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Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃
Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
For size212, 1515, 1818, maximum weight is 216, for 2020, 3636, 4040, 4545, 4848, maximum weight is 6lb, and for 5454, 7254, maximum weight is 9lb.

Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization.
Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping.
Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model's size.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Sterilization Wrap (K223600).

Here's the breakdown of the information requested:

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

The document presents the acceptance criteria and device performance as "Test Items" and "Test Result" (always "Pass"). The specific numerical/quantitative acceptance criteria are listed under "Standard and Acceptance Criteria".

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

The document does not specify the exact sample sizes used for each of the non-clinical tests. It only states that the tests were conducted and "all results can meet standards requirements" or "Passed".

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective for each specific test. However, the submitter is "Wuhan Zonsen Medical Products Co., Ltd." located in Wuhan, Hubei, China, which implies the testing likely occurred in China.

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 device is a medical accessory (sterilization wrap) and the validation involves non-clinical laboratory and performance testing, not expert interpretation of medical images or data requiring ground truth establishment by medical experts. The "ground truth" for this device's performance is established by meeting the specified international and national standards for physical properties, sterilization efficacy, and biocompatibility.

4. Adjudication method for the test set

This information is not applicable for the type of testing performed for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers for diagnostic accuracy, which is not relevant here.

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 tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to its evaluation.

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

This information is not applicable. As stated above, this is a physical medical accessory, not an algorithm or software device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established international and national standards for medical device physical properties, biocompatibility, and sterilization process validation (e.g., ASTM, AATCC, ISO standards). The "truth" is whether the device's measured properties and performance meet the predefined thresholds set by these standards.

8. The sample size for the training set

This information is not applicable. This is a physical medical device that undergoes manufacturing and quality control testing, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.

The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Surgical Mask (Models ZSFM23 and ZSFM24)
Manufacturer: Wuhan Zonsen Medical Products Co., Ltd

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For performance tests, three non-consecutive lots were tested for each model (ZSFM23 and ZSFM24). Within each lot, a sample size of 32 was used for each performance test (BFE, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability). For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number of masks, but "the device" was evaluated.
• Data Provenance: Not specified in the provided text (e.g., country of origin for the testing facilities, specific dates). The study appears to be a prospective evaluation of newly manufactured devices/lots, rather than a retrospective analysis of existing data.

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

• This device (Surgical Mask) involves performance testing against established industry standards and biological evaluations, not diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is defined by the objective pass/fail criteria of the specified ASTM, EN, and ISO standards.

4. Adjudication Method

• Again, this is not applicable for performance testing of a physical medical device like a surgical mask. Results are determined by standardized laboratory methods and measurements, not by human expert adjudication of subjective findings.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human interpretation (e.g., in radiology). The submitted device is a physical product (surgical mask) whose performance is evaluated against material standards.

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

• Not applicable. This is not an AI algorithm or software device. The "standalone performance" is the direct physical and biological performance of the surgical mask itself, as measured by the specified tests.

7. The Type of Ground Truth Used

• The "ground truth" for the acceptance criteria and evaluation is derived from established international standards and regulatory guidance for medical face masks. Specifically:
  • ASTM F2100-20 (Standard Specification for Performance of Materials Used In Medical Face Masks)
  • ASTM F1862-17 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
  • EN 14683:2019 (Requirements and Test Methods of Differential Pressure of Medical Face Mask)
  • ASTM F2101-19 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
  • ASTM F2299-17 (Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates)
  • 16 CFR Part 1610-2008 (Flammability of clothing textiles)
  • ISO 10993-5:2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
  • ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
• The "ground truth" is therefore objective, measurable, and defined by these recognized scientific and regulatory benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The masks are physical products subject to direct performance testing.

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

• Not applicable, as there is no training set for this type of device.

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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical 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. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).

The Surgical Isolation Gown 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 requirement.

The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.

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

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

The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).

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

Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.

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 document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:

• Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
• Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, for the same reason as point 8.

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The Surgical 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 Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip.
Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and performance of the Wuhan Zonsen Medical Products Co., Ltd SURGICAL MASK (Model: ZSFM 21, barrier level 2, blue).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance (ASTM F1862): 3 lots of the proposed device were tested, with 32 samples per lot (total 96 samples).
• Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta P), Flammability: The document states "Pass at" for these tests, implying testing was conducted on samples of the device. The exact sample sizes for these specific tests are not explicitly quantified beyond a general implication of adequate testing to assess compliance.
• Biocompatibility: The document states "Under the conditions of the study," indicating specific samples were used for these assays.
• Data Provenance: The document does not explicitly state the country of origin of the data for the testing. However, the manufacturer is Wuhan Zonsen Medical Products Co., Ltd in China, suggesting the testing was likely conducted in China or a laboratory commissioned by them. The studies appear to be non-clinical (laboratory-based) and conducted specifically for this premarket notification. Therefore, this testing can be considered prospective in relation to this submission.

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

This document describes non-clinical performance testing of a surgical mask, not a diagnostic device that requires expert interpretation for ground truth. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is defined by the standardized testing methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, CFR 1610, ISO 10993) and their respective acceptance criteria.

4. Adjudication method for the test set:

Not applicable. This is not a human-reader-based assessment requiring adjudication. The results are based on objective measurements and compliance with scientific standards.

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 document is for a surgical mask, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This document is for a physical medical device (surgical mask), not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the performance characteristics of the surgical mask is established by standardized laboratory testing protocols and their defined acceptance criteria. These standards are recognized industry-wide and often mandated by regulatory bodies like the FDA. Examples include:

• ASTM F1862 for Fluid Resistance
• ASTM F2299 for Particulate Filtration Efficiency
• ASTM F2101 for Bacterial Filtration Efficiency
• EN 14683 Annex C for Differential Pressure
• CFR 1610 for Flammability
• ISO 10993 for Biocompatibility (cytotoxicity, irritation, sensitization)

8. The sample size for the training set:

Not applicable. This document describes the performance of a physical device, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set or ground truth in that context.

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