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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

sempermed® SUPREME is a sterile powder-free surgeon's glove. It is a disposable device made of natural rubber inside coated with a layer of polyurethane derivatives, and butadiene-based copolymer cross-linked by polyacrylates- free of process, siliconized. This glove is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Water soluble protein less than 50 ug/dm2

The provided text is a 510(k) summary for a surgeon's glove and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. This document is for a physical medical device (surgeon's glove) and focuses on demonstrating substantial equivalence to a predicate device based on material and performance characteristics, not on a data-driven AI/ML model.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all specific to AI/ML device evaluations and are not applicable to the content provided.

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade

The provided text is a 510(k) summary for the Sempermed Derma Plus Powered Latex Surgeon's Gloves. The document states that the device is substantially equivalent to a predicate device, "Supreme" Sempermed® Latex Surgeon's gloves, powder-free (510k #K981096).

However, the 510(k) does not contain the specific detailed acceptance criteria and a study proving the device meets those criteria in a format that can be extracted into the requested table. Instead, it relies on a comparison of technological characteristics to establish substantial equivalence to the predicate device.

Here's an analysis based on the information provided regarding the requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria (e.g., minimum tensile strength, maximum protein content, AQL for pinholes) and numerical performance data for the Sempermed Derma Plus gloves to compare against those criteria.

Instead, it states:

• Performance: Identical (to the predicate device)
• Mechanical Safety: Identical (to the predicate device)
• Chemical Safety: Identical (to the predicate device)
• Biocompatibility: Identical (to the predicate device)
• Sterility: Identical (to the predicate device)

This implies that the device is expected to meet the same performance standards as the predicate device, but the specific numerical criteria and test results are not detailed in this 510(k) summary. The summary refers to "additional technical comparative table within 510K submission" for a more detailed comparison, which is not included in the provided text.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text, beyond the submitter's location (Vienna, Austria). There is no mention of retrospective or prospective study data for a primary test set. The claim relies on the identity of the physical and chemical properties of the device relative to the predicate device to establish equivalence.

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

This information is not applicable as the submission is a 510(k) for substantial equivalence of a physical medical device (surgical gloves). It does not involve diagnostic image analysis or similar tasks that would require expert-established ground truth. The "ground truth" here would be objective physical and chemical testing results, which are not detailed.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as 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:

This information is not applicable. This is a submission for a physical medical device (surgical gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

This information is not applicable. This is a physical medical device, not an algorithm or AI.

7. The type of ground truth used:

For a physical device like surgical gloves, the "ground truth" would typically refer to objective measurements of physical properties (e.g., tensile strength, elongation, barrier integrity assessed by leak tests, protein content) and chemical properties (e.g., types of materials used, powder content). The 510(k) summary indicates that the "Performance," "Mechanical safety," "Chemical safety," "Biocompatibility," and "Sterility" are "Identical" to the predicate device, implying that the ground truth for these aspects was established through appropriate testing methods for both the new device and the predicate. However, detailed results or the specific "type" (e.g., specific test standards or laboratory results) are not provided in this summary.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.

Latex patient surgeons 'gloves powderfree

Here's a breakdown of the acceptance criteria and study information for the Sempermed Latex Surgeons' Gloves, Powder-Free device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to meeting ASTM Standard D 3577-91 and EN 455/1-3 as the primary acceptance criteria. Specific performance items are listed under "Quality characteristics acc. ASTM D3577-91".

Notes on "Reported Device Performance": The document states "Sempermed powderfree surgeons gloves Supreme meets ASTM D 3577-91 and EN 455 standard but exceed FDA pinhole requirements (AQL 1,0)." This implies all listed criteria were met or exceeded, even if specific numerical results are not provided in this summary. The mention of attached test results further supports this.

Regarding Specific Study Details (as requested):

This document describes a 510(k) submission for a medical glove, which is a Class I device. The nature of testing for such devices, especially prior to 1998, focuses on compliance with established standards (like ASTM and EN) rather than complex clinical studies or AI-driven performance evaluations. Therefore, many of the requested details about advanced studies (like MRMC, standalone AI performance, large ground truth expert panels, and specific sample sizes for training/test sets common in AI submissions) are not applicable to this type of device and submission.

Here's an attempt to address the requested points based on the available information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of AI evaluation. For "Freedom from holes," it mentions "Sampling acc. ISO 2859 (att. 9 - 14/13)". ISO 2859 refers to acceptance sampling procedures, which involve statistical sampling plans to assess quality characteristics. The number of gloves sampled would depend on the lot size and the specific sampling plan used under ISO 2859.
• Data Provenance: The document refers to "Bioservice scientific Laboratories - Germany" for sterility testing. It's likely that other physical and chemical tests were performed internally by Semperit or by other specialized laboratories. The general provenance is Austria (Semperit's location) and Germany (for sterility).
• Retrospective or Prospective: This distinction is not relevant for the type of device testing described. These are laboratory-based, prospective tests on manufactured products.

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

• Not Applicable. The "ground truth" for the performance of these gloves is defined by the technical specifications of ASTM D 3577-91 and EN 455/1-3. Compliance is determined by objective physical, chemical, and sterility tests, not by human expert consensus or clinical judgment on a test set.

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

• None. Adjudication methods are used when there's subjective interpretation involved, typically in imaging or diagnostic AI. The tests for these gloves are 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:

• No. MRMC studies are for evaluating the impact of AI on human diagnostic performance. This device is a physical product (surgical glove), not an AI diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc):

• The "ground truth" is established by objective measurement against predefined physical, chemical, and sterility standards (ASTM D 3577-91 and EN 455/1-3). For example, "Freedom from holes" has a numerical definition (AQL 1.0) and "Tensile Strength" has a minimum MPa value.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI device for this submission. The manufacturing process of gloves is controlled to meet these standards.

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

• Not Applicable. As there's no training set for an AI model, this question is not relevant. The standards themselves were established by expert committees (e.g., ASTM, CEN) through scientific and technical consensus over time.

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