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ProPel SG3TM Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.

The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:

Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)

The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.

The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.

The provided text describes the non-clinical testing performed on the ProPel SG3™ Surgical Gown to demonstrate its equivalence to a predicate device. It is important to note that this is a 510(k) submission, which aims to show substantial equivalence, not necessarily a study proving clinical effectiveness in the same way a new drug or high-risk device might.

Here's the information requested, based on the provided text:

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

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

The document refers to non-clinical testing of the physical and biological properties of the surgical gown material and design. For each test, "specimens" or "gowns" would be used as samples. However, the exact sample size (N) for each specific test (e.g., number of gowns for tensile strength, number of fabric pieces for hydrostatic resistance, number of biological samples for cytotoxicity) is not explicitly stated in this summary. For Evaporative Resistance, it mentions "average of 3 specimens".

The data provenance (country of origin, retrospective/prospective) is not provided in this document. Given that it's non-clinical testing of a manufactured product, it is likely that the testing was performed in a controlled laboratory environment, but the location is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a non-clinical, laboratory-based study for a surgical gown. It does not involve medical imaging, diagnosis, or clinical decision-making by human experts where "ground truth" would be established by referring radiologists or other clinicians. The "ground truth" or "acceptance criteria" for these tests are based on established national and international standards (like ANSI/AAMI, ASTM, ISO, AATCC, 16 CFR, USP), which reflect a consensus of scientific and technical experts in materials science, biology, and medical device regulations. Therefore, this question is not applicable in the context of this device and study type.

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

Since this is non-clinical laboratory testing against predefined, objective standards, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations) is not applicable. The 'adjudication' is inherent in the test method itself, where results are measured objectively and compared against numerical acceptance criteria in a pass/fail manner.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is performed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a surgical gown, which is a physical barrier protection device. Therefore, an MRMC study and effects related to human reader improvement with AI assistance are not applicable. The document explicitly states "SUMMARY OF CLINICAL TESTING Not Applicable", further confirming no clinical effectiveness study (which would include MRMC) was performed.

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

This refers to the performance of an AI algorithm without human involvement. Since the device is a surgical gown and not an AI-powered diagnostic or assistive tool, this question is not applicable.

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

The "ground truth" for the performance claims of the surgical gown is based on established national and international standards and test methods. These standards define measurable physical and biological properties (e.g., tensile strength, tear strength, barrier performance, biocompatibility) and their respective acceptance criteria.

8. The sample size for the training set

This question typically applies to machine learning or AI models. Since this is non-clinical testing of a physical medical device (surgical gown), there is no "training set" in the context of an AI algorithm. The gown samples tested were used to demonstrate compliance with the specified performance standards.

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

As there is no "training set" for an AI algorithm in this context, this question is not applicable. The "ground truth" for evaluating the gown's performance was established by recognized industry standards and test methodologies.

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Standard Supreme Sterilization Wrappers are intended to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain steriity of the enclosed device until used.

Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by heath care facilities and/or contract sterilization/laundry companies.

Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.

This document describes the Standard Supreme Sterilization Wrappers, a medical device used to enclose other medical devices for sterilization and maintain sterility. The information provided is from an FDA 510(k) premarket notification summary (K172207).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size for each individual test (e.g., how many wrappers were tested for strength, linting, or sterile barrier). It only describes the tests performed and the outcomes.

The data provenance is retrospective, as this is a 510(k) summary submitted to the FDA, detailing testing that has already been completed. The country of origin of the data is not specified, but the applicant (Standard Textile Co., Inc.) is based in Cincinnati, Ohio, USA, suggesting the testing was likely conducted in the US or under US regulatory standards.

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

This information is not provided in the document. The tests described are non-clinical performance tests (e.g., ASTM standards, cytotoxic tests, sterilization efficacy tests). These types of tests typically rely on established protocols and laboratory measurements rather than human expert consensus for "ground truth" in the same way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical performance tests described. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) to establish ground truth or resolve discrepancies. The performance tests here appear to be objective measurements against established 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

This information is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and effects on human reader improvement with AI are irrelevant to this device.

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

This information is not applicable. The device is a physical product (a sterilization wrapper), not an algorithm or software. There is no algorithm-only performance to assess.

7. The Type of Ground Truth Used

The ground truth used for these tests appears to be:

• Established industry standards and test methods: e.g., ASTM #D-5034-2013 for strength, AATCC #61-1993(4A) for colorfastness, MEM Elution for cytotoxicity.
• Microbiological challenge studies: For sterilization efficiency/penetration, the "no growth of the indicator organism" serves as the ground truth for effective sterilization.
• Physical and material property measurements: Performance against specified thresholds for linting, strength, and use life.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The development and testing involve manufacturing and material science, not algorithm training.

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

This information is not provided and is not applicable for the same reasons as point 8.

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Barrier Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Barrier Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Barrier Supreme Sterilization Wrappers are made from Barrier Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric, dyed and treated with a fluoropolymer finish. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Barrier Supreme Sterilization Wrappers:

Please Note: The provided document is a 510(k) premarket notification summary for a medical device (sterilization wrappers), not a typical AI/software medical device submission. Therefore, many of the requested fields (like sample size for test set/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable or explicitly mentioned in this type of document, as it concerns a physical product and its non-clinical performance testing.

Acceptance Criteria and Reported Device Performance for Barrier Supreme Sterilization Wrappers

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table lists ">20 psi" for the predicate in the comparative table on page 6, but the specific test description on page 5 lists ">50 psi" for the Barrier Supreme product. This indicates the Barrier Supreme product met and exceeded the general strength requirement, likely derived from the predicate or industry standards.

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

• Sample Size: The document does not explicitly state the sample size (number of wrappers tested) for each specific test (e.g., how many wrappers were subjected to 75 cycles, how many were used in the whole package challenge). However, the language implies that testing was conducted on "Barrier Supreme Sterilization Wrappers" as a product line.
• Data Provenance: The tests are non-clinical performance tests, likely conducted in a laboratory setting by the manufacturer (Standard Textile Co., Inc.) or a contracted testing facility. The document does not specify a country of origin for the data beyond the manufacturer's location in Cincinnati, Ohio, USA. The studies are by nature prospective as they are simulating real-world use conditions to determine performance before market introduction.

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 this type of device submission. The "ground truth" for a physical product like sterilization wrappers is established through objective, measurable non-clinical performance tests (e.g., tensile strength, biological indicator results, linting measurements), not through expert consensus on interpretations of data or images.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging. For physical product performance, results are typically objective measurements against a predefined standard.

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. This is a submission for a physical medical device (sterilization wrap) and does not involve AI, human readers, or diagnostic interpretation.

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

• This question is not applicable. No algorithm or AI is involved in this device.

7. The Type of Ground Truth Used

• The "ground truth" for the performance of the Barrier Supreme Sterilization Wrappers is established through objective non-clinical performance test results. These include:
  • Laboratory measurements of physical properties (e.g., strength, linting).
  • Biological challenge tests (e.g., sterilization efficiency, cytotoxicity) with clear pass/fail criteria (e.g., "no growth of indicator organism," "non-toxic").
  • Simulated use cycles (e.g., 75 wash, dry, and sterilization cycles) to assess durability and continued sterile barrier effectiveness.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical medical device that undergoes non-clinical performance testing. Training sets are relevant for AI/machine learning models.

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

• This question is not applicable. As there is no training set for this type of device, no ground truth was established for it.

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ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.

All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

Here's an analysis of the provided information regarding the ComPel® 1-Ply Surgical Gowns, formatted to address your request:

Acceptance Criteria and Device Performance Study

The provided document describes the safety and effectiveness summary for ComPel® 1-Ply Surgical Gowns. This submission is for a medical device (surgical gowns) and the "device performance" refers to the gowns' physical properties and durability, rather than a diagnostic algorithm or AI. Therefore, concepts like "test set," "training set," "experts," and "ground truth" as they apply to AI/algorithm performance are not directly relevant in the context of this document. However, I can extract the acceptance criteria (standards/tests performed) and the reported device performance (successful completion of these tests).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided document for each specific test. However, the tests are applied to the "ComPel® 1-Ply Surgical Gowns" product. For durability, the claim is "through 125 complete cycles – wash, dry and sterilization," implying a sample of gowns was subjected to this number of cycles.
• Data Provenance: The document does not specify the country of origin where the tests were conducted. It is a submission by an American company (Standard Textile Company, Cincinnati, Ohio) to the U.S. FDA. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

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

• This is not applicable for this type of medical device submission. The "ground truth" is defined by the established standards and test methodologies (e.g., AATCC #127-1980, ASTM D-1682-75). The "experts" would be the accredited laboratories and technicians performing these standardized tests, who follow the documented procedures to determine if the product meets the specified criteria. Their qualifications are in conducting these specific material science and safety tests accurately.

4. Adjudication Method for the Test Set

• Not applicable in the context of product testing against material standards. The tests have defined pass/fail criteria, and results are typically determined by measurements and observations against those criteria, not by expert adjudication of subjective interpretations.

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

• No. This type of study is relevant for diagnostic devices or AI algorithms where human readers' performance is compared with and without AI assistance. This document describes physical product performance.

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

• No. This concept is not applicable. The device is a surgical gown, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is objectively defined by established engineering and material science standards and test methods. For example, a Suter Hydrostatic Test has a quantifiable pressure reading that determines barrier performance. Toxicity tests have specific indicators for cytotoxicity or irritation.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/algorithm. There is no concept of a "training set" for a physical product like a surgical gown.

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

• Not applicable. As there is no training set for a physical product, the method for establishing its "ground truth" is irrelevant in this context.

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ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids across critical areas of the gown.

When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable medical devices that are intended to be processed through 100 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.

All the components used in these ComPel® Gowns are made from 100% Dacron. All the ouripented acomPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Gowns will function as surgical attire when processed according to instructions through 100 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

This document describes the regulatory submission for the "ComPel 1-Ply Surgical Gowns." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices. The study conducted is a series of laboratory tests to confirm the physical properties and performance characteristics of the surgical gowns against established standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each individual test. It refers to "the tests that have been successfully completed," implying that a sufficient number of samples were tested to demonstrate compliance.

• Sample Size: Not specified in the provided text for individual tests.
• Data Provenance: The data is generated from laboratory testing of the ComPel 1-Ply Surgical Gowns, conducted by the manufacturer (Standard Textile Company 1). This is prospective data generation for the purpose of regulatory submission. The country of origin for the data generation would be the United States, as the manufacturer is based in Ohio.

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

This type of information is not applicable for this device. The "ground truth" for a surgical gown is adherence to established industry standards and test methods for physical and biological properties. These standards themselves are developed by expert consensus, but the testing itself does not require expert adjudication of "ground truth" for individual samples in the way a diagnostic AI might. The results are objective measurements against predefined thresholds within the standards.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective laboratory measurements against predefined standards. There is no human "adjudication" in the sense of multiple reviewers making subjective decisions. The results of the tests are either within the acceptance criteria for the standard or they are not.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation plays a significant role, often comparing AI-assisted human performance against unaided human performance. A surgical gown is a protective barrier, not a diagnostic tool requiring image interpretation or similar cognitive tasks.

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

No, a standalone algorithm performance study was not done. This device is a physical product (a surgical gown), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on performance against established industry standards and test methods.

• For barrier properties: Adherence to AATCC #127-1980 and AATCC 42-2000, which then correlates to a classification like "Level 2 Barrier" as per ANSI/AAMI PB70:2003.
• For physical properties (strength, durability, flammability, lint): Meeting thresholds defined in ASTM D-1682-75, CFR 1610, IST 160.0-83, and manufacturer's internal durability specifications (lasting 100 cycles).
• For biocompatibility: Meeting criteria in MEM Elution (MG023) and Primary Skin Irritation (FHSA).
• For sterilization: Compatibility with steam sterilization implies the material structure and performance are not negatively affected.

These standards and methods represent a consensus of scientific and technical understanding for the performance of surgical attire.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set." The materials used in the gowns (100% Dacron, fluorocarbon finish) are known materials with established properties.

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

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

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COMBOsafe/Promax Surgical Gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. COMBOsafe/Promax Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All fabric components used in COMBOsafe™ Surgical Gowns are made from 100% polyester. dyed blue and/or green and are laminated with a urethane film. COMBOsafe Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

This request is about a medical device and describes the information to be extracted from the provided text. The provided text is a 510(k) premarket notification for a surgical gown. However, the request asks for information relevant to an AI/ML powered device (e.g., sample size for training set, number of experts for ground truth, adjudication method, MRMC study). These concepts are not applicable to the traditional medical device described in the document.

Therefore, I cannot fulfill the request with the given input. The provided document does not contain any information about an AI/ML powered device, and thus cannot answer the questions regarding acceptance criteria, study design, or performance metrics for such a device.

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ComPel Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.

When processed according to instructions, ComPel Surgical gowns will function and perform as a surgical gown. The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles. The gowns are manufactured and distributed as non-sterile surgical gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

ComPel® 'O' Surgical Attire/Gowns. All the components used in ComPel® Surgical Gowns are made from 100% Dacron polyester filaments. ComPel 'O' fabrics are dyed and treated with a fluorocarbon finish. ComPel® 'O' Surgical Gowns will function as surgical attire when processed according to instructions through 75 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed (wash/dried) by health care facilities and/or contract sterilization/laundries companies. ComPel® 'O' Surgical Gowns are intended to be used as surgical attire in an operating theater. The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 2-ply gowns with the flat felled seam design are classified as a Level 2 Barrier.

This document is a 510(k) premarket notification for surgical gowns and does not contain information about a device that uses AI or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, study details, expert involvement, or AI-specific performance metrics.

The document discusses the physical properties and intended use of ComPel® Surgical Gowns, including:

• Device Name: ComPel® Surgical Gowns
• Intended Use: To be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids.
• Classification: Level 2 Barrier per ANSI/AAMI PB70:2003 standard.
• Durability: Reusable through 75 complete cycles (wash, dry, and sterilization).
• Materials: 100% Dacron® polyester filaments, treated with a fluorocarbon finish.
• Tests Successfully Completed: Suter Hydrostatic Testing, Impact Penetration Testing, Flammability, Durability, Strength, Lint, Toxicity (Cytotoxicity, Primary Skin Irritation), Compatibility with Steam Sterilization.

The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use as a device already on the market.

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ComPel MLR Surgical gowns are medical devices that are intended to be worn by operating room personnel to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.

When processed according to instructions, ComPel MLR Surgical gowns will function and perform as a barrier through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns and are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All fabric components used in ComPel® 3000 Surgical Gowns are made from 100% polyester, solution luble outer for the outer ComPel 3000 layer and non-dyed filaments with carbon yarns for the inner layer, and are treated with a fluorochemical finish.

ComPel® 3000 Surgical Gowns will function as a surgical attire when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

ComPel® 3000 Surgical Gowns are intended to be worn by personnel functioning in the surgical theater and will be put in all critical areas of the product where liquid protection is needed. The liquid barrier properties with minon the migrated "inverted" 2-ply sleeve designs are classified as a Level 3 Barrier.

The provided text describes the ComPel MLR™ Surgical Gowns, but it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it details the safety and effectiveness summary for a physical medical device (surgical gowns) and its regulatory clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to a diagnostic algorithm.
• Sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details for a diagnostic algorithm.

The document discusses performance criteria for the surgical gowns themselves, such as barrier performance after 75 wash/dry/sterilization cycles, and lists various physical and material tests. These are not applicable to the AI/ML-focused questions you've asked.

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TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

The provided text is a 510(k) summary for the TriMax Surgical Gown. It outlines the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not describe acceptance criteria in quantifiable terms or a comparative study as typically performed for diagnostic or AI-driven medical devices.

The document focuses on claiming substantial equivalence to a predicate device (ComPel XTR® Surgical Gowns #K922753) based on the performance of the gown materials and the gown itself after undergoing a specified number of processing cycles. The "acceptance criteria" here are implied through successful completion of standardized material and product performance tests.

Here's an attempt to extract the requested information, acknowledging that some fields may not be directly applicable or fully detailed given the nature of a 510(k) for a surgical gown:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria (Implied by success)": For a 510(k) of this nature, the demonstration of "success" in meeting the requirements of recognized standards is the primary form of acceptance criterion. The document states "The tests that have been successfully completed include:", indicating that the device met the performance thresholds defined by each respective standard.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of gowns tested for viral resistance or durability). It broadly states that the gown "will function as surgical gowns... through 75 complete wash, dry and sterilization cycles," implying a test sample was put through this process, but the number of units is not quantified.
• Data Provenance: Not specified. However, the tests are against international (ISO) and US (ASTM, AATCC, CFR) standards, suggesting the testing was performed in compliance with these regulations. It does not mention country of origin for the data or if it was retrospective or prospective, as these are typically not relevant for material performance tests of this type.

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

• Not Applicable. This type of information (experts establishing ground truth) is typically relevant for diagnostic devices where human interpretation is involved. For a surgical gown, the "ground truth" is based on objective, standardized physical and material performance tests. The standards themselves are generally developed by expert committees, but there isn't a "ground truth" established by individual experts for this specific test set.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in diagnostic or imaging studies. For objective material performance tests, the outcome is determined by the test protocol and measurement, not by expert consensus or adjudication.

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

• No. An MRMC study is relevant for evaluating the impact of a system (often AI) on human reader performance in tasks like diagnosis or detection. This is not applicable to a surgical gown, which is a physical barrier device. The document does not describe any human reader involvement.

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

• Yes, in spirit, but not in the context of an algorithm. The tests described are "standalone" in the sense that they evaluate the gown's material properties and performance objectively, without human intervention in the outcome assessment (beyond conducting the test and recording results). There is no "algorithm" involved, as this is a physical medical device, not a software or AI product.

7. The Type of Ground Truth Used

• The ground truth used is primarily objective physical and chemical testing against established industry and regulatory standards. This includes:
  • Material properties: Flammability, strength, lint.
  • Barrier performance: Viral resistance, hydrostatic pressure.
  • Biocompatibility: Cytotoxicity, systemic toxicity, skin irritation.
  • Durability and integrity: Performance after repeated processing cycles.
  • The "ground truth" is defined by the passing criteria of the specific ASTM, AATCC, EDANA, ISO, and CFR standards cited.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not an AI/ML algorithm or software. Therefore, there is no "training set" in the computational sense. The product's design and manufacturing processes are refined through engineering and material science, not through machine learning.

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

• Not Applicable. As there is no training set for an algorithm, there is no ground truth established for it. The performance of the gown itself is proven through the testing detailed in Section 7.

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ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective other of Dargious such as to isolate a site of surgical incision from microbial and other contamination.

ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. Com of Dargical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic. ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

The provided text describes a 510(k) summary for "ComPel Surgical Drapes and Covers," a non-sterile, reusable surgical drape. The document outlines various performance tests and does not focus on a standalone algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, sections related to AI performance, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable to this document.

Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual test. It merely states that the tests were "successfully completed."
• Data Provenance: Not explicitly stated, but the tests refer to established international and national standards (e.g., AATCC, ASTM, ISO, CFR) which imply laboratory testing rather than data from human subjects or retrospective studies from specific countries.

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

• This information is not applicable. The device's performance is measured against established scientific and engineering standards and test methods, not against expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations in medical studies, which is not relevant for physical and chemical performance testing of a medical device like a surgical drape.

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 information is not applicable. This document describes a physical medical device (surgical drape), not an AI-powered diagnostic or assistive tool.

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

• This information is not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth in this context is defined by the established performance specifications and limits within the referenced national and international standards (e.g., specific hydrostatic pressures for barrier performance, acceptable lint levels, non-toxic classifications, strength thresholds, and functional integrity after a certain number of processing cycles).

8. The sample size for the training set:

• This information is not applicable. There is no machine learning or AI component described that would require a training set.

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

• This information is not applicable. There is no machine learning or AI component described.

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