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The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.

The modified HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The modified HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure. Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.

The provided text describes modifications to the Davol HydroFlex™ HD System, a hysteroscopic distention and irrigation system. The 510(k) submission aims to demonstrate substantial equivalence to previous versions and predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of devices or test runs) used for the performance testing. It refers to "testing was performed to evaluate the effect of the modifications on performance."

The data provenance is for a medical device manufactured by Davol Inc. in Cranston, RI, USA. The testing appears to be prospective testing conducted specifically for this 510(k) submission to demonstrate the performance of the modified device in comparison to its predicates.

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

This type of information is not applicable to this submission. The device is a fluid management system, and its performance is evaluated through engineering and functional testing against specified parameters (e.g., pressure, flow rate). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes in the context of this device's performance claims.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication. Performance is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The HydroFlex HD System is an accessory device that provides mechanical functions (distention and irrigation).

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

This concept is not applicable to this device. The HydroFlex HD System is a physical device, not an algorithm. Its performance is inherent to its design and functionality, which is what the testing evaluated.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing in this submission is established through objective engineering measurements (e.g., pressure gauges, flow meters) against pre-defined specifications and regulatory guidance. For biocompatibility, the ground truth is adherence to established standards and guidelines (e.g., FDA General Program Memorandum #G9S-1).

8. The Sample Size for the Training Set

This is not applicable. The device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.

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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Hydroflex is intended to be used for taking intra-oral impressions of a person's dentition.

Hydroflex is a dental silicone impression material used for making intra-oral impressions. The resulting impression is poured in dental stone or plaster to form a hard replica of the oral tissues. This product will be available in five viscosities: Regular, Injection, Monophase, Heavy Body and Heavy Body Hard.

This document, K913343 refers to a 510(k) submission for a dental impression material named "Hydroflex". The submission uses a "substantial equivalence" claim, comparing the new device against existing predicate devices (Exaflex and Examix). This type of submission relies on demonstrating that the new device has similar performance characteristics to a legally marketed device, rather than conducting extensive clinical efficacy studies typically required for novel devices.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a pass/fail form but are implied by the comparison to predicate devices, which are assumed to meet acceptable performance standards. The "reported device performance" are the physical properties measured for the Hydroflex product line and the predicate devices. The study demonstrates that the Hydroflex varieties (Injection, Regular, Monophase, Heavy Body, Heavy Body Hard) have physical properties that are comparable to or within the range of their respective predicate devices (Exaflex and Examix).

Below is a consolidated table with the properties of Hydroflex and its predicate devices:

Table of Performance Characteristics - Hydroflex vs. Predicate Devices (Based on ISO 4823)

Study Proving Device Meets Acceptance Criteria:

The study presented is a comparative analysis of the physical properties of the "Hydroflex" dental impression material and its predicate devices ("Exaflex" and "Examix"), both manufactured by GC Corporation. The comparison is based on ISO 4823 standards, which outlines requirements for elastomeric dental impression materials. The data provided demonstrates that Hydroflex possesses similar material characteristics to the predicate devices across various parameters, including working time, setting time, consistency, strain in compression, recovery from deformation, linear dimensional change, detail reproduction, and compatibility with gypsum. This similarity in performance under standardized tests is the basis for the claim of substantial equivalence.

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

• Sample Size: The document does not specify the sample size for each test of physical properties (e.g., how many measurements were taken for working time, setting time, etc.). This kind of detail is typically found in the full test report, not usually summarized in a 510(k) abstract.
• Data Provenance: The data stems from laboratory testing of the physical properties of the dental impression materials. The country of origin for the data is implied to be from the manufacturer (GC America Inc. for Hydroflex, and GC Corporation, Tokyo, Japan for Exaflex/Examix). The data is prospective in the sense that these tests were conducted on the materials as part of the submission process to demonstrate their properties.

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

N/A. This is not applicable in this context. The "ground truth" for material properties is established through standardized physical and chemical testing methods (ISO 4823), not clinical expert consensus. The reported values are direct measurements from these tests.

4. Adjudication Method for the Test Set

N/A. This is not applicable as the study involves objective physical measurements based on ISO standards, not subjective assessments requiring expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. This submission concerns a dental material's physical properties, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This concept applies to AI/ML algorithms where the algorithm's performance is evaluated independently. This submission is for a physical dental impression material, not a software algorithm. The "standalone" performance here refers to the intrinsic physical properties of the material as measured in a lab.

7. The Type of Ground Truth Used

The ground truth used consists of objective physical measurements obtained through standardized laboratory tests (specifically, tests outlined in ISO 4823 for elastomeric dental impression materials). These standards define procedures for measuring characteristics such as working time, setting time, consistency, strain in compression, recovery from deformation, linear dimensional change, detail reproduction, and compatibility with gypsum. The values obtained from these tests serve as the "ground truth" for the material's properties.

8. The Sample Size for the Training Set

N/A. This concept is for AI/ML models. For this medical device (dental impression material), there isn't a "training set" in the machine learning sense. The "development" or "formulation" of the material would involve iterative testing and refinement, but this isn't a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

N/A. As mentioned above, there is no training set as this is not an AI/ML device. The "ground truth" for material development would be the desired performance characteristics based on clinical needs and existing industry standards, which are then verified through controlled laboratory testing.

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