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The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.

The Merit Coronary Control Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector or male luer rotating adaptor, which are compatible with ISO 594-2 compliant female luer hubs.

This document is a 510(k) premarket notification for the Merit Coronary Control Syringe. It focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized consensus standards for medical devices. Therefore, the information provided does not specifically describe a study that proves the device meets acceptance criteria through clinical or AI-based performance metrics. Instead, it relies on bench testing as per established standards for mechanical and material properties.

However, I can extract the acceptance criteria and the "reported device performance" (which in this context refers to the demonstration of compliance with those criteria through testing) from the provided text.

Here's an interpretation of the request using the available information:

Acceptance Criteria and Device Performance (as demonstrated by compliance with standards):

The document states that the Merit Coronary Control Syringe complies with FDA recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."

The acceptance criteria are implicitly defined by the requirements of these standards and other listed tests. The "reported device performance" is that the device met these criteria.

Now, addressing the other specific points:

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

• Sample Size: The document does not specify the exact sample sizes used for each of the performance bench tests. It broadly states that "A battery of tests was performed."
• Data Provenance: The tests are "Performance Bench Testing" conducted on the physical device, indicating this is laboratory testing. The provenance is internal testing by Merit Medical Systems, Inc., to demonstrate compliance with international standards. There is no mention of country of origin for data in the sense of patient data, as this is a physical device rather than an AI/software device. The product is manufactured by Merit Medical Systems, Inc. (South Jordan, Utah, USA).

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

• This device is a hardware product (coronary control syringe) that undergoes mechanical, chemical, and biological performance testing, not a diagnostic AI device requiring expert ground truth for interpretation of images or clinical outcomes.
• Therefore, there are no "experts" in the context of clinical interpretation establishing ground truth for a test set in this document. Ground truth for these tests is based on the quantifiable, measurable criteria defined by the ISO, ASTM, and AAMI standards themselves (e.g., specific thresholds for leakage, force, or biological reactivity). The "experts" would be the engineers and scientists conducting the tests and verifying compliance with the standard specifications.

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

• Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The tests are objective and based on measurable parameters defined by the consensus 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 document pertains to a physical medical device (a syringe), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to the device's function.

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 (expert consensus, pathology, outcomes data, etc.):

• The ground truth for this device's performance testing is based on predefined, measurable acceptance criteria specified by internationally recognized consensus standards (ISO, ASTM, AAMI). These standards set quantitative limits for performance attributes (e.g., "freedom from air and liquid leakage past piston," specific force for unscrewing torque, cytotoxicity levels). Compliance is determined by objective measurement against these established benchmarks.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI that would require a "training set." The focus is on manufacturing control and adherence to established engineering and material science standards.

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

• Not applicable, as there is no training set for this type of device submission.

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The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.

The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use.
The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type.
The volume of two type control syringes that to be offered in 10ml, 12ml.
The sunmed™ Control Syringes are available with rotating male luer and fixed male luer.
The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.

This document is a 510(k) premarket notification for the Sunmed™ Control Syringes. It describes the device and claims substantial equivalence to predicate devices, but it does not describe a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document discusses "acceptance criteria" only in a very general sense, referring to standard non-clinical tests for medical devices like biocompatibility, sterility, and bench testing, to demonstrate substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or software performance evaluation.

Therefore, I cannot provide the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in the provided text.

Here's a breakdown of why I cannot fulfill the request based on the provided text:

• No AI or Algorithm: The device is a "Sunmed™ Control Syringes," a physical medical device intended to inject contrast media or saline. This is not an AI or algorithm-based device.
• No "Device Performance" in the AI sense: The document assesses physical characteristics (pressure rating, clarity, sterility, etc.) against predicate devices, not AI performance metrics like sensitivity, specificity, or AUC.
• No Study Design for AI: There's no mention of training sets, test sets, ground truth, expert adjudication, or MRMC studies, all of which are relevant to AI device evaluations.

The document's purpose is to demonstrate substantial equivalence for a physical device, not to evaluate an AI's diagnostic or predictive capabilities.

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The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.

The NMI Control Syringes are manual control, piston type syringes consisting of a clear, calibrated, hollow barrel accommodating volumes of either 7 mL or 8 mL. As a manual control syringe, each configuration includes bilateral, external finger rings located on the proximal thumb ring, located on the piston, in tandem with the external finger rings, allows for single handed movement to create aspiration and/or expulsion of fluids.

The provided document is a 510(k) premarket notification for a medical device called the "NMI Control Syringe." It details the device's intended use, its similarities to a predicate device, and the performance testing conducted. However, the document does not describe a study involving human readers, AI, or the establishment of ground truth by clinical experts, nor does it provide an effect size for human performance improvement with AI assistance. The device is a physical syringe, not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories are not applicable to this document. I will fill in the applicable information and state when a category is not applicable based only on the provided text.

Here's an analysis based on the provided text:

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

The document lists "key tests" that were performed and states that the "successful results... demonstrate that the proposed NM1 Control Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, the exact quantitative acceptance criteria and the specific reported performance measurements for each test are not detailed in the provided text. The table only lists the types of tests performed.

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 Test Set: Not specified in the provided document. The document refers to "testing" and "successful results" but does not quantify the number of devices tested.
• Data Provenance: Not specified in the provided document. The data would likely be from laboratory testing of the physical syringe components.

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. This device is a physical syringe, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in a clinical context. The "truth" for this device's performance would be objective measurements against engineering and safety standards.

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

• Not Applicable. This concept applies to studies where human interpreters or algorithms identify findings that require a consensus or adjudication process. For a physical device like a syringe, performance is measured against objective standards, not subject to adjudication in this manner.

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. The device is a physical NMI Control Syringe, not an AI software. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or described.

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

• Not Applicable. The device is a physical NMI Control Syringe, not an algorithm.

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

• Not Applicable. The "ground truth" for the NMI Control Syringe's performance would be derived from engineering and material standards (e.g., ISO standards, FDA guidance) and objective measurements of physical properties (e.g., freedom from leakage, dimensions, forces, material compatibility). It does not involve clinical "ground truth" like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. The device is a physical syringe, not a machine learning model. There is no concept of a "training set" for the type of testing described.

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

• Not Applicable. As there is no training set for a physical device like this syringe, establishing ground truth for it is irrelevant.

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An angiographic syringe is a device that consists of a syringe which is used to inject contrast material into the heart, great vessels, and coronary arteries during angiographic or CT procedures.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for the "Medline Angiographic Control Syringe," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and indications for use but does not include any performance study data or acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.

Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The documents are a regulatory approval letter (K972655) for "Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205" and an "Indications For Use" statement.

Specifically, the text is missing:

1. A table of acceptance criteria and reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and data provenance: No details about a test set or its characteristics are provided.
3. Number of experts and their qualifications for ground truth: No mention of experts or ground truth establishment for a test set.
4. Adjudication method: Not discussed in the provided documents.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information on such a study.
6. Standalone performance study: No details about an algorithm-only performance study.
7. Type of ground truth used: Not specified, as no study details are given.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The documents focus solely on the regulatory approval process based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria.

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The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Volume Control Delivery Syringe. The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.

This looks like a 510(k) summary for a medical device submitted in 1997. The level of detail you're requesting regarding acceptance criteria, study design, and ground truth is typical for more recent AI/ML device submissions. Based on the provided text, the device is a "Volume Control Delivery Syringe," which is a relatively simple, non-AI medical device used for inflation during angioplasty.

Therefore, many of the questions you've asked are not applicable to this type of device and the information provided. I will answer what I can based on the text.

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

The document mentions "required release specifications" and "product design specifications" but does not provide a table or specific quantitative acceptance criteria or reported performance for the device (e.g., flow rate, pressure accuracy, volume accuracy). It states:

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

This information is not provided in the document. For a non-AI device like this syringe, testing would typically involve manufacturing quality control and lab-based performance testing rather than a clinical "test set" in the context of clinical data.

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

This is not applicable as there is no "ground truth" establishment in the context of clinical data or expert evaluation for this type of device. The quality control process involves meeting defined product specifications.

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

This is not applicable. There is no "test set" and no adjudication method 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

This is not applicable. This is not an AI device, and therefore, no MRMC study or AI assistance comparison was conducted.

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

This is not applicable. This is not an AI device.

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

This is not applicable. The "ground truth" for this device's performance would be its adherence to its engineering and design specifications as verified through physical and visual testing during manufacturing and quality control.

8. The sample size for the training set

This is not applicable. This is not an AI device; therefore, there is no "training set."

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

This is not applicable. This is not an AI device.

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Output:
This device is intended for hand injection of contrast media during angiography.

The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.

This document provides a Summary of Safety and Effectiveness for SDM Control Syringes, which are high-pressure syringes intended for hand injection of contrast media during angiography. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it focuses on establishing substantial equivalence to currently marketed devices based on intended use, materials, and design.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document. The document primarily makes the following claims:

• Classification: Class II device; no performance standards established yet.
• Product Description: Visibly clear high-strength polycarbonate barrels, elastomeric piston, polymeric plunger with palm plate. Two models with different internal volume reservoirs. Supplied single-packaged and sterile.
• Intended Use: Hand injection of contrast media during angiography.
• Rationale for Substantial Equivalence: Similar to predicate devices (Medex, Namic, Becton Dickinson, Merit) in intended use, materials, and design. No significant changes or modifications from predicates.
• Biocompatibility: Materials are same type and grade as substantially equivalent devices. Testing performed per ISO Standard 10993, Part I, shows the device to be biocompatible for an externally communicating device (blood path indirect).

The document concludes that, based on these factors, the SDM Control Syringes are substantially equivalent in safety and effectiveness to other high-pressure syringes currently approved for use. None of the detailed study information you requested (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) is present in this regulatory submission summary.

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