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Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user

Not Found

This FDA 510(k) clearance letter pertains to a surgical gown, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not present in the provided text.

The document discusses the regulatory clearance of a physical medical device: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets.

Here's what the document does provide regarding the device and its compliance:

• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical Apparel
• Regulatory Class: Class II
• Product Code: FYA
• Intended Use: To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
• Performance Standard: The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. This reference to AAMI Level 4 and ANSI/AAMI PB70 is the primary "acceptance criterion" mentioned, indicating the device's barrier performance.

Since this is a traditional medical device, not an AI/ML product, the questions related to AI/ML specific criteria (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

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Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.

Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.

The provided text is a 510(k) premarket notification for surgical gowns, which are physical medical devices. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical properties and barrier protection of the gowns.

Therefore, the concepts of acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training sets are not applicable in the context of this document. These concepts are relevant to the evaluation of AI/ML-driven software as a medical device (SaMD) or devices that incorporate such software, which rely on data analysis and interpretation.

The document describes the performance criteria for the surgical gowns, which are based on physical barrier protection standards.

Here's the relevant information from the document related to "acceptance criteria" and "device performance":

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not detailed in the provided document. The 510(k) summary (which is typically a separate document) or the full submission would contain details about the specific tests performed (e.g., synthetic blood penetration, hydrostatic pressure, impact penetration) and the number of samples tested to demonstrate AAMI Level 4 compliance. This involves physical testing of the gowns, not analysis of medical image data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for surgical gowns is established through standardized laboratory testing protocols, not by expert medical interpretation.

4. Adjudication Method

Not applicable.

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

Not applicable. This is relevant for diagnostic or interpretive AI/ML devices.

6. Standalone Performance Study

Not applicable in the context of a physical surgical gown. The "standalone performance" of the gown refers to its ability to meet the AAMI Level 4 barrier standards independently, which is what the submission attests to.

7. Type of Ground Truth Used

The "ground truth" for surgical gowns is defined by the objective, quantifiable results of standardized physical tests according to AAMI PB70:2012. This involves tests for fluid resistance, microbial barrier properties, etc.

8. Sample Size for the Training Set

Not applicable. Surgical gowns are physical devices; there is no "training set" in the AI/ML sense.

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

Not applicable.

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Convertors® Surgical gowns are made from natural and synthetic materials that are 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 transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.

SMS polyolefin, the standard, fabric and poly-reinforced gowns are comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

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

The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.

The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.

The provided text describes the Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, and O.R. Surgical Gowns. This document is a 510(k) summary for these surgical gowns, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for the device itself.

Therefore, much of the requested information regarding detailed performance studies, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, as typically found for AI/ML medical devices, is not present in this document because it pertains to traditional medical device clearance based on substantial equivalence.

However, I can extract the available information, particularly regarding the acceptance criteria as defined by the "performance attributes" being the same as the predicate devices, and the general testing conducted.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit numerical acceptance criteria and corresponding device performance values. Instead, the primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing predicate devices. This means that the new devices are considered safe and effective if their performance attributes are "the same" as the legally marketed predicate devices.

• Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices": Cytotoxicity, sensitization, and primary skin irritation were performed and found acceptable.
• Industry recognized test methods: Materials were tested and found acceptable for the intended use. (Specific tests/results are not detailed). |
  | Sterilization:
  Ability to withstand specified sterilization methods (Industrial Moist Heat Sterilization and Ethylene Oxide). | The single-use product is designed to be repackaged and sterilized prior to use. It may be sterilized using Industrial Moist Heat Sterilization (under ANSI/AAMI/ISO 11134) and Ethylene Oxide (under ANSI/AAMI/ISO 11135).
  However, the SMS polyolefin reinforced gown cannot undergo steam sterilization as it may damage the impervious reinforcement; Ethylene Oxide is the only method for this specific gown. |

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

• Sample Size: Not specified for the performance testing. The document states "All materials used in the fabrication of this Convertors® SMS Polyolefin Gowns... were evaluated through biological qualification safety tests" and "These materials also were tested in accordance with industry recognized test methods." The exact number of gowns or material samples tested is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily lab-based (biological and material performance tests). The country of origin of the data is not specified beyond being generated by Cardinal Health Inc.

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/not provided. The "ground truth" for this type of device clearance is generally established through adherence to recognized consensus standards for material properties and biological safety (e.g., ISO 10993) and comparison to predicate devices, rather than through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typical in diagnostic studies where multiple readers interpret images. This document describes material and biocompatibility testing.

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/not provided. MRMC studies are relevant for diagnostic devices that involve human interpretation assisted by AI. This document is for surgical gowns.

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

This information is not applicable/not provided. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Consensus Standards: Adherence to established standards such as ISO 10993 Part-1 for biological evaluation of medical devices.
• Industry Recognized Test Methods: Performance against established material and barrier property tests.
• Predicate Device Equivalence: The performance of the new gowns is considered "acceptable" because their intended use and performance attributes are "the same" as legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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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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The Convertors® Breathable 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 gowns are comprised of a single layer of spunlaced nonwoven fabric laminated to a breathable impervious film.

This document does not contain the requested information regarding acceptance criteria and a study proving device performance against those criteria.

The provided text is a 510(k) summary for a medical device (Convertors® Breathable Gowns). It focuses on:

• Device identification and classification.
• Statement of substantial equivalence to a predicate device based on similar intended use and performance attributes.
• Summary of biological qualification safety tests (cytotoxicity, sensitization, irritation/intracutaneous reactivity) conducted according to ISO 10993 Part-1. It states these materials were "found to be acceptable for the intended use" but does not define specific acceptance criteria or provide detailed performance data.
• FDA's response letter, confirming substantial equivalence and allowing the device to be marketed.

Missing Information:

The document lacks the following details typically expected for describing acceptance criteria and a study showing performance:

1. A table of acceptance criteria and reported device performance: While it mentions biological qualification tests, it doesn't specify numerical or qualitative acceptance criteria (e.g., "cytotoxicity level must be below X" or "no irritation observed in Y% of subjects") nor does it provide the results of these tests in a comparative format.
2. Sample size used for the test set and data provenance: No details on the number of samples or subjects used in the biological qualification tests, or the origin of this data (e.g., country, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: Not applicable for biological safety tests.
4. Adjudication method: Not applicable for biological safety tests.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device (surgical gown) and the described tests.
6. Standalone (algorithm only) performance: Not applicable as this is not an AI-powered device.
7. Type of ground truth used: Not explicitly defined beyond the "biological qualification safety tests" and "industry recognized test methods."
8. Sample size for the training set: Not applicable as this is not an AI-powered device.
9. How ground truth for the training set was established: Not applicable.

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