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The Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The proposed device, the Biogel PI Indicator Underglove is manufactured of polyisoprene colored with blue pigmentation. The Biogel PI Indicator Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device that has been legally marketed by Molnlycke Health Care for many years with the addition of a surfactant.

This describes the Biogel® PI Indicator® Underglove, a surgical glove. As a Class I device, it is subject to general controls and does not require extensive clinical studies or complex acceptance criteria typically seen with higher-risk medical devices or AI-powered diagnostics.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "No clinical data was required." This indicates that the device's performance was evaluated against established standards for surgical gloves, rather than through
comparative clinical trials with human subjects.

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

• Sample Size: The document does not specify the exact sample size used for each test (Dimensions, Physical Properties, Freedom from Holes, Biocompatibility, LAL Test). It only states that the device "Meets" the respective ASTM and ISO standards. These standards themselves specify sampling plans and test methodologies.
• Data Provenance: Not specified. The testing was likely conducted in a lab setting by the manufacturer or a contracted lab to confirm compliance with the standards.

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

This is not applicable as the evaluation is based on objective physical and chemical testing against established engineering standards (ASTM, ISO), not on expert subjective assessment or medical diagnosis.

3. Adjudication method for the test set:

This is not applicable. The assessment is based on objective measurements against pass/fail criteria defined by the ASTM and ISO standards. There is no subjective interpretation requiring adjudication.

4. 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. This device is a surgical glove, not an AI-powered diagnostic or decision-support system. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

This is not applicable. This device is a physical product (surgical glove), not a software algorithm.

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

The "ground truth" used for this device's acceptance is adherence to established industry standards and regulatory requirements for surgical gloves (ASTM D3577, ISO 10993-1, ASTM D7102) via objective physical and chemical testing. These standards define the acceptable performance characteristics for devices of this type.

7. The sample size for the training set:

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

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

This is not applicable for the same reason as above.

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The Biogel® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Biogel® OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Brown Surgical Glove to provide the user with this additional feature: Slightly Curved Former with Independent/Displaced thumb.

The document describes the Biogel® OrthoPro® Brown Surgical Glove.

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):

The document does not specify the sample sizes used for the performance tests (Primary Skin Irritation, Sensitization, Dimensions, Physical Properties, Freedom from Holes, Protein Extractables, Powder Residual). It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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):

Not applicable. The ground truth for this medical device (surgical gloves) is established through standardized performance testing against recognized ASTM and CFR standards, not through expert consensus in a diagnostic sense.

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

Not applicable. As noted above, the ground truth is established through standardized testing, 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-assisted diagnostic device; it is a surgical glove.

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 based on established, objective, and quantitative performance standards outlined in:

• ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
• 21 CFR 800.20 (Listing and Labeling of Articles for Sanitary Purposes - pertaining to freedom from holes for gloves)
• ASTM D5712 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Latex Products Using the Modified Lowry Method)
• ASTM D6142 (Standard Test Method for Residual Powder on Medical Gloves)

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 device is evaluated through direct performance testing against established standards.

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

Not applicable, as no training set is relevant for this device.

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The Biogel Orthopedic Surgeon's Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Biogel Orthopedic Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical effectiveness with extensive studies. As such, many of the requested elements (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) are not relevant or typically included in such filings for this class of device.

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:

• Sample Size: Not specified. For this type of device and regulatory pathway, testing typically involves validating against specified ASTM and ISO standards. These standards define the sampling plans and testing methodologies.
• Data Provenance: Not specified, but generally refers to in-house laboratory testing following established international standards (ASTM, ISO).

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 performance characteristics of surgical gloves is established by objective, standardized laboratory tests according to ASTM and ISO specifications, not by expert consensus on individual cases.

4. Adjudication method for the test set:

• Not applicable. Performance is measured objectively through lab tests against predefined specifications, not through adjudication of expert opinions.

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 surgical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not applicable. This device is a physical product (surgical glove), not an algorithm.

7. The type of ground truth used:

• The "ground truth" is defined by the objective thresholds and methodologies specified in the ASTM D3577 standard for surgical gloves, ISO 10993-1 for biocompatibility, and LAL test standards for endotoxin levels, along with the specified protein content limit. These are laboratory-derived, validated standards.

8. The sample size for the training set:

• Not applicable. This device is manufactured to meet specifications, not "trained" like a machine learning model.

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

• Not applicable. See point 8.

Summary of Study (Performance Data):

The performance data presented in the 510(k) summary are derived from testing the Biogel Orthopedic Surgical Glove against established industry standards. The manufacturer states that the device was tested to meet the requirements of:

• ASTM D3577: This standard specifies the requirements for rubber surgical gloves, covering aspects like dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
• ISO 10993-1: This standard covers biological evaluation of medical devices, ensuring biocompatibility.
• LAL Test: This test measures endotoxin levels. The device met the requirement of <0.25 EU/ml (non-pyrogenic claim).
• Protein Content Claim: The glove contains 50 micrograms or less of total water extractable protein per gram, meeting its specific labeling claim.

The submission concludes that "No clinical data was required" because the device demonstrated substantial equivalence to predicate devices (K980516 and K060030) based on these technological characteristics and performance data against recognized standards.

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The Biogel® Sensor™ Surgeon's Glove is a sterile disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel® Sensor™ Surgeon's Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The provided document is a 510(k) summary for the Biogel® Sensor™ Surgeon's Glove. This device is a Class I surgical glove, which is a low-risk device. As such, the "study" demonstrating its performance is primarily based on meeting established industry standards for surgical gloves, rather than complex clinical trials or AI-specific validation studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The Biogel® Sensor™ Surgeon's Glove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate devices cited in this 510(k) summary." For protein content, the device name explicitly includes "Protein Content Labeling Claim (50 micrograms or less)," indicating it meets this claim.

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

The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). For surgical gloves, compliance with ASTM and ISO standards typically involves standardized testing of batches of gloves, but the specific sample sizes for these tests are not provided in this summary.

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

This is not applicable. For surgical gloves, the "ground truth" is adherence to established engineering and material science standards (ASTM D3577, ISO 10993-1) and specific chemical limits (LAL test, protein content) rather than expert interpretation of a clinical dataset. These standards define objective pass/fail criteria.

4. Adjudication method for the test set

Not applicable. As noted above, the evaluation is based on objective measurements against established standards, not on expert adjudication of subjective assessments.

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 (surgical glove), not an AI algorithm or an imaging/diagnostic tool requiring human reader studies.

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

Not applicable. This is a physical medical device (surgical glove), not an algorithm.

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

The "ground truth" for this device is based on objective measurements against established national and international standards for surgical gloves (ASTM D3577 and ISO 10993-1) and specific chemical assays (LAL test for endotoxins, protein content for extractable proteins). It's a materials science and manufacturing quality ground truth, not a clinical diagnostic or pathology ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there's no AI model or training set, this question is not relevant.

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