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UltraPhonic® Scanning Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.

Ultra/Phonic® Scanning Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.

Here's a summary of the acceptance criteria and the study details for the Ultra/Phonic® Scanning Gel, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Sound velocity
• Density
• Acoustic impedance
• Attenuation coefficient as a function of frequency | - Sound velocity: 1590 ms-1 at 22.5°C
• Density: 1035 kg/m3 at 22.5°C
• Acoustic impedance: 1.65 MRayls at 22.5°C
• Attenuation coefficient (a/f): 0.06 + 0.01116 f^1.3706
  Conclusion: "Virtually identical to that of human skin" and "Similar to other coupling gels commonly used in the United States." Acoustic properties of the predicate gel (Sonishield™ 100) are also provided for comparison and are considered "virtually identical." |
  | Antimicrobial Effectiveness (USP Category 2) | - Log reductions > 5 for bacterial counts (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa) at 14 and 28 days.
• Yeasts and molds (Aspergillus brasiliensis, Candida albicans) did not increase, and "considerably decreased." |
  | Biocompatibility (ISO 10993-10):
• Skin Irritation
• Skin Sensitization | - Non-sensitizing
• Non-irritating |
  | In Vitro Cytotoxicity (ISO 10993-5:2009) | - Meets the requirements of the test and is "not considered cytotoxic." |

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

The document does not explicitly state sample sizes for each specific test (acoustic, antimicrobial, biocompatibility, cytotoxicity). It refers to "evaluations," "tests conducted," and "studies." The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective, though performance testing is generally prospective.

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

This information is not provided in the document. The studies performed are non-clinical (laboratory and animal) and do not involve human interpretation or subjective expert ground truth establishment in the traditional sense of diagnostic AI studies.

4. Adjudication Method for the Test Set

Not applicable, as this device does not involve subjective diagnostic interpretations requiring adjudication. The performance criteria are based on objective physical, chemical, and biological measurements.

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 a medical device (ultrasound scanning gel) and not an AI-powered diagnostic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is not an algorithm or AI model. Its performance is evaluated through direct physical, chemical, and biological testing, not through standalone algorithm performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by recognized scientific and regulatory standards and validated laboratory methods.

• Acoustic Properties: Comparative measurements against human skin properties and other commercially available gels.
• Antimicrobial Effectiveness: Defined log reduction criteria established by USP .
• Biocompatibility: Absence of irritation and sensitization as per ISO 10993-10.
• Cytotoxicity: Meeting negative control requirements and absence of cytotoxic effects as per ISO 10993-5:2009.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

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Ultra Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.

Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.

It is packaged in 5L Cubitainers and 250 mL bottles.

Major characteristics include:

• Non-sensitizing, non-irritating
• Water soluble, non-staining, and easily cleanable
• Does not contain oil or fatty matter
• Does not damage the probe
• pH level is 6.25 ± 0.25 @ 25°C
• Resists thinning and decomposition when exposed to perspiration and body heat
• Sheer thinning gel is easy to apply, but doesn't run or drip
• High viscosity allows for thick application, adapting to contours and hair to minimize interference

This document describes the premarket notification (510(k)) for the Ultra/Phonic® Free Conductivity Gel, a diagnostic ultrasonic transducer accessory. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than a detailed algorithm performance study for an AI-powered device. Therefore, many of the requested elements for AI/algorithm performance (e.g., test set sample size, ground truth details, MRMC studies) are not applicable or not present in this document.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate and reference devices, as the goal is to demonstrate "substantial equivalence." The reported performance focuses on acoustic properties and biocompatibility.

2. Sample size used for the test set and the data provenance:

• Acoustic performance: The document states that the acoustic properties of the gel were evaluated and compared to human skin and other coupling gels. No specific sample size (number of gels tested, or number of measurements) is provided for this evaluation. The data provenance is implied to be laboratory testing.
• Antimicrobial Effectiveness Test: The test followed USP (Category 2) standards, involving specific bacterial and fungal strains (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231). The sample size typically refers to the number of replicates per microbial challenge, which are standard for this test method.
• Biocompatibility (Skin Irritation, Skin Sensitization, Cytotoxicity): These refer to ISO 10993-10 and ISO 10993-5:2009 standards. These are in vitro or animal tests that follow specific protocols for sample sizes of cells or animals. The document does not specify the exact number of animals or cell cultures used but confirms that tests were conducted according to the stated ISO standards.
• Human-Repeated-Insult-Patch-Test (RIPT): This is a human clinical study. The document does not specify the number of human subjects used but indicates that such testing was performed. Data provenance is likely the testing laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical accessory (ultrasound gel), not an AI-powered diagnostic algorithm requiring expert "ground truth" for classification. The "truth" is established by physical/chemical measurements and biological assays.

4. Adjudication method for the test set:
Not applicable (refer to point 3).

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-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used:
The "ground truth" for this device revolves around its physical, chemical, and biological properties:

• Acoustic Properties: Measured values (sound velocity, density, acoustic impedance, attenuation coefficient).
• Biocompatibility: Results of standardized in vitro and in vivo tests adhering to ISO 10993 guidelines, and the USP antimicrobial test.
• Functional Properties: pH, viscosity, ingredients, etc., measured via standard laboratory methods.

8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable (refer to point 8).

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Other-Sonic™ Transmission Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.

Other-Sonic™ Transmission Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles.

The device under review is "Other-Sonic™ Transmission Gel," which is a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. The device is compared to a predicate device, "Sonishield™ 100 Antimicrobial Ultrasound Gel," and an additional reference device, "Ecogel 100 Ultrasound Gel."

Here's the breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance metric but rather presents a comparison of technological and non-clinical characteristics between the subject device and the predicate/reference devices to demonstrate substantial equivalence. The "performance" column below reflects the characteristics of the "Other-Sonic™ Transmission Gel" and the "Acceptance Criteria" column indicates that its performance should be substantially equivalent or similar to the predicate/reference devices for these characteristics.

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

• Acoustic Testing: The document does not specify a separate "test set" sample size for acoustic testing. The acoustic properties are reported as values for "Other-Sonic™ Transmission Gel" and "Sonishield™ 100 Antimicrobial Ultrasound Gel." It implicitly compares the characteristics of the gel rather than a study on a specific number of instances.
• Antimicrobial Effectiveness Testing: The sample size is not explicitly stated as a number of distinct gel samples. However, the test was performed according to USP (Category 2) using standard microbial challenges: Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, and Candida albicans ATCC 10231. These represent specific strains used in lab testing.
• Biocompatibility (Skin Irritation and Sensitization): The document states "Animal tests" were conducted, referring to "Skin Irritation and Skin Sensitization." The number of animals or specific experimental setup (e.g., number of patches, individual subjects) is not provided.
• In Vitro Cytotoxicity: The test was conducted according to ISO 10993-5:2009. The sample size refers to the cell cultures used in the in vitro test, but specific numbers are not given.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. These tests are typically conducted in laboratory settings (i.e., in vitro or in vivo animal studies) rather than using retrospective or prospective human clinical data.

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

This section is not applicable. The evaluations conducted for this device (acoustic properties, antimicrobial effectiveness, biocompatibility, cytotoxicity) are non-clinical laboratory tests. They do not involve expert interpretation of images or clinical data to establish a "ground truth" in the way a diagnostic algorithm might. The "ground truth" for these tests comes from established scientific methodologies and standards (e.g., USP , ISO 10993).

4. Adjudication Method for the Test Set:

This section is not applicable as the studies were non-clinical laboratory tests that do not involve human adjudication of results in the context of diagnostic interpretation.

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 MRMC comparative effectiveness study was done. This device is an ultrasound transmission gel, not an AI-powered diagnostic tool requiring human reader assistance.

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

No standalone (algorithm-only) performance was done because this is a physical medical device (ultrasound transmission gel), not an algorithm or AI software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance claims comes from:

• Acoustic Properties: Direct physical measurements of the gel's sound velocity, density, acoustic impedance, and attenuation coefficient.
• Antimicrobial Effectiveness: Quantitative microbial count reductions as measured by standard microbiological assays (USP ).
• Biocompatibility: Results from standardized animal (in vivo) irritation and sensitization tests (ISO 10993-10).
• In Vitro Cytotoxicity: Results from standardized cell culture tests (ISO 10993-5:2009) to assess cell viability.

8. The Sample Size for the Training Set:

This section is not applicable. This device is a physical product (ultrasound transmission gel) and does not involve AI or machine learning algorithms that require a training set.

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

This section is not applicable as there is no training set for this type of device.

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UltraPhonic® Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.

Ultra/Phonic® Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, 250 mL bottles, and 250 mL tubes.

The request asks for specific details about the acceptance criteria and the study proving the device meets them. However, the provided document describes an ultrasonic conductivity gel, not an AI/ML device, and therefore does not contain information typically found in a study for AI/ML device performance.

Therefore, most of the requested fields cannot be filled from the provided text as they are not applicable to the type of device described.

Here's a breakdown of what can and cannot be extracted:

Device Type: Ultrasonic Conductivity Gel (not an AI/ML device)

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Not applicable. The performance data for this product is based on physicochemical and biological testing in a laboratory setting, not on a test set of patient data.
• Data Provenance: The acoustic testing used the Ultra/Phonic® Conductivity Gel and the predicate Sonishield™ 100 Antimicrobial Ultrasound Gel. Biocompatibility and cytotoxicity tests were conducted on the Ultra/Phonic® Conductivity Gel. The document does not specify the country of origin for the testing data. The studies are non-clinical performance evaluations.

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)

• Not applicable. This is not an AI/ML device that requires expert ground truth labeling.

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

• Not applicable.

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.

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

• Not applicable.

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

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is based on established laboratory testing standards (e.g., USP for antimicrobial effectiveness, ISO 10993 for biocompatibility and cytotoxicity) and physical property measurements.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.

Clear, water-soluble lubricating gel

This 510(k) summary (K961222) describes the EVRON GEL, a lubricating gel intended to facilitate breast self-examination. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed lubricants, primarily by emphasizing its long history of safe use and the common mechanism of lubrication. Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets such criteria because this information is not present in the provided text.

Here’s why the requested information cannot be extracted:

• No quantifiable acceptance criteria are stated. The document asserts the device's effectiveness based on its lubricating properties and its similarity to soapy water for reducing friction. There are no numerical targets or thresholds provided for lubrication, friction reduction, or other performance metrics.
• No specific study or clinical trial is described. The document relies on the device's long history of commercial distribution (over 25 years) and the lack of reported safety concerns as evidence for its safety. For effectiveness, it uses logical reasoning about lubrication being similar to soapy water. This is not a study with the elements requested (sample size, ground truth, expert opinions, etc.).

Therefore, for all the requested points (1-9), the answer is "Not applicable" or "Information not provided in the document." The submission focuses on demonstrating substantial equivalence through established use and a common mechanism, rather than presenting a performance study against specific acceptance criteria.

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