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A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

Non-Sterile Powder Free Nitrile Examination Gloves

The provided text
describes the FDA's administrative change and substantial equivalence (SE)
determination for "Non-Sterile Powder Free Nitrile Examination Gloves" (K223221).
However, it does not contain any information regarding acceptance criteria,
device performance study results, sample sizes, expert qualifications, or ground
truth establishment.

This document is an FDA 510(k) clearance letter, which
primarily addresses the regulatory classification and marketing authorization of a
medical device. It confirms that the device is substantially equivalent to
legally marketed predicates and can be marketed subject to general controls. It does
not include the detailed technical performance study data typically found in a
submission document or a summary of safety and effectiveness.

Therefore, I cannot provide the requested information
(Table of acceptance criteria, sample sizes, expert details, adjudication,
MRMC study, standalone performance, ground truth types, or training set
details) based on the provided text.

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Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" in comparison to a predicate device. This is a medical device submission, and the information is presented as part of a 510(k) summary to the FDA. As such, the "study" referred to is a series of non-clinical tests performed to demonstrate substantial equivalence, rather than a clinical study involving human patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the acceptance criteria and results mainly in reference to established ASTM and ISO standards for medical gloves. The "Reported Device Performance" column directly reflects the results from the non-clinical tests.

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

• Sample Size for Test Set: The document does not explicitly state a consolidated sample size for all tests. However, for specific tests, it does provide some details:
  • Freedom from Holes (ASTM D5151-19): AQL = 2.5, Inspection level G1. This standard outlines sampling plans, but the exact number of units tested is not provided in this summary. The predicate device mention "125 samples from batch of 35000", which gives a hint on the sample size used, but this is for the predicate not the subject device.
  • The other non-clinical tests (e.g., physical properties, biocompatibility, chemotherapy permeation) would also have specific sample sizes as per their respective standards, but these are not enumerated in this summary.
• Data Provenance: The document does not explicitly state the country-of-origin for the "data" or whether the tests were retrospective or prospective. Given that this is a 510(k) summary for a device manufactured by "RUBBEREX ALLIANCE SDN BHD" in Malaysia, it is highly probable that the testing was performed in conjunction with the manufacturer or by contract labs. The tests are prospective as they are conducted specifically for the device submission.

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

This section is not applicable as the described "study" consists of non-clinical, laboratory-based tests of physical properties and chemical resistance of gloves against established standards (ASTM, ISO). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes data in this context. The "ground truth" is adherence to the objective criteria defined by the test methods and standards.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective human interpretation (e.g., reviewing medical images) to resolve discrepancies. The tests described here are objective laboratory measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. An MRMC study assesses the effectiveness of a diagnostic device or AI with and without human readers. The device in question is a medical glove, for which such a study design is irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This section is not applicable. "Standalone" performance usually refers to the performance of an AI algorithm without human interaction. This document describes the performance of a physical medical device (gloves) through laboratory tests, not an AI algorithm. The performance described is "standalone" in the sense that it's the intrinsic performance of the glove material.

7. Type of Ground Truth Used:

The "ground truth" for the performance of these gloves is based on:

• Established Standard Specifications: e.g., ASTM D6319-19 for dimensions, tensile strength, elongation.
• Standardized Test Methods and Protocols: e.g., ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility.
• The results are quantitative measurements interpreted against pre-defined thresholds or criteria derived from these standards.

8. Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not an AI/ML device. The tests performed are to evaluate manufactured products against predefined specifications.

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

This section is not applicable for the same reason as point 8.

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A non-sterile powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.

The provided document is an FDA 510(k) summary for a medical device (Non-sterile Powder Free Nitrile Examination Gloves). It does not describe an AI/ML-driven medical device, nor does it involve image analysis, expert-based ground truth, or MRMC studies. Therefore, many of the requested elements for describing a study proving an AI/ML device meets acceptance criteria are not applicable.

However, I can extract the relevant "acceptance criteria" (performance specifications) and the "study that proves the device meets the acceptance criteria" (non-clinical performance tests) from the document as it pertains to this specific device.

Here's the information based on the provided document:

Device: Non-sterile Powder Free Nitrile Examination Gloves (K210990)
Device Type: Patient Examination Glove (Class I, reserved)
Intended Use: Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use.

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

2. Sample sized used for the test set and the data provenance
The document refers to standard test methods (e.g., ASTM D6319-19, ASTM D5151-19, ISO 28590:2017 for sampling). These standards specify the sample sizes for tests like AQL inspections for pinholes. For example, ASTM D5151-19, "Standard Test Method for Detection of Holes in Medical Gloves," would define the process for testing pinholes using an AQL (Acceptable Quality Limit) of 2.5. ISO 28590:2017 is explicitly mentioned as a "Sampling Procedure for Inspection by Attributes."

• Sample Size: Not explicitly stated as a single number, but implied to follow the sampling plans within the referenced standards (e.g., AQL 2.5, Inspection Level G-1 for pinholes).
• Data Provenance: The tests are non-clinical (laboratory tests on physical samples/materials). The manufacturer is Rubberex Alliance Sdn Bhd, based in Ipoh, Perak, Malaysia. The testing would have been conducted by the manufacturer or a contracted lab. The data is prospective as it describes the testing performed on the device samples to support the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (gloves), not an AI/ML device that requires expert-established ground truth for image interpretation or similar. The "ground truth" for these tests are objective measurements and compliance with chemical/physical standards.

4. Adjudication method for the test set
Not applicable. See 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/ML device.

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. The "performance" is the physical properties of the glove itself.

7. The type of ground truth used
The "ground truth" is established by:

• Objective Measurement: Adherence to specified dimensions (length, width, thickness), tensile strength, and elongation through standardized testing methods.
• Chemical Analysis: Measurement of residual powder.
• Biological Testing: Standardized in-vitro and in-vivo biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) as defined by ISO 10993 series.
• Statistical Sampling: AQL (Acceptable Quality Limit) tests for defects like pinholes, using established statistical sampling procedures (ISO 28590:2017).

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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