosed.
• Data Provenance: The tests are described as "in-vitro testing" and "functional testing," implying they were conducted in a lab environment. The document does not mention human subject testing or data from specific countries of origin in this context. It's retrospective in the sense that the testing was completed before the submission.

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

This information is not provided. Given the nature of functional and in-vitro testing for an insulin pump, the "ground truth" would typically be established based on engineering specifications, regulatory standards, and established scientific principles for measuring device performance (e.g., fluid delivery accuracy, software functionality, material biocompatibility). These evaluations would be performed by qualified engineers, testers, and scientists, but the number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where independent reviewers assess outcomes. For functional and in-vitro testing, the assessment typically involves comparing test results against pre-defined specifications and pass/fail criteria, which is a different process than multi-expert adjudication.

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

• MRMC Study: No MRMC comparative effectiveness study was conducted or described.
• AI vs. Human Assistance: This device is an insulin infusion pump and associated software, not an AI-powered diagnostic or assistive technology for human 'readers'. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.

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

• Standalone Performance: The core components being tested are the insulin pump's mechanical and software functions, and the PC communication system's software functionality. These are inherently "standalone" in the sense that the device's accuracy and function are tested independently of a human user's direct intervention in that specific test setting (though the ultimate use involves human interaction).
• Details: The document states "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified," and "In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge." These represent standalone evaluations of the device components. However, specific performance metrics from these standalone tests are not provided.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for the various tests mentioned would be based on:

• Engineering Specifications/Standards: For functional testing (e.g., insulin delivery rates, alarm accuracy).
• Software Requirements Specifications: For software validation and verification.
• Biocompatibility Standards: For the cartridge (e.g., ISO 10993 series).
• Material Specifications: For the cartridge components.

The document does not refer to expert consensus from healthcare professionals, pathology, or outcomes data to establish ground truth for these tests. Clinical studies were "not deemed necessary."

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a mechanical/software medical device, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning to develop its functionality. Its design and operation are based on explicit programming and engineering principles rather than learned patterns from data.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this device. The functionality of the pump and its software is designed and validated against engineering specifications and regulatory requirements.

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The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.

The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.

The provided document describes the GRIPPER PLUS™ Needle, a medical device designed to protect against needlestick injuries. Below is an analysis of its acceptance criteria and the study used to demonstrate compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GRIPPER PLUS™ Needle are primarily functional, focusing on the successful activation of the needle-stick protection feature and the biocompatibility of its components.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state a numerical sample size for the "simulated use test." Instead, it mentions that the device was "evaluated by health care professionals during a simulated use test."
• Data Provenance: The testing was "in-vitro testing and simulated use testing." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards. The study was retrospective in the sense that the testing was performed to support the 510(k) submission after the device's design.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: The document states the device was "evaluated by health care professionals." It does not specify the exact number of professionals involved.
• Qualifications of Experts: The qualifications are broadly stated as "health care professionals." Specific expertise (e.g., years of experience, specific medical field) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The assessment appears to be based on the direct observation and feedback from the "health care professionals" during the simulated use test, where the protection feature "successfully activated during all attempts."

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

No multi-reader multi-case (MRMC) comparative effectiveness study was performed or cited. The document does not mention any comparison of human readers' performance with and without AI assistance, as AI is not a component of this device.

6. Standalone Performance Study

Yes, a standalone study was performed. The "functional testing" and "simulated use testing" evaluated the device's inherent performance. The key finding from this standalone testing was that the device's protection feature "successfully activated during all attempts."

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was primarily based on:

• Functional performance standards: The device's ability to activate its safety mechanism and protect the needle tip.
• Expert evaluation/observation: Healthcare professionals' assessment of the device's acceptability in simulated use.
• Biocompatibility testing: Laboratory results confirming material safety.

8. Sample Size for the Training Set

This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

9. How Ground Truth for Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

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A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.

The provided 510(k) summary (K994216) describes the "Plastic Port Implantable Venous Access Systems" and evaluates their safety and effectiveness through in-vitro functional testing and biocompatibility testing. It explicitly states that clinical studies were not deemed necessary due to the device's similarity to existing, legally marketed predicate devices. Therefore, the device performance is primarily assessed against functional specifications and material properties rather than clinical outcomes or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro functional tests. It generally refers to "In-vitro testing" and "Biocompatibility testing."
• Data Provenance: The data provenance is from "In-vitro testing" and refers to laboratory tests, not human or animal subjects. As it's in-vitro testing performed by the manufacturer, it's considered retrospective in the sense that the test results would be analyzed after the experiments were conducted. There is no country of origin specified for the testing data itself, assumed to be internal to the manufacturer (SIMS Deltec, Inc. in St. Paul, MN, USA).

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

• Not applicable. This study primarily involved in-vitro functional testing and biocompatibility testing, not diagnostic or clinical accuracy evaluations requiring expert interpretation of ground truth. The "ground truth" for these tests would be established by engineering specifications and established material testing standards, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this study focused on in-vitro functional and biocompatibility testing, which typically relies on objective measurements against predefined specifications rather than expert adjudication of interpretations.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems." Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone performance study was done in the form of in-vitro functional testing and biocompatibility testing. This assessment was purely on the device's physical and material properties against specifications without any human-in-the-loop interaction for performance evaluation.

7. Type of Ground Truth Used

• Engineering specifications and material science standards. For functional testing (catheter to port connection, septum puncture, system leakage, clearance), the ground truth is defined by the device's design specifications and industry standards for performance. For biocompatibility testing, the ground truth is established by recognized biocompatibility standards and material properties deemed safe for human contact.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm requiring a training set. The performance evaluation was based on traditional in-vitro testing.

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

• Not applicable. As mentioned above, there is no training set as this is not an AI/ML device.

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A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

The provided text describes a 510(k) submission for the PORT-A-CATH® II Trans-Arterial Percutaneous System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials with specific acceptance criteria as would be the case for novel devices.

Therefore, the requested information on acceptance criteria and a study proving those criteria are met for this specific device is largely not applicable in the traditional sense of a performance study. Instead, the submission argues that the device's similarity to existing, legally marketed devices implies its safety and effectiveness.

Here's how to address the request based on the provided text:

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

Since no specific performance acceptance criteria or direct performance data for the PORT-A-CATH® II Trans-Arterial Percutaneous System is reported for this 510(k), we can infer the "acceptance criteria" were related to demonstrating substantial equivalence.

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

• Sample size for the test set: Not applicable. No clinical or functional performance test set was used for this device as part of the 510(k) submission. The submission relied on the established safety and effectiveness of the predicate devices and biocompatibility testing of the materials.
• Data provenance: Not applicable.

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. No ground truth was established by experts for a test set for this device in this submission, as no new performance study was conducted.

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

• Not applicable. No test set requiring adjudication was used.

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

• Not applicable. This is a medical device, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable for performance evaluation in this 510(k). The "ground truth" for the submission's approval was essentially the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. No training set was used for this device in this submission.

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

• Not applicable. No training set was used.

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