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The Heat Sealing Sterilization Pouch Flat are intended 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 Heat Sealing Sterilization Pouch Flat 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 °C; 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 Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300x, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.

The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.

Device Size (mm): 90x559, 102x203, 127x381, 150x300, 150x300, 152x254, 152x559, 191x330, 200x300, 203x406, 300x400, 305x381, 305x457, 400x500, 457x559, 500x600.

Heat Sealing Sterilization Pouch Gusseted

The Heat Sealing Sterilization Pouch Gusseted are intended 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 Heat Sealing Sterilization Pouch Gusseted 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 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.

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 Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.

The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 65x40x254.70 x 35 x 145.90 x 50 x 155.128 x 50 X 190.137x40x305, 150x50x380, 165x75x295. 200x33x340, 200x98x440,250x60x340,250x60x480,300x65x560.

Heat Sealing Sterilization Pouch Roll Flat

The Heat Sealing Sterilization Roll Flat 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 Heat Sealing Sterilization Roll Flat 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 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.

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 Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g.

The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 50 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200.

Heat Sealing Sterilization Pouch Roll Gusseted

The Heat Sealing Sterilization Roll Gusseted are intended 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 Heat Sealing Sterilization Roll Gusseted 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 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.

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 Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.

The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 75 x 100,100 x 100,200 x 100,200 x 100,300 x 100,350 x 100,400 x 100,500 x 100,

The Heat Sealing Sterilization Pouch/Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:

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 medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark Green (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

The Sterilization Pouch/Roll is offered in the follow 4 types:

• Heat Sealing Sterilization Pouch Flat;
• Heat Sealing Sterilization Pouch Gusseted;
• Heat Sealing Sterilization Pouch Roll Flat;
• Heat Sealing Sterilization Pouch Roll Gusseted.

The defining characteristics of the 4 types as follows:

Heat Sealing Sterilization Pouch Flat: These pouches are made from a medical grade paper and plastic (CPP/PET) film that is heat sealed on three sides, the forth side is left opened and will be heat-sealed when using. The Process Indicators Ink printed on the Pouch will exhibit a color change after the pouch is exposed to EtO gas or Steam.

Heat Sealing Sterilization Pouch Gusseted: These rolls are the same with the Heat Sealing Sterilization Pouch Flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

Heat Sealing Sterilization Pouch Roll Flat: These rolls are made from a medical grade paper and plastic (CPP/PET) film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on it are the same with the sterilization pouches.

Heat Sealing Sterilization Pouch Roll Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The provided text is a 510(k) Summary for a medical device (Heat Sealing Sterilization Pouch/Roll). It details the device's technical characteristics and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance. Therefore, information regarding effect size of human readers with AI assistance (MRMC study) and standalone algorithm performance, as well as several aspects related to AI/ML device studies, cannot be extracted directly from this document.

Here's the breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test listed. It mentions "Non-clinical tests were conducted with the subject device," implying samples of the device were tested according to the specified ASTM and ISO standards.

• Provenance: These are non-clinical (laboratory) tests performed on samples of the manufactured device. The manufacturing company is Tianchang Jiarui Packaging Material Co., Ltd. in Anhui Province, China.

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

Not applicable. This is a non-clinical device that does not involve expert interpretation or AI/ML ground truth establishment in this context. The acceptance criteria are based on standardized physical, chemical, and biological performance tests.

4. Adjudication method for the test set

Not applicable, as this involves objective laboratory tests with predefined pass/fail criteria, not subjective interpretation requiring adjudication.

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 MRMC study was done. This document is for a physical medical device (sterilization pouches/rolls) and does not describe an AI/ML component or human reader interaction.

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

No standalone algorithm performance study was done. This device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified international (ISO) and national (ASTM) standards for physical, chemical, and biological properties of sterilization barrier systems and chemical indicators. For instance, the ground truth for "Microorganism Penetration" is a retention rate >99.9% as measured by ASTM F1608.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it's a physical product, not an AI/ML model.

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

Not applicable.

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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.")

Ask a specific question about this device