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The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:

Lumen Cycle
Non Lumen Cycle
Flexible Cycle

Device lumen dimensions:

Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.

Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm

.114 pounds for pouch sizes below (Flexible and Lumen Cycles) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

.158 pounds for pouch sizes below (Non-Lumen Cycle) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERIS® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERIS® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.

Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.

Sterilization Systems:

STERIS® V-PRO® Cycles:
Lumen Cycle,
Non Lumen Cycle
Flexible Cycle

The information provided describes the Steriking LT-Blueline Pouches with Tyvek device, which is a sterilization wrap. The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis 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 the data provenance

The document does not explicitly state the specific sample sizes for each test. It refers to "samples," "items," and "pouches" but does not provide numerical quantities for the test sets.

The data provenance is from non-clinical tests conducted on the device itself (Steriking LT-Blueline Pouches with Tyvek). The country of origin of the data is not specified, but the applicant, Wipak Oy, is located in Nastola, Finland, suggesting the testing may have been conducted there or by a contracted lab. The studies are prospective in the sense that they are designed to evaluate the performance of the manufactured device.

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

This is a non-clinical device performance study, not a study involving human interpretation of medical images or data. Therefore, the concept of "experts" to establish ground truth in the context of medical imaging interpretation is not applicable here. The "ground truth" is established by adherence to recognized international and industrial standards (e.g., ISO, ASTM, AAMI) for testing materials and sterilization packaging.

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

Not applicable. This is a non-clinical device performance study, not a study involving diagnostic interpretation or human consensus. Test results are determined by quantitative measurements and observations against pre-defined criteria from recognized 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 non-clinical device performance study for a sterilization pouch, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical device performance study for a sterilization pouch, not an algorithm. The device performance itself is "standalone" in the sense that it is evaluated directly against physical and biological criteria.

7. The type of ground truth used

The ground truth is based on established scientific and engineering standards and validated test methodologies.

• Biocompatibility: Absence of cytotoxicity as per ISO 10993-5.
• Sterilant Penetration: 6-log reduction of Geobacillus stearothermophilus spores, demonstrating a 10^-6 Sterility Assurance Level. This is a biological indicator's response to sterilization.
• Package Integrity (Dye Migration): Absence of dye penetration as per ASTM F1929-15.
• Microbial Barrier Properties: Maintenance of sterility (no microbial growth) after exposure to aerosolized spores as per ISO 11607 and related AAMI standards.
• Seal Strength: A minimum peel strength of 1.5N/15mm as per ASTM F88.
• Material Compatibility: Meeting specifications defined in technical data sheets.

8. The sample size for the training set

Not applicable. This is a non-clinical device performance study, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning study, there is no training set or associated ground truth for that purpose.

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The SteriKing® LT Blueline with Tyvek® pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

The SteriKing® LT Blueline with Tyvek® pouches are intended for use in the following STERRAD® Sterilization Cycles:

NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard

Max weights:

NX Standard Cycle:

75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds

NX Advanced Cycle:

75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds

100NX Duo Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds

100NX Flex Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds

100NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds

Max lumens:

1 mm min ID and 1 max lumen for all cycles

NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.

NX Advanced Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length is 50 mm for all other pouch sizes.

100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes.

100NX Flex Cycle: Max length is 850 mm for all pouch sizes.

100NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length, Max length is 50 mm for all other pouch sizes.

Pouch Sizes:
250 mm x 500 mm
250 mm x 390 mm
205 mm x 390 mm
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm

Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.

Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERRAD® Sterilization Systems.

Sterilization Systems:

STERRAD® Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard

This document is a 510(k) Premarket Notification from the FDA, and as such, it describes the non-clinical testing performed for a medical device (sterilization pouches), rather than an AI-powered software device. Therefore, many of the requested elements for describing an AI study (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable in this context.

However, I can extract the information related to the acceptance criteria and the studies that prove the device meets these criteria, focusing on the traditional medical device testing rather than AI performance.

Here's the breakdown of the acceptance criteria and study findings for the SteriKing® LT-Blueline Pouches with Tyvek®:

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

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

The document does not explicitly state numerical sample sizes for each test. However, it mentions "test samples" and "stainless-steel coupons" were used. The data provenance is based on lab testing of the device itself, likely conducted by the manufacturer (Wipak Oy in Finland) for submission to the FDA. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human data.

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

This is not applicable as the testing involves physical and biological properties of a medical device (sterilization pouches), not an AI model requiring human expert interpretation for ground truth. Ground truth is established through adherence to recognized international standards and documented laboratory methods (e.g., measuring direct physical properties, culturing for microbial growth, assessing cytotoxicity).

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

Not applicable. This is not a human interpretation study. The results are based on objective measurement against predefined 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 not an AI-powered device or a study involving human readers.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated through its physical and biological integrity and functionality.

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

The ground truth for this device is based on:

• Compliance with recognized international and national standards: e.g., ISO 10993-5 (Biocompatibility), AAMI TIR12:2010 (Sterilant Penetration, Microbial Barrier), ASTM F1929-15 (Seal Leaks, Dye Migration), ASTM F88 (Seal Strength), ASTM F1980 (Accelerated Aging).
• Objective laboratory measurements: Such as absence of cell growth/lysis, 6-log reduction in spores, absence of dye penetration, specified seal strength values, and "no growth in any of the culture tubes."
• Performance specifications: Material compatibility against technical data sheets.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI or machine learning model.

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

Not applicable. There is no training set for this type of medical device.

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