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Disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between patient and examiner.

Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.

Acceptance Criteria and Device Performance Study for CLK International Powder-Free Latex Examination Glove

This document outlines the acceptance criteria and the study performed to demonstrate that the CLK International Powder-Free Latex Examination Glove meets these criteria, based on the provided 510(k) summary (K974371).

1. Table of Acceptance Criteria and Reported Device Performance

The CLK International Powder-Free Latex Examination Glove is assessed against the requirements of ASTM D3578 voluntary standards for latex examination gloves, as well as biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1.

Note: The 510(k) summary states that "Characteristics of the CLK Int'l latex powder-free examination gloves are compared with ASTM D3578 in Attachment I, Table I" and "Tests show they meet the requirements of ASTM D3578 for latex examination gloves." However, the actual Attachment I, Table I, and detailed numerical results are not provided in the excerpt. Similarly, for biocompatibility, it states "biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1," again without specific data points in the provided text.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., physical characteristics, leakage, biocompatibility). It only generally refers to "Tests" and "Test Data."

Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the data was collected specifically for the purpose of demonstrating equivalence, suggesting it was prospectively generated to meet the defined standards.

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

This information is not applicable in the context of this device. The ground truth for this device (a Class I medical device, examination glove) is established by adherence to recognized voluntary consensus standards (ASTM D3578) and international biocompatibility standards (ISO-10993 modified by FDA guidance), rather than expert consensus on medical images or clinical outcomes. The "experts" in this context would be the testing laboratories and their qualified personnel who perform the standardized tests according to the specified methodologies.

4. Adjudication Method for the Test Set

This information is not applicable. As the ground truth is based on objective, standardized test methods defined by ASTM and ISO, there is no need for expert adjudication methods (like 2+1 or 3+1 consensus) that are typically used for subjective assessments (e.g., medical image interpretation). The tests produce quantifiable results that either meet or do not meet the predefined criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. For a medical glove, performance is measured against physical and biological standards, not through human reader interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This concept is not applicable to this device. A medical glove does not involve an algorithm or AI. Its performance is intrinsic to its physical and material properties.

7. The Type of Ground Truth Used

The ground truth used for this device is based on two main types:

• Standardized Performance Metrics: Defined by ASTM D3578 for physical characteristics (e.g., tensile strength, elongation, freedom from holes).
• Biocompatibility Standard Metrics: Defined by ISO-10993 (modified by FDA G95-1) for biological safety (e.g., dermal irritation, sensitization).

These are objective, quantifiable measures established by industry and regulatory bodies to ensure the safety and efficacy of medical gloves.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for AI/ML algorithms where a model learns from data. A medical glove is a physical product, not an algorithm. Its properties are inherent to its manufacturing process and materials.

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

This information is not applicable for the reasons stated above.

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Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.

These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.

This 510(k) pertains to a medical device, specifically the CLK™ Int'l, Sanitary Latex Probe Cover. The submission focuses on demonstrating substantial equivalence to predicate devices already on the market rather than proving performance against novel acceptance criteria through a specific study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of an accuracy or performance study for the device. The data mentioned (ASTM D3578-95, ISO-10993) refers to standardized material and biocompatibility testing. The sample sizes for these types of tests are typically defined by the respective standards. The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed in the provided text.

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

This information is not applicable to this 510(k) submission. The "ground truth" here is compliance with established material and biocompatibility standards, not expert consensus on device performance in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies where multiple observers or algorithms are evaluated against a "ground truth" established by experts. Here, compliance is determined by laboratory testing against predefined specifications.

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 physical probe cover, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was 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 probe cover, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence and device safety/effectiveness for this product relies on:

• Established industry standards for material properties: ASTM D3578-95 for latex exam gloves.
• Established international standards for biocompatibility: ISO-10993 (as modified by FDA G95-1).
• Comparison to legally marketed predicate devices: The characteristics and intended use of the CLK probe cover were compared to several existing cleared devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device is a physical product.

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

This information is not applicable for the same reasons as #8.

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