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This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

Airlife Demand Nasal Cannula

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "Airlife Demand Nasal Cannula," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: Airlife Demand Nasal Cannula
• Regulation Number/Name: 21 CFR 868.5905, Oxygen Conserving Devices
• Regulatory Class: II
• Product Code: 73 NFB
• Indications For Use: "This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle."

However, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Information on standalone algorithm performance.
5. The type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed technical report or study summary. Therefore, I cannot fulfill your request based on the provided text.

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The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.

The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.

The provided text describes a 510(k) submission for the Allegiance Healthcare Corporation's Airlife® Misty Max 10™ Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, many of the requested details, such as acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, data provenance for AI model development, expert qualifications, and adjudication methods for ground truth, are not applicable to this type of regulatory submission. The document explicitly states that the substantial equivalence is based on the same intended use and similar performance attributes to the predicate device.

However, I can extract the information that is present and explain why other requested information is not available in this document.

Acceptance Criteria and Device Performance (as interpreted for a 510(k) submission for a non-AI medical device):

Detailed Information (as per your request, with explanations for missing data):

1. A table of acceptance criteria and the reported device performance:

   • See table above. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence by showing the new device is as safe and effective as a legally marketed predicate device, meeting relevant material safety and performance benchmarks. The performance is reported in terms of meeting those standards and being comparable to the predicate.

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

   • Not applicable / Not provided. This document does not detail specific sample sizes for clinical "test sets" in the context of an AI/diagnostic algorithm testing. The testing described is primarily focused on material safety (biological compatibility) and comparative physical performance (particle size distribution) of the nebulizer hardware, not a diagnostic algorithm. Therefore, concepts like data provenance (country, retrospective/prospective) are not relevant here.

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 / Not provided. "Ground truth" in the context of expert consensus or pathology for a diagnostic algorithm is not relevant to this submission for a simple medical device (nebulizer). The "truth" here is established by standardized material and device performance tests.

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

   • Not applicable / Not provided. Adjudication methods are typically used for establishing consensus ground truth in studies involving subjective assessment (e.g., image interpretation). This is not relevant to the described testing for a nebulizer.

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. An MRMC study is not mentioned. This is a submission for a pneumatic nebulizer, not an AI-assisted diagnostic tool.

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

   • No. This is not an algorithm; it is a physical medical device.

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

   • Not applicable / Not provided in these terms. The "ground truth" for this device would be established through objective, standardized test methods for material safety (ISO 10993 Part-1) and physical performance (particle size distribution), as well as comparison to the established performance of the predicate device. There is no subjective "ground truth" established by experts or pathology in this context.

8. The sample size for the training set:

   • Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning model.

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

   • Not applicable / Not provided. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a legacy class II medical device (nebulizer) seeking clearance based on substantial equivalence to a predicate device. It demonstrates performance through standard engineering and biocompatibility testing rather than clinical study designs focused on diagnostic accuracy or AI performance metrics. Therefore, most of the specific questions geared towards AI/diagnostic device evaluation are not applicable or answered within this type of regulatory submission.

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The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

These drapes will be comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Several drapes will also have clear polyethylene side panels on either end of the drapes.

The provided text describes a 510(k) premarket notification for "Convertors® Trilaminate Drapes." This document focuses on the substantial equivalence to a predicate device and safety testing for the materials used. It does not describe a study that involves acceptance criteria for device performance based on a test set, expert ground truth, or human reader performance.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI performance cannot be extracted from this document, as they are not present.

Here's a breakdown of what the document does provide in relation to your request format:

1. A table of acceptance criteria and the reported device performance

• Not applicable. The document does not describe acceptance criteria in terms of device performance metrics for a specific function or a study comparing performance against such criteria. It describes safety testing of the materials.

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

• Not applicable. There is no "test set" described for device performance. The testing mentioned is for the materials used in the drapes.

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. No ground truth establishment for a performance study is mentioned.

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

• Not applicable. No adjudication method for a performance study is mentioned.

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 document is for a physical medical device (surgical drapes), not an AI/software device that would involve human readers or AI assistance.

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, not an algorithm.

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

• Not applicable. No ground truth for a performance study is mentioned. The "ground truth" here would relate to the established standards for biocompatibility and material properties, not diagnostic or clinical accuracy.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/software device.

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

• Not applicable.

Information that is available regarding testing (for materials, not device performance):

• Summary of testing: "All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use."

This indicates that the device met safety requirements by adhering to ISO 10993 Part-1, which specifies standards for biocompatibility. The specific numerical acceptance criteria or detailed results of these tests (e.g., specific cytotoxicity values, sensitization indices) are not provided in this summary. The "reported device performance" in this context refers to the materials meeting the requirements of these biological safety tests.

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The Disposable Semi-Automated Temno® Biopsy Device is a system used for tissue sampling from several different organs, including, but not limited to, the Kidney, Liver, Breast and Prostate.

This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.

Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.

The provided text is a 510(k) summary for the Disposable Semi-Automated Temno® Biopsy Device, indicating its substantial equivalence to a predicate device. This type of regulatory document focuses on establishing equivalence and does not contain information about acceptance criteria, detailed study designs, or performance metrics typically found in clinical studies or validation reports.

Therefore, I cannot provide the requested information from the given input. The document explicitly states:

• "Performance attributes are the same" as the predicate device, but does not quantify these attributes or provide acceptance criteria.
• "Summary of testing: All materials used in the manufacturing of the Disposable Semi-Automated Temno® Biopsy Device have been evaluated as outlined in the ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The materials were found to be acceptable for this intended use." This refers to biocompatibility testing, not performance testing of the device's efficacy in obtaining tissue samples.

To answer your questions, I would need a different type of document, such as a detailed pre-clinical or clinical study report, or a validation plan that explicitly defines performance metrics and their acceptance criteria.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.

Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.

This document is a 510(k) Summary of Safety and Effectiveness for "Positive Touch Powder-Free Latex Examination Gloves With Protein & Chemotherapy Labeling Claim." As such, it reports on a device, not an algorithm or AI. Therefore, most of the requested fields are not applicable.

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

The document does not specify the sample sizes used for each of the tests (e.g., how many gloves were tested for barrier defects, how many animals for irritation/sensitization). The data provenance is internal to the manufacturer, Allegiance Healthcare Corporation, based in McGaw Park, Illinois, USA. The study is prospective in nature, as it is a pre-market notification for a medical device.

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

Not applicable. This is a medical device (gloves), not an AI/algorithm-based diagnostic or prognostic tool that requires expert interpretation for establishing ground truth. The tests are laboratory and physical performance tests against established standards.

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and physical measurements, not subjective evaluations requiring 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 a medical device (gloves), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (gloves), not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-01 (Standard Specification for Rubber Examination Gloves) for physical characteristics (elongation, tensile strength, barrier defects, powder level).
• 21 CFR §800.20 (Barriers) for barrier defects.
• ASTM 5712-95 (Standard Test Method for Protein in Natural Rubber Latex Devices) for protein content.
• ASTM F 739-99a (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact) for chemotherapy drug resistance.
• Standard toxicological testing methods (Primary Skin Irritation, Guinea Pig Maximization) for biocompatibility.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/Machine Learning model that requires a training set. The "training" here refers to the development and manufacturing processes of the glove to meet specified standards.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's manufacturing and design would be the specifications and performance requirements derived from the standards listed above.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for "Primary Skin Irritation" and "Guinea Pig Maximization" are implicitly derived from the reported results, as the document states the gloves "do not display any potential for irritation" (which, for Guinea Pig Maximization, typically implies no sensitization).

Regarding the device and study described, it's important to note the following based on the provided text:

This submission is for a medical device (examination gloves), not a diagnostic AI/imaging algorithm. Therefore, many of the requested categories related to AI studies, like MRMC studies, ground truth establishment by experts, and training/test set details, are not applicable to this type of device. The "study" here refers to standard performance testing for a physical product.

Here's an attempt to address the remaining points as best as possible given the nature of the device:

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

• Sample Size: Not explicitly stated in the provided text for any of the tests. Standard ASTM and regulatory testing typically involves specific sample sizes, but these are not disclosed here.
• Data Provenance: Not explicitly stated. For physical product testing, this typically means the samples were manufactured and then tested according to established protocols. It is assumed to be prospective, as the testing was done on the device prior to marketing approval.

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

• Not Applicable. For physical product testing like gloves, "ground truth" is established through standardized laboratory tests (e.g., measuring tensile strength using a machine, or observing skin reactions in animal models), not by human experts interpreting data.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data (e.g., medical images). For physical product testing, results are objective measurements or observations during laboratory procedures.

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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Ultimate Elongation & Tensile Strength and Barrier Defects: The "ground truth" is based on the objective physical and chemical properties of the glove as measured by standardized industrial and regulatory test methods (ASTM D3578-01, 21 CFR §800.20).
• For Primary Skin Irritation and Guinea Pig Maximization: The "ground truth" is based on the biological response of test subjects (e.g., animals for sensitization, human volunteers for irritation if not animal-based) under controlled laboratory conditions.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI model, so there is no "training set."

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

• Not Applicable. There is no training set for this type of device.

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The Convertors®Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

The drapes are comprised of a base layer of nonwoven material to which the absorbent reinforcement structure is laminated.

The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documents do not contain information on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for Convertors® Surgical Drapes. The testing described is general and refers to adherence to "industry recognized test methods."

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 document refers to "industry recognized test methods" for biocompatibility and general performance, implying standardized protocols rather than expert consensus on specific cases.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (surgical drapes) and the type of testing described (biocompatibility, general performance), a traditional adjudication method for a "test set" as understood in AI/diagnostic device studies is unlikely to be applicable.

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

No MRMC comparative effectiveness study is mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant to the evaluation of surgical drapes.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical product (surgical drapes), not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the device's performance appears to be established through adherence to industry recognized test methods for biocompatibility (cytotoxicity and primary skin irritation) and general performance attributes. This likely involves laboratory measurements and assessments against established chemical and physical standards.

8. Sample Size for the Training Set

No information regarding a "training set" or its sample size is provided. This concept is typically relevant for machine learning algorithms, not for physical medical devices like surgical drapes.

9. How Ground Truth for the Training Set Was Established

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

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

This document describes the safety and effectiveness of "Nitrile Powder-Free Examination Gloves" and does not relate to artificial intelligence or machine learning devices. Therefore, most of the requested information (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods, details about AI-related ground truth) is not applicable to this submission.

However, I can extract and present the information that is relevant to the acceptance criteria and the summary of testing for these medical gloves.

Acceptance Criteria and Device Performance for Nitrile Powder-Free Examination Gloves

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):

• Sample Size: Not specified in the provided document for any of the tests.
• Data Provenance: Not specified. Standard practice for these tests is typically prospective testing of manufactured batches.

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 as this is not an AI/ML device requiring expert ground truth for interpretation of complex data. The "ground truth" for glove performance tests is determined by standardized physical and biological testing methodologies.

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

• Not applicable. These are laboratory tests with objective outcomes based on established standards, not subjective interpretations requiring 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/ML device.

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.

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

• The "ground truth" is established by the specified standards and regulations:
  • Primary Skin Irritation & Guinea Pig Maximization: Biological tests to assess skin reactions, interpreted by trained personnel following toxicological guidelines (implied).
  • Tensile Strength: Objective measurement against specifications defined in ASTM D6319-00a.
  • Barrier Defects: Objective measurement against specifications defined in 21 CFR§800.20 (Pinholes in Medical Gloves) and ASTM D6319-00a.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of Safety and Effectiveness Explanation (Based on Provided Text):

The "Nitrile Powder-Free Examination Gloves" were determined to be substantially equivalent to the predicate device (Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.) based on shared characteristics and testing results. The device's safety and effectiveness were demonstrated by laboratory testing confirming:

• No primary skin irritation.
• No potential for irritation in a guinea pig maximization test.
• Conformity to or exceeding the tensile strength requirements of ASTM D6319-00a.
• Conformity to or exceeding the barrier defect requirements of 21 CFR§800.20 and ASTM D6319-00a.

These tests ensure the gloves perform their intended function of preventing contamination and protecting the wearer, without causing adverse biological reactions, and meet the mechanical and barrier integrity standards for medical examination gloves.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

The provided text describes a 510(k) premarket notification for "Nitrile Powder-Free Examination Gloves" by Allegiance Healthcare Corporation. It is a submission for a medical device that does not involve AI or algorithms, and therefore, many of the requested categories are not applicable.

Here's the information based on the provided text, indicating "N/A" (Not Applicable) for categories that pertain to AI/algorithm-based devices:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not specified, as this is a physical device rather than an AI/data-driven one. The tests are for physical properties and biocompatibility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility tests would be established through standardized testing protocols executed by designated laboratory personnel, not clinical experts for ground truth in the AI sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The tests involve objective measurements and observations against established standards, not 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: Not applicable, as this is not an AI-assisted device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:

   • Biocompatibility tests (Skin Irritation, Guinea Pig Maximization): "No irritation" or "no potential for irritation" as determined by standardized biological evaluation methods.
   • Tensile Strength: Measurements meeting specified values in ASTM D6319-00a.
   • Barrier Defects: Compliance with defect limits set in 21 CFR §800.20 and ASTM D6319-00a.

7. The sample size for the training set: Not applicable, as there is no training set for a physical device like examination gloves.

8. How the ground truth for the training set was established: Not applicable.

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The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms. body fluids and particulate material.

The Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.

The submission for the Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific quantitative performance acceptance criteria. Therefore, much of the requested information regarding detailed study methodology, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable to this type of submission for this particular device.

However, based on the provided text, I can extract the following relevant information 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:

• The document mentions "All materials used in the fabrication of this Convertors® Breathable Gowns were evaluated". This indicates material-level testing rather than a patient- or case-based "test set" in the context of AI/diagnostic devices. The sample size for material testing (e.g., number of material samples) is not specified.
• Data provenance is not specified (e.g., country of origin). The testing is described as in accordance with "industry recognized test methods."

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

• Not applicable. This device is a surgical gown, and its evaluation focuses on material properties and biocompatibility, not on diagnostic accuracy requiring expert interpretation of medical images or data. Ground truth for biocompatibility is typically established through standardized laboratory tests.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as in diagnostic imaging. Biocompatibility tests have objective endpoints.

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 surgical gown, not an AI-powered 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 gown), not an algorithm or AI system.

7. The type of ground truth used:

• For biocompatibility tests, the ground truth is established by the results of standardized biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices." This includes objective measurements for cytotoxicity, sensitization reactions, and irritation/intracutaneous reactivity.
• For performance attributes, the "ground truth" is adherence to industry-recognized test methods for material properties, which are then compared to the predicate device.

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device (surgical gown) and does not involve machine learning or a "training set."

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

• Not applicable. See point 8.

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