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The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.

The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.

The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.

The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.

The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.

HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.

The provided text describes the 510(k) summary for the AquaFlate Pre-Filled Sterile Water Syringe 10mL. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for a new and novel AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, specific study design for AI/ML performance, ground truth establishment, expert involvement, and statistical comparisons is not applicable to this type of regulatory submission.

However, I can extract the information relevant to the performance data and equivalence claims made for this product.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of AI/ML performance metrics, the "acceptance criteria" here refer to conformance with established industry standards and regulations for medical devices of this type. The reported device performance is its successful adherence to these standards.

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

• Sample Size: The document does not specify exact sample sizes for each of the testing protocols (e.g., how many syringes were tested for sterility, or how many materials were tested for biocompatibility). It broadly states that "performance testing conducted per HR Pharmaceuticals' protocols" and that validation was performed. These are not "test sets" in the AI/ML context, but rather samples used for engineering and quality control validation.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer and third-party labs according to recognized consensus standards.

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

• Not Applicable. This device is a pre-filled sterile water syringe, not an AI/ML diagnostic or therapeutic device. Ground truth, in the AI/ML sense, is not established by human experts for basic device functionality and safety testing like biocompatibility or sterility. Conformance to standards is the "ground truth" here.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring adjudication. Test results (e.g., pass/fail for a sterility test) are objective and determined by the methodology of the standard.

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 is not an AI/ML device. No human reader studies or comparative effectiveness studies with AI assistance were performed or are relevant.

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

• Not Applicable. This is not an AI/ML device. No algorithm-only performance testing was conducted.

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

• The "ground truth" for this device's performance, safety, and effectiveness is established by conformance to recognized consensus standards and regulations (e.g., ISO for connectors, USP for sterility, ISO for biocompatibility, ASTM/ISTA for packaging). These standards define acceptable limits and methodologies.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

The proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.

The document describes the acceptance criteria and performance data for EcoVue® Sterile and Non-Sterile Ultrasound Gels, which are coupling media for diagnostic ultrasound.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

* Note: These values for the predicate devices are reported in the comparison table, but the document states they were obtained from performance testing conducted per HR Pharmaceuticals' protocols, implying they are the subject device's performance measured against the predicate, rather than the predicate's reported performance from its own submission. The "Proposed Device" column directly lists the acceptance criteria for EcoVue®. While the table presents them side-by-side, the "Acceptance Criteria" for the subject device are explicitly listed in the first column, indicating what the new device must achieve.

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 for the performance bench testing (Sound Velocity, Acoustic Impedance, etc.), biocompatibility testing, sterilization validation, or packaging validation. It refers to these tests as "internal methods," "USP ," "USP ," "USP ," "ASTM D445-17a," and various ISO/AAMI/ASTM standards. These standards typically specify minimum sample sizes or allow for statistically sound justifications, but the specific numbers are not provided in this summary.

The data provenance is not specified regarding country of origin; the testing appears to be conducted by or for the device manufacturer, HR Pharmaceuticals, Inc., as indicated by "Values obtained from performance testing conducted per HR Pharmaceuticals' protocols" (Page 7). All testing described is prospective, as it was conducted to support the 510(k) submission for the EcoVue® gels.

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 (ultrasound gel). The tests conducted are primarily physical, chemical, and biological characterizations according to established standards, not diagnostic performance evaluations requiring expert interpretation.

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

This information is not applicable for this type of device or study. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved.

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. The device is a medical accessory (ultrasound coupling gel), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not applicable. The device is a physical product (ultrasound gel), not an algorithm or software. Therefore, standalone algorithm performance was not assessed.

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

The "ground truth" for the performance data of the ultrasound gel is based on:

• Bench Test Standards: Industry-recognized physical and chemical measurement standards (e.g., ASTM D445 – 17a, USP , USP , USP ) and internal methods.
• Biocompatibility Standards: International standards for biological evaluation of medical devices (ISO 10993-1, 10993-5, 10993-10).
• Sterilization Standards: International standards for sterilization validation (ISO 11137 series, ISO 11737 series).
• Packaging Validation Standards: International and national standards for packaging of sterile medical devices and accelerated aging (ISO 11607-1, ASTM F88, ASTM F1886, ASTM F2096, ASTM F1980).

The "ground truth" is adherence to these established scientific and regulatory standards.

8. The sample size for the training set:

This is not applicable. There is no training set mentioned, as this device does not involve machine learning or AI models that require training data.

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

This is not applicable, as there is no training set for this device.

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