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An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.

The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.

This document describes the premarket notification (510(k)) for the "Preventive Care, Inc. Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel®".

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Additional Acceptance Criteria and Reported Performance from Section 10 (Substantial Equivalence Comparison Table):

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

• Sample Size: The document mentions "Data of an actual representative shipment is detailed in Section 14 (original submission)" for various tests. However, the specific sample sizes (e.g., number of gloves tested for watertight, tensile strength, etc.) are not explicitly stated in the provided text.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "an actual representative shipment," implying that the data was collected from manufactured products.

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

• This device is an examination glove, and the "ground truth" for its performance is established through adherence to recognized international standards (ASTM, ISO) for physical and chemical properties. These standards define the test methodologies and acceptance criteria.
• Therefore, the "experts" involved are the organizations and committees that develop and validate these standards, and the personnel in testing laboratories who are qualified to perform these standard tests. The document does not specify the number or qualifications of individual experts who directly established the "ground truth" for this specific device's test set.

4. Adjudication method for the test set:

• For physical and chemical property testing (e.g., watertight, tensile strength), the "adjudication method" is the direct comparison of test results against the established quantitative acceptance criteria defined in the relevant ASTM and ISO standards. There is no mention of a human adjudication process (like 2+1 or 3+1) for these types of objective 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:

• This is a medical device (examination glove) and not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess improvement with AI assistance is not applicable and was not conducted.

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

• Again, this is an examination glove, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

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

• The ground truth for this device's performance is based on established objective technical specifications and test methods outlined in international standards (ASTM D3578, ASTM D5712, ASTM D6124, ASTM D412, ASTM D5151, ISO 10993).
• For biocompatibility, the ground truth is established by passing standard biocompatibility test criteria (e.g., for not being sensitizers or irritants), which are laboratory tests.

8. The sample size for the training set:

• This is a manufactured physical good. The concept of a "training set" in the context of machine learning or AI is not applicable here. There is no algorithm being trained. Manufacturing processes are optimized through quality control and adherence to specifications, not a training set.

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

• As explained in point 8, the concept of a "training set" is not relevant to this type of device. The "ground truth" for the device's performance is established through adherence to the objective criteria of the specified ASTM and ISO standards during manufacturing and quality control.

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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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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 patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated)". This document does not contain any information about acceptance criteria, device performance studies, or details regarding AI systems.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input, as this information is not present in the document.

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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of

This document is an FDA 510(k) clearance letter for "Powderfree Latex Examination Gloves (Protein Trade Name: Label Claim)." It is not a study that evaluates a medical device against acceptance criteria using performance data. Therefore, I cannot extract the requested information.

The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. It does not contain any details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS

The provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less)." This type of document does not typically contain acceptance criteria or study details in the way a clinical study report or a technical design document for a complex medical device (like an AI algorithm) would.

A 510(k) clearance is based on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing that the new device meets recognized standards, performs similarly in basic tests, and has the same intended use and technological characteristics as the predicate. The focus is usually on manufacturing, material conformity, and basic performance parameters relevant to the device's function (e.g., barrier integrity for gloves), rather than complex diagnostic accuracy studies.

Therefore, many of the requested categories for acceptance criteria and study information will not be directly available or applicable from this specific document.

However, I can extract what is implied or stated (even if it's minimal) and indicate where information is missing or not relevant for this type of device and document.

Implied Acceptance Criteria and Performance (Based on Device Type and Clearance Letter):

The core "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Not specified in this document. For gloves, testing would typically involve batches of manufactured gloves to assess properties like tensile strength, elongation, barrier integrity (e.g., freedom from pinholes), and protein levels. This would likely be internal testing by the manufacturer.
   • Provenance: This would be generated by the manufacturer, likely from their production batches. Country of origin for testing is not stated, but the manufacturer is based in Malaysia.

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

   • Not applicable/specified for this type of device. "Ground truth" in the context of examination gloves isn't established by expert consensus on diagnoses. It's established by laboratory testing against recognized standards (e.g., ASTM standards for medical gloves) for physical properties and chemical composition. The "experts" would be laboratory technicians or engineers qualified to perform such tests.

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

   • Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for objective laboratory testing of glove 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 is a medical glove, 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 a medical glove, not an AI algorithm.

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

   • The "ground truth" for this device would be established by objective laboratory measurements of physical properties (e.g., barrier integrity, tensile strength, elongation) and chemical analysis (e.g., protein content) in accordance with relevant national or international standards (e.g., FDA guidance documents, ASTM standards).

8. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device. There is no concept of a "training set" in this context.

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

   • Not applicable. As above, no training set.

In summary, the provided document is an FDA clearance letter for a low-risk medical device (examination gloves), which is fundamentally different from devices that would require complex clinical trials, AI algorithm validation, or expert consensus "ground truth" studies. The "study" for this device would involve internal validation testing by the manufacturer to ensure the gloves meet specifications and recognized standards, which FDA reviews for substantial equivalence to a predicate device.

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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Protein Label Claim) 50 MICROGRAMS OR LESS

I'm sorry, but without further context, I cannot extract the specific acceptance criteria and detailed study information you're looking for. The provided text is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of Powderfree Latex Examination Gloves to a predicate device.

This document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The letter focuses on the regulatory clearance process for a medical device (gloves), not on a study proving a device meets specific technical performance criteria in the way you've outlined.

To provide the information you requested, I would need a different document, such as a clinical study report, a performance evaluation report, or a detailed technical specification document for a device that uses algorithms or requires complex performance analysis.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Latex Examination Gloves

I am sorry, but based on the text provided, there is no information about acceptance criteria or a study proving that a device meets any such criteria. The document is a letter from the FDA to a medical device manufacturer, acknowledging a 510(k) premarket notification for "Powderfree Latex Examination Gloves" and stating that the device is substantially equivalent to legally marketed predicate devices.

The letter discusses regulatory classifications, general controls provisions of the Act, and contact information for further inquiries. The "Indications For Use" section merely defines what a patient examination glove is and its intended purpose.

Therefore, I cannot provide the requested information as it is not present in the given text.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Latex Examination Gloves ( Polymer Coated )

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powderfree Latex Examination Gloves (Polymer Coated)." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter is a notification of substantial equivalence for a medical device (examination gloves) and focuses on regulatory compliance for marketing the device. It discusses:

• The device's name and regulatory class.
• The determination of substantial equivalence to pre-amendment devices.
• General controls and potential additional controls applicable to the device.
• Information on marketing, labeling, and other regulations.
• The "Indications For Use" statement.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, ground truth, or expert involvement, as this data is not present in the provided document.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.

Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)

This document is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)" manufactured by Servicom Services Sdn. Bhd. It does not contain the detailed information necessary to answer the questions about acceptance criteria for a medical device's performance study.

The letter acknowledges the submission and states that the device is substantially equivalent to a legally marketed predicate device. The "Indications For Use" attachment specifies that the medical glove is used to prevent contamination between healthcare personnel and patients, and that it is a single-use disposable glove.

The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Information on experts or ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, as it's not relevant for this type of device.
6. Information on standalone algorithm performance (as it's not an algorithmic device).
7. The type of ground truth used (as it's not an AI/diagnostic device).
8. Sample size for a training set (as it's not an AI/diagnostic device).
9. How ground truth for a training set was established (as it's not an AI/diagnostic device).

Therefore, I cannot provide the requested information based on the provided text.

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