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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. 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 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.

The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.

The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.

The 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 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

This document is a 510(k) Premarket Notification from Sigma Medical Supplies Corp. to the FDA regarding their SIGMA Sterilization Pouch and Roll. It seeks to prove substantial equivalence to a previously cleared device (K102158).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the comparison of the proposed device to the predicate device and the requirement to meet various ISO and ASTM standards. The study's "performance" is reported as "Passed" or "Meets requirements."

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify the exact sample sizes used for each test. It states that "The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll" and "The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll."
   • Data Provenance: The manufacturer is Sigma Medical Supplies Corp. located in Taiwan (R.O.C.). The testing (non-clinical) would likely have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but given it's a premarket notification for a new device (albeit similar to a predicate), it would be prospective data generated specifically for this submission.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • This document describes performance testing of a medical device (sterilization pouches and rolls) against established standards (ISO, ASTM). It does not involve human interpretation of images or other data for which "ground truth" would be established by experts in a clinical sense (e.g., radiologists for diagnostic AI).
   • The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., attainment of SAL 10^-6^ for sterilization, specified physical properties, color change of chemical indicators).
   • Therefore, the concept of "ground truth" established by a panel of human experts in the way it's used for AI/clinical diagnostic studies is not directly applicable here. The validity of the tests themselves is based on adherence to the referenced standards.

3. Adjudication Method for the Test Set:

   • Not applicable in this context. Adjudication is typically used for reconciling disagreements among human readers or evaluators in clinical studies. Here, the tests are objective measurements against defined standards.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. This type of study is relevant for assessing the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its reported testing.

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

   • Yes, implicitly. All the described tests (Sterilant Penetration, Package Integrity, Biocompatibility, Chemical Indicator Efficacy, etc.) are evaluating the physical and functional properties of the device itself, independent of human interaction during its use (beyond following instructions). These are "algorithm only" in the sense that the device's performance is measured against objective criteria, not as part of a human-AI system.

6. The Type of Ground Truth Used:

   • The ground truth is based on industry-recognized technical standards (e.g., ISO, ASTM) for sterilant efficacy, package integrity, biocompatibility, and chemical indicator performance. For example, "SAL 10^-6^" or physical property thresholds defined by the standards.

7. The Sample Size for the Training Set:

   • This document describes premarket notification for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications and then tested.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by prior engineering knowledge and adherence to quality systems for medical device production.

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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® Sterilization System. 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 3 years post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The H2O2 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. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

• Self-sealing sterilization pouches .
• . Sterilization pouches, Flat
• . Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted

This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each test (e.g., number of pouches/rolls tested for peel strength, burst strength, etc.). It mentions that "the test items were performed on materials of the products" for some physical property tests, implying samples of the materials were used.

The data provenance is from Taiwan (R.O.C.), as the manufacturer is Sigma Medical Supplies Corporation located in New Taipei City, Taiwan. The studies appear to be prospective as they involve testing the newly developed device against established standards and a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this type of device and study. The "ground truth" for this medical device (sterilization pouches/rolls) is established through adherence to recognized international and national consensus standards for physical properties, sterilization efficacy, biocompatibility, and product performance, rather than through expert clinical assessment or interpretation of medical images. The studies are laboratory-based and measure objective physical and biological parameters. Therefore, there are no "experts" in the traditional sense of medical image interpretation (like radiologists) establishing ground truth.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. For laboratory-based testing of physical and chemical properties of a medical device like a sterilization pouch, direct measurements are taken against predefined acceptance criteria from standards. There isn't a process of expert adjudication for these types of objective measurements.

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 section is not applicable. MRMC studies are related to the evaluation of AI-powered diagnostic devices that involve human readers (e.g., radiologists, pathologists). This document is for a physical medical device (sterilization pouches/rolls) and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This section is not applicable. This device is a physical product, not an algorithm related to AI or software.

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

The "ground truth" for the performance of the Sterilization Pouch/Roll Made with Tyvek® is based on established international and national consensus standards for medical device packaging, sterilization processes, and biocompatibility. These include:

• Sterilant Penetration: Adherence to SAL 10-6 as per ANSI/AAMI/ISO 14937:2009.
• Package Integrity and Material Properties: Defined by standards like AAMI/ANSI/ISO 11607-1:2006/(R) 2010, ASTM D882, ISO 1924-2, ASTM D 5035, ASTM F 2251-03, ASTM D 1922, ASTM D 1004, ASTM F 1140-07, ASTM F 1929-98 (04), ASTM F88/F88M-09, ASTM F 1980-2007.
• Microbial Barrier: DIN 58953-6:2010-05.
• Biocompatibility: ISO 10993-10 Third Edition 2010-08-01.
• Chemical Indicator Efficacy: AAMI / ANSI / ISO 11140-1:2005.

These standards provide objective, measurable criteria for the device's performance, thereby defining the "ground truth" for its acceptability.

8. The sample size for the training set

This section is not applicable. This submission is for a physical medical device and does not involve machine learning algorithms that require a "training set." The materials and manufacturing processes are validated, not "trained."

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

This section is not applicable as there is no training set involved for this device submission.

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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 5 types:

• Self-sealing sterilization pouches .
• . Sterilization pouches, Flat
• . Sterilization pouches, Gusseted
• . Sterilization rolls, Flat
• . Sterilization rolls, Gusseted

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 5 types:

• Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 is 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 Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
• Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
• Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, 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.
• Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic 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 the medical grade paper are the same with the self-sealing sterilization pouches.
• Sterilization rolls, 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 SIGMA Sterilization Pouch and Roll underwent numerous validation studies to demonstrate its effectiveness and safety, confirming its substantial equivalence to predicate devices. These studies adhered to recommended practices, standards, and guidelines from organizations such as AAMI, ISO, and ASTM.

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 explicitly state the sample sizes used for each specific test within the validation studies. The studies reference adherence to international standards (AAMI, ISO, ASTM), which typically define appropriate sample sizes for such tests.
The data provenance can be inferred as originating from testing laboratories in connection with Sigma Medical Supplies Corp., which is based in Taiwan. The studies appear to be prospective, as they were conducted specifically for the validation of the SIGMA Sterilization Pouch and Roll.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The studies rely on established international standards and laboratory testing rather than expert-based ground truth for the performance criteria of sterilization pouches and chemical indicators.

4. Adjudication Method for the Test Set:
This information is not provided in the document. The validation methods described are primarily objective physical and chemical tests, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or clinical data. The SIGMA Sterilization Pouch and Roll is a Class II device for sterilization wraps and indicators, and its performance is evaluated through laboratory testing against established physical and chemical standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance evaluations of the device itself (the pouches and their integrated chemical indicators). This is inherent to the nature of testing sterilization packaging and chemical indicators, which are designed to function independently based on physical and chemical principles, without human interpretation of "algorithm-only" performance in the context of AI.

7. The Type of Ground Truth Used:
The ground truth used for these studies is based on established scientific and engineering principles codified in international consensus standards (AAMI, ISO, ASTM). These standards define the acceptable performance parameters for sterilant penetration, drying time, aeration, biocompatibility, package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy. The "ground truth" is therefore the successful compliance with these predefined objective criteria.

8. The Sample Size for the Training Set:
This is not applicable. The device is a physical product (sterilization pouch and roll) and does not involve AI or machine learning algorithms that require a training set. The validation studies focused on testing the manufactured product's compliance with performance standards.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for this device.

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