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A palient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powdered Latex Examination Gloves

This document is a marketing authorization letter for "Powdered Latex Examination Gloves" and does not contain information about the acceptance criteria or a study proving a device meets them.

The letter is from the FDA to PT. Shamrock Manufacturing Corporation, confirming that their gloves are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions.

Therefore, I cannot provide the requested information.

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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Device Name: Powder free Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the test set during the performance evaluation for the "Powder Free Latex Examination Gloves." It refers to the ASTM D 3578-05 standard, which would typically define the sampling plan for such tests.

The data provenance is not explicitly mentioned beyond the manufacturer being PT. Shamrock Manufacturing Corpora in Medan, North Sumatra, Indonesia. The testing itself would have been conducted to meet the ASTM standard.

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

This information is not applicable as the device is a physical product (examination gloves), not an AI/software device that requires expert-established ground truth for diagnosis/interpretation. The "ground truth" here is defined by objective physical and chemical properties measured against a standard (ASTM D 3578-05).

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations, not objective measurements of physical properties.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The device is a medical device (gloves), not an AI system.

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

This information is not applicable. The device is a medical device (gloves), not an AI system. Even if it were an AI system, "standalone" in this context refers to AI performance without human intervention, which isn't relevant for a physical product.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device is based on objective physical and chemical standards as defined by ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) and FDA pinhole requirements.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/machine learning system, so there is no concept of a "training set" in the traditional sense for algorithm development. The manufacturing process would involve internal quality control and production monitoring, but not a "training set" like an AI model.

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

This information is not applicable for the reasons stated in #8. The "ground truth" for manufacturing would be established by the specifications of the ASTM standard.

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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Blue

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves, Blue, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the total sample size for the test set. However, it indicates specific inspection levels (e.g., "Inspection Level I" for freedom from holes, "Inspection Level S-2" for dimensions and physical properties, and specific N values for powder-free residue and powder amount). These inspection levels and AQLs (Acceptable Quality Levels) are standard in quality control for products like gloves and imply a sampling plan rather than a single fixed "test set" size.
• Data Provenance: The data is generated by PT. Shamrock Manufacturing Corp. in Indonesia. The context implies it's retrospective testing conducted on finished products for regulatory submission.

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

• This type of device (medical gloves) does not typically involve "experts" establishing ground truth in the sense of medical diagnosis. The "ground truth" is established by adherence to a recognized international standard, ASTM D 6319-00ae2, which defines objective physical and performance characteristics.
• The individuals conducting the tests would be qualified laboratory technicians or quality control personnel trained in performing the specified ASTM test methods. No specific number or qualifications are provided, but competency in these tests is assumed for ISO/ASTM compliance.

4. Adjudication method for the test set:

• Not applicable in the typical sense for medical device AI/diagnostic studies. Adherence to the ASTM standard would involve objective measurements and pass/fail criteria based on quantitative data rather than expert adjudication.
• For defects like "freedom from holes," the AQL (Acceptable Quality Level) system is an adjudication method, where a certain number of defects within a sample are allowed before the lot is rejected. The AQLs are specified in the table (e.g., 2.5 for holes, 4 for dimensions and physical properties).

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 a physical product (medical gloves), not an AI diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance with AI are irrelevant to its evaluation.

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 device. The "standalone" performance here refers to the glove's physical and mechanical properties as measured by standard tests, independent of human interaction (other than the testing process itself).

7. The type of ground truth used:

• The ground truth is based on objective measurements and adherence to the performance specifications outlined in the ASTM D 6319-00ae2 standard for Nitrile Examination Gloves. This includes:
  • Direct physical measurements (dimensions, thickness).
  • Material property tests (tensile strength, ultimate elongation) conducted in a laboratory setting.
  • Defined acceptance criteria for defects (e.g., pinholes) based on AQLs.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a "training set." The gloves are manufactured and tested against predefined standards.

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

• Not applicable, as there is no training set for this type of device. The "ground truth" for glove characteristics is established by the well-defined, internationally recognized ASTM D 6319-00ae2 standard, which is a consensus standard developed by industry experts and updated over time.

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Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves with Bubblegum Aroma

The provided text describes the 510(k) summary for "Powder free Latex Examination Gloves with Bubblegum Aroma." This document is a premarket notification for a medical device, which means it aims to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device. Instead, it details the characteristics and performance of the examination gloves themselves, comparing them to established industry standards like ASTM D 3578-01ae2.

Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. I will answer based on the information provided for the physical device (gloves).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and 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)

This information is not provided in the document. For physical products like gloves, testing is typically done on batches during manufacturing and as part of compliance to standards, but the specific sample sizes for these tests are not detailed here. The manufacturing company is located in Indonesia.

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 is not applicable as the document describes physical product testing against engineering standards rather than diagnostic interpretation.

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

This is not applicable as the document describes physical product testing against engineering standards rather than 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

This is not applicable as the document describes physical product testing, not an AI-assisted diagnostic device.

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

This is not applicable as the document describes physical product testing, not an algorithm.

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

The "ground truth" for this device is the compliance with established industry standards and regulatory requirements, specifically:

• ASTM D 3578-01ae2 Standard for Latex Examination Gloves.
• FDA pin hole requirement.
• Protein content limits (50 mcg/gm or less).
• Labeling claims.

8. The sample size for the training set

This is not applicable as the document describes physical product testing, not a machine learning model.

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

This is not applicable as the document describes physical product testing, not a machine learning model. The "ground truth" for the device's performance is established by adhering to the standards mentioned in point 7.

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Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Latex Examination Gloves Powder Free With Lined.

The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.

The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.

Here's an analysis of the available information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
• The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.

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

The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.

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

This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."

4. Adjudication Method for the Test Set

This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective assessments requiring adjudication.

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 question is not applicable. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.

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

This question is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
• Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
• Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").

8. The Sample Size for the Training Set

This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.

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

This question is not applicable, as there is no "training set" for this type of device. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.

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Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

This document is a 510(k) summary for "Powderfree Latex Examination Gloves with Grape" submitted by PT. Shamrock Manufacturing Corp. It describes the device, its intended use, and its technological characteristics as a medical device.

Acceptance Criteria and Study for "Powderfree Latex Examination Gloves with Grape"

The acceptance criteria and performance data for the "Powderfree Latex Examination Gloves with Grape" are based on the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. The document states that the gloves "meet or exceed the ASTM D 3578-01ae2 Standard" and also "meet FDA pinhole requirement" and "meet labeling claim."

The study that proves the device meets the acceptance criteria is a series of tests performed against the ASTM D 3578-01ae2 standard.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size for the test set. However, it indicates these are standard tests performed on manufactured batches. The data provenance is presumed to be from the manufacturer, PT. Shamrock Manufacturing Corp. in Indonesia, based on the contact information and factory location listed. The data is retrospective, as it refers to compliance with an existing standard.

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

This information is not provided. The ground truth is established by the specifications defined in the ASTM D 3578-01ae2 standard itself, which is a consensus standard developed by industry experts.

4. Adjudication Method for the Test Set:

This information is not provided. Compliance with ASTM standards typically involves specified testing methodologies and acceptance sampling plans, not clinical adjudication by experts in the same way a medical image diagnosis might be.

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

No MRMC comparative effectiveness study was done. This type of study is not applicable to the assessment of physical properties and barrier integrity of examination gloves.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Its performance is assessed through physical and chemical testing.

7. Type of Ground Truth Used:

The ground truth used is established industry standards and regulatory requirements, specifically:

• ASTM D 3578-01ae2 Standard
• FDA Pinhole Requirement

8. Sample Size for the Training Set:

Not applicable. As this is a manufactured physical product, there is no "training set" in the context of an AI/algorithm. Quality control and manufacturing processes ensure that gloves produced in bulk meet the standards.

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

Not applicable. The "ground truth" for manufacturing quality is established by the ASTM standard and FDA requirements for medical gloves, which guide the manufacturing process and subsequent quality checks for each batch produced.

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A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… '
Powder free Latex Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder Free - Latex Examination Gloves

The provided document, a 510(k) summary for PT. Shamrock Manufacturing Corporation's Powder Free - Latex Examination Gloves, describes the device and its performance data. However, it does not include detailed acceptance criteria or a study that specifically "proves" the device meets these criteria in the typical sense of a clinical or comparative effectiveness study for AI/medical imaging devices.

Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Class I Examination Gloves 80 L YY meeting ASTM D 3578-99) by presenting performance data that meets established industry standards.

Here's an analysis based on the information provided, framed to address your requested points where applicable, and highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this device are the specifications outlined in the ASTM D 3578-99 standard and FDA pin hole requirements. The reported device performance matches these criteria exactly, as stated in section (6) "Technological characteristic of the gloves" and (9) "Non-clinical data."

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

The document does not specify the exact sample size used for testing these physical and performance characteristics. The testing methodology for ASTM standards would dictate this, but it is not elaborated upon in this 510(k) summary. The data provenance is not explicitly stated in terms of country of origin for the testing, but the manufacturer is PT. Shamrock Manufacturing Corporation in Indonesia. The testing would be considered retrospective as it likely occurred during product development and validation prior to this submission.

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

This is not applicable in the context of this device and document. "Ground truth" in the sense of expert consensus for medical imaging interpretations (like a radiologist reading an image) is not relevant here. The ground truth for glove performance is established by objective measurements against a recognized standard (ASTM D 3578-99).

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human readers or expert panels, typically in subjective assessment tasks. The testing of gloves involves objective measurements against a standard, not subjective interpretations requiring adjudication.

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 (latex examination gloves), not an AI diagnostic or assistive imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

The ground truth used for this device is based on objective measurements against established engineering and material science standards (ASTM D 3578-99) and regulatory requirements (FDA pin hole requirement). This is a form of performance standard ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning models, not for manufacturing specifications of gloves.

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

Not applicable, as there is no "training set" in the context of this device. The standards (ASTM D 3578-99) were established through a consensus process by relevant industry and scientific bodies over time.

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