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The Certa Dose™ Pediatric Midazolam 5 mg/mL intramuscular (IM) Syringe is intended for the delivery of midazolam 5 mg/mL for use in pediatric (non-neonatal) patients up to 30kg in weight.

The Certa Dose™ Pediatric Midazolam 5 mg/mL IM Syringe is comprised of (A) a 510(k)-cleared Monoject 1mL Tuberculin Syringe with a regular tip, non-luer lock (K850190), and (B) a plastic overlay which provides barrel markings. The items on the overlay include (1) a zero line, (2) 0.01 mL unit graduation markings, (3) secondary graduation markings at 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.9, 1.0 mL, (4) color bars, and (5) the name of the drug for which the syringe is indicated, midazolam 5 mg/mL.

The provided document is a 510(k) summary for the Certa Dose™ Pediatric Midazolam 5 mg/mL IM Syringe. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria and reported device performance in the format typically used for evaluating the performance of AI/ML devices.

The document focuses on demonstrating substantial equivalence based on:

• Same intended use as the predicate device (delivery of fluid).
• Similar technological characteristics to the predicate, with differences not adversely affecting safety or effectiveness or raising new questions. These differences include drug and device compatibility, color zones and drug-specific barrel markings, and the application of barrel markings via a plastic overlay.

Instead of a typical AI/ML device performance study with acceptance criteria, the document refers to several types of performance testing:

• Human factors testing: This was primarily supported by a previously submitted human factors study for a reference device (Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe, K160589), which included comparative assessments with a standard (non-color coded) 1 mL syringe. The rationale is that critical tasks and design features are highly similar between the epinephrine and midazolam syringes. No specific acceptance criteria or reported performance metrics from this human factors study are detailed in this document, nor is an effect size for human readers with and without AI mentioned (as this is not an AI/ML device in the traditional sense).
• Drug-device compatibility studies: Confirmed that short contact times do not adversely impact drug quality.
• Syringe accuracy testing: Verified that markings are applied correctly and remain accurate.
• Break loose and glide force testing: Assured adequacy for the intended use.
• Biocompatibility testing: Performed per ISO10993-1:2009/(R) 2013, including cytotoxicity and hemocompatibility tests.
• Sterilization validation: Conforms to BS EN ISO 11137-2:2015 and ISO 11137-2:2015.
• Shelf-life testing: Based on the predicate's shelf-life and one-year real-time stability testing for the plastic overlays using the reference epinephrine syringe.

Since the device is a drug-specific syringe with color-coded barrel markings and not an AI/ML diagnostic or predictive system, many of the requested elements for an AI/ML study (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this 510(k) summary.

Therefore, it is not possible to provide a table of acceptance criteria and reported device performance as requested for an AI/ML study. The document serves to establish substantial equivalence for a physical medical device.

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The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is intended for healthcare professionals to deliver epinephrine 1 mg/mL via intramuscular or subcutaneous injection for pediatric patients.

The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is comprised of (A) a 3/10mL Syringe with an attached 29 Gauge x ½ inch Needle, and (B) a plastic overlay which provides barrel markings. The items on the overlay include (1) a zero line, (2) 0.01 mL unit graduation markings, (3) secondary graduation markings at 0, 0.05, 0.10, 0.15, 0.20, 0.25, 0.30 mL, (4) color bars, and (5) the name of the drug for which the syringe is indicated, epinephrine 1 mg/mL.

The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is a pre-filled syringe designed for healthcare professionals to deliver epinephrine to pediatric patients.

Acceptance Criteria and Reported Device Performance

Study Information (Based on the Provided Text)

The provided text focuses on demonstrating substantial equivalence to predicate devices and describes the rationale for design choices and conducted tests rather than a standalone clinical study with detailed statistical results. Therefore, many of the requested details about a "study" in the traditional sense of a diagnostic device's performance are not explicitly available. However, based on the information provided, we can infer the following:

• 1. Sample size used for the test set and the data provenance: This information is not provided in the document for any of the described tests. The studies mentioned (drug-device compatibility, syringe accuracy, biocompatibility, human factors) are engineering and laboratory tests, not clinical studies with patient data.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided as these were not studies involving expert consensus on patient data.
• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided as these were not studies involving expert consensus on patient data.
• 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: An MRMC comparative effectiveness study was not performed. The device is a syringe and does not involve AI or human readers for interpretation. The human factors study would assess usability, not diagnostic accuracy improvement.
• 5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The concept of "standalone performance" typically applies to AI algorithms. This device is a physical syringe, so this question is not applicable. The performance tests focus on the physical and material integrity and accuracy of the syringe itself.
• 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Drug-Device Compatibility: The ground truth would be the expected chemical stability and quality of epinephrine.
  • Syringe Accuracy: The ground truth would be established by metrological standards for volume measurement.
  • Biocompatibility: The ground truth is defined by the ISO10993-1 standard.
  • Human Factors Study: The "ground truth" would be the identified usability issues and user errors during tasks performed by healthcare professionals, evaluated against predefined success criteria.
• 7. The sample size for the training set: This information is not applicable as this is not an AI/machine learning device.
• 8. How the ground truth for the training set was established: This information is not applicable as this is not an AI/machine learning device.

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