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Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

Protective Gown AAMI Level 4

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Protective Gown AAMI Level 4" does not contain the information required to answer your request about acceptance criteria and a study proving a device meets these criteria.

The document is a regulatory clearance letter for a medical device (a protective gown), and as such, it focuses on the administrative aspects of regulatory approval, such as:

• Device name and product code
• Regulation number and name
• Regulatory class
• Date of submission and receipt
• Determination of substantial equivalence
• General controls provisions and other applicable regulations (e.g., registration, listing, labeling, GMP)
• Contact information for regulatory questions

It does not include details about:

1. Acceptance criteria table and reported device performance: This type of information would typically be found in test reports, design specifications, or a summary of safety and effectiveness (SSE) document that supports the 510(k) submission, not the clearance letter itself. For a protective gown, acceptance criteria would likely involve fluid barrier properties (e.g., AAMI Level 4 standards for liquid barrier performance), tensile strength, tear resistance, and other material properties.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm only) performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

These points are highly relevant to studies involving AI/ML medical devices or complex diagnostic/imaging devices, where performance metrics like sensitivity, specificity, AUC, and expert reader studies are crucial. The device in question, a protective gown, is a physical barrier device, and its performance is evaluated through standardized material testing, not typically through human reader studies or AI algorithms.

Therefore, I cannot fulfill your request based on the provided text.

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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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The Isolation Gown AAMI Level 3 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 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(ANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.

Not Found

The provided text is related to the FDA 510(k) clearance for an "Isolation Gown AAMI Level 3" and primarily concerns regulatory approval. It does not describe a study involving a device with AI or software components that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them, as the provided text pertains to a physical medical device (an isolation gown) and its regulatory clearance based on AAMI Level 3 barrier protection standards, not a software-driven device.

The information I can extract directly related to performance and standards is:

Acceptance Criteria for the Isolation Gown AAMI Level 3:

The provided document does NOT contain information regarding:

• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (beyond implying compliance with AAMI PB70 standards, which often involve laboratory testing for physical properties).
• Sample size for the training set.
• How ground truth for the training set was established.

This is because the cleared device is a physical barrier product, not an AI/software as a medical device (SaMD). The assessment for such devices typically involves laboratory testing against established standards (like AAMI PB70) rather than clinical studies with human readers or AI algorithms.

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The Procedure Masks / 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 Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) Premarket Notification for a Procedure Mask/Surgical Mask. It describes the device's technical specifications and performance testing. However, it is important to note that this document is for a medical device (a mask) and not a software or AI-based device. Therefore, many of the requested elements for describing an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details, are not applicable in this context.

The document focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device by meeting certain performance criteria.

Here's the information derived from the document that is applicable to your request, formatted as closely as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against the ASTM F2100 requirements for Level 1 and Level 3 masks.

Acceptance Criteria and Device Performance for Level 1 Masks:

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