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The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.

Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.

This document describes the premarket notification (510(k)) for the StringKing Disposable Isolation Gown (K212633). This is a disposable medical device intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It is a Class II device and is not intended for use in the operating room.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for Level 3 barrier protection, along with other physical performance and biocompatibility standards.

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

• Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. However, it provides mean, min, and max values for various physical tests, implying multiple samples were used for each. For the hydrostatic pressure and impact penetration tests, the results include mean, min, and max values for "Fabric (body)", "Sleeve", and "Armhole", suggesting multiple measurements across different regions of the gown. For the armhole hydrostatic pressure, it mentions "Each lot tested had less than 4 failures", indicating testing across lots.
• Data Provenance: The tests were non-clinical performance data and biocompatibility tests. The document does not specify the country of origin where the tests were explicitly conducted. It is implied that these are lab-based tests. The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, based on the manufactured device.

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

• This device is a physical product (disposable isolation gown), not an AI/software device requiring human expert annotation for "ground truth". The "ground truth" for this device is established by its physical and biological performance against standardized, internationally recognized test methods (e.g., AAMI, AATCC, ASTM, ISO, CPSC).
• Therefore, the concept of "experts" to establish ground truth in the traditional sense of image interpretation or clinical diagnosis is not applicable here. The "experts" verifying the device's performance would be qualified lab technicians and engineers performing the standardized tests, and subsequently regulatory reviewers from the FDA.

4. Adjudication Method for the Test Set

• Not applicable. This is not an observational study requiring adjudication of interpretations. The tests are objective measurements of physical and biological properties.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document pertains to a disposable physical medical device (isolation gown), not a diagnostic or AI-assisted device.

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

• Not applicable. This is a physical medical device, not an algorithm or software. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective, standardized measurements and laboratory testing results as defined by:
  • ANSI/AAMI PB70:2012 (Liquid Barrier Performance Classification)
  • AATCC 127:2017 (Water Resistance: Hydrostatic Pressure Test)
  • AATCC 42 (Water Resistance: Impact Penetration Test)
  • 16 CFR Part 1610 (Flammability of Clothing Textiles)
  • ASTM D5587-15 (Tearing Strength of Fabrics by Trapezoid Procedure)
  • ASTM D5034 (Breaking Strength and Elongation of Textile Fabrics (Grab Test))
  • ASTM D1683 (Failure in Sewn Seams of Woven Fabrics)
  • ISO 10993-5:2009 (Biological Evaluation - In-Vitro Cytotoxicity)
  • ISO 10993-10:2010(R)2014 (Biological Evaluation - Irritation and Delayed-Type Hypersensitivity)

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the context of data used to train an algorithm. The device's manufacturing processes would be subject to quality control, but this is distinct from a "training set" for an AI model.

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

• Not applicable, as there is no "training set" in the AI/ML context for this physical device.

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The disposable surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device provided non-sterile.

The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.

The provided text describes the acceptance criteria and performance study for a Surgical Mask - Level 3 & Procedure Mask - Level 3. This is a medical device (PPE), not an AI/software device, so the requested information regarding AI-specific studies (experts establishing ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this submission.

Here is the information directly relevant to the acceptance criteria and study for this physical device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 (K202607)

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

The sample size is explicitly stated for the Level 3 Fluid Resistance test: 32 samples (32 Out of 32 pass). For the other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly provided in the summary, but the results are reported as meeting the criteria, implying sufficient samples were tested according to the respective standards.

Data Provenance: The data comes from non-clinical benchtop performance testing and biocompatibility testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying testing conducted to U.S. and international standards (ASTM, ISO). The testing is implicitly prospective, as it's conducted to demonstrate meeting the criteria for regulatory submission.

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

Not Applicable. This is a physical medical device (surgical mask), not an AI/software device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device is established through standardized laboratory testing protocols of its physical properties and biological compatibility.

4. Adjudication Method for the Test Set

Not Applicable. As this is a physical device tested against established engineering and biological standards, "adjudication" in the sense of expert review for ambiguous cases is not relevant. The results are quantitative measurements against defined thresholds.

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

No. MRMC studies are typically performed for AI or diagnostic devices where human reader performance is a key metric. This is a physical protective device. The study performed was non-clinical benchtop testing.

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

Not Applicable. This is a physical medical device. There is no algorithm to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements from standardized laboratory tests according to recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, ASTM F2100, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the test methods and the performance criteria for surgical masks.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Not Applicable. As there is no training set, there is no ground truth to establish for it.

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