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The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.

The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.

The provided text describes the MEDRAD Twist & Go High Pressure Connector Tubing and its clearance through the FDA 510(k) process. This document is a summary for a medical device (tubing for contrast media delivery) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a comprehensive clinical study to prove performance against specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic algorithm.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, type of ground truth for learning algorithms) are not applicable to this type of device submission as it is not an AI/ML-based algorithm or a diagnostic tool requiring such rigorous evaluation against clinical endpoints.

Instead, the "acceptance criteria" here are largely defined by equivalence to the predicate device and adherence to bench and laboratory testing standards relevant for a fluid delivery tube.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a direct "acceptance criteria" table with numerical targets in the same way an AI/ML study would. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device (MEDRAD High Pressure Connecting Tube K810924) and passing various bench and laboratory tests.

The comparison of features table (page 2) serves as the primary evidence for demonstrating functional equivalence.

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

• Sample Size: Not specified in terms of a "test set" for a diagnostic algorithm. The testing described is bench and laboratory testing on device prototypes or production samples. The number of samples for each specific test (e.g., pressure rating, leak testing, material property verification) is not provided in this summary.
• Data Provenance: The data is generated from bench and laboratory testing conducted by MEDRAD, Inc. (Bayer Medical Care, Inc.) in Indianola, PA, USA. There is no mention of country of origin of clinical data, as this is a device component, not a clinical diagnostic. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.

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

• Not applicable. This submission is for a medical device (connector tubing) and does not involve AI/ML or a diagnostic test where expert-established ground truth would be required. The "ground truth" for a connector tube's performance relies on engineering specifications and physical test results (e.g., pressure resistance, flow rates, biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI/ML device or a diagnostic requiring a reader study.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" refers to the physical and functional performance of the tubing itself when subjected to specified conditions (e.g., pressure, flow). The summary states "System level testing with a MEDRAD automated injector" which implies testing the device in its intended use environment, but this is not an algorithm's standalone performance.

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

• The "ground truth" for this device type is primarily based on engineering specifications, material science standards, and performance test results. For example, pressure rating is verified against a specified mechanical test standard, and biocompatibility is confirmed against ISO standards. There is no pathology or outcomes data mentioned for this type of device component in a 510(k) summary.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. Device design and development would involve various iterations and testing, but not in the sense of training a machine learning model.

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

• Not applicable. See point 8.

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for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe

The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coeur, Inc. Disposable Transfer Sets:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the bond testing, leak testing, or sterilization product adoption study.
The studies appear to be retrospective in nature, done by Coeur, Inc. to verify the performance of their device prior to seeking regulatory approval.
The data provenance is Coeur, Inc., within the USA (Washington, NC, and Lebanon, TN are listed company addresses).

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

The document does not mention the use of experts or a ground truth established by experts for these non-clinical tests. The tests appear to be objective measurements of physical performance.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of expert-led adjudication for these non-clinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (transfer set), and the evaluation focuses on its physical and functional performance, not on clinical diagnostic or treatment efficacy that would involve human readers or AI.

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

This is not applicable. The device is a physical medical accessory, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be:

• Engineering specifications/standards for bond and leak testing (implied by "performs acceptably").
• Microbiological standards (Surgical Aseptic Level (SAL) of 10⁻⁶) for sterilization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "product adoption study" may refer to testing on a set of actual production units, but it's not a "training set" in the context of AI.

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

Not applicable as there is no training set for an AI algorithm.

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The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.

The provided document for the Hospira, Inc. LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets (K063239) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use, and states that it is substantially equivalent to predicate devices.

However, this document does not contain the specific acceptance criteria or the study that proves the device meets those criteria.

510(k) summaries typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance study results with specific acceptance criteria in the public summary. While the summary states that "The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set will meet the functional described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicates," it does not explicitly list the acceptance criteria or the specific data from a study that demonstrates this.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This information would typically be found in a more detailed technical report or in the full 510(k) submission, which is not publicly available in this format. The provided document is a high-level summary for regulatory clearance purposes.

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The Medtronic MiniMed Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.

The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion.

The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.

The provided text is a 510(k) summary for a medical device (Medtronic MiniMed Leapfrog II Infusion Set). This type of document is for premarket notification and focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than detailed performance studies or AI algorithm validation. Therefore, most of the information requested in your prompt (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, expert qualifications, etc.) is not present in this document.

The document primarily describes the device, its intended use, and states that its technological features are comparable to predicate devices, with a specific modification to the attachment mechanism that "does not affect the safety or effectiveness of the device." This implies that the device is expected to perform similarly to its predicates, but no specific performance metrics or studies are directly described to prove this in the context of the requested details.

Here's what can be extracted and what cannot:

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

• Cannot be provided. This document does not specify quantitative acceptance criteria or report particular performance metrics beyond stating that a design modification "does not affect the safety or effectiveness."

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

• Cannot be provided. The document does not describe any specific testing involving a "test set" of data or samples in the way an AI algorithm would be evaluated.

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)

• Cannot be provided. This is not relevant to a 510(k) for an infusion set, which is a physical medical device, not an AI diagnostic tool.

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

• Cannot be provided. 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

• Cannot be provided. See point 3. This is entirely irrelevant to the type of device described.

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

• Cannot be provided. See point 3. This device is not an algorithm.

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

• Cannot be provided. See point 3.

8. The sample size for the training set

• Cannot be provided. See point 3.

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

• Cannot be provided. See point 3.

Summary of available information relevant to "proving device meets acceptance criteria," albeit in a limited sense for this type of document:

The primary "proof" in a 510(k) process is demonstrating substantial equivalence to legally marketed predicate devices. The document states:

• Predicate Devices: Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®), and Avail Medical Products Inc., Sof-Site™ Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9.
• Technological Comparison: "The modified device and the lawfully marketed predicate devices contain similar materials of construction. Features of the modified device are comparable to those of the predicate devices with the exception of the modified attachment mechanism that offers multiple alignments and locking sites for the attachment to the site connection. This modification does not affect the safety or effectiveness of the device."

The "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate devices. The "study" (or rather, the justification presented in the 510(k)) is this comparison, asserting that the new device's modification does not negatively impact its safety or effectiveness relative to the predicates. Specific test results or performance data are not typically included in the public 510(k) summary, although they would be part of the full submission for FDA review.

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The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.

This document is a 510(k) summary for the E-Z-EM Empower Transfer Set, seeking clearance for a medical device. It does not contain information about studies or acceptance criteria for device performance in the way a clinical or AI performance study would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory compliance, device description, and comparison to a predicate device, not on analytical or clinical performance studies with specific acceptance criteria and detailed study designs.

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The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.

The provided document is a 510(k) premarket notification for a medical device modification, specifically the Medrad Swabbable Valve Transfer Set (SVTS). This type of document is a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than a study proving performance against acceptance criteria in the way a clinical trial for an AI/ML device would.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable to this submission. The document focuses on comparing the modified device to a predicate device and demonstrating substantial equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the design specifications and safety requirements that the modified device must meet and be "substantially equivalent" to in comparison with the predicate device. The performance is reported in terms of meeting these specifications and maintaining existing safety standards.

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

Not applicable in the context of this 510(k) submission. This is a device modification submission, not a study evaluating an AI/ML diagnostic or prognostic tool. The "test set" would typically refer to physical units of the device tested against engineering specifications and biocompatibility standards, not a dataset for an algorithm. Clinical trials or large-scale human data collection are generally not required for these types of Class II device modifications unless significant new risks are introduced.

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

Not applicable. There is no "ground truth" established by experts in the sense of AI/ML or clinical diagnosis. The "truth" here is engineering compliance and biocompatibility. The regulatory body (FDA) reviews the submission.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" of device performance in the sense of expert review for ambiguous cases. Device compliance is determined through testing against predetermined specifications and standards (e.g., ISO for biocompatibility).

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 physical medical device (a transfer set), not an AI/ML diagnostic or assistive tool.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device modification is compliance with established engineering specifications, safety standards (e.g., ISO/AAMI for biocompatibility), and demonstration that the modified design maintains the intended function without raising new questions of safety or effectiveness when compared to the predicate device. This is based on design verification and validation testing results, not clinical outcomes or expert consensus on diagnostic images.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.

The provided text describes a 510(k) premarket notification for a medical device called the "Medrad Transfer Set." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics in the way one might expect for a diagnostic AI device.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, ground truth types, training set details) are not applicable or not present in this type of regulatory submission for a simple medical device.

The study described here is essentially a comparison of features and principles of operation between the proposed device and a predicate device (Merit Contrast Management System K961794) to demonstrate substantial equivalence.

Here's a breakdown based on the information provided:

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

Since this is a substantial equivalence submission for a simple transfer set, the "acceptance criteria" are not reported as quantitative performance metrics. Instead, the acceptance criteria are met by demonstrating that the proposed device is substantially equivalent to a predicate device in terms of intended use, principle of operation, materials, and other characteristics. The "reported device performance" is essentially the comparison of features.

Key Difference/Consideration for Equivalence:
The primary difference highlighted is that the predicate device included a separate disposable single-patient use tubing component for direct patient connection, whereas the Medrad Transfer Set does not. The Medrad set must be removed from the syringe before the syringe can be connected to the patient, thus preventing contact with patient fluid. This difference is addressed in the submission to ensure it does not raise new questions of safety or effectiveness.

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

Not Applicable. This submission does not involve a "test set" in the sense of a dataset for performance evaluation of an AI algorithm. It's a review of device characteristics and intended use against a predicate.

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. There is no "ground truth" establishment in this type of submission. The comparison is based on the technical specifications and intended use of the devices.

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

Not Applicable. No test set or expert adjudication is 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 device is a mechanical transfer set, not an AI or diagnostic imaging device. No MRMC study was conducted.

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

Not Applicable. This is a hardware device, not an algorithm.

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

Not Applicable. No ground truth for performance evaluation is established or used for this type of device. The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. No training set is involved as this is not an AI algorithm.

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

Not Applicable. No training set and no ground truth for a training set are involved.

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The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.

The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device at the proximal end to a medication reservoir, such as the MiniMed reservoir, model 103, and at the distal end to an infusion set such as the Polyfin infusion set, model 106. The Polyfin extension set may also be used to administer drugs labeled for intravenous administration from an external pump by attaching the distal end to a "Y-site" or "Heparin lock."

This document is a 510(k) summary for a medical device (Polyfin Infusion Extension Set Model 128). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training set.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.

The document is purely a regulatory submission describing a device and its perceived equivalence to a predicate device, focusing on statements about safety and effectiveness without providing the underlying study data you are asking for.

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