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The Non-sterile Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive 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 gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The proposed device, Non-Sterile Ultrasound Transmission Gels, are non- irritating, 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 improve the acoustic transmission of sound waves to create the ultrasound image.

The subject device is available in the below sizes: 20g/bag,250ml/bottle, 1000ml/bottle,2000ml/bottle,5000ml/bottle,250g/bottle,1000g/bottle,2000 g/bottle,5000g/bottle.

This document is a 510(k) Premarket Notification for a non-sterile ultrasound transmission gel, not an AI/ML medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth establishment for AI/ML performance is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363) through physical, chemical, and performance testing for the ultrasound gel itself.

Here's a breakdown of the relevant information present in the document that aligns with the spirit of your request regarding product validation, but adapted for a non-AI/ML medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML context)

The document presents performance testing results for the Non-Sterile Ultrasound Transmission Gels. The "Acceptance Criteria" here are the specified ranges or conditions that the gel must meet for various physical and chemical properties.

2. Sample Size and Data Provenance (Non-AI/ML context)

• Sample Size: The document does not specify the exact number of samples used for each bench test. These are typical material property tests, and standard laboratory practices would involve a sufficient number of samples to ensure reproducibility and statistical significance, though the detailed protocol and exact sample counts are not included in this summary.
• Data Provenance: The tests were conducted internally by Hony Medical Co., Ltd. in China. The nature of the study is "bench testing" or "non-clinical testing," implying experimental evaluation in a laboratory setting rather than retrospective or prospective clinical data.

3. Number of Experts and Qualifications (Not Applicable for this type of device)

This concept is not relevant for the validation of an ultrasound transmission gel's physical and chemical properties. The "experts" would be the laboratory personnel conducting and analyzing the bench tests, qualified in chemical and physical analysis.

4. Adjudication Method (Not Applicable)

This is a concept for reconciling disagreements in human annotations for ground truth in AI/ML studies, which is not applicable to bench testing of a physical product.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study (Not Applicable)

This study type is used to assess the impact of AI on human reader performance, which is not relevant for an ultrasound transmission gel. The document explicitly states: "No clinical study is included in this submission."

6. Standalone Performance (Non-AI/ML context)

The performance data provided in Table 1 ("Performance testing summary - Bench") represents the "standalone" performance of the Non-Sterile Ultrasound Transmission Gels as a product, independent of human interaction in an AI context. The device's performance is measured against its own specifications, not as an algorithm assisting a human.

7. Type of Ground Truth (Non-AI/ML context)

The "ground truth" for this device's performance is established by objective laboratory measurements of its physical and chemical properties, compared against predefined specifications based on industry standards (e.g., ASTM F1980 for shelf life, ISO 10993-1 for biocompatibility) and the requirements for effective ultrasound transmission.

8. Sample Size for Training Set (Not Applicable)

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

9. How Ground Truth for Training Set was Established (Not Applicable)

As there is no training set for this traditional medical device, this question is not applicable.

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Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for body surface, endocavity and intra-operative diagnostic ultrasound. This may help with easier cleaning and disinfection of the probe.

Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.

The subject device is furnished in sterile condition, for single use patient/procedure use, disposable.

As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

This document is a 510(k) summary for a Transducer Probe Cover. It primarily discusses the equivalence of the subject device to a predicate device, focusing on an expanded indication for use. Therefore, the information provided does not describe a study to prove the device meets acceptance criteria in the typical sense of performance metrics for an AI/algorithm-based device.

Instead, the document asserts substantial equivalence based on the device's characteristics and the performance of its predicate, along with additional biocompatibility testing for the expanded use.

Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria for performance as would be expected for an AI/algorithm. Instead, it compares the subject device's technological characteristics to predicate devices to establish substantial equivalence. The "performance" here refers to the device's characteristics fulfilling its intended purpose (acting as a barrier and not impairing ultrasound imaging).

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

This information is not applicable and not provided. This submission is for a physical medical device (transducer probe cover), not an AI/algorithm. Therefore, there isn't a "test set" in the context of data for an algorithm. The evaluation is based on non-clinical testing of the physical properties and biological compatibility of the device.

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 and not provided. As this is a physical device, not an AI, there is no "ground truth" establishment by experts for a test set of data.

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

This information is not applicable and not provided. As this is a physical device, not an AI, there is no "adjudication method" for a test set of data.

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 information is not applicable and not provided, as this is a physical device and not an AI or AI-assisted diagnostic tool.

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

This information is not applicable and not provided, as this is a physical device and not an AI/algorithm.

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

This information is not applicable and not provided. For this physical device, "ground truth" would refer to established standards for material properties, sterilization efficacy, biocompatibility, and barrier function, which are evaluated through standardized non-clinical tests (e.g., ASTM F1671-13 for microbial barrier, ISO 10993 for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "training set" in the data science context.

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

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "ground truth" establishment for a "training set."

Summary of the Study and Acceptance Criteria (as interpreted for this device type):

The "study" presented here is a pre-market notification (510(k)) submission seeking to demonstrate substantial equivalence to a previously cleared predicate device (K221278), with an expanded indication for use.

The primary "acceptance criterion" for this submission is that the device is as safe, as effective, and performs as well as the legally marketed predicate device and raises no new questions of safety or effectiveness.

The "study" to prove this involves:

• Technological Characteristic Comparison: Detailed comparison of the subject device's design, materials, manufacturing, and performance characteristics (e.g., microbial barrier, acoustic properties, sterilization, shelf life) to the predicate device. The conclusion is that these characteristics are largely identical.
• Non-Clinical Testing Confirmation: Because there were no changes in materials, structure, dimensions, or performance that were deemed to impact the previous clearance, no new performance bench testing was considered necessary, except for additional biocompatibility evaluation related to the expanded indications for use.
• Biocompatibility Testing: For the expanded scope to include endocavity and intra-operative diagnostic ultrasound, additional biocompatibility tests (Thrombogenicity and Complement Activation Testing per ISO 10993-4) were conducted. The results of these tests, along with the previously reviewed biocompatibility data for the predicate, were deemed valid and supportive.

In essence, the "study" is a comparative analysis and targeted supplementary testing demonstrating that the changes (expanded indications) do not introduce new hazards and that the device remains substantially equivalent to market predicates under the new conditions of use.

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Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for external intact skin diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application. The subject device is furnished in sterile condition, for single use patient/procedure use, disposable. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The provided text describes the performance and acceptance criteria for a medical device called "Transducer Probe Cover". Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details performance testing for various physical and acoustic properties. It does not explicitly state the sample sizes for each specific test (e.g., how many covers were tested for tensile strength). The data provenance is from bench testing conducted by Hony Medical Co., Ltd. in China. The studies described are non-clinical tests, not involving human subjects, and therefore are inherently prospective in their setup (designed and executed to prove compliance).

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

Not applicable. The tests performed are bench tests evaluating physical properties and acoustic effects of the device. There's no mention of human experts defining "ground truth" for these types of engineering and material science evaluations. The ground truth for these tests is defined by established international standards (e.g., ASTM, ISO).

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are bench tests against defined international standards. There is no human interpretation or adjudication beyond the direct measurement of physical properties against a set threshold.

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

No. The document explicitly states: "No clinical study is included in this submission." This device is a transducer probe cover, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

No, as this is not an algorithm-based device. The "standalone" performance refers to the physical and acoustic properties of the cover itself.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established by:

• International Consensus Standards: For example, ASTM F1671-13 for viral penetration, ISO 527-3:1995 for tensile properties, ISO 9073-4-2021 for tear resistance, ISO 10993 for biocompatibility, etc.
• Defined Physical and Acoustic Parameters/Thresholds: The acceptance criteria for acoustic properties (sound attenuation, impedance, velocity) and physical properties (force at break, tear resistance, water resistance, airburst pressure) serve as the ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. There is no training set for this device.

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Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive 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 gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, 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. The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It 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 subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The provided document describes the regulatory submission for "Ultrasound Transmission Gels" and does not contain information about an AI-powered medical device. Therefore, it is not possible to answer the request with the provided information.

The document details the technical characteristics and non-clinical testing of an ultrasound couplant (gel) to demonstrate its substantial equivalence to a predicate device. This involves material composition, sterilization, biocompatibility, and physical properties like sound velocity, acoustic impedance, and viscosity. There is no mention of algorithms, AI, machine learning, or any form of software that would involve diagnostic performance metrics, training sets, or expert adjudication.

Specifically, the document states:

• "No clinical study is included in this submission."
• The device is a physical product (gel) used to facilitate ultrasound imaging, not an image analysis software.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.

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