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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 wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.

Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes.

b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar

c) Aeration time: 12 hours

d) Aeration temperature: 55℃

e) Aeration pressure : 841 mBar to 864 mBar

Sterilization Wrap is single use, non-sterile provide. It is divided into single and double layers, with double layer edges closed by ultrasonic suture. The sterilization Wrap is made from 100% polypropylene spunbond- meltblown - spunbond (SMS), not made with natural rubber latex.

The provided text describes the regulatory clearance of a "Sterilization Wrap" device (K222151) and its comparison to a predicate device (K181174). The information focuses on the physical, chemical, and sterilization properties of the wrap. The document does not contain information related to a study involving an AI-powered medical device or human readers for image interpretation. Therefore, I cannot provide details on the sample size for a test set, expert qualifications, or MRMC studies, as these concepts are not applicable to the provided document.

However, I can extract the acceptance criteria and performance data for the Sterilization Wrap based on the provided text, as it relates to the device's functional and safety aspects.

Here's the analysis based on the provided text:

Analysis of Sterilization Wrap Acceptance Criteria and Performance

The "Sterilization Wrap" device (K222151) has undergone non-clinical testing to demonstrate its performance and establish substantial equivalence to a predicate device (K181174). The acceptance criteria and reported device performance are generally based on meeting recognized industry standards for medical device sterilization wraps.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to various standard tests (e.g., ASTM, ISO standards) for physical properties, sterilization validation, and biocompatibility. The specific sample sizes for each of these non-clinical tests are not provided in the document.

The data provenance is from non-clinical tests conducted by the manufacturer of the proposed device, Kenpax International Limited. The country of origin of the data is not explicitly stated beyond the manufacturer's address in Hong Kong and the contact person's address in Beijing, China. The studies are prospective in nature, as they involve testing the device to verify its performance against established standards.

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

This question is not applicable. The "ground truth" for this device is established through quantitative measurements and adherence to international testing standards (e.g., sterility assurance level, physical property thresholds) rather than expert consensus on interpretation, as might be the case for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for non-clinical, objective performance testing of a physical product like a sterilization wrap.

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 question is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic tool, and therefore, an MRMC study with human readers is irrelevant.

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

This question is not applicable. The device is a physical product, not an algorithm.

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

The "ground truth" for this device is based on pre-defined, quantitative performance metrics and established international standards. For example:

• Sterility: Achieved a 10⁻⁶ sterility assurance level (objective microbial growth testing).
• Physical Properties: Meeting specific tensile strength, bursting strength, water resistance, air permeability, mass per unit area, tearing strength, and dimension parameters (objective physical measurements).
• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization (objective biological tests against ISO standards).
• Residuals: Levels of ethylene oxide residuals below specified thresholds (objective chemical analysis).

8. The sample size for the training set

This question is not applicable. The device is a physical product, and there is no "training set" in the context of machine learning or AI models. Its design and manufacturing process would involve internal validation and quality control, but not a "training set" for an algorithm.

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

This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

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Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes

Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

The size of the Devices to be sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for Sterilization Wraps is 12kg.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. Sterilization Wraps provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. Sterilization Wraps is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice. Sterilization Wraps is made of polypropylene and blue pigment by non-woven process.

The provided document describes the acceptance criteria and the results of the study for the Sterilization Wraps device (K220133). This is a non-clinical study focused on the physical and biological characteristics of the wrap, rather than a clinical study involving human or AI performance.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting the requirements of recognized industry standards. The study demonstrates that the proposed device complies with these standards.

Additional Information

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

• The document does not explicitly state numerical sample sizes for each test. Instead, it refers to "test samples" or "subject wrap."
• Data Provenance: Not specified, but generally, these types of non-clinical tests are performed in a laboratory setting. There is no information regarding country of origin for the test data, nor if it's retrospective or prospective.

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

• This is a non-clinical study involving material and biological performance testing (e.g., sterilization effectiveness, physical properties, biocompatibility). It does not involve "experts" establishing a ground truth in the way a clinical diagnostic study would (e.g., radiologists interpreting images). The "ground truth" is established by the technical specifications and performance requirements outlined in the referenced international standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is a non-clinical performance study against predetermined technical standards, not a diagnostic accuracy study requiring adjudication of interpretations.

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 a study involving human readers, AI assistance, or diagnostic effectiveness.

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

• Not applicable. This device is a physical sterilization wrap, not an algorithm.

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

• The ground truth is based on the requirements and methodologies defined by internationally recognized standards (e.g., ISO, ASTM, AAMI, AATCC, USP) for sterilization wraps and medical device packaging. Compliance with these standards serves as the "ground truth" for acceptable performance.

8. The sample size for the training set:

• Not applicable. This is a physical product, not an AI/machine learning model that requires a training set.

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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