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GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days.

GCI Sterilization Wrapper sizes and validated load limitations are as follows:

GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures.

Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.

GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used.

The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification.

Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.

This document pertains to the 510(k) clearance for GCI Sterilization Wrappers, a Class II medical device. The information provided outlines the non-clinical performance data used to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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CDB Hospital ® Sterilization Wraps intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

· Pre-vacuum Steam 270°F/132°C for 4 minutes

· Advanced Sterilization Products (ASP) STERRAD® 100S

· Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)

• STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)

The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Pre-Vacuum Steam Sterilization:

• · Validated for dry time of 30 minutes for 44gsm.
• · Validated for dry time of 30 minutes for 70gsm.
• · Validated maximum weight of 6 lbs for 44 gsm.
• · Validated maximum weight of 15 lbs for 70 gsm.

• All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load.

Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization:

All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs.

Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization:

All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below:

VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle

Intended Load for 100NX Standard Cycle:

Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: · An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens.

Intended Load for 100NX Flex Cycle:

One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle).

Intended Load for 100NX Express Cycle:

Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.

STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems:

• All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below.

· CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.

VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle

Intended Load for Lumen Cycle:

Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.

Intended Load for Non Lumen Cycle:

Non lumened reusable metal and non-metal medical devices.

Intended Load for Flexible Cycle:

Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:

1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter.

2.) An additional tray containing non-lumened medical devices.

The CDB Hospital ® Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The CDB Hospital ® Sterilization Wraps' SMS fabric is made of 100% polypropylene, blue color, and are separated into two distinct product offerings:

CDB Hospital® Sterilization Wraps, 44gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard health care practices.

CDB Hospital® Sterilization Wraps, 70gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.

CDB Hospital® Sterilization Wraps are composed of polypropylene with the addition of light blue and dark blue pigment and an antistatic treatment. The CDB Hospital ® Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically. This product is over-the-counter use.

The provided text is a 510(k) summary for a sterilization wrap, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.

Below is a table describing the acceptance criteria and reported device performance from the provided document where information is available.

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

Study Details:

• 2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the document mentions "a series of nonclinical tests." The provenance is internal testing by Comercializadora Brever, S.A. de C.V. as stated: "all testing refers to the same product(s) that are manufactured by Comercializadora Brever, S.A. de C.V."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical device (sterilization wrap), and "ground truth" in the context of expert medical interpretation is not relevant here. The 'ground truth' for these tests would be the established scientific and engineering standards and methods.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a sterilization wrap.
• 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 device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The 'ground truth' for this type of device is established through documented standard test methods (e.g., ASTM, ISO, AATCC, USP-NF) and validated sterilization cycles.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Additional Information from the "Summary of Non-Clinical Testing":

The study described the performance data for the CDB Hospital Sterilization Wrap, which included a series of nonclinical tests "associated with specific unique codes." These tests were conducted to demonstrate conformance with microbial barrier properties. The testing encompassed:

• Low Temperature Efficacy
• Steam Efficacy
• Shelf Life (up to 180 days under standard conditions)
• Aerosol Challenge
• Biocompatibility / Cytotoxicity (referencing ISO 10993 parts 5 and 23)

The key finding from these tests was that "All results met the defined acceptance criteria." The purpose of these tests was to validate the wrap's ability to maintain the sterility of package contents after sterilization, across different sterilization methods and for a specified shelf life.

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The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

• Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
• 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
• Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
• Advanced Sterilization Products STERRAD 100S system
• Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
• Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:

• 1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
• 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
• 3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

The provided text describes the acceptance criteria and the comprehensive non-clinical testing performed for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each test set. However, it indicates that the testing was non-clinical. This implies that the data provenance is from laboratory testing and not from human patient data. The origin of the data is implicit in the "non-clinical" nature and the use of ISO/ASTM standards for testing.

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

This information is not applicable to this type of device and study. The "ground truth" for sterilization wraps and their performance is established through adherence to recognized international standards (ISO, AAMI, ASTM, EN) and empirical laboratory testing, not through expert consensus from human observation (e.g., radiologists).

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are based on objective laboratory measurements against predefined technical specifications and standards, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable as the device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (algorithm only without human-in-the-loop performance), as they focus on the intrinsic properties and performance of the sterilization wrap itself against established technical and biological criteria. The "algorithm" in this context refers to the defined device specifications and its physical/chemical interactions, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used is primarily based on established industry standards and regulatory requirements for medical device sterilization and packaging, including:

• Biological indicators (for sterilant penetration and sterility maintenance) which have a known, predictable response.
• Physical and chemical property specifications (e.g., burst strength, air permeability, pH, leachable content) that are objectively measurable and defined by standards.
• Biocompatibility standards that define acceptable levels of cytotoxicity, irritation, and sensitization.
• Package integrity criteria for maintaining a sterile barrier for a specified duration.

8. Sample Size for the Training Set

This information is not applicable. The device is a sterilization wrap, not an AI/ML-based algorithm that requires a "training set" of data. The development and validation process for this device involves material science, engineering, and microbiology, not machine learning.

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

This information is not applicable for the reasons stated in point 8.

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Medline Reusable Sterilization Wrappers are intended to be used to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap.

Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times; Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris.

A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.

Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79 • AAMI ANSI ST65

The Medline Reusable Sterilization Wrappers are offered in bulk, non-sterile packaging. The Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be sterilized and laundered per the instructions.

The provided text describes the acceptance criteria and the results of non-clinical testing for the Medline Reusable Sterilization Wrappers.

Here's the breakdown of the requested information:

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 specific sample sizes for each test listed. It mentions "Each test sample" for Cleaning Validation, implying multiple samples were tested. For other tests like Resistance to Water Penetration, Tensile Strength, and Particle Generation, it refers to "Test and Report" without specifying quantity.
The data provenance is not specified. It can be inferred that these tests were conducted by the manufacturer, Medline Industries, LP, to support their 510(k) submission.

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 listed tests are non-clinical bench tests and sterilization validations, which typically rely on standardized methods and laboratory analysis rather than expert human interpretation for "ground truth" establishment in the same way, for example, medical image analysis would.

4. Adjudication method for the test set

Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of results in the traditional sense.

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 medical accessory (sterilization wrapper) and does not involve AI or human "readers" for interpretation. Therefore, an MRMC study is not relevant.

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

Not applicable, as this device does not involve an algorithm or AI component.

7. The type of ground truth used

The ground truth for these tests is established by:

• Standardized Test Methods and Criteria: For physical and material properties (e.g., AATCC 127-2018 for water penetration, ASTM D5034-21 for tensile strength, ISO 9073-10:2004 for particle generation).
• Biological Test Outcomes: For biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity), the "ground truth" is determined by the biological response observed according to the protocols of ISO 10993 series.
• Sterilization Efficacy Indicators: For Sterilization Validation and Dry Time Validation, the "ground truth" is determined by the results of biological indicators, chemical integrators, and physical observations (e.g., moisture, weight difference) as per ST79:2017.
• Chemical Analysis: For Cleaning Validation, the "ground truth" is based on measurable chemical residuals (TOC level) and visual inspection for soil, guided by AAMI TIR30:2011.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML component, so there is no "training set."

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

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

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HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 110° F/43.3ºC.

STERIS V-PRO® Low Temperature Sterilization Systems.

• · STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® 1 (Lumen Cycle)

• · STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

• Advanced Sterilization Products STERRAD® Sterilization System

• STERRAD® 100S

• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)

• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)

• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GL Cycle)

• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)

HALYARD* ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600.

• · 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3℃.
  · STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.

• · STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® 1 (Lumen Cycle)

• · STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

· Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 30 minute dry time for Models 400, 500 and 600)

• · Advanced Sterilization Products STERRAD® Sterilization System
• · STERRAD® 50, 100S, and 200
• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• · STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle)
• · STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles)
• · Stryker Sterizone® VP4 Sterilizer Cycle 1

HALYARD SEQUENTIAL Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD ONE-STEP, HALYARD QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* SEQUENTIAL Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously.

The HALYARD ONE-STEP, QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider.

The document describes the regulatory submission for HALYARD sterilization wraps. It focuses on demonstrating substantial equivalence to a predicate device through performance testing. No AI/ML algorithm is involved in the device. Therefore, a complete response is not possible for all aspects of your request.

Here's a breakdown of the available information:

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

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HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.

The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes

The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Halyard Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* Sequential Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously. The HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products, Inc. (ASP) STERRAD 100NX Sterilizer ULTRA™ GI Cycle.

The provided text describes the performance testing for the HALYARD* SMART-FOLD* Sterilization Wrap (H450 and H650).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for each test. The data provenance is not explicitly mentioned as a country of origin, nor is it stated whether the data is retrospective or prospective. These are non-clinical (laboratory) tests by their nature.

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

This section is not applicable as the tests performed are non-clinical, performance-based, and biocompatibility assessments, which rely on defined technical standards and measurements rather than expert human interpretation of complex data (like image analysis).

4. Adjudication Method

This section is not applicable for the same reasons as point 3.

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. This submission is for a medical device (sterilization wrap), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

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

This section is not applicable for the same reasons as point 5.

7. The Type of Ground Truth Used

For the tests conducted, the "ground truth" is defined by the technical standards and specifications outlined in the referenced ISO, AAMI, ASTM, and CPSC documents. For instance:

• Sterilant Penetration/Efficacy: The ground truth is a sterility assurance level (SAL) of 10$^{-6}$. This is an objective measurement based on microbiological testing.
• Performance Testing: The ground truth is compliance with specified physical properties (e.g., tensile strength, tear resistance as defined by the standards).
• Maintenance of Package Integrity: The ground truth is the ability to maintain sterility for up to 90 days, which is determined through microbial barrier testing and accelerated aging studies.
• Biocompatibility: The ground truth is material properties meeting non-cytotoxic, non-irritating, and specific residual level criteria, evaluated through chemical extractions and biological assays.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical sterilization wrap and does not involve machine learning or AI models with training sets.

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

This section is not applicable for the same reasons as point 8.

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The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

• Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
• 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
• Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
• Advanced Sterilization Products STERRAD 100S system
• Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
• Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:
1-The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
3- The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

The provided document is a 510(k) Summary for the PRIMED Sterilization Wrap. It outlines the device's technical characteristics, intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.

However, the document does not describe an AI/ML-enabled medical device. It pertains to a physical sterilization wrap. Therefore, the questions related to AI/ML model performance, such as:

• Sample sizes for test and training sets
• Data provenance
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC studies and effect sizes
• Standalone AI performance
• Type of ground truth

cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence of a physical product to a predicate device through non-clinical testing of its physical, chemical, and functional properties related to sterilization and sterility maintenance.

Here's an analysis of the acceptance criteria and study as presented for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document refers to "non-clinical testing" and does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to tests performed on the physical sterilization wraps.
• The sample sizes for each specific physical test (e.g., number of wrap samples for sterilant penetration, integrity, etc.) are not provided in this summary.
• Data provenance is not applicable in the AI/ML sense; the data is generated from laboratory testing of the physical device. The country of origin for the data (where the tests were conducted) is not specified, but the manufacturer is based in Canada.

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

• Not applicable to this device. Ground truth, in this context, refers to established scientific and engineering standards and methods for assessing the performance of sterilization wraps, not expert interpretation of images or clinical data.

4. Adjudication method for the test set:

• Not applicable to this device. Testing is based on established laboratory protocols and quantitative or qualitative measurements leading to pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This device is a physical sterilization wrap, not an AI/ML-assisted diagnostic or treatment aid for humans.

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:

• For this device, the "ground truth" is established by adherence to recognized international and national standards for medical device sterilization and packaging. These include:
  • ANSI/AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)
  • ANSI/AAMI/ISO 11138-7 (Sterilization of health care products - Biological indicators - Part 7: Biological indicators for ethylene oxide sterilization processes)
  • ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
  • AAMI TIR12 (Guidance for establishing product family groupings for sterilization)
  • ANSI/AAMI ST77 (Sterilization of health care products - Sterile device packaging - Requirements)
  • ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
  • ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
  • EN 868-2 (Packaging for terminally sterilized medical devices - Part 2: Sterilization wraps - Requirements and test methods)
  • Various ASTM (American Society for Testing and Materials) standards for fabric properties (D3776, D737-04, D3786, D5034-09, D5587-15)
  • AATCC127-2014 (Water Resistance: Hydrostatic Pressure Test)
  • NWSP 160.1 (Nonwoven Standard Procedure for linting)
• These standards define the methodologies and acceptable performance limits.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML model.

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

• Not applicable.

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The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes.
· In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃.

Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.

Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.

These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

Models 100, 200, 300, 400, 500 and 600
Available in one or two sheets of blue nonwoven Polypropylene fabric. Each sheet of fabric is composed of three thermally- bonded layers consisting of a Meltblown polypropylene layer surrounded by Spunbond polypropylene layers (SMS).

The provided document is a 510(k) Premarket Notification for a medical device, specifically Dukal SMS Sterilization Wrap. It details the device's technical characteristics, indications for use, and a comparison to predicate devices, along with non-clinical test results.

However, this document does not describe a study involving an AI/software device or human-in-the-loop performance. The "device" in this context is a physical sterilization wrap, not an AI or software algorithm. Therefore, many of the requested criteria related to AI/software performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The acceptance criteria provided in the document are for the physical properties and performance of the sterilization wrap itself (e.g., burst strength, air permeability, sterility maintenance) and its biological compatibility. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed on the physical wrap.

Here's a breakdown based on the provided document, addressing the applicable criteria for a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size 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 sample sizes for each specific test. However, it references numerous ASTM, ISO, AATCC, and USP standards for non-clinical testing. These standards typically define the number of samples required for robust testing. For example, specific test procedures for tensile strength or burst strength would involve testing a statistically relevant number of samples.

• Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical," implying laboratory testing of the material. There is no indication of retrospective or prospective data as this refers to patient data collection, which is irrelevant for a physical device like a sterilization wrap.

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

Not applicable. This device is a physical product (sterilization wrap), not an AI/software. Ground truth is established by objective physical and chemical testing methods as per international standards, not by human expert interpretation of images or clinical data.

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

Not applicable. This is not a study requiring adjudication of human interpretations.

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/software device, so MRMC studies are irrelevant.

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

Not applicable. This is not an AI/software device.

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

For this physical device, the "ground truth" is defined by the validated and established performance requirements outlined in the referenced national and international standards (e.g., ASTM, ISO, AATCC, USP). These standards define the quantitative and qualitative criteria for material properties, sterilization efficacy, and biocompatibility. For example:

• Sterilant Penetration/Sterility Maintenance: Demonstrated by "BI result: Negative" (Biological Indicator) and "No growth" in sterility tests, which are objective microbiological tests.
• Material Properties: Measured objectively (e.g., in grams per square meter for basis weight, Pascals for bursting strength, Newtons for tearing strength).
• Biocompatibility: Determined by laboratory tests for cytotoxicity, irritation, and sensitization against established biological thresholds.

8. The sample size for the training set

Not applicable. This is not an AI/software device requiring a training set.

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

Not applicable. This is not an AI/software device requiring a training set or ground truth for training.

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Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

• . Pre-vacuum Steam 270°F/132°C for 4 minutes
  • Dry time of 12 minutes for Fusion Light O
  • Dry time of 20 minutes for Fusion Heavy O
  • Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
• 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes
  • Aeration time of 8 hours at 55oC O
  • Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.

The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices. The Fusion wraps consist of two distinct nonwovens for each layer.

Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment.

Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties.

The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.

The provided text describes the regulatory clearance for the Ahlstrom-Munksjo Nonwovens LLC's Reliance® Fusion Sterilization Wraps (K230137), not an AI/medical imaging device. Therefore, the details requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets in AI studies, expert qualifications for ground truth in AI, MRMC studies, and training set details, are not applicable to this document.

This document focuses on the substantial equivalence of a physical medical device (sterilization wraps) to a predicate device, which is demonstrated through non-clinical performance data related to material science, sterilization efficacy, and biocompatibility.

Here's a breakdown of the information that is available in the document, framed in the context of the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria," but adapted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive table in Section VII "PERFORMANCE DATA" detailing the tests performed, the standards followed, the acceptance criteria, and the results for both the predicate and proposed devices.

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

The document does not specify exact sample sizes for each test. For a physical device like sterilization wraps, individual tests (e.g., sterilization efficacy, dry time, physical properties) would involve a certain number of units or replicates to demonstrate statistical validity. The provenance is not explicitly stated beyond being part of the manufacturer's non-clinical testing performed for regulatory submission. It is inherently "prospective" in the sense that these are specific tests conducted by the manufacturer for this submission, rather than retrospective analysis of existing data.

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

This information is not applicable as this is not an AI/medical imaging device. Ground truth in this context would be established by validated laboratory testing procedures and adherence to the specified standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

This is not applicable as there are no human interpretations or judgments to adjudicate in the performance testing of a physical sterilization wrap. The results are quantitative measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

This is not applicable as this is not an AI/medical imaging device that would involve human readers.

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

This is not applicable as there is no algorithm or AI involved. The "performance" is the physical functional performance of the wrap itself.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by validated laboratory testing methods against recognized industry standards (e.g., ANSI/AAMI, ISO, ASTM). For example:

• Sterilization Efficacy: Determined by the absence of microbial growth from biological indicators and test samples.
• Dry Time: Quantified by weight difference and visual assessment of moisture.
• Physical Properties: Measured using standardized mechanical and material testing methods (e.g., tensile strength, burst strength, air permeability).
• Biocompatibility & Residuals: Determined by laboratory assays per ISO standards.

8. The sample size for the training set:

This is not applicable as there is no training set for a physical medical device like this.

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

This is not applicable as there is no training set.

In conclusion: The provided document details the non-clinical performance testing of a physical medical device (sterilization wraps) to demonstrate substantial equivalence to a predicate device for FDA clearance. The acceptance criteria and "studies" are laboratory and physical tests, not AI model evaluations.

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