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Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

• · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
• · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
• Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
• The recommended hydrogen peroxide vapor sterilization cycle is :
• · Standard Cycle of STERRAD® 100S
• Standard cycle and Advanced cycle of STERRAD® NX
• · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
• · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX

The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:

• Standard Cycle of STERRAD® 100S
• inside diameter ≥ 1 mm and length ≤ 125 mm
• inside diameter ≥ 2 mm and length ≤ 250 mm
• Standard cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 150 mm
• Inside diameter ≥ 2 mm and length ≤ 400 mm
• · Single channel PE/PTFE tubing with:
• Inside diameter ≥ 1 mm and length ≤ 350 mm
• Advanced cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 500 mm
• · Single PTFE lumen tubing with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• · Single channel PE/PTFE flexible endoscopes with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Standard cycle of STERRAD® 100NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 0.7 mm and length ≤ 500 mm
• Single channel PE/PTFE instruments with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• Flex cycle of STERRAD® 100NX
• Single channel PE/PTFE flexible endoscope with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Lumen Cycle of V-PRO® maX
  △ Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
  △ Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
• Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and

The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape.

They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization.

The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle.

The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed.

The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.

The provided text describes the regulatory clearance for "Safe Secure Sterilization Pouches and Rolls" and details non-clinical testing performed to establish its substantial equivalence to a predicate device. It is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not present in this document.

The document focuses on the physical and chemical performance of sterilization pouches, not on an algorithm's diagnostic or predictive capabilities.

However, I can extract the general acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Points 2-9 are not applicable/available based on the provided text, as this document pertains to a physical medical device (sterilization pouches) and its physical and chemical properties, not a software-based AI/ML medical device.

• 2. Sample sized used for the test set and the data provenance: Not applicable. Testing involves physical units of pouches and rolls. The data provenance is laboratory testing rather than patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements and established standards (e.g., integrity, strength, color change), not expert consensus on interpretations of complex data like medical images.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established engineering and materials science standards for sterile barrier systems (e.g., seal strength, dye penetration for integrity, microbial ingress for sterility maintenance, chemical color change for indicator function).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 sterile.

The model EH-1 is made of mask body, nose clip, ear loops and nose pad, whit color. The model EH-2 is made of mask body, nose clip, straps and nose pad, green color.

The mask body is manufactured with three layers, the inner and outer layers are made of nonwoven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The straps and ear loops are held in place over the users' mouth and nose by two elastic straps welded to the mask body. It is made of nylon & spandex.

The nose clip in the layers of mask body is to allow the user to fit the mask body around their nose. It is made of polypropylene plastic wrapped metallic wire.

The nose pad which is made by 100% polyurethane is placed between the nose bridge and the mask body to let the user feel comfortable.

The buckle is use to clamp the ear loops and adjust the length and tightness of the mask. It is made of Polypropylene.

The colorant of white (EH-1)is Titanium dioxide, CAS Number is 13463-67-7; and the colorant of green(EH-2) is Pigment Green 7, CAS Number is 1328-53-6.

The EH-1 will be provided in white and the EH-2 will be provided in green. The Surgical Masks are sold sterilized with ethylene oxide gas and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and results for a Surgical Mask (device name). It details non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Physical Performance Tests (e.g., Blood Penetration, BFE, PFE, Delta P): The acceptance criteria explicitly state "≥ 29 samples out of 32 pass". This indicates that 32 samples were likely used for these specific tests for each model (EH-1 and EH-2).
• Sample Size for Biocompatibility Tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The specific sample sizes for these tests are not provided in the document, only the qualitative results.
• Data Provenance: The document states "non-clinical tests were conducted to verify that the subject device met all design specifications." The manufacturer is Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA. The tests appear to be prospective as they were conducted to demonstrate compliance for this specific device submission.

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

• Not applicable. This study involved non-clinical performance testing of a physical device (surgical mask) against established industry standards (e.g., ASTM, EN, ISO, CFR). Ground truth is established by the test methods themselves and their quantifiable outcomes, not by expert consensus or interpretation of medical images/data.

4. Adjudication Method for the Test Set:

• Not applicable. As stated above, this is non-clinical performance testing against objective standards, not a study requiring adjudication of expert opinions.

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. This is a submission for a surgical mask, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance was performed.

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

• No. This is a physical medical device (surgical mask). There is no algorithm involved.

7. The Type of Ground Truth Used:

• The ground truth for the device's performance is established by objective, quantitative measurements against recognized international standards (ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific test procedures and criteria for evaluating properties like bacterial filtration efficiency, blood penetration resistance, differential pressure, flammability, and biocompatibility.

8. The Sample Size for the Training Set:

• Not applicable. This refers to non-clinical testing 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. See explanation for point 8.

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