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The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a single-use disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a class I medical device classified under Product Code LZA. It is a single-use disposable device that meets all requirements of ASTM D 6319-10.

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue were evaluated for substantial equivalence based on a comparison to a predicate device and adherence to recognized consensus standards. The study demonstrates the device meets the acceptance criteria through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each test within the ASTM and ISO standards. However, the tests were "non-clinical testing" as indicated by "Summary of Non-clinical Testing Data." The provenance of the data is from the manufacturer's testing of their product, Koon Seng SDN. BHD., located in Tangkak, Johor, Malaysia. The testing is reported retrospectively as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not explicitly provided in the document. For these types of glove tests, the "ground truth" is typically established by the standardized methods and criteria defined within the ASTM and ISO standards themselves, rather than through expert consensus in the same way clinical diagnostic studies would. The testing would be performed by qualified laboratory personnel following these established protocols.

4. Adjudication method for the test set:

Adjudication methods like 2+1 or 3+1 are not applicable here. The evaluation involves standardized laboratory tests against predefined physical and chemical specifications in the ASTM and ISO standards. The results of these tests are objectively measured and compared directly to the passing criteria within the standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging or AI-assisted clinical decision-making devices, not for patient examination gloves. The evaluation of these gloves focuses on physical and biological material properties and performance.

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

This is not applicable as the device is a medical device (examination gloves), not an algorithm or AI system. The performance evaluated is the physical properties and biocompatibility of the gloves themselves, not a standalone algorithm.

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

The "ground truth" for the device's performance is established by the specified requirements and testing methodologies outlined in the referenced FDA-recognized consensus standards: ASTM D3578-05, ASTM D6124-06, ASTM D6319-10, and ISO 10993-10. These standards define the acceptable performance characteristics (e.g., tensile strength, elongation, barrier integrity, residual powder, biocompatibility) that the gloves must meet.

8. The sample size for the training set:

This is not applicable, as there is no training set for a physical medical device like examination gloves. Training sets are used in the context of machine learning or AI models.

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

This is not applicable, as there is no training set.

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A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove:

The provided document is a 510(k) Summary for a medical device: 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

The "study" in this context refers to the testing performed against recognized standards and comparative data with predicate devices to demonstrate the new device is as safe and effective as existing ones.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from ASTM D3578-05 (Standard Specification for Rubber Examination Gloves) and in comparison to predicate devices.

Note on "Minor difference": The document explicitly labels the Tensile Strength after aging as having a "Minor difference" compared to one predicate, indicating that while the measurement itself meets the minimum, the specific value is divergent from one of the predicate devices. However, it still meets the stated "Min 14 Mpa" acceptance criteria. The thickness and elongation values also show variation from predicates but generally meet the stated minimums.

Study Details:

This submission describes non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence. It does not involve a multi-reader, multi-case study with human readers or an AI algorithm.

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

• Test Set Sample Size: Not explicitly stated as a single "test set" in the context of clinical trials or AI evaluation. The testing performed involves samples of gloves taken from manufacturing lots. For example, for physical specifications and dimensions testing, the inspection level is S-2 with an AQL 4.0, and for pinholes, an AQL of 2.5 is used. These AQLs (Acceptance Quality Limit) specify the maximum percentage of defective units in a lot that can be considered acceptable.
• Data Provenance: The data originates from internal testing conducted by the manufacturer, Koon Seng Sdn. Bhd., in Malaysia to demonstrate compliance with ASTM D3578-05a and other standards (biocompatibility). It is retrospective in the sense that these are manufacturing quality control tests, not a prospective clinical study specifically designed for this submission.

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

• Not Applicable. For a medical examination glove, "ground truth" typically relates to objective measurements performed by laboratory technicians or validated testing equipment against established standards (e.g., ASTM standards for glove properties, ISO standards for biocompatibility). There are no "experts" in the sense of clinical specialists establishing a "ground truth" for interpretation, as would be the case for diagnostic imaging.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used in studies where there's subjective interpretation by multiple human readers (e.g., radiologists) and a need to resolve discrepancies. The testing for this glove involves objective, quantitative measurements and pass/fail criteria based on standards.

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

• No. This type of study is not relevant for a patient examination glove. An MRMC study would typically be used to assess the impact of an AI algorithm on human reader performance (e.g., in medical image interpretation).

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a physical product (a glove), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• The "ground truth" for this device is based on objective, quantitative measurements against recognized industry standards (ASTM D3578-05a) and biocompatibility testing performed according to international standards. For example:
  • Physical dimensions: Measured length, width, thickness.
  • Physical properties: Measured tensile strength and elongation.
  • Biocompatibility: Results from standardized tests for skin irritation and dermal sensitization.
  • Defect levels: Based on accepted quality limits (AQL) which define the maximum allowable percentage of defects (e.g., pinholes).
  • Chemical residues: Quantitative measurement of powder and protein content.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. (See point 8).

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Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

ROYAL IMPERIAL LATEX Pre-Powdered Patient Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

This document is a 510(k) premarket notification from the FDA for a medical device: "Royal Imperial Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)". It's an approval letter, not a study report. Therefore, the requested information about acceptance criteria, device performance, ground truth, and study specifics cannot be extracted from the provided text.

The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for patient examination gloves. However, it does not contain the detailed technical specifications, test results, or study design information needed to answer your specific questions about acceptance criteria and how they were met.

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Powder Free Polymer Coated Patient Examination Gloves are disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Powder Free Polymer Coated Patient Examination Gloves

This document is a 510(k) premarket notification from the FDA, specifically concerning a medical device: Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less).

The document does not contain the detailed study information needed to answer your request about acceptance criteria and device performance as if it were a software or AI device. This is a regulatory clearance letter for a physical medical glove. The type of "study" for a glove would involve physical testing and chemical analysis, not the kind of AI/software performance studies you're asking about.

Therefore, I cannot extract the information required for the table and subsequent questions (sample sizes, expert qualifications, MRMC studies, standalone performance, training set data) from this document.

However, I can infer some "acceptance criteria" for this type of device based on general FDA requirements for examination gloves, even though the specific numerical criteria are not in this letter.

Inferred Acceptance Criteria for Examination Gloves (General, Not from this document):

• Protein Content: The claim in the device name "50 Micrograms or Less" is a key acceptance criterion for latex gloves intended to mitigate allergic reactions. This is typically measured through recognized testing standards.
• Physical Integrity/Barrier Protection: This involves testing for pinholes and leaks (e.g., water leak test, air inflation test).
• Tensile Strength and Elongation: To ensure the gloves do not break easily during use.
• Dimensions (Length, Width, Thickness): To ensure proper fit and coverage.
• Biocompatibility: Tests for skin irritation and sensitization.
• Sterility (if claimed): Absence of microorganisms, verified through sterilization validation.
• Powder Residue (if powder-free): A specific limit on residual powder.

Since the provided document is a 510(k) clearance letter, it confirms that the device met the necessary criteria for substantial equivalence to a predicate device, as determined by the FDA. The specific studies and their results would be detailed in the manufacturer's 510(k) submission, which is not this letter.

To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Information Not Provided".

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Information Not Provided in the document. For physical medical devices like gloves, testing involves batches, and the sample size would depend on the specific ISO or ASTM standards applied (e.g., AQL sampling plans).
• Data Provenance: The manufacturer is Koon Seng Sdn. Bhd. in Muar, Johor, MALAYSIA. The testing would likely have originated in Malaysia or a certified lab approved by the manufacturer. It would be prospective testing of manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of this device. "Ground truth" in this context refers to physical/chemical properties measured objectively against established standards, not interpretation by human experts in the way AI/software devices are evaluated. The "experts" would be laboratory technicians and engineers performing these tests, and regulatory reviewers from the FDA.

4. Adjudication method for the test set

• Not applicable in the context of this device. Adjudication typically refers to resolving discrepancies in expert interpretations. For physical testing, results are objective measurements. Regulatory review by the FDA (e.g., via a 510(k) process) serves as the "adjudication" or approval of the submission based on the provided 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

• Not applicable. This device is an examination glove, not an AI or software device that "human readers" would interact with in this manner.

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

• Not applicable. This device is an examination glove, not an algorithm.

7. The type of ground truth used

• Objective Physical and Chemical Measurements: For gloves, ground truth is established through standardized laboratory tests that measure physical properties (e.g., tensile strength, elongation, dimensions, leak resistance) and chemical properties (e.g., protein content, powder residue, biocompatibility). These are defined by international standards (e.g., ASTM, ISO).

8. The sample size for the training set

• Not applicable. This device is an examination glove and does not involve a "training set" in the machine learning sense. The manufacturing process involves quality control and process validation, which might involve data collection from production runs, but it's not a "training set" for an algorithm.

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

• Not applicable. As above, no training set for an algorithm.

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