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The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.

The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Abdominal Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.

The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The Avance® Foam Abdominal Dressing Kit consists of the following components:

Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.

Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.

Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal.

A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.

The provided document describes the Avance® Foam Abdominal Dressing Kit, a negative pressure wound therapy device, and its acceptance criteria and performance data.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the functional and material property tests (e.g., how many kits were tested for vacuum level, drapability, etc.). It refers to "all test articles," implying a defined, but unquantified, test set.

For biocompatibility testing, the sample size or number of biological units tested for each component is not specified.

The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin details provided. However, the tests are laboratory-based performance and biocompatibility assessments, not human clinical trials.

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

This question is not applicable to the presented data. The acceptance criteria for this medical device are based on objective, quantifiable engineering and biological tests (e.g., vacuum levels, fluid transport rates, material strength, biocompatibility assays) and not on expert interpretation of observational data. Therefore, there's no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable to the presented data. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers or evaluators make subjective assessments that require consensus, such as interpreting medical images or clinical outcomes. The tests described are objective, laboratory-based physical and chemical 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

This question is not applicable. The device in question is a negative pressure wound therapy dressing kit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI's effect on human reader performance is not relevant.

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

This question is not applicable. The device is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

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

For the functional and material performance tests, the "ground truth" is established by the defined specifications and engineering standards for the device's operation. For example, a specific vacuum level range or a minimum tear strength might be the "ground truth" against which the device's performance is measured.

For biocompatibility, the "ground truth" is established by ISO 10993 standards and the biological responses observed in the in vitro and in vivo tests.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

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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:

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The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.

Here's a breakdown of the acceptance criteria and the study information for the Barrier® N95 Particulate Respirators, Models #4272 and #4273, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various standards and NIOSH certifications. The document states that the device "meets the requirements" of these standards and certifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting the requirements of established standards and NIOSH certifications. For example, for Fluid Resistance, it states it meets ASTM F1862, which would have its own defined sample sizes for testing. The data provenance is not explicitly mentioned as a specific "country of origin" for testing, but given the applicant is a US LLC and the submission is to the FDA, it is likely that testing adhered to US regulations or internationally recognized standards. The study appears to be retrospective in the sense that it relies on existing standardized tests and certifications rather than a new prospective clinical trial.

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

This information is not provided in the document. The "ground truth" for the performance characteristics is established by the methods, parameters, and pass/fail criteria defined within the referenced standards (e.g., ASTM F1862, NIOSH TC 84A-4350, 16 CFR 1610). These standards are developed by expert committees, but the specific number and qualifications of individuals involved in the testing that led to these results are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this submission. The "adjudication method" usually refers to how discrepancies are resolved when multiple human readers interpret data, often in medical imaging studies. Here, the performance is measured against objective technical standards which typically have clear pass/fail criteria, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was required." The clearance is based on substantial equivalence to a predicate device, supported by technical performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical N95 respirator, not an algorithm or AI system. The performance evaluated is that of the physical product itself.

7. The Type of Ground Truth Used

The ground truth used is primarily objective technical standards and certifications. These include:

• ASTM F1862 (for Fluid Resistance)
• NIOSH Certification Number (TC 84A-4350 for filtration efficiency and differential pressure)
• 16 CFR 1610 Standard for Flammability of Clothing Textiles
• Implied biological reactivity testing standards (for cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

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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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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:

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