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The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.

The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip. The barrel contains a fixed male luer connector, which is compatible with female luer hubs.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Merit Syringe, based on the given requirements:

The document does not contain information about a device that uses AI, or a device that specifically needs human readers to interpret its output. Thus, questions 2, 3, 4, 5, 6, 7, 8, and 9 from your prompt are not applicable to the provided text. The device described, the "Merit Syringe," is a mechanical medical device (a piston syringe) and its evaluation focuses on physical performance, material compatibility, and sterilization.

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

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 is a medical device (syringe) clearance based on bench testing to established standards and comparison to a predicate device, not on clinical study data involving patients or AI performance on a test set.

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. Ground truth for a diagnostic device/AI is not relevant for a mechanical syringe. Performance is measured against engineering standards.

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

Not applicable. No expert adjudication is described for a syringe's performance against engineering 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 device is not an AI-assisted diagnostic tool.

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

Not applicable. There is no algorithm for a mechanical syringe.

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

Not applicable. The "ground truth" for this device's performance is compliance with recognized international and FDA standards for syringes (e.g., ISO 7886-1, ISO 594-2) and biocompatibility standards (ISO 10993-1).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

Not applicable. As above, no training set or ground truth in the context of AI/ML is relevant for this device.

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The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.

The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, plunger, and O-ring seal. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs. The syringe uses a fluorocarbon based non-silicone lubricant.

This document describes the premarket notification (510(k)) for the Merit Syringe, which is a piston syringe used to inject or withdraw fluids from the body. Given the nature of this submission (a 510(k) for a Class II medical device like a syringe), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to performance bench testing against recognized consensus standards and biocompatibility testing, rather than studies involving human readers or AI algorithms.

Here's a breakdown based on the provided text:

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

The document doesn't provide a direct table format for each acceptance criterion with a pass/fail. Instead, it states that the device "complies with the 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 general categories of acceptance criteria and the overall reported performance are:

Specific Biocompatibility Tests Performed:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Hemolysis
• Bacterial Endotoxins (AAMI/ANSI ST72:2011/(R) 2016)
• Pyrogen Test (United States Pharmacopeia 40, National Formulary 35, )

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

The document does not specify the exact sample sizes used for each test (e.g., number of syringes tested for flow rate, number of samples for biocompatibility). The testing is described generally as "a battery of tests" and "Performance testing... was completed against FDA recognized consensus standards." For device performance (like the Merit Syringe), the "test set" would typically refer to the samples of the manufactured device subjected to the physical and chemical tests, not a dataset of patient images or clinical data.

Data provenance: Not explicitly stated, as this refers to a medical device's physical/chemical performance, not clinical data collection. It's implied the testing was performed by "Merit Medical Systems, Inc." directly or by a contracted lab.

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

This question is not applicable to a 510(k) submission for a piston syringe or the type of performance testing described. "Ground truth" and "experts" in this context typically refer to clinical validation studies, particularly for AI/imaging devices, where expert radiologists/clinicians establish diagnostic labels. For a syringe, the "ground truth" is established by the specifications of the recognized consensus standards (e.g., ISO 7886-1 defines specific dimensions, pressures, and flow rates that the device must meet).

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

Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting medical images or patient outcomes, not for bench testing of a physical device. The "adjudication" in this context would be the pass/fail criteria defined by the consensus standards themselves, and the testing results are objectively measured.

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. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms used in conjunction with human interpretation. This submission is for a physical medical device (syringe) and does not involve imaging or AI.

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

Not applicable. This device is not an algorithm. "Standalone performance" would refer to the bench testing of the syringe against the specified standards, as described in section 1.

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

For this type of device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international consensus standards (e.g., ISO 7886-1, ISO 594-2). These standards stipulate acceptable ranges for attributes like dimensional accuracy, fluid leakage, plunger force, and luer connection integrity. Biocompatibility testing refers to established chemical and biological test methods detailed in standards like ISO 10993.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, for the same reasons as #8.

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The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.

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

The provided document describes the acceptance criteria and the study conducted for the Merit Syringe, which is a medical device used to inject and withdraw fluids from the body.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2. The performance data for biocompatibility is also mentioned.

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

The document does not explicitly state the sample sizes used for each specific test described under ISO 7886-1, ISO 594-2, or the biocompatibility tests. It broadly mentions "A battery of tests was performed." Nor does it specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective tests conducted on manufactured units of the Merit Syringe.

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 information is not provided. The compliance is based on meeting the established acceptance criteria of recognized consensus standards (ISO standards) and FDA guidance, rather than ground truth established by human experts in the context of diagnostic interpretation.

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

Not applicable. The tests are based on objective measurements and compliance with specified standards, not on human interpretation requiring 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

Not applicable. This device is a piston syringe, 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 device is a physical medical device (syringe), not an algorithm. The performance evaluation is based on bench testing and material compatibility, which is analogous to "standalone" performance for a physical device.

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

The "ground truth" for the device's performance is defined by the acceptance criteria specified within the referenced international consensus standards and FDA guidance documents (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series). Compliance means the device's physical and biological properties meet these pre-defined, objectively measurable standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical device undergoing performance and biocompatibility testing, not a machine learning algorithm.

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

Not applicable. There is no training set mentioned for this type of device submission.

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The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.

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

The provided text describes the performance testing of the Merit Syringe, a medical device. Here's a breakdown of the requested information based on the text:

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

Reported Device Performance Summary: The device "met the standards' established acceptance criteria for the device". The text explicitly states, "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."

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

The document does not explicitly state the sample size used for the test set for performance or biocompatibility testing. It only refers to a "battery of tests" being performed. Data provenance (country of origin, retrospective/prospective) is also not specified.

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 information is not applicable to this type of device and study. The testing described involves objective, standardized measurements against recognized consensus standards for physical, chemical, and biological properties of a piston syringe, not subjective interpretation by human experts.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in clinical trials or diagnostic studies. The performance testing of the Merit Syringe involves objective measurements against predefined 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the evaluation of diagnostic algorithms or AI tools, often in imaging, which is not relevant to the Merit Syringe.

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

A standalone performance evaluation was done, but it refers to the performance of the syringe itself, not an algorithm. The testing described (bench testing, biocompatibility, sterilization, packaging) assesses the device's inherent properties and adherence to standards without human intervention influencing the device's function.

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

The "ground truth" for the performance testing of the Merit Syringe was established by FDA recognized consensus standards (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series, ASTM standards, USP). These standards define objective, measurable criteria for the various aspects of the syringe's function and safety.

8. The sample size for the training set

This information is not applicable. The Merit Syringe is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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