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The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:

• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.

There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.

Therefore, I cannot provide the requested information based on this document.

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The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.

The Self Sealing sterilization Pouches are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 540g or 1.19 lbs. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.

The pouches are available in the following sizes:

Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 13 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 190 x 330 mm, 190 x 360 mm, 255 x 380 mm, 279 x 406 mm, 300 x 400 mm, 300 x 474 mm, 305 x 457 mm;

There are 18 models of the Self Sealing Sterilization Pouches in this application with different physical specification.

These pouches are made from a medical grade paper and plastic (CPP/PET) film that are heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The indicators printed on the medical grade paper will exhibit a color change (EtO- Pink to Yellow/Steam- Blue to Dark Green) after the pouch is exposed to steam or ethylene oxide gas. The validated maintenance of sterility period is 6 months.

The provided text describes the acceptance criteria and study results for "Self Sealing Sterilization Pouches" (K162258). However, this document is a 510(k) summary for a medical device that is not an AI/ML device.

The questions you've asked are specifically geared towards the evaluation of AI/ML-driven medical devices, which typically involve performance metrics like sensitivity, specificity, AUC, and studies with human experts establishing ground truth, multi-reader multi-case studies, and details about training/test sets.

Since this device is a physical product (sterilization pouches), the information requested (e.g., number of experts for ground truth, sample size for training set, MRMC study effect size) is not applicable to this type of FDA submission.

Therefore, I cannot provide answers to your specific questions based on the provided document.

Instead, I can extract the acceptance criteria and the types of non-clinical tests performed, as this is relevant to the document you provided.

Acceptance Criteria and Device Performance (Non-AI/ML Device)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating that the device meets relevant standards and performs as intended.

Table of Acceptance Criteria and Reported Device Performance

Since the device is a physical sterilization pouch and not an AI/ML device, the following points are not applicable (N/A) based on the provided document:

2. Sample size used for the test set and the data provenance: N/A (No AI model, thus no "test set" in the AI sense. Testing was physical product testing to standards.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No "ground truth" establishment by experts in this context; performance assessed against physical standards and functional tests.)
4. Adjudication method: N/A (Not an AI-based diagnostic/screening device.)
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: N/A (Not an AI-based device for human readers.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth is based on physical/chemical testing standards and functional performance parameters, not clinical outcomes or expert consensus on interpretations.)
8. The sample size for the training set: N/A (No AI model, thus no "training set.")
9. How the ground truth for the training set was established: N/A (No AI model, thus no "training set.")

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