(171 days)
Cardinal Health™ Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Cardinal Health™ Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Cardinal Health™ Gown is a single use, disposable medical device provided non-sterile.
The Cardinal Health™ Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Cardinal Health™ Isolation Gown is a single use, disposable medical device provided non-sterile. The Cardinal Health™ Isolation Gown is offered in two color (blue and yellow) models and each model is offered in two sizes for a total of four models. Each model is constructed of a nonwoven material and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
The provided text is a 510(k) Summary for the Cardinal Health™ Isolation Gown. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it details performance testing for a medical garment.
Therefore, for aspects related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance), the information is not applicable (N/A) because this document is about a physical medical device (an isolation gown), not an AI/algorithm.
Here's the breakdown of the information that is available or N/A based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for the Cardinal Health™ Isolation Gown are based on physical and barrier properties, primarily meeting AAMI Level 3 requirements as per ANSI/AAMI PB70:2012.
Table of Acceptance Criteria and Reported Device Performance
| Element of Comparison | Acceptance Criteria (Specification) - Proposed Device (Yellow/Blue) | Reported Device Performance - Yellow (Mean/Min/Max) | Reported Device Performance - Blue (Mean/Min/Max) |
|---|---|---|---|
| Basis Weight (oz/yd2) | Target Mean= 1.18, Mean min = 1.13, Mean max = 1.25 | Mean = 1.21, Ind Min = 1.19, Ind Max = 1.23 | Mean = 1.18, Ind Min = 1.15, Ind Max = 1.20 |
| Grab Tensile MD (lb) | N/A (MD Grab tensile not specified as limiting) | Mean = 24.38, Ind Min = 21.94, Ind Max = 26.28 | Mean = 22.23, Ind Min = 20.42, Ind Max = 24.03 |
| Grab Tensile CD (lb) | Target Mean = 16.00, Mean min = 14.00 | Mean = 14.54, Ind Min = 12.70, Ind Max = 16.45 | Mean = 14.18, Ind Min = 12.40, Ind Max = 15.76 |
| Trap Tear MD (lbs) | Target Mean = 5.40, Mean min = 3.60 | Mean = 4.74, Ind Min = 3.67, Ind Max = 5.47 | Mean = 4.40, Ind Min = 3.26, Ind Max = 5.54 |
| Trap Tear CD (lbs) | N/A (CD Trap Tear not specified) | Mean = 9.24, Ind Min = 7.54, Ind Max = 12.98 | Mean = 7.99, Ind Min = 6.64, Ind Max = 11.11 |
| Flammability | Class I | Class I | Class I |
| Hydrostatic Head (cm) | Body/Sleeve: Target Mean = 67, Mean min = 55, Ind Min = 52 | Body/Sleeve: Mean = 69, Ind Min = 56, Ind Max = 84 | Body/Sleeve: Mean = 72, Ind Min = 53, Ind Max = 80 |
| Water Impact (g) (AATCC-42) | Body/Sleeve: Target Mean = 0.10, Max = 0.5, Ind Max = 1.0 (mean values are the primary reference) | Body/Sleeve: Mean = 0.08, Ind Min = 0.05, Ind Max = 0.13 | Body/Sleeve: Mean = 0.08, Ind Min = 0.04, Ind Max = 0.13 |
| Liquid Barrier Performance Classification | Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012 | Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012 | Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012 |
| Biocompatibility | Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1 | Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1 | Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1 |
Study Information (as requested, with N/A for AI/algorithm-specific points)
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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 explicitly stated as a single "test set" sample size. The performance data tables provide "Mean", "Ind Min" (Individual Minimum), and "Ind Max" (Individual Maximum) for various physical tests, indicating multiple units were tested per property. For example, for Hydrostatic Head, "Ind Min" and "Ind Max" values are given, implying multiple samples were tested for each measure. No overall "test set" number is provided.
- Data Provenance: N/A for geographic origin or retrospective/prospective nature in the AI/algorithm sense. The tests were performed on "multiple lots" of the gowns.
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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)
- N/A. This refers to a physical product. "Ground truth" in this context is established by standardized physical and chemical testing methods (e.g., ASTM, AATCC, ISO standards), not expert interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for human-interpreted test results, not physical product performance testing.
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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
- N/A. This is a physical medical device (an isolation gown), not an AI/algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device (an isolation gown), not an AI/algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Physical Testing Standards: For the isolation gown, the "ground truth" or reference for acceptance is established by recognized international and national standards for barrier performance and material properties, such as ANSI/AAMI PB70:2012 (Liquid Barrier Performance and Classification of Protective Apparel and Drapes), AATCC 127 (Hydrostatic Head), AATCC 42 (Water Impact), and various ASTM standards for material strength (e.g., ASTM D3776 for Basis Weight, ASTM D5034 for Grab Tensile, ASTM D5587-15 for Trapezoidal Tear). Biocompatibility is assessed against ISO 10993-1.
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The sample size for the training set
- N/A. This is a physical medical device, not an AI/algorithm that requires a "training set."
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How the ground truth for the training set was established
- N/A. This is a physical medical device, not an AI/algorithm. The concept of "training set ground truth" is not applicable.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices 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 transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.