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The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing syringe. This 30 ATM Monarch™ is a combination of a 20 ml syringe, microcomputer, back-lit LCD, threaded device with an integral pressure bar, a flexible high pressure extension tube and a plunger assembly with a lock and release button. The 30 ATM Monarch™ is capable of generating and monitoring pressures over a range of -1 to +30 atmospheres (-7 to + 441 PSI). The pressure is increased by turning the syringe plunger handle. The pressure increases by approximately 1 atmosphere with each 360° turn of the syringe plunger handle.

The provided text is a 510(k) Safety and Effectiveness Summary for a medical device called the "30 ATM Monarch Syringe," a balloon inflation and fluid dispensing syringe. This document is from 2001 and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed studies with acceptance criteria, sample sizes, or ground truth validation as would be typical for more complex AI/software as a medical device (SaMD) clearances today.

Therefore, much of the requested information regarding acceptance criteria for device performance, expert-established ground truth, sample sizes for test and training sets, and MRMC studies is not present in the provided document, as it outlines a different type of regulatory submission from nearly two decades ago.

However, I can extract the information that is available and indicate when information is not provided.

Acceptance Criteria and Device Performance

The concept of specific "acceptance criteria" and "reported device performance" as might be seen for a software algorithm is not explicitly detailed in this 510(k) for a mechanical device. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices (Monarch™ Inflation Syringe K943597 and Universal Fluid Dispensing Syringe K973230) by comparing materials, intended use, and operational capabilities. The key performance aspect mentioned is the ability to generate and maintain pressures.

Study Details (Information Not Fully Provided for AI/SaMD Context)

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

   • Not provided. This document does not describe a clinical study with a test set in the manner of an AI/SaMD product. The submission is based on demonstrating substantial equivalence through comparison with predicate devices and possibly bench testing, but details of such testing (sample sizes, data provenance) are not included in this summary.

2. 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/Not provided. This is a hardware device (syringe), not a diagnostic algorithm where expert-established ground truth is typically used for performance evaluation.

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

   • Not applicable/Not provided. This concept relates to the establishment of ground truth for diagnostic decisions, which is not relevant to this device's regulatory submission based on the provided text.

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, not done. This is a medical device (syringe), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

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

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

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

   • Not applicable/Not provided in this context. For a syringe, the "ground truth" would relate to its physical performance metrics (e.g., pressure accuracy, volume delivery accuracy, material integrity) measured through engineering tests, rather than clinical diagnostic ground truth. These test details are not in the summary.

7. The sample size for the training set:

   • Not applicable/Not provided. This device does not have a "training set" in the context of an AI/machine learning algorithm.

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

   • Not applicable/Not provided. See the previous point.

Summary of Non-Applicability/Missing Information:

The provided document is a 510(k) summary from 2001 for a mechanical medical device (a syringe). This type of submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. It does not contain the detailed study methodologies, sample sizes, ground truth establishment, or AI-specific performance metrics that are requested in the prompt, as these are more characteristic of regulatory submissions for advanced software or AI/Machine Learning as a Medical Device (SaMD) products, especially in recent years.

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