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The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

This document does not contain information about an AI/ML device, nor does it provide the specific details required to complete your request about acceptance criteria and study data for an AI/ML device.

The document is a 510(k) summary for a Barrier EasyWarm Active Self-Warming Blanket, a medical device intended to prevent hypothermia by providing warmth to patients. It discusses modifications to a previously cleared device (K132048).

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample sizes, data provenance, or details about test and training sets for an AI/ML device.
3. Information on experts or adjudication for ground truth for an AI/ML device.
4. MRMC studies or effect sizes for AI assistance.
5. Standalone performance for an AI algorithm.
6. Types of ground truth for AI.

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The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.

Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.

Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.

• . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
• . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
• . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
• . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds

Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.

Avance Solo NPWT System is intended for adults.

The provided text is a 510(k) summary for the Avance Solo Negative Pressure Wound Therapy (NPWT) System. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed.

However, the request asks for information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for test sets.
5. MRMC comparative effectiveness study results (human readers improve with AI vs without AI assistance).
6. Standalone (algorithm only) performance.
7. Type of ground truth (consensus, pathology, outcomes).
8. Training set sample size and ground truth establishment.

The provided document does not contain information related to AI/algorithm performance, human reader studies, or how ground truth for an AI model would be established (e.g., expert consensus, pathology). It focuses on the safety and effectiveness of a physical medical device (a Negative Pressure Wound Therapy system) through bench testing, biocompatibility, software validation, and electrical safety testing.

Therefore, I cannot fulfill the request using only the provided text as it does not describe an AI medical device or a study of the type requested (e.g., MRMC, standalone algorithm performance).

Specifically, the document states:

• "No clinical data was provided to support substantial equivalence." (Page {8})
• It describes "Non-Clinical Testing" which includes:
  • Biocompatibility
  • Bench testing (fluid transport, pressure delivery, alarm functionality, device lifetime, pressure safety)
  • Software validation (IEC 62304)
  • Electromagnetic compatibility and electrical safety testing (various IEC/AAMI standards)
  • Human factors/usability testing.

The "Bench testing" section does mention acceptance criteria were met, but it does not provide a detailed table, sample sizes for "test sets" in the context of an AI model, expert involvement for ground truth, or MRMC studies as it pertains to the performance of a physical device.

If the request implies that the provided text describes an AI device or a study involving an AI component, that is incorrect. The device is a traditional medical device for wound therapy.

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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 Max NPWT pump and its accessories.

The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.

This document describes a 510(k) premarket notification for the Avance Abdominal Dressing Kit. It is not an AI/ML device, and therefore does not contain information about acceptance criteria for AI/ML performance, study details for AI/ML models, or ground truth establishment.

Based on the provided text, here's what can be extracted regarding the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" but does not quantify the number of tests or samples.
• Data Provenance: Not applicable. This is bench testing, not patient data from a specific country or collected retrospectively/prospectively.

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" here refers to pre-defined engineering and biocompatibility standards, not expert interpretations of medical data.

4. Adjudication method for the test set

• Not applicable. Performance was assessed against pre-defined technical 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

• Not applicable. This is not an AI/ML device; therefore, no MRMC study with human readers and AI assistance was conducted or discussed.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance relates to the dressing kit's physical and functional properties, evaluated during bench testing.

7. The type of ground truth used

• Engineering and Biocompatibility Standards: The ground truth for this device's performance evaluation were established engineering specifications for fluid transport and ISO 10993-1 standards for biocompatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. No training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is based on established medical device standards and engineering principles.

Summary relevant to the prompt:

This document describes a medical device undergoing 510(k) clearance, which is a process to demonstrate substantial equivalence to a legally marketed predicate device. The evaluation focuses on the device's physical and functional properties, as well as its biocompatibility. It is not an AI/ML device, hence most of the questions related to AI/ML specific criteria (like training/test sets, expert adjudication, MRMC studies, etc.) are not applicable. The studies mentioned are "non-clinical testing" focusing on ISO standards and bench testing for fluid transport.

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The Biogel® PI Micro 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 subject device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic polyisoprene material (not made from natural rubber latex).

The provided text describes a 510(k) summary for the Biogel® PI Micro Indicator Underglove (K150146). This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI algorithm or its performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to this document as it pertains to a physical medical device (surgical glove) and not an AI/ML-driven device.

However, I can extract the acceptance criteria and reported device performance related to the physical characteristics and biocompatibility of the surgical glove.

1. Table of Acceptance Criteria and Reported Device Performance

Details Not Applicable to this Document:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device, not an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the results of standardized physical and biological tests on the glove material.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI algorithms, not a physical surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For physical characteristics and biocompatibility, the ground truth is established by the specified ASTM and ISO standards for measuring these properties (e.g., tensile strength, hole detection via water leak test, irritation response).
8. The sample size for the training set: Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

This submission is primarily comparing a new physical device (Biogel® PI Micro Indicator Underglove) to a previously cleared predicate device (Biogel® PI Indicator® Underglove) based on established regulatory standards for surgical gloves.

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The Avance® NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject device of this submission, the Avance Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® is an offering of components developed for negative pressure wound therapy. These dressing kits which are intended for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac ViewPad™ and Mepitel® is a combination of different components developed and arranged to meet the needs of the clinician for specific size and types of wounds.

The provided document is a 510(k) summary for the Avance® Foam Dressing Kits. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance criteria for a novel device. As such, it does not contain the information requested in points 1-9 of your prompt.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance details.
3. Information on experts used to establish ground truth.
4. Details on any adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results from a standalone algorithm-only performance study.
7. Details on the type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for a training set.
9. How ground truth for a training set (if any) was established.

Instead, the document states:

• Performance Data: "The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac® ViewPad™and Mepitel® perform in the same manner as the predicate device kits (K122132) and are compatible with a similar type of pump. The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior. The fluid was efficiently transported from the wound model without lockage or problems. The system was tested over the time period of 73 hours without any problems or errors."
• Clinical Testing: "No clinical data was required."
• Conclusion: The device is substantially equivalent to the predicate device(s) identified with respect to intended use, materials (with the exception of ViewPad™ Materials), design and technological characteristics.

To obtain the detailed information requested regarding acceptance criteria and specific study results (especially for performance metrics, sample sizes, and ground truth establishment), you would typically need to consult a full 510(k) submission or a scientific publication related to the device, which are not provided in this excerpt. This document is a summary designed to state substantial equivalence, not to provide deep technical validation details.

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Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject devices are disposable powder-free surgical gloves that are supplied sterile and are not made from natural rubber latex. They have been tested for use with chemotherapy agents. The Biogel® PI UltraTouch™ G surgical gloves are made from synthetic polyisoprene material and the Biogel® SkinSense® surgical gloves are made from synthetic polychloroprene material. The gloves have been previously 510(k) cleared through K050184 and K053102 respectively.

Here's a breakdown of the acceptance criteria and study information for the Biogel® PI UltraTouch™ G Surgical Glove and Biogel® SkinSense® Surgical Glove, based on the provided document:

This document is a 510(k) Pre-Market Notification, specifically addressing the addition of an "intended use claim" for "Tested for use with Chemotherapy Drugs" to existing surgical gloves. Therefore, the "device" in question refers to the performance of these gloves when exposed to chemotherapy agents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the testing standard ASTM D6978, which is "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs". The reported device performance is the "Breakthrough Detection Time" for various chemotherapy drugs. A longer breakthrough time indicates better protection. The document primarily compares the subject devices to predicate devices.

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for breakthrough times (e.g., "must be greater than X minutes"). Instead, the performance is presented to demonstrate substantial equivalence to predicate devices, which are also marketed for chemotherapy drug protection. The implied acceptance is that the subject devices perform at least as well as, or better than, the predicate devices, particularly for comparable "Breakthrough Detection Times." The "Summary of features and technological characteristics" table (pages 9-10) states that the intended use is supported by these permeation breakthrough times and "Comparisons are made between the subject devices and predicate devices that are currently 510(k) cleared and marketed for this specific use."

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

• Sample Size: The document does not specify the exact number of gloves or replicates tested for each chemotherapy agent. It only states that "Permeation testing was conducted... according to ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."
• Data Provenance: Not specified, but generally, such testing for FDA submissions is performed by accredited laboratories. The document does not indicate the country of origin of the data or whether it was retrospective or prospective, as this type of in-vitro testing is typically performed prospectively in a lab setting.

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

This is not applicable to this study. The "ground truth" for this device is established through an objective, standardized chemical permeation test (ASTM D6978), not through human expert assessment or clinical judgment. The "truth" is the measured breakthrough time of the chemical through the glove material.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication for chemical permeation testing.

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

No, an MRMC study was not done. This study is an in-vitro chemical permeation test of gloves, not an AI or human reader performance study.

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

This concept is not applicable to the device being described. The device is a surgical glove, and the study evaluates its physical/chemical barrier properties, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is the measured chemical permeation breakthrough time according to the standardized test method ASTM D6978. This is a form of objective, quantitative laboratory measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device. The testing conducted is for physical and chemical properties of a product.

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

Not applicable, as there is no training set.

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The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The BARRIER® EasyWarm® Active Self-Warming Blanket is a disposable blanket 152 x 92 cm in size. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its' packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air.

Here's the analysis of the BARRIER® EasyWarm® Active Self-Warming Blanket based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for BARRIER® EasyWarm® Active Self-Warming Blanket

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, side-by-side format. However, based on the Evaluation of Device Performance section, the implicit acceptance criteria and the device's reported performance can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Clinical Study:

  • Sample Size: Not explicitly stated for the test set. It mentions "Subjects in the BARRIER® EasyWarm® treatment arm" and "subjects in the control treatment arm," indicating a patient population, but the specific number is not provided.
  • Data Provenance: The clinical study was described as a "prospective multi-center randomized controlled clinical study." This indicates that data was collected specifically for this study with a forward-looking design, and from multiple locations (centers). The country of origin is not specified.

• Independent Non-Interventional Evaluation:

  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated, but it's a separate evaluation.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

• The document does not mention the use of experts to establish a ground truth for the clinical study's primary outcomes (core body temperature, incidence of hypothermia, adverse events). These outcomes are typically measured directly or observed by medical staff involved in the study rather than being adjudicated by external experts in the way that, for example, imaging studies might require.
• The independent non-interventional evaluation involved determining average and maximum skin temperatures, which would likely be measured by instruments. There is no mention of experts establishing ground truth for this.

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned. Given the nature of the primary endpoints (core body temperature, incidence of hypothermia, adverse events), these are typically direct measurements or clinician observations, rather than requiring expert adjudication of complex interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly done. The clinical study performed was a randomized controlled clinical study comparing the device (treatment arm) to a control arm to assess effectiveness in maintaining core body temperature and reducing hypothermia. This is a common and appropriate study design for medical devices that directly impact physiological parameters.
• The concept of "human readers improving with AI vs. without AI assistance" is not applicable to this device, as it is a physical warming blanket, not an AI-assisted diagnostic or interpretative tool.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a physical active self-warming blanket. It does not employ an algorithm or AI that would have a "standalone" performance. Its performance is directly tied to its physical interaction with the patient.

7. Type of Ground Truth Used

• For the clinical study, the ground truth was based on direct physiological measurements and clinical observations:
  • Core body temperature: Measured directly.
  • Incidence of hypothermia: Defined and observed based on measured core body temperatures.
  • Adverse events: Clinically observed and reported.
• For the independent non-interventional evaluation, the ground truth for skin temperature was based on direct temperature measurements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the conventional sense. The "training" for such a device would be its design, manufacturing, and testing to meet performance specifications.

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

• Not applicable. As mentioned above, there is no "training set" for this type of device. The extensive "bench testing" conducted (temperature characteristics, rise time, duration) characterizes the device's physical performance, similar to how a product's specifications are verified, but it's not a "training set" for an algorithm.

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The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, 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 OrthoPro® Brown Surgical Glove is manufactured of non-latex (polyisoprene) colored with brown pigmentation. The Biogel® Pl 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. The differences in the proposed glove and the predicate are as follows:

• Addition of a Brown Colorant .
• Thicker Glove .
• New Former .
  The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature:
• Slightly Curved Former with Independent/Displaced thumb ●

Here's an analysis of the acceptance criteria and supporting study for the Biogel® PI OrthoPro® Brown Surgical Glove:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or dimensions). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The general phrasing "Results generated values" suggests data collection was performed to derive these values.

3. Number of Experts and Qualifications for Ground Truth

This device is a surgical glove, which falls under Class I medical devices and undergoes performance testing against established standards (ASTM, CFR). There is no indication that human expert review for establishing "ground truth" (in the typical sense of diagnostic imaging or clinical assessment) was required or used in these performance tests. The ground truth for these tests is defined by the objective metrics and thresholds within the cited ASTM and CFR standards.

4. Adjudication Method

Not applicable. As noted above, the assessment relies on objective measurement against predefined standards, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a surgical glove. MRMC studies are typically used to evaluate the effectiveness of diagnostic devices or AI algorithms in clinical decision-making with human readers.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical product (surgical glove), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on established industry standards and regulatory requirements, specifically:

• ASTM D3577: Standard Specification for Rubber Surgical Gloves.
• 21 CFR 800.20: Regulations related to barrier integrity for gloves (implied for "Freedom from Holes").
• ASTM D6142: Standard Test Method for Residual Powder on Medical Gloves.

These standards define the acceptable physical properties, dimensions, and integrity requirements for surgical gloves.

8. Sample Size for the Training Set

Not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The manufacturing process and quality control would involve ongoing testing and process adjustments, but not a dataset used for AI model training.

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

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

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The Skinsense Polyisoprene Underglove is a disposable device made of non-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 Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

This document is a 510(k) summary for a medical device called the "Skinsense Polyisoprene Underglove." It describes characteristics and performance data related to physical properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For the LAL Test, the acceptance criterion specifically states "<0.25 EU/ml" which is also presented as the reported performance, implying this is the established threshold.

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

The document does not specify the exact sample sizes used for testing each characteristic. It lists the tests performed (e.g., Cytotoxicity Study, ISO Skin Irritation Study, LAL Test, and conformance to ASTM D3577 for Dimensions, Physical Properties, and Freedom from Holes). The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It is implied that these are lab-based tests 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 document describes performance testing against established standards (ASTM D3577) and biocompatibility tests, not the interpretation of complex data requiring expert consensus for a "ground truth" in the way it might for AI diagnostic tools. Therefore, the concept of "number of experts used to establish the ground truth" with specific qualifications is not applicable in this context. The "ground truth" is defined by the objective criteria within the ASTM standard and the pass/fail thresholds for the biocompatibility tests.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The performance is determined by objective measurements against predefined standards and thresholds.

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 a study of an AI-assisted diagnostic device, but rather a
summary for a surgical glove.

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

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

7. The type of ground truth used

The "ground truth" for the performance data in this document is defined by:

• Established Industry Standards: ASTM D3577-01-ae2, which specifies requirements for various characteristics of surgical gloves.
• Biocompatibility Test Pass/Fail Criteria: Standardized protocols for Cytotoxicity, ISO Skin Irritation, and LAL (Endotoxin) tests with defined pass/fail thresholds.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

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

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The Biogel Eclipse Indicator Underglove 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 Eclipse Indicator Underglove 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 text describes a 510(k) submission for a surgical glove (Biogel Eclipse Indicator Underglove). This document does not contain information about an AI-powered medical device or any study that would typically include the requested details about acceptance criteria for AI performance, sample sizes, expert adjudication, or MRMC studies.

The "performance data" section in the K071414 510(k) summary refers to the device meeting physical and chemical characteristics of a surgical glove as per ASTM standards, not the performance of an AI algorithm. The device is a physical product (a glove), not a software or AI diagnostic tool.

Therefore, I cannot fulfill your request as the input document is not about an AI-powered device or a study of its performance. The fields you've requested (such as sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are irrelevant to this particular device and its review process.

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