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Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time .
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time .
• . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
• . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
• . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
  The device is not intended and has not been validated for sterilization of devices that contain lumens.
  The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
  The Tyvek version of the pouch is for EO sterilization only.
  If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
  The maximum validated pouch load is 2.64 pounds (1.2kg).

The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material:

• ABSST - Self seal Tyvek
• ABHST Heat seal Tyvek .
• ABHSP Heat seal paper ●
• ABSSP Self seal paper .
  The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process.
  The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.

The document describes the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, and its substantial equivalence to a predicate device (K112591). It details the device's indications for use, material composition, and performance testing.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" as a distinct section. However, it provides a "Substantial Equivalence Table" (starting on page 9) that compares various characteristics of the subject device to its predicate. This table implicitly highlights the acceptance criteria by stating how the subject device performs compared to the predicate, often indicating "Same" or "Substantially Equivalent."

Below is a consolidated table based on the information provided in the "Substantial Equivalence Table" and the "Functional Testing" section. The "Acceptance Criteria" column is inferred from the values or descriptions given for the predicate and often directly matched by the subject device. The "Reported Device Performance" column reflects the subject device's characteristics.

Summary of Device Performance: The "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators" generally meets the same criteria as its predicate device. The primary changes in the subject device are the expansion of available model numbers to include Tyvek versions (specifically for EO sterilization) and additional pre-vacuum steam sterilization cycles. For most physical and chemical properties, the acceptance criteria are met by matching the predicate's performance. For "Seal strength after steam sterilization" and "Seal strength after EO sterilization," the acceptance criteria shifted from "2.5 to 5.5 N/15mm" to "> 1.5 N / 15mm", still indicating a performance deemed "Substantially Equivalent."

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

The document states that "testing was conducted in accordance with ASTM and ISO standards relating to sterile packaging of medical devices" and "bench performance tests were performed." However, specific sample sizes for these tests (test sets) are not provided in this summary.

Regarding data provenance:

• Country of Origin of the Data: Not explicitly stated, but the submission sponsor and manufacturer are "Safe Secure Packaging (Shenzhen) Co., Ltd" in China. It is reasonable to infer that the testing data originated from or was managed by this entity, potentially through a testing lab.
• Retrospective or Prospective: The testing described (functional testing, biocompatibility, accelerated aging, validation of sterilization cycles) is typically prospective as it's conducted to demonstrate the performance of the device for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests described are largely objective physical, chemical, and biological tests (e.g., seal strength, air permeance, sterilization indicator function, biological indicator tests) performed against established industry standards (ASTM, ISO). These types of tests typically do not involve human experts establishing a "ground truth" in the same way clinical image analysis would. Instead, their results are measured against predefined specifications or pass/fail criteria derived from these standards.

4. Adjudication Method for the Test Set

Given the nature of the tests (bench performance, physical, chemical, biological tests), an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1, 3+1 for clinical reads) is not applicable or mentioned. The results of the tests would be objectively measured and compared against specified acceptance criteria.

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 diagnostic devices where human readers interpret data, often with and without AI assistance, to measure changes in reader performance. The "Safe Secure Sterilization Pouch" is a sterilization packaging device, not a diagnostic device involving human interpretation of medical images or data.

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

This question is not applicable as the device is a physical sterilization pouch and not an AI algorithm. The performance evaluation focuses on the pouch's physical, chemical, and functional attributes, not on an algorithm's standalone performance.

7. The Type of Ground Truth Used

For the various tests conducted:

• Physical and Chemical Tests (e.g., Seal Strength, Air Permeance, Dimensions, Acidity, Metals, EO Residual): The "ground truth" is established by the specified ISO/ASTM standards and internal specifications derived from these standards. These are objective measurements compared against quantitative limits.
• Sterilization Indicator Test: The "ground truth" is the visually observable color change (Green to Purple for Steam, Yellow to Brown for EO) as specified, which indicates exposure to the sterilization process.
• Biological Indicator Test: The "ground truth" for sterilization effectiveness is typically the absence of microbial growth after exposure to the sterilization process, demonstrating a Sterility Assurance Level (SAL) of 10^-6.
• Shelf-life Tests: The "ground truth" is the maintenance of specified physical, chemical, and sterility properties over the stated shelf-life durations (6 months after steam, 24 months after EO, 5 years before sterilization) as determined by various challenge tests and aging studies.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical sterilization pouch and does not involve machine learning or a "training set" in the context of AI/algorithms.

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

This question is not applicable for the same reason as point 8.

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Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.

These pouches are manufactured from a medical grade paper and plastic film that is aged to are heat sealed on three sides. The fourth side has an addesive tape that is wed to seal the pouch or heat-seated by the heat-seel machine. The modical brade pager conforms to recognized material standards and can be steellized by steam or conforms fo recognized material starkers childreators has the same intended use, Essential Component, Raw material, Sterillzator method, manufacturing mellods and same technological characteristics as these predical testing of Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. five and fifthelion officiency) and tilln (thickness, tensile strength and elongation) from non-stermanner of these linished ellygene oxice sterlilzed linished devices, as well as, performance diatribution for devices (seal strength, package burst, dye migralian cride sterfitzalion for steam and ethytene oxide sterlilzabions, ataam and ethylene oxide storibalion of shoum and einytene balde bennizators meet the performance requirements of ANSI/AAMMSO 11140-1:2005 standard entitled "Sterlizztion of health caro products-ANOMANICAL indications- Part 1: General requirements".

The pouches are manufactured from modical grade paper that is the fourth side an to laminated film on the left, right, and bottom of pouch. The fourth side has an edhealve tape that is used to that is used to see to see to section dealers. The pouches heat-seal machine prior to sterlization of the enclosed medical devices were processed contain extennal chemical indicators used to indicato the pouches were processed to via steam or EIO sterilization. See Chatper 10 for a detailed device description via steam or ENO sterility achievement and compatibility with stearn and EIO starilization processes and Bill of Materialis.

The provided document is a 510(k) Premarket Notification for a medical device: "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria in the way a new drug or high-risk device might.

Therefore, the study outlined here is a substantial equivalence comparison study against predicate devices, rather than a traditional efficacy study with AI components. The "acceptance criteria" are effectively demonstrating that the device performs similarly or identically to the predicate device across various parameters and meets relevant performance standards.

Here's an attempt to extract the information requested within the context of this 510(k) submission:

Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence to predicate devices (Winner Medical USA, Inc. - K062704 and K051242). The "acceptance criteria" are implicitly met if the "Proposed Device" performs at least as well as, or comparably to, the "Predicate Device" in the specified tests and adheres to the relevant standards.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state numerical sample sizes for each test (e.g., how many pouches were tested for seal strength or sterilant penetration).
   • The data provenance is not specified in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA (K112591), implying it adheres to U.S. regulatory standards.
   • The study is retrospective in the sense that it's a series of laboratory and physical tests comparing a newly manufactured device to existing predicate devices and established standards. It's not a prospective clinical trial.

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

   • This is not applicable in the context of this device and study type. "Ground truth" here refers to the objective measurements of physical properties, performance characteristics (e.g., sterilization indicator color change, seal strength), and adherence to recognized standards (like ISO 11140-1:2005). These are determined by established testing methodologies and equipment, not expert consensus in the same way an image diagnosis might be.

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

   • Not applicable. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data, which is not the case for material property or performance testing of a sterilization pouch.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this is a physical medical device (sterilization pouch) and does not involve AI or human readers in an MRMC study context.

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

   • No. This device does not involve an algorithm or AI.

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

   • The "ground truth" for this device's performance is based on:
     • Objective physical measurements: (e.g., thickness, tensile strength, elongation of film; pressure drop, filtration efficiency of paper; seal strength, package burst, dye migration of pouches).
     • Standardized chemical indicator response: The indicator's color change proving exposure to sterilant, validated against the requirements of ANSI/AAMISO 11140-1:2005.
     • Material properties and performance parameters defined by recognized industry standards for sterilization packaging.

7. The sample size for the training set:

   • This is not applicable as there is no "training set" in the machine learning sense. The device is a physical product, not an algorithm.

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

   • Not applicable.

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