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The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.

I am sorry, but the PDF provided does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA regarding "Surgeon's Glove Powder Free" and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/device performance study.

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A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's

Latex Surgeon's Gloves Pre-Powdered Sterile

The provided document is a 510(k) summary for "Latex Surgeon's Gloves Pre-Powdered Sterile" from PT. MAJA AGUNG LATEXINDO. It details the device's characteristics, performance criteria, and a statement that the performance data meets these criteria.

Here's an analysis to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It refers to "Inspection Level S-4" and "S-2" and "AQL" values for performance characteristics, which imply sampling plans were used according to standards like ASTM or ISO, but the exact number of units tested is not provided.
• Data Provenance: The data appears to be from the manufacturer, PT. MAJA AGUNG LATEXINDO, based in Indonesia. The nature of the data (retrospective or prospective) is not specified, but it represents testing conducted to demonstrate compliance with standards.

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

This information is not provided in the document. The established ground truth for performance characteristics is based on objective measurements and adherence to ASTM D 3577 and FDA requirements, rather than expert consensus on subjective findings.

4. Adjudication method for the test set

This information is not provided in the document. Given the objective nature of the tests (dimensions, tensile strength, elongation, watertightness, sterility), an adjudication method in the context of expert review would likely not be applicable. The results would be a direct measurement against the specified criteria.

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 MRMC study was done. This device is a physical product (latex surgeon's gloves), not an AI-assisted diagnostic or therapeutic tool. Therefore, a study comparing human reader performance with or without AI assistance is not applicable.

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

• Not applicable. As the device is a physical product, there is no algorithm or AI component to perform in a standalone manner.

7. The type of ground truth used

The ground truth used for this device is based on objective measurement against established industry standards and regulatory requirements.

• ASTM D 3577 Standard: For dimensions and physical properties.
• FDA pin hole requirement: For watertightness.
• Sterility Assurance Level: For sterility.
  These are well-defined, quantitative standards.

8. The sample size for the training set

• Not applicable. This device is a physical product; there is no machine learning model or algorithm that requires a "training set" in the conventional sense. The product design and manufacturing processes are likely informed by industry experience and engineering principles rather than a data-driven training set.

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

• Not applicable. As explained above, there is no training set for this type of device. The "ground truth" for ensuring the quality of the manufacturing process would be established through quality control procedures, adherence to Good Manufacturing Practices (GMP), and material specifications, all designed to meet the performance standards.

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Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.

Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.

The device being described is a Surgeon's Glove manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The acceptance criteria and performance data are primarily based on the ASTM D3577-91/95 specifications for latex surgeon's gloves.

Here's the breakdown of the information requested:

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

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for tensile strength testing, number of gloves for hole testing). It refers to "SARI Value" and "Performance Test Data," suggesting internal testing by the manufacturer.
• Data Provenance: The data is retrospective, generated by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, a company located in Nagercoil, Tamil Nadu, S. India. It represents their internal testing results for the purposes of a 510(k) submission to the FDA.

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

• Number of Experts: Not applicable. The ground truth is established by adherence to a recognized international standard, ASTM D3577-91/95, which defines the specifications for surgeon's gloves. The "Pioneer Manikandan Buildings" entity appears to be the manufacturer, not an expert panel for ground truth assessment.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This type of study does not involve human expert adjudication in the traditional sense. The device's performance is objectively measured against a predefined technical standard (ASTM D3577).

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This is a technical performance study for a physical medical device (surgeon's gloves), not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical product (surgeon's gloves), not an algorithm or software. Its performance is measured directly through physical and chemical tests.

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

• Type of Ground Truth: The ground truth is established by existing regulatory standards and technical specifications, specifically the ASTM D3577-91/95 for latex surgeon's gloves. This standard defines the required physical and chemical properties.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's evaluation, as it is not a machine learning model. The manufacturer would have internal quality control and manufacturing processes that produce gloves meeting the specifications, but this isn't a "training set" in the AI sense.

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

• Ground Truth for Training Set: Not applicable (as per point 8). The manufacturing process and quality control would be geared towards consistent production of gloves that adhere to the ASTM D3577 standards.

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Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.

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

Device: Surgeon's Glove (Latex, Powdered with Absorbable Dusting Powder) manufactured by Shiva Medicare Limited.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main sets of criteria: Technological Characteristics and Performance Requirements.

Conclusion of Performance Test Data: The document explicitly states:

• "The Surgeon's gloves manufactured by Shiva Medicare Limited"
• "Meet or exceed the ASTM D3577"
• "Meet FDA Pin hole Requirement."
• "Meet labelling claim as shown by the data in 6 -" (presumably referring to section 6.0, intended use).

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 (length, width, tensile strength, etc.). It provides 'values' for characteristics and 'levels followed' (e.g., S4, S2) for performance requirements, which are typically associated with sampling plans (e.g., ISO 2859). However, the exact number of units tested for any given parameter is not provided.

The data provenance is retrospective, as it refers to performance data obtained from manufacturing processes already completed by Shiva Medicare Limited. The origin of the data is India (Chennai, specifically, where Shiva Medicare Limited is located).

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

Not applicable. This device is a medical glove, not a diagnostic or AI-driven device requiring expert adjudication for ground truth. The "ground truth" here is defined by the objective physical and chemical properties and performance standards outlined in ASTM D3577 and FDA requirements.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI or diagnostic study requiring expert adjudication. The assessment is based on direct measurement and comparison to established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., medical imaging AI) where human readers interpret cases, and the AI's impact on their performance is measured. This document pertains to a physical medical device (surgical gloves).

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used:

The ground truth used is based on International Standards and Regulatory Requirements. Specifically:

• ASTM D3577: Standard specification for rubber surgical gloves. This provides the objective, measurable criteria for physical dimensions and mechanical properties.
• USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility requirements.
• FDA Requirements: For aspects like pinhole (freedom from holes), protein content, moisture content, and biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. There is no AI model, and thus no "training set" for this device. The data presented are from product testing and quality control processes.

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

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by consensus standards organizations (like ASTM) and regulatory bodies (like FDA), which define the required physical, chemical, and performance attributes for the product.

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The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.

Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right). Available in sizes 6, 6½, 7, 7½, 8, 8½, 9. Made from Natural Rubber Latex, Sulphur, Zinc Oxide, ZDEC, ZDBC, Titanium Dioxide, Antioxidant (Styrenated Phenol), and Absorbable Corn Starch. Designed to comply with the physical measurements of ASTM D 3577.

The provided document describes a 510(k) submission for Surgeon's Gloves (SUR-G GLOV®) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI-based device. Therefore, many of the requested elements for an AI device study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable and not present in this document.

However, the document does contain information regarding the performance characteristics of the gloves, which can be interpreted as acceptance criteria based on the ASTM D 3577 standard.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is compared against the ASTM D 3577 (91) standard. This standard serves as the acceptance criteria for various physical characteristics of surgeon's gloves.

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

The document states "A test certificate of the above is in Appendix B." but Appendix B is not provided in the extracted text. Therefore, the specific sample sizes used for testing these performance characteristics are not available. The data provenance (country of origin, retrospective/prospective) is also not available from the provided text.

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

Not Applicable. This is a physical device (surgical gloves), and its performance is measured against established engineering and material standards (ASTM D 3577), not by expert interpretation or ground truth derived from expert consensus.

4. Adjudication method for the test set

Not Applicable. As per point 3, the assessment is against a standard, not expert 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 not an AI-based device, and therefore, no MRMC study or AI assistance is relevant.

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

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to the ASTM D 3577 standard for surgical gloves, which defines acceptable physical properties.

8. The sample size for the training set

Not Applicable. This is not an AI device that requires a training set. The gloves are manufactured and tested against specifications.

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

Not Applicable. No training set is relevant for this device. The "ground truth" (i.e., the standard specifications) for manufacturing and testing are established by ASTM International.

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