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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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
• · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
• · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
• · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
  · EO sterilization cycle is 4 hours at 55°C (131°F) 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 pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouches and rolls 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.

The provided document is a 510(k) premarket notification for the SIGMA Sterilization Pouch and Roll. It does not describe an AI/ML medical device, but rather a sterilization packaging product. Therefore, the questions related to AI/ML device performance metrics such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K180661) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study as presented for this non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are extensively detailed across multiple tables, primarily Table 2 ("Summary of the Proposed and Predicate Devices Technological Characteristics") and Table 3 ("Summary of Non-Clinical Testing"). I will extract the key information from these tables.

Regarding the sections that are not applicable to non-AI/ML devices (points 2-9):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device. The testing involves laboratory evaluations of material properties and sterilization efficacy, not interpretation of data. The document does not specify general "sample sizes" in terms of number of patients/cases, but rather the number of units tested for specific physical and chemical properties. The provenance is likely from the manufacturer's testing facilities in Taiwan.

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): Not applicable. "Ground truth" in the context of AI/ML refers to expert-labeled data. For this device, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI) and their specified pass/fail criteria for physical and chemical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling of AI/ML data. The "acceptance criteria" here are objective measurements against defined standards.

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: Not applicable. This is a standalone physical product, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm. The device's performance is inherently standalone in its function as a sterilization pouch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical device, the "ground truth" for its performance is determined by adherence to established international and national standards for sterilization packaging, material science, and chemical indicators (e.g., microbial barrier, tensile strength, peel strength, chemical indicator color change).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established: Not applicable. Same reason as point 8.

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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 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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