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

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

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

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

(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.

(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

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

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set.

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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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The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:

• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.

There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.

Therefore, I cannot provide the requested information based on this document.

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The Turbett Surgical Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical Filters.

The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes.

• The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes.
• The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs.
• The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
• The system was validated with 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens.

Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container with a fenestrated door holding a single use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain.

The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel.

The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal.

The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.

The provided FDA 510(k) clearance letter and summary for the Turbett Surgical Instrument Pod does not describe an AI/ML device or a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data. Instead, it describes a rigid sterilization container used for medical instruments.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this medical device submission.

The "study" in this context refers to non-clinical performance testing of the physical sterilization container.

Here's the information that can be extracted and presented based on the provided document, framed within the context of hardware device performance testing:

Device Description

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container designed to enclose other medical devices for sterilization by a healthcare provider. It allows sterilization of enclosed materials and maintains sterility for up to 30 days. It is intended for use in pre-vacuum steam sterilizers with specific temperature and exposure times. The container is made of stainless steel and aluminum, includes a single-use filter, and accommodates various sizes of instrument loads and lumens.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to demonstrate its safety and effectiveness as a sterilization container. The acceptance criteria were based on medical device sterilization standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

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

   • The document does not specify exact sample sizes (e.g., number of containers tested) for each non-clinical test.
   • It mentions three specific container models (TS1500, TS1200, TS1000) and indicates that the system was validated with specific rigid and flexible lumens (0.7 mm x 500 mm and 1.0 mm x 850 mm for the subject device).
   • Data provenance: Not explicitly stated, but typically for 510(k) submissions, non-clinical tests are conducted by the manufacturer or accredited testing laboratories in a controlled environment as part of the design validation process. This is a prospective testing design to meet regulatory standards.

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

   • Not applicable in the context of AI/ML. For this physical device, "ground truth" is established by adherence to recognized consensus standards for sterilization and medical device testing (e.g., ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2007, TIR 30:2011, ANSI/AAMI HE75:2013). The "experts" are the qualified personnel within the testing laboratories who perform the tests according to these validated methods.

3. Adjudication method:

   • Not applicable. This is not a human-in-the-loop or interpretation-based task that would require adjudication. Results are quantitative measurements against defined criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvements:

   • No. This is not a study assessing human reader interpretation of images or data.

5. 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.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is defined by established consensus standards and validated chemical/physical/biological testing methods (e.g., sterility assurance levels, gravimetric measurements for dryness, chemical residue analysis, microbial growth/no-growth observations).

7. The sample size for the training set:

   • Not applicable. No AI/ML training set is mentioned or implied.

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

   • Not applicable. No AI/ML training set is mentioned or implied.

Summary regarding AI/ML criteria: The provided document pertains to a physical medical device (sterilization container) and its non-clinical performance testing. It does not involve AI/ML, human readers, image analysis, or expert consensus-based ground truth typical of AI/ML device clearances.

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The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.

The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called "Sterilization Package/Reel." This document focuses on the substantial equivalence of the device to existing predicate devices, primarily through non-clinical bench testing and comparisons of technological characteristics.

The information you requested, relating to acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD)'s performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided text.

The document discusses validation of sterilization processes (ISO 11135, ISO 17665-1), material compatibility, package integrity, and biocompatibility, which are standard tests for physical sterilization packaging, not for AI device performance.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
• · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).

Furthermore, there are 3 thicknesses for health care workers to choose from as follows:

• · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m
• Pouch of Combination B: Medical grade paper 60g+laminated film 52um
• · Pouch of Combination C: Medical grade paper 70g+laminated film 52um

The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO).

The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization.

The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization.

The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas.

The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows:

• Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M
• Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M
• · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M

The provided text is a 510(k) summary for the Medicom Sterilization Pouch and Reel. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria as would be done for a novel AI/software medical device.

Therefore, much of the requested information (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, AI effect size, training set details) is not applicable to this type of device submission and is not present in the document.

However, I can extract the acceptance criteria and reported performance for the physical and chemical properties of the Medicom Sterilization Pouch and Reel, as these are the relevant performance metrics for this specific device.

Based on the provided document, here's an analysis:

Device: Medicom Sterilization Pouch and Reel (FRG, JOJ - Sterilization Wrap)

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

The document provides extensive tables (Table 5-4 and Table 5-5) detailing the tests performed, the standards followed, the acceptance criteria, and the results ("Pass"). I will consolidate and present these.

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

• Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, and biological test. It only states that the "results of the Medicom Sterilization Pouch and Reel validation studies demonstrate that the sterilization pouches perform as intended."
• Data Provenance: Not explicitly stated regarding the origin of the test samples (e.g., country of manufacture). The studies appear to be prospective validation tests conducted by the manufacturer to demonstrate performance against established standards.

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. The "ground truth" for this device (sterilization pouches and reels) is established by adherence to recognized international standards (e.g., ISO, ASTM, AAMI) for physical, chemical, and biological performance. These standards define the test methods and acceptance criteria. There is no subjective human interpretation or "expert consensus" on ground truth in the way there would be for an AI diagnostic device evaluating medical images.

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

• Not applicable. Adjudication methods like "2+1" are relevant for clinical studies involving human readers and subjective interpretations, especially in AI-assisted diagnosis. For physical product testing conforming to specific standards, the results are typically objectively measured and evaluated against predefined thresholds.

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 sterilization pouch and reel, not an AI or imaging device that would involve human readers or MRMC studies.

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

• Not applicable. This is not a software algorithm or AI device.

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

• The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized international standards (e.g., successful microbial inactivation as per SAL 10^-6, specific tensile strengths, lack of leaks, defined color changes for chemical indicators, biocompatibility profiles). These are established through laboratory testing following validated protocols, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

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

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The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:

• Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
• b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
  The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
  The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.

Based on the provided text, the device in question is "Sterilization Pouches and Reels" (K242898), which is a medical device intended for enclosing other medical devices for sterilization. There is no mention of "AI" or "human readers" in the context of this device. The document describes a traditional 510(k) submission, primarily focusing on non-clinical performance testing and comparison to a predicate device.

Therefore, many of the requested points in your prompt that relate to AI/algorithm performance, human readers, ground truth establishment for complex data, and MRMC studies are not applicable to the information provided.

However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical performance testing described.

Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted to demonstrate the safety and effectiveness of the Sterilization Pouches and Reels. The acceptance criteria are implicitly met if the "Pass" status is achieved for each test, indicating conformity to the referenced ISO or ASTM standards.

Information Not Applicable or Not Found in the Provided Text:

2. Sample size used for the test set and the data provenance: The document does not specify the sample sizes (number of pouches/reels) used for the non-clinical performance and biocompatibility tests. It also does not specify the provenance (country of origin, retrospective/prospective) of any "data" beyond general testing. The tests are laboratory-based performance tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is adherence to established engineering and material science standards (e.g., ISO, ASTM), rather than expert consensus on medical image interpretation.
4. Adjudication method: Not applicable, as there's no expert interpretation involved in the performance testing described.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
7. The type of ground truth used: For this device, the "ground truth" is adherence to established physical, chemical, and biological performance standards (e.g., seal strength, sterility barrier, chemical indicator color change, biocompatibility). It is determined by the results of specific standardized laboratory tests, not by expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.
8. The sample size for the training set: Not applicable. There is no AI/machine learning component, so no training set is used.
9. How the ground truth for the training set was established: Not applicable. There is no AI/machine learning component, so no training set or its ground truth establishment is mentioned.

Summary of Applicable Information:

The study proving the device meets its acceptance criteria is primarily based on non-clinical performance testing as outlined by various international and national standards (ASTM, ISO, DIN). The document explicitly states: "Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards..."

The core method of verification is demonstrating "Pass" for each of the listed tests according to the requirements of the specified standards. This type of device relies on engineering and material science validation rather than clinical trials involving human subjects or AI performance metrics.

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

• · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
• · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
• Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
• The recommended hydrogen peroxide vapor sterilization cycle is :
• · Standard Cycle of STERRAD® 100S
• Standard cycle and Advanced cycle of STERRAD® NX
• · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
• · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX

The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:

• Standard Cycle of STERRAD® 100S
• inside diameter ≥ 1 mm and length ≤ 125 mm
• inside diameter ≥ 2 mm and length ≤ 250 mm
• Standard cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 150 mm
• Inside diameter ≥ 2 mm and length ≤ 400 mm
• · Single channel PE/PTFE tubing with:
• Inside diameter ≥ 1 mm and length ≤ 350 mm
• Advanced cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 500 mm
• · Single PTFE lumen tubing with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• · Single channel PE/PTFE flexible endoscopes with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Standard cycle of STERRAD® 100NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 0.7 mm and length ≤ 500 mm
• Single channel PE/PTFE instruments with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• Flex cycle of STERRAD® 100NX
• Single channel PE/PTFE flexible endoscope with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Lumen Cycle of V-PRO® maX
  △ Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
  △ Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
• Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and

The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape.

They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization.

The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle.

The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed.

The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.

The provided text describes the regulatory clearance for "Safe Secure Sterilization Pouches and Rolls" and details non-clinical testing performed to establish its substantial equivalence to a predicate device. It is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not present in this document.

The document focuses on the physical and chemical performance of sterilization pouches, not on an algorithm's diagnostic or predictive capabilities.

However, I can extract the general acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Points 2-9 are not applicable/available based on the provided text, as this document pertains to a physical medical device (sterilization pouches) and its physical and chemical properties, not a software-based AI/ML medical device.

• 2. Sample sized used for the test set and the data provenance: Not applicable. Testing involves physical units of pouches and rolls. The data provenance is laboratory testing rather than patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements and established standards (e.g., integrity, strength, color change), not expert consensus on interpretations of complex data like medical images.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.): Ground truth is based on established engineering and materials science standards for sterile barrier systems (e.g., seal strength, dye penetration for integrity, microbial ingress for sterility maintenance, chemical color change for indicator function).
• 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.

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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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