Search Results

Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic Instruments during steam sterilization that maintains the sterility of the enclosed medical devices until they are used.

Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for steam sterilization in health care establishments. The products are for single use only. The pouches allow sterilization, mamtain sterility and enable aseptic presentation of packed medical device.

The recommended sterilization cycles are as follows: Pre-vacuum steam at 132ºC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135℃ for 3 minutes: Drying time of 16 minutes

The maximum load for the Steriking® Pouch for Robotic Intuitive Endowrist Robotic Instrument or other medical devices with a combined weight of metal and plastics of 2.6 pounds or less.

Steriking® Pouch for Robotic Instruments consist of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic) with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper.

Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and pouch sizes that are selfsealed.

For heat-sealed sizes: The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C-200°C (329°F - 392°F).

Steriking® Pouch for Robotic Instruments have Dimensional heat-seal configurations (2 sizes 200mm x 800mm, 250mm x 900mm).

Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture.

For self-sealed sizes: The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.

Steriking® Pouch for Robotic Instruments have Dimensions (2 sizes 200mm x 800mm x 800mm x 875mm).

Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The provided text describes the acceptance criteria and the results of performance tests for the "Steriking® Pouch for Robotic Instruments". However, it does not include information about any AI-powered function, a "study that proves the device meets the acceptance criteria" in the context of an algorithm's performance, or details regarding ground truth establishment, expert involvement, or sample sizes related to AI/algorithm development.

The document is a 510(k) Premarket Notification from the FDA for a medical device (sterilization pouch), which is a physical product, not a software or AI device. Therefore, the questions about AI, algorithms, ground truth, expert consensus, and training/test set sizes are not applicable to this document.

Here's a summary of the available information regarding acceptance criteria and performance, as it relates to a physical medical device.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for each test. The data provenance is not explicitly stated, but the submission is from Wipak Oy, Nastola, Finland, suggesting the testing was conducted or overseen by this company. The tests are for device performance, not a dataset in the context of an algorithm.

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. This is a physical medical device; the performance tests are based on established international and national standards for sterilization packaging, not on expert interpretation or ground truth derived from clinical data in the way an AI algorithm would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device, not an algorithm where adjudication of results would be relevant.

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 physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance is objective measurement against established industry standards and regulations for sterilization, package integrity, microbial barriers, and biocompatibility.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.

Ask a specific question about this device

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 1 year post sterilization. The products are for single use only.

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 max and 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen max for all pouch sizes.

1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm

Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm

.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

Pouch Sizes: 300 x 450 mm 250 x 400 mm

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 1 year post sterilization. The products are for single use only.

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 max and 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen max for all pouch sizes.

1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm

Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm

.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

Pouch Sizes: 300 x 450 mm 250 x 400 mm

This document is an FDA 510(k) clearance letter for a medical device: "Steriking® LT-Blueline Pouches with Tyvek®". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a regulatory approval for a physical medical device (sterilization pouches), not an AI/ML diagnostic or therapeutic device.

Therefore, I cannot answer your specific questions regarding acceptance criteria and performance studies for an AI/ML device based on the input provided. The requested information (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is relevant for AI/ML device submissions, but this document pertains to a physical sterilization product.

Ask a specific question about this device

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 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 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek 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:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds.

NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds.

100NX Duo Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds.

100NX Flex Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds.

100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds.

Max Count of lumens:
1 lumen max for All cycles

Max ID of lumens:
NX Standard Cycle:
1 mm ID for all pouch sizes

NX Advanced Cycle:
2 mm ID for all pouch sizes

100NX Cycle:
1 mm ID for all pouch sizes

100NX Flex Cycle:
1 mm ID for all pouch sizes

100NX Standard Cycle:
2 mm ID for all pouch sizes

Max lumen lengths:
NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.

NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.

100NX Duo Cycle:
850 mm for all pouch sizes

100NX Flex Cycle:
850 mm for all pouch sizes

100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.

Pouch Sizes:
300 x 450 mm
250 x 400 mm
190 x 330 mm
130 x 380 mm
130 x 270 mm
90 x 250 mm
90 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 self-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 1 year post sterilization. The products are for single use only.

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

Sterilization Systems:

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

The document provided describes the Steriking® LT-Blueline Pouches with Tyvek®, which are intended to enclose devices for sterilization in STERRAD® Sterilizer Systems and maintain their sterility for up to one year. This device is a sterilization wrap, regulated as Class II.

The study presented is a non-clinical performance study to demonstrate that the proposed device, a self-seal pouch, is as safe and effective as its predicate device, a heat-seal pouch, with an added adhesive strip for sealing.

Here's an analysis of the acceptance criteria and the study results based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes ("N") for each test. Instead, it refers to "All self-seal pouches," "All samples," and "Each pouch." This implies that the tests were conducted on a sufficient number of samples according to the referenced standards (e.g., ASTM, AAMI, ISO), which typically specify minimum sample sizes.

The data provenance is not specified regarding country of origin. The study appears to be prospective as it's a performance study for a new iteration of a device (the addition of a self-sealing adhesive strip) on the market. The phrase "Studies on the self-seal pouch were performed concurrently to the heat-seal pouch studies" suggests newly generated data for the proposed device.

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

This information is not provided in the document. The tests performed are primarily laboratory-based physical, chemical, and microbiological evaluations against established standards, rather than expert-based assessments of images or patient data. Therefore, the concept of "ground truth" derived from human experts in the context of diagnostic interpretation is not applicable here.

4. Adjudication Method for the Test Set

This is not applicable as the tests are analytical and objective measurements against defined standards, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a sterilization pouch and not a diagnostic imaging or AI-driven decision support tool that would typically involve human readers.

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

No, a standalone study in the context of an algorithm or AI is not applicable. The device is a physical product (sterilization pouch), and the performance assessments are for the device's physical and functional properties.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on established industry standards and scientific principles as outlined in various ASTM, AAMI, and ISO documents (e.g., ASTM F1929 for dye migration, ASTM F88 for tensile strength, ISO 10993-5 for cytotoxicity, AAMI TIR12 for microbial aerosol challenge and sterilization penetration). For biological tests like sterility, the "ground truth" is determined by the absence or presence of microbial growth under specified conditions (e.g., kill of $1.0\times10^6$ Geobacillus stearothermophilus spores, no growth after exposure).

8. The Sample Size for the Training Set

This is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device is a physical product.

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

This is not applicable as there is no "training set" for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes

The Steriking Packaging for Medical Devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the centre working outwards to ensure a good, even seal. Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 875mm).

This document is a 510(k) premarket notification for a medical device, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on showing equivalence to an existing device rather than presenting new clinical study data with acceptance criteria for a novel AI device.

Therefore, the requested information about acceptance criteria, specific study details (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), and ground truth establishment methods is not applicable to this document. This document details the technical characteristics of a sterilization packaging material and its comparison to a predicate device, not the performance of an AI/ML algorithm.

The table for acceptance criteria and reported device performance is presented in the original document as a comparison between the submitted device and its predicate, rather than against specific pre-defined acceptance criteria for an AI model.

Here's a summary of the information provided in the document, framed in the context of device equivalence rather than AI performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table (pages 4-6) showing the technical characteristics of the new device ("Submission Device – Steriking Packaging for Medical Devices") against its predicate device ("Predicate Device – Steriking Packaging for Medical Devices K210810"). This comparison serves as the "acceptance criteria" in the context of a 510(k) submission, where the new device must be substantially equivalent to the predicate. "Reported device performance" here refers to the measured physical and functional properties of the submitted device.

The following points are N/A (Not Applicable) as the document describes a traditional medical device (sterilization packaging) and not an AI/ML powered device.

2. Sample sizes used for the test set and the data provenance: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

Ask a specific question about this device

Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes

The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).

Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm)

The Steriking Packaging for Medical Devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C – 200°C (329°F - 392°F) Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 900mm).

The provided document is a 510(k) Premarket Notification summary for "Steriking Packaging for Medical Devices." It details the device's characteristics, indications for use, comparison to a predicate device, and the results of non-clinical testing to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text, formatted to address your specific points.

The document describes pre-market testing of a medical device packaging system, not an AI/ML-driven device. Therefore, many of the questions related to AI/MRMC studies, training sets, and expert consensus for ground truth are not applicable to this kind of submission. I will address the applicable parts of your request.

Acceptance Criteria and Device Performance for Steriking Packaging for Medical Devices

The study proves that the device meets its acceptance criteria through a series of non-clinical performance tests, designed to demonstrate the safety and effectiveness of the packaging for maintaining sterility of medical devices after steam sterilization.

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

The document provides a detailed table within the "Summary of Non-Clinical Testing" section. This table lists the test methodology, purpose, acceptance criteria, and the results (which are uniformly "Pass" or specific measurements that meet the criteria).

2. =>66N/15mm
3. =>33N/15mm
4. =152 +/- 10% μm

5. 550mN (MD & CD)

6. 10N

7. 230kPa

8. 3.9 – 5.7 µm/PAS
9. Corresponds
10. 1.5N/15mm
11. No irregularities or splitting >10mm
12. evaluation grade = 5
13. No objections
14. No pinholes | Pass |
    | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to 1.5N/15mm | Pass |
    | ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Package Integrity | No dye penetration/channeling travelling full width of seal in ~5 seconds | Pass |

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. This type of information is typically found in the full test reports referenced by the standards, not in the summary.

Data Provenance: The manufacturing entity is Wipak Oy in Nastola, Finland, indicating the origin of the device. The testing was non-clinical (laboratory/material testing) rather than clinical data from human subjects. Therefore, terms like "retrospective" or "prospective" and "country of origin of the data" in the sense of patient data are not applicable. The testing was performed according to international standards (e.g., ISO, ASTM, EN, DIN), which are universally recognized.

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

This question is not applicable. The device is a medical packaging product, and its "ground truth" is established through physical and material science testing against recognized international engineering and materials standards (e.g., ISO, ASTM). These tests do not involve expert human interpretation in the way, for example, a diagnostic imaging AI would. The "ground truth" is determined by the objective measurements and criteria defined in the specific test methodologies.

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

This question is not applicable. Adjudication methods are typically used in studies involving human readers or subjective interpretations, such as clinical trials or diagnostic accuracy studies. For material and physical properties testing, the results are objectively measured against predefined scientific criteria, not adjudicated.

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. The submission is for a medical device packaging material, not an AI or imaging device that would involve human readers or comparative effectiveness studies of diagnostic performance.

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

This question is not applicable. The device is physical packaging, not an algorithm.

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

The "ground truth" for this device is established by objective measurements of physical, chemical, and biological properties against established industry and international standards (e.g., seal strength, microbial barrier, puncture resistance, sterility assurance level, material compatibility, cytotoxicity). This is based on scientific and engineering principles, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device packaging product, not an AI/ML device.

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

This question is not applicable, as there is no training set mentioned or relevant to this type of device submission.

Ask a specific question about this device