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These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Esteem Sterile Polyisoprene Surgical Gloves with Coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.

This document pertains to the 510(k) summary of safety and effectiveness for the Esteem Sterile Polyisoprene Surgical Gloves with Coating. The information provided focuses on the physical and biological characteristics of the gloves, and therefore, many of the requested criteria regarding AI/algorithm performance are not applicable.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the 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 (e.g., number of gloves tested for barrier defects, number of animals for skin irritation/sensitization). The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated, but it can be inferred that these are standard laboratory tests conducted by the manufacturer, Cardinal Health, likely in the US where the 510(k) application was made.

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 to the evaluation of surgical gloves. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ASTM standards, CFR regulations) and laboratory measurements, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. The tests involve objective measurements against predefined standards. There is no mention of adjudication in the context of interpretation or consensus building.

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 medical device (surgical gloves), not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-related performance metrics are irrelevant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the performance of these surgical gloves is based on:

• Established Industry Standards: ASTM International (e.g., D3577-01 for rubber surgical gloves, D6124-00 for residual powder).
• Regulatory Requirements: 21 CFR §800.20 related to barrier defects.
• Biological Testing Standards: Methods for evaluating skin irritation and sensitization (e.g., Guinea Pig Maximization Test).
  These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a training set.

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

Not applicable, as there is no training set for this type of device.

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These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Powder-Free Sterile Synthetic Surgical gloves are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.

The provided document describes the safety and effectiveness of "Esteem Sterile Polyisoprene Surgical gloves," which are powder-free, sterile, synthetic surgical gloves. The study summarized in the document is a series of tests to demonstrate substantial equivalence to a predicate device, "Duraprene Powder-Free Sterile Synthetic Surgical Gloves." This is a premarket notification (510(k)) submission to the FDA.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the 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)

The document does not specify the sample sizes used for any of the tests. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device (surgical gloves), these tests would typically be laboratory-based and conducted prospectively to evaluate the physical and biological properties of the manufactured gloves.

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 a diagnostic device or a device where "ground truth" is established by human expert interpretation in the way it is for imaging or clinical decision support AI. The "ground truth" for surgical gloves is defined by recognized industry standards (ASTM, CFR) and biological safety assessments. Therefore, the concept of "experts establishing ground truth for the test set" with specific qualifications (like a radiologist) is not applicable here. The tests themselves are the "truth" against established scientific and regulatory benchmarks.

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

Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or clinical endpoints where there might be disagreement. This is not relevant for the objective laboratory and biological tests conducted for surgical gloves. These tests yield quantitative results that are then compared against predefined 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

An MRMC comparative effectiveness study is not applicable as this is a device (surgical glove), not an AI algorithm for interpretation or diagnosis.

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

This question is not applicable as the device is a physical product (surgical glove), not a standalone AI 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:

• Industry Standards: ASTM D3577-00, ASTM Standard D6124-97
• Regulatory Requirements: 21 CFR §800.20
• Biological Safety Assessments: Intracutaneous Reactivity and Guinea Pig Maximization tests, which rely on established methods for assessing biocompatibility.

8. The sample size for the training set

This question is not applicable as this is a physical device, not an AI model that requires a training set.

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

This question is not applicable as this is a physical device, not an AI model that requires a training set.

Ask a specific question about this device