Search Results

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth 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. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.

(3) 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.

(4) 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.

(5) 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 Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the 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 to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• The weight difference before sterilization and after drying shall not exceed 3% | Pass |
  | Biocompatibility - Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass |
  | Biocompatibility - Irritation | Non-irritating | Under the conditions of the study, not an irritant. Pass |
  | Biocompatibility - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass |
  | Package Appearance | The appearance of the sterilization pouch is clean, intact, and sealed on all four sides. | Pass |
  | Thickness | 52 ± 12% μm | Pass |
  | Tensile Strength of Paper | MD ≥ 4.4 KN/m
  CD ≥ 2.2 KN/m | Pass |
  | Bursting Test | Burst value > 3 Kpa or No Burst | Pass |
  | Dye Penetration Test | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | Pass |
  | Seal Strength Test | ≥ 2.5 N/15mm | Pass |
  | Vacuum Leakage Test | No water can penetrate the sterilization pouch. | Pass |
  | Microbial Barrier | 0 CFU No growth | Pass |
  | Chemical Indicator Functionality | Color of indicator changes from blue to dark grey after Steam sterilization | Pass |
  | Chemical Indicator Shelf Life & Endpoint Stability | Shelf life: 3 months
  Endpoint stability: 3 months | Pass |
  | Shelf Life (Product) | Shelf life: 3 months | Pass |
  | Maintenance of Sterility | Maintains sterility of enclosed devices for up to 6 months post steam sterilization. (This is an indication from the "Indications for Use" and is generally supported by the package integrity and microbial barrier tests over time, often through accelerated aging studies). | The document states "The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization." The "Maintenance of Sterility" is listed as a "Different" characteristic compared to the predicate (6 months vs. 3 years for EO and 6 months for Steam). The microbial barrier test is passed, supporting the general concept of sterility maintenance, but the specific validation for the 6-month claim is not detailed in the summary table. |

2. Sample Size Used for the Test Set and Data Provenance

The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.

The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this device's testing is based on:

• Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
• Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
• Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
• Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
• Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Ask a specific question about this device

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 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 EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.

The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.

Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days 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 24 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (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.

Based on the provided text, the device in question is a "Sterilization Pouch and Roll" and the document describes non-clinical performance testing rather than a study involving human subjects or AI algorithms. Therefore, many of the typical acceptance criteria and study design elements for AI/ML-based medical devices (like MRMC studies, expert adjudication for ground truth for training/test sets, effect sizes of human performance improvement with AI, etc.) are not applicable to this document.

The document discusses the physical and chemical performance of a sterilization packaging product. The studies described are bench testing and laboratory validation against established ISO and ASTM standards.

Here's the breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical device (sterilization pouch), the following points are not applicable as they relate to clinical studies, AI/ML models, and human expert evaluations of diagnostic imaging.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples of the sterilization pouches and rolls tested in a laboratory setting, not a "test set" in the context of an AI/ML model. The provenance would be the manufacturing site (China) and the tests are prospective lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by physical measurements and compliance with international standards (ISO, ASTM), not by human expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is determined by standardized test methods.
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 not an AI/ML diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on the specified performance criteria defined by international standards (ISO, ASTM) and physical/chemical properties.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
• · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
  The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.
  The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO 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 EO sterilization process.
  The SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 Steam or EO gas sterilization.
The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization.
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 the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas.
The Chemical Indicator offers an additional way to verify 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 SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.

This document is a 510(k) premarket notification for the SterileRight Sterilization Pouch and Roll. It details the device's characteristics, intended use, and comparative performance against a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The primary table summarizing acceptance criteria and results is Table 3. Summary of Non-Clinical Testing (pages 14-15).

2. Maintain the endpoint stability of the color change after being in the presence of the sterilant.
   All performance attributes should maintain the original color: 3 years shelf life | Real-time test shows the test group exposed to Steam maintained Black color, EO maintained Yellow color, and Control group maintained original color from March 15, 2018 to April 15, 2021 (3 years). | Pass |

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing. It does not explicitly state the exact sample sizes for each test within the "Summary of Non-Clinical Testing" section. However, it indicates these are validation studies and the results are presented as having "Passed." No specific number of units/pouches per test is given.

• Data Provenance: The studies were conducted by the manufacturer, SterileRight Packaging Mfg., Inc., based in Taiwan (address 1F, No.33-7, Dahua 2nd Rd., Qidu Dist., Keelung City 206, Taiwan, on page 4). The data is prospective as it's part of the premarket submission for a new device.

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

This document is for a sterilization pouch and roll, which is a physical device, and the testing is primarily non-clinical performance testing (physical, chemical, and biological barrier tests).

• No human expert interpretation of images or other medical data (like radiology reads) is involved. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of medical data is not applicable here.
• The ground truth is established by objective laboratory measurements against defined engineering and biological standards (e.g., SAL 10-6 for sterility, specific ranges for physical properties, specific color changes for chemical indicators).

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the testing involves objective measurements against established standards, not human interpretation requiring adjudication.

5. 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 diagnostic devices where multiple human readers interpret medical cases, and the AI's impact on their performance is evaluated. This device is a sterilization wrap, subjected to engineering and biological performance testing, not interpretation by human readers.

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

This question implies an AI/algorithm. This device is a physical product (sterilization pouch and roll), not an AI algorithm. Its "standalone" performance is assessed by the non-clinical tests summarized in Table 3, demonstrating its ability to meet acceptance criteria for sterility, barrier integrity, and indicator function independently.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by:

• Objective laboratory measurements and validated test methods according to recognized consensus standards (e.g., ISO, ASTM, AAMI).
• Biological indicators (BIs): For sterility, the "ground truth" is the absence of bacterial growth after sterilization, indicating a sterility assurance level (SAL) of $10^{-6}$.
• Physical property measurements: For package integrity, measurements like tensile strength, burst strength, seal peel strength, and thickness variations are compared against defined numerical acceptance criteria.
• Chemical indicator color changes: The "ground truth" for the chemical indicators is a specific, visually identifiable color change after exposure to the sterilant under defined conditions, and the absence of a change under non-sterilant or harsh conditions.
• Biocompatibility testing: Ground truth for biocompatibility is the absence of irritation or sensitization (index of 0).

8. The Sample Size for the Training Set:

This question is typically relevant for machine learning models that require a training set. As this is a physical medical device (sterilization pouch and roll) undergoing non-clinical performance testing, there is no concept of a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed through traditional engineering methods, not trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Sterilization Pouch 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 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:

Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.

Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.

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 Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.

Sterilization Pouch Gusseted

The Sterilization Pouch Gusseted 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 sterlity of the enclosed device until used. The 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:

Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.

Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°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 Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.

Sterilization Roll Flat

The 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 Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices and instruments with lumen/channels).

The intended sterilization cycles are listed below:

Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.

Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.

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 Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.

Sterilization Roll Gusseted

The Sterilization Roll Gusseted 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 sterlity of the enclosed device until used. The 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:

Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.

Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°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 Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.

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

Steam; 30 minutes at 121°C; 25 minutes dry time.

Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.

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 Red/Pink to Yellow/Brown (EtO) or Blue to Brown/Black (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 Paper Sterilization Pouch and Roll is offered in the follow 4 types:

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

The defining characteristics of the 4 types as follows:

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.

Sterilization Pouch Gusseted: These rolls are the same as the Sterilization Pouch Flat, with the Heat Sealing 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 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 as the sterilization pouches.

Sterilization 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 medical device in question is a Paper Sterilization Pouch and Roll. The K182184 submission includes non-clinical testing to demonstrate that the device meets its acceptance criteria. No clinical studies were included in this submission.

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 generalized "sample sizes" for the test sets. Instead, it refers to "all samples" for each specific test, indicating that a sufficient number of units were tested to demonstrate compliance with the acceptance criteria for each non-clinical test. The data provenance is described as "Non-clinical tests were conducted to subject device." This implies tests were performed on the actual device components or finished products. The country of origin of the data is not explicitly specified as part of the test report, but the manufacturer is MDK (ShangHai) Medical Packing Co., Ltd., which is located in China. The studies are retrospective as they were conducted (and results obtained) prior to the submission.

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

Not applicable. This submission involves non-clinical performance testing of a physical device (sterilization pouches and rolls) rather than studies requiring expert interpretation or ground truth establishment by clinical experts. The ground truth for these tests is based on established performance standards and laboratory measurements.

4. Adjudication method for the test set:

Not applicable. As noted above, this submission involves non-clinical performance testing against pre-defined engineering and biological standards, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.

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 device is a physical product (sterilization pouches and rolls) and does not involve AI or human readers.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used:

The ground truth for the non-clinical tests is based on established standard specifications and methodologies (e.g., ASTM, ISO standards) for material properties (tensile strength, thickness, tear strength, air permeability, burst strength, seal strength), microbial barrier properties, chemical indicator performance, residual levels of sterilants (EO and ECH), biocompatibility (cytotoxicity, skin irritation, skin sensitization), shelf-life validation, and sterilization process validation (Sterility Assurance Level - SAL).

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve a training set for an algorithm.

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

Not applicable. This device is a physical product and does not involve a training set for an algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EtO 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 90 Davs 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 EtO sterilization process.

The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration).

This document is a 510(k) summary for the U&U Sterilization Pouch and Roll, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, the document does contain performance testing results for the sterilization pouch and roll, which can be presented as acceptance criteria and reported device performance.

Here's an attempt to answer your questions based only on the provided document, adapting where necessary to the context of a non-AI/ML medical device submission:

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

The document lists "Performance Tests" and the results for the U&U Sterilization Pouch and Roll. The "acceptance criteria" are implied by the "PASSED" result, meaning the device met the requirements of the standards or internal thresholds for each test. For elements where direct comparison with the predicate device implies the "acceptance criteria", those are noted.

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

• Sample size: The document does not specify the exact sample sizes used for each performance test. It only states that "Performance testing was conducted" and refers to validation of "Two types of sterilization loads."
• Data provenance: The document is a submission from U&U Medical Technology Co., Ltd, located in China. The testing was conducted to support their 510(k) submission to the US FDA. No specific country of origin for the raw test data is explicitly stated, nor is it specified if the studies were retrospective or prospective, though performance testing for regulatory submission is typically prospective for the device being submitted.

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 question is not applicable to the provided document. The device is a sterilization pouch and roll, not an AI/ML-powered diagnostic or predictive device that relies on expert interpretation to establish ground truth for testing. The "ground truth" for this device's performance is based on established engineering and microbiological test methods (e.g., AAMI/ANSI, ISO, ASTM standards) and physical/chemical properties.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for establishing ground truth in image analysis or similar diagnostic contexts, which is not relevant for this device. The performance tests rely on objective laboratory measurements and standardized methods.

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 question is not applicable. MRMC studies are designed for assessing the impact of AI on human reader performance, which is not relevant for a sterilization pouch and roll.

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

This question is not applicable. The device is a physical product (a sterilization pouch and roll), not an algorithm or software.

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

The "ground truth" (or basis for evaluation) for this device's performance is derived from:

• Compliance with recognized material and performance standards (e.g., AAMI/ANSI ST77, AAMI TIR22, AAMI/ANS//ISO 11140-1).
• Results from standardized physical and chemical tests (e.g., EN 868-2:1999 Annex C, ASTM 1608, ASTM 1929, ISO10993 for biocompatibility).
• Observed changes in chemical indicators (color change).
• Comparison with the performance characteristics of a legally marketed predicate device (SIGMA Sterilization Pouch and Roll - K102158).

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

Ask a specific question about this device