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The Surgical Face Mask is 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(s), provided non-sterile.

The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.

The provided text describes the regulatory clearance for a Surgical Face Mask (K222529). This is a medical device, not an AI/ML-driven device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML systems (such as expert consensus, MRMC studies, training set details, or an 'algorithm only' performance) are not applicable.

The acceptance criteria here pertain to the physical and performance characteristics of the surgical face mask, comparing it to established industry standards (ASTM, ISO, EN, CFR) for medical face masks. The study proving the device meets these criteria is a non-clinical performance and biocompatibility testing.

Here's the information extracted from the provided text, adapted to the requested format where applicable, and noting when a requested AI/ML specific criterion is not relevant to this type of device:

Device Name: Surgical Face Mask (Xiantao Rayxin Medical Products Co., Ltd.)
Regulatory Classification: Class II Surgical Apparel (Product Code FXX, 21 CFR 878.4040)
Predicate Device: Surgical Face Mask (K212368, Anhui Tiankang Medical Technology Co., Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Synthetic Blood Penetration: 32 samples per test condition for each of 3 lots.
• Other Performance Tests (PFE, BFE, Delta P, Flammability): Specific sample sizes are not explicitly stated for each of these, but performance is reported as averages or 'Pass' implying multiple samples were tested to demonstrate compliance with the standards.
• Biocompatibility Tests: Sample sizes are not explicitly stated.
• Data Provenance: The tests appear to be laboratory performance tests, not clinical data from patients. The sponsor, Xiantao Rayxin Medical Products Co., Ltd., is based in China. The specific location where these tests were performed is not detailed, but it would typically be a certified testing laboratory. The data is based on prospective testing of the manufactured devices to the specified standards.

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

• Not applicable. This is a hardware device where ground truth is established through standardized laboratory measurements and physical properties, not human interpretation or expert consensus. The "ground truth" is defined by the performance standards themselves (e.g., a specific percentage filtration, a specific pressure differential).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3. Testing involves objective measurements against established physical and chemical standards, not subjective interpretations requiring adjudication.

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

• No. This is not an AI/ML-assisted diagnostic device, so an MRMC study is not relevant. The device's effectiveness is based on its physical barrier properties and breathability, not its ability to assist human readers.

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

• No. This is a physical product (surgical face mask), not an algorithm or software. The concept of "standalone performance" for an algorithm is not applicable here.

7. The Type of Ground Truth Used:

• Standardized Physical and Chemical Measurements & Definitions: Ground truth is defined by the requirements of the specific ASTM, ISO, EN, and CFR standards referenced. For example, "Level 1 pass at ≥95%" for BFE means that any value of 95% or higher, as measured by the ASTM F2101 method, constitutes a 'pass'. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" phase.

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

• Not applicable. See point 8.

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The Disposable Ultra Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile

The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

The provided document describes the K173847 Disposable Ultra Reinforced Surgical Gown, for which a 510(k) premarket notification was submitted. The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison to a predicate device and non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by being "same or better performance to the predicate device" (K170762 Cardinal Health Surgical Gown) and meeting specific industry standards.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gowns tested for tensile strength, hydrostatic pressure, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests conducted by the manufacturer, Xiantao Rayxin Medical Products Co., Ltd., and a third party, and is prospective as these tests were conducted on the proposed device to support its submission.

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 as the evaluation of the surgical gown is based on objective, standardized physical and biological performance tests (e.g., tensile strength, fluid resistance, biocompatibility) rather than subjective expert interpretation or ground truth establishment typically associated with diagnostic or image-based devices. The "ground truth" for these tests is defined by the specific parameters and limits set by the referenced international and national standards (e.g., AAMI PB70:2012, ASTM, ISO).

4. Adjudication method for the test set

This information is not applicable. As stated above, the evaluation relies on objective measurements against defined standards, not on subjective assessments requiring adjudication among experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a surgical gown, which is a physical medical device, not an AI or diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI component.

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

The "ground truth" for the performance of the surgical gown is based on objective measurements against established national and international standards for material properties, barrier protection, and biocompatibility. These include:

• AAMI/ANSI PB70:2012: Liquid Barrier Performance and Classification of Protective Apparel and Drapes
• ISO 10993 Series: Biological Evaluation of Medical Devices (Part 5: Cytotoxicity, Part 10: Irritation and Skin Sensitization, Part 7: Ethylene oxide sterilization residuals)
• ASTM F2407-06: Standard Specification For Surgical Gowns
• CPSC 16 CFR Part 1610: Standard for the Flammability of clothing textiles
• AATCC 127-2014: Water Resistance: Hydrostatic Pressure Test
• AATCC 42-2013: Water Penetration Resistance: Impact Penetration Test
• ASTM D5034-09: Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ASTM D5587-15: Tearing Strength of Fabrics by Trapezoid Procedure

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.

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

This information is not applicable as there is no training set for this 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(s), provided non-sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.

The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

This document describes the premarket notification (510(k)) for a Disposable Surgical Face Mask, and as such, it does not detail a study involving AI or human reader performance for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Therefore, many of the requested criteria related to AI/human reader studies, expert ground truth, adjudication, and large-scale data sets for training/testing are not applicable to this type of device and submission.

However, I can provide the information that is available in the document regarding the acceptance criteria and the study that proves the device meets them, primarily focusing on its physical and biological performance characteristics.

Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)

The acceptance criteria for this medical device are based on demonstrating that the proposed Disposable Surgical Face Mask is substantially equivalent to a legally marketed predicate device (K133070 Surgical Face Mask). This is primarily achieved through non-clinical testing against established industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM F2100-11 for Level 2 classification, MIL-M-36945C, 16 CFR 1610, and ISO 10993 standards for biocompatibility. The reported device performance is the result of the non-clinical tests conducted on the proposed device.

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