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Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.

These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.

The provided text is a 510(k) summary for the "Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of document is for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria for a new, innovative AI/software device.

Therefore, much of the requested information (like sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document because it describes a physical sterilization pouch, not a software or AI-driven diagnostic device.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The process indicators meet the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements"." However, the specific quantitative acceptance criteria defined within ANSI/AAMI ST60:1996 and the detailed reported device performance against those criteria are not provided in this summary. Instead, a general statement of compliance is made.

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

• Sample Size: Not explicitly stated. The document mentions "physical testing of the medical grade paper... and film... as well as, performance of these finished devices." The number of units tested is not specified.
• Data Provenance: The testing was conducted as part of the submission process, likely by the manufacturer (Winner Industries Co., LTD & Winner Medical USA, Inc.). The country of origin of the data is not specified beyond where the company is based (Shenzhen, China, and Pomona, CA, USA). The testing is prospective in nature, as it relates to evaluating the newly manufactured device.

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 physical sterilization pouch, not an AI/software diagnostic device requiring expert interpretation for ground truth. Performance is assessed against physical and chemical standards.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as above.

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 is not applicable. The device is not an AI product and does not involve human readers.

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

This is not applicable. The device is not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on established material standards (e.g., medical grade paper and plastic film standards) and performance standards (e.g., ANSI/AAMI ST60:1996 for chemical indicators). It also involves demonstrating the ability to maintain sterility and allow sterilization, which would be verified through microbiology (sterilization of biological indicators) and physical integrity testing.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This is not applicable for the same reasons as above.

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Winner Medical facemask / shield are intended to be used by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate matter.

These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization.

The provided document is a 510(k) summary for surgical masks. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. This type of regulatory submission in the medical device field typically does not involve the types of acceptance criteria and studies (e.g., MRMC studies, expert consensus for ground truth on a large dataset, standalone algorithm performance) that you are asking about, which are more common for AI/ML-based diagnostic or clinical decision support devices.

Therefore, much of the requested information cannot be extracted from this document, as it describes a different kind of regulatory submission and testing. However, I can extract what is relevant to the information provided.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The device (Winner Medical Facemasks) was compared to predicate devices through non-clinical testing. The document states that the masks are "identical to the predicate devices in design, materials used and performance in non-clinical testing." This implies that the acceptance criteria were met if the performance in these non-clinical tests was equivalent to the predicate devices.

Study Details (Based on available information)

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

   • Sample Size: Not specified in terms of number of masks tested or number of trials for each non-clinical test.
   • Data Provenance: The testing was "non-clinical testing." The document does not specify the country of origin of the data related to these specific tests, but the submitter is based in China, and the U.S. Agent is in California, USA. It's retrospective in the sense that the data was collected and then submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for non-clinical performance tests like BFE or flammability is determined by standardized laboratory measurements against established test methods, not by expert consensus in a clinical diagnostic sense.

3. Adjudication method for the test set: Not applicable. Laboratory tests have defined protocols, and the results are typically quantitative measurements, not subjective adjudications.

4. 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 a surgical mask, not an AI-powered diagnostic device. No human reader studies (with or without AI assistance) are relevant or mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (surgical mask), not an algorithm or AI system.

6. The type of ground truth used: For the non-clinical tests, the "ground truth" is established by the specified standards and protocols for each test (e.g., standardized methods for measuring BFE, Delta P, flammability, skin irritation, and sensitization). The performance of the predicate device serves as the benchmark for substantial equivalence.

7. The sample size for the training set: Not applicable. There is no AI/ML model or "training set" in the context of this device and its regulatory submission.

8. How the ground truth for the training set was established: Not applicable. No training set exists for this type of device.

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