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For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.

The 200mL Syringe for Stellant Injectors are syringes / kits intended for use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes. Each configuration is listed below in the "Models"section and provided sterile. To further define the device, the kits may include (depending on package configuration) extension lines, fill tubes, prime tubes, and spikes. The extension lines are used to connect the svringe to a patient's IV. The prime tube is used for catching fluid while purging air from the extension line. The fill tubes and spikes are used to connect the syringe to contrast media or saline containers for filling. The Fascia (installed on the surface of the injector case and through which the ram/ram tip moves) and the RamTip (connected to the injector ram and to which the syringe is connected), used in adapting the Medrad* Stellant* Injector for use with the Coeur 200mL Syringe for Stellant Injectors are not sterile, and after installation onto the injector, remain installed as long as the Coeur 200mL Syringe for Stellant Injectors is used with the injector. (Cleaning instructions for the Fascia and Ram Tip are provided in the IFU.)

Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.

The provided text is a 510(k) summary for the Coeur 200mL Syringe for Stellant Injectors. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about an AI/ML powered device, a multi-reader multi-case (MRMC) comparative effectiveness study, or details about ground truth establishment as would be relevant for such a device.

Here's an analysis based on the information provided, focusing on what can be extracted and noting what cannot, given the nature of the device (a syringe, not an AI system):

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria and device performance in a formal table format as requested, nor does it define acceptance criteria in numerical targets. Instead, it lists the types of nonclinical tests performed and states that the product conforms to various standards or functions as intended. Since this is a mechanical device, performance is typically assessed against engineering specifications and international standards rather than AI-specific metrics like AUC, sensitivity, or specificity.

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

The document does not specify exact sample sizes for each nonclinical test (e.g., how many syringes were pressure tested). It refers to "inspection of the product," "evaluation of product," and "functional testing" without providing the number of units tested. This is standard for a 510(k) for a mechanical device, where testing often involves a statistically determined sample or a representative sample.

Data provenance is not applicable here as the "performance data" refers to in-house laboratory testing of the physical syringe components, not clinical data from patients. There's no country of origin for "data" in the sense of patient records, nor is it retrospective or prospective.

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

Not applicable. This device is a mechanical syringe, not an AI/ML device relying on expert-annotated ground truth. "Ground truth" in this context would likely refer to engineering specifications and measurements performed by qualified technicians.

4. Adjudication method for the test set

Not applicable. There is no adjudicated "ground truth" for this type of mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those using AI, to compare human performance with and without AI assistance. This document is for a medical syringe.

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

Not applicable in the AI/ML context. For a syringe, "ground truth" corresponds to established engineering specifications, international standards (ISO 594-2, ISO 7886-2), and the physical properties of the materials. Performance is verified against these objective, predetermined values.

8. The sample size for the training set

Not applicable. There is no training set for a mechanical syringe.

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

Not applicable. There is no training set or associated ground truth for a mechanical syringe.

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For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.

The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension YLine and Fill Spikes
ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Fill Spikes
iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Contrast and Saline Spikes
v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension YLine and Fill Tube
vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube

This document is a 510(k) summary for the MR Syringe Dual Pack for Solaris Injectors (K161471), a medical device. It does not describe an AI or algorithm-driven device, but rather a physical syringe product. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the information extracted from the document that aligns with your request, with "NA" (Not Applicable) for categories that don't fit this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices. The document implies that "the product," "syringes and Extension Lines," and individual units were subjected to these tests without specifying the quantity.
• Data Provenance: Not specified, but this is a physical medical device. The testing would have been conducted by the manufacturer (Coeur, Inc.) in a lab setting. It is not patient or case data.

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

• NA, as this is not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The ground truth for physical properties (e.g., pressure resistance, dimensions) is based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

• NA, no adjudication method is mentioned as there are no expert readings or interpretations to adjudicate for this type of device.

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

• NA, this is not an AI device.

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

• NA, this is not an AI device.

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

• The "ground truth" for this device's performance is based on engineering specifications, material properties, and established international standards (e.g., ISO 594-2:1998) for physical medical devices.

8. The sample size for the training set

• NA, this is a physical medical device, not an AI algorithm requiring a training set.

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

• NA, this is a physical medical device, not an AI algorithm.

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The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)

The provided document is a 510(k) summary for a medical device called "330psi Extension Y-Line with Dual Check Valve". This document describes the device, its intended use, and the testing conducted to establish substantial equivalence to a predicate device. It specifically states that no clinical tests were submitted.

Therefore, it is not possible to provide a detailed response to most of the questions as they relate to performance studies, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, which are typically associated with software as a medical device (SaMD) or AI/ML-driven devices. This document describes a physical medical device (an extension line) and its acceptance criteria are primarily based on non-clinical engineering and biocompatibility tests.

However, I can extract the acceptance criteria and summarize the study type to the best of what's available in the document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on non-clinical laboratory testing. The document lists the tests conducted and their respective outcomes (Pass/Fail).

Studies Proving Device Meets Acceptance Criteria:

The studies conducted were nonclinical laboratory tests to verify the physical and biological characteristics of the device.

1. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but standard engineering and biocompatibility testing typically uses a representative sample size of manufactured devices. The data provenance is from internal testing conducted by Coeur, Inc. (e.g., test dates provided for biocompatibility).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For engineering and biocompatibility tests, "ground truth" is typically defined by standardized test methods and established scientific principles, not expert consensus on individual cases.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Test results are typically objective (e.g., pressure readings, pass/fail for biological reactions) and do not require expert adjudication in the way clinical image interpretation might.
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, not an AI/ML diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For dimensional and functional tests, the ground truth is against engineering specifications and industry standards. For biocompatibility, the ground truth is against ISO 10993 cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility standards.
7. The sample size for the training set: Not applicable. This is a physical medical device; there is no "training set" in the context of an algorithm.
8. How the ground truth for the training set was established: Not applicable.

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For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.

The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
i. 125mL Syringe and Fill Tube
ii. 125mL Syringe with Coiled Line and Spike
iii. 2 125mL Syringes with 2 Spikes
iv. 125mL Syringe and Coiled Extension Line
v. 2 125mL Syringes with Extension Y-Line and 2 Spikes

The provided text is a 510(k) summary for the Coeur 125mL CT Syringe, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on engineering and performance characteristics of a medical device, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, the information requested about AI performance, multi-reader multi-case studies, ground truth establishment for AI, and similar metrics are not applicable to this document.

However, I can extract the relevant acceptance criteria and study information provided for the device itself.

Acceptance Criteria and Reported Device Performance

Note: The document only indicates that these tests were performed and the conclusions drawn were that the device is "substantially equivalent." Specific quantitative performance values are not typically included in these summary documents, but rather reported in full test reports submitted to the FDA.

The following information is not applicable to this 510(k) submission as it pertains to a physical medical device (syringe) and not an AI or diagnostic algorithm:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

This document outlines the engineering and material equivalence of a syringe to a previously approved device, not the performance of a diagnostic or AI-powered system.

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For use with the LF OptiStar Injector for injection of contrast media or saline.

The MR Syringe is a pack that includes two 60ml MR Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes. The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike. Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.

The MR Syringe Dual Pack is intended for use with the LF OptiStar Injector for injection of contrast media or saline. The device was deemed substantially equivalent to predicate devices based on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, functional, age verification, biocompatibility). It references "testing used to verify substantial equivalence" and "inspection of the product" for visual and dimensional. For functional tests, it mentions "the syringe, spike and Y-Line were tested." Biocompatibility tests were conducted on "the kit."

The data provenance is from non-clinical tests conducted by or for Coeur, Inc. The dates provided for the biocompatibility tests (e.g., March-April 2014) suggest these were prospective tests specifically performed for this 510(k) submission. There is no indication of country of origin for the data, but the submitter is based in Lebanon, TN, USA.

3. 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 study involved non-clinical performance and biocompatibility testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth establishment. The "ground truth" for these tests would be the established scientific and engineering standards (e.g., ISO 594, ISO 10993) and the objective measurements confirming compliance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication processes typical of diagnostic studies. The results of the non-clinical tests are objective measurements against predefined acceptance criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The submission relates to a medical device (syringe kit) and does not involve an AI component or any human-in-the-loop performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The submission relates to a medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests was established by predetermined objective standards and specifications. This includes:

• Engineering specifications and visual standards for visual and dimensional evaluations.
• Mechanical and fluid dynamics principles for functional verification (pressure, flow rate).
• Established industry standards such as ISO 594 for luer compliance and ISO 10993 for biocompatibility, specific parts of which define the acceptable limits and methodologies for tests like cytotoxicity, sensitization, systemic toxicity, and hemocompatibility.

8. The sample size for the training set:
This information is not applicable. This is a submission for a medical device (syringe kit) and does not involve an AI algorithm with a training set.

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for an AI algorithm.

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For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes

The proposed device is a Front Load Adapterfor Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.

Here's a breakdown of the acceptance criteria and the study details for the Coeur, Inc. Front Load Adapter for CT Injector, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated. The text only mentions "Such testing was conducted for the design for use on the Liebel-Flarsheim Optivantage DH Injectors." This implies a physical, non-clinical test, not a data-driven test set.

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 was established through functional performance testing against pre-defined engineering criteria, not expert review of data.

3. Adjudication method for the test set: Not applicable. This was a functional performance test, not a review requiring adjudication.

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 done. The device is an adapter for a CT injector, not an AI or imaging analysis device.

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. However, the functional performance testing of the adapter itself can be considered "standalone" in the sense that its performance was evaluated intrinsically without a human operator's variable input being the primary focus of the test itself (though a human would have performed the installation/operation for the test).

6. The type of ground truth used: Functional performance against predetermined engineering and design requirements for installation, loading, filling, and injection, and ensuring no negative impact on the power injector's function.

7. The sample size for the training set: Not applicable. This device is not an AI or machine learning product that requires a training set.

8. How the ground truth for the training set was established: Not applicable. No training set was used.

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to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Disposable, 330psi Extension Lines

This document is a 510(k) summary for a medical device (Disposable 330psi Extension Lines) and does not contain the type of acceptance criteria and study information requested. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• Acceptance criteria or reported device performance in a table format.
• Sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts, nor adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size or ground truth establishment for a training set.

This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) premarket notification, not in the FDA's substantial equivalence determination letter.

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to facilitate manipulation of a guide wire during a vascular procedure

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Coeur, Inc. Disposable Torque Device." It's a regulatory approval document and does not contain the information requested in your prompt.

The prompt asks for details about a study proving a device meets acceptance criteria, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This FDA letter simply states that the device is "substantially equivalent" to legally marketed predicate devices and is approved for marketing. It does not provide any of the study design, acceptance criteria, or performance data that would be found in a clinical or validation study report.

Therefore, I cannot extract the requested information from the provided text.

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to maintain a fluid-tight seal around interventional and diagnostic devices while allowing control/manipulation of such devices during use

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "Disposable Hemostatic Y-Connectors." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt.

The letter explicitly states that it is a review of the premarket notification and a determination of substantial equivalence to previously marketed predicate devices. It does not include the actual study data or the specific performance metrics used to make that determination.

Therefore, I cannot provide the requested information from this document. The information you are looking for would typically be found in the 510(k) submission itself, not in the clearance letter.

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for injecting contrast media and saline, for angiography

Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for "Disposable Angiographic Syringes for Nemoto Injectors," which primarily addresses regulatory approval based on substantial equivalence to predicate devices, not performance studies with detailed acceptance criteria.

Therefore, I cannot extract the requested information, which includes:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for the test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size and ground truth establishment for the training set

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