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Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃.

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.

The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device.

The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g

Disposable Medical Device Sterilization Reel Pouch

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C.

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.

The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.

Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃.

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.

The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device.

The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g

Disposable Medical Device Sterilization Reel Pouch

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C.

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.

The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.

The provided document is a 510(k) clearance letter from the FDA for a medical device: "Disposable Medical Device Self-Seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch."

This document does not contain the acceptance criteria or a study proving the device meets those criteria in the format usually associated with assessing the performance of AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy, F1 score).

Instead, it's a regulatory clearance stating that the device is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" section describes the intended purpose of the sterility pouches, the sterilization cycles they are compatible with, and lists the sizes/models available. It also mentions the maximum load weights for different pouch sizes as part of the testing performed, which are effectively performance specifications for the physical product.

Therefore, I cannot extract the requested information regarding acceptance criteria and a detailed study proving the device meets those criteria in the context of an AI/ML or diagnostic device using the provided text. The document is about regulatory clearance for a physical sterilization pouch, not a computational device.

However, if we interpret "acceptance criteria" for this physical device, it would relate to its ability to maintain sterility and indicate successful sterilization, and the "study" would be the validation testing performed to demonstrate this. Based on the text, the following can be inferred:

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 provide specific sample sizes (e.g., number of pouches) used in the testing for sterility or indicator function.
• The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. It would be manufacturer-supplied data as part of the 510(k) submission.

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

• This information is not applicable and not provided. The testing for sterilization pouches involves laboratory validation (e.g., microbiological challenge tests, physical integrity tests, indicator performance tests) rather than expert interpretation of data.

4. Adjudication method for the test set:

• Not applicable and not provided.

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

• Not applicable. This is for a physical medical device, not an AI/ML or diagnostic imaging device.

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

• Not applicable.

7. The type of ground truth used:

• For a sterilization pouch, the "ground truth" would be established through laboratory testing and validated sterilization processes. This would include:
  • Sterility testing: Verifying that devices sterilized within the pouches indeed achieve sterility (e.g., biological indicator kill, microbiological challenge tests).
  • Physical integrity testing: Ensuring the pouch maintains its barrier properties before, during, and after sterilization.
  • Chemical indicator performance testing: Verifying the color change of the indicators accurately reflects exposure to the specified sterilization process parameters.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical sterilization pouch.

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

• Not applicable.

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The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.

The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.

The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

There are 2 models of the Sterilization Pouches in this application with different physical specification. The Disposable Medical Device Seff-seal Sterilization Pouch is made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. 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 or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

The Disposable Medical Device Sterilization Reel Pouch are made from a medical grade paper and plastic (PP/PET) film that are heat sealed on opposite two sides. It will be cut to suitable length and the opened sides will be heat-sealed. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

The provided document is a 510(k) Summary for a medical device, which is an application to demonstrate substantial equivalence to an existing legally marketed device. It describes the device, its intended use, and the non-clinical tests conducted. However, it does not detail specific acceptance criteria for a study in the way one might expect for a clinical trial or a performance study with numerical thresholds.

Instead, the document primarily focuses on verifying that the proposed device (Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch) meets design specifications and complies with recognized standards and validation tests. The "acceptance criteria" can be inferred from the successful completion of these tests as per the relevant standards.

Here's an attempt to extract the requested information, acknowledging that the document doesn't explicitly present acceptance criteria and reported performance in a table format for a single study, but rather refers to various validation methods.

Acceptance Criteria and Device Performance for Disposable Medical Device Self-seal Sterilization Pouch and Disposable Medical Device Sterilization Reel Pouch

The device's performance is demonstrated through non-clinical testing against various international and ASTM standards. The acceptance criteria are implicit in the successful fulfillment of these standards and validation tests.

1. Table of Acceptance Criteria and Reported Device Performance

• Half cycle overkill: No microbiological growth after half-cycle sterilization.
• Dry time validation: Samples free of visible moisture with no significant weight gain after full cycle sterilization and specified dry time. | "Half cycle overkill validation of the claimed steam sterilization cycle: Challenge loads consisted of scalers, hemostatic forceps and tooth probes. No cavities or complex devices. All loads showed no growth at 1/2 cycle."
  "Dry time validation: Full cycle sterilization testing showed samples to be free of visible moisture with no signification weight gain following sterilization and stated dry time." (Both criteria were met). |
  | Material Compatibility: Materials must not degrade after sterilization. | "After sterilization, the materials were not degraded." (Reported as met for the proposed device, predicate, and reference devices). |

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

The document does not explicitly state the sample sizes for each non-clinical test. It lists the standards and types of validation performed. The data provenance is not specified beyond the tests being conducted for submission to the U.S. FDA, likely implying internal company testing or testing by certified labs for the manufacturer (Weihai Xingtai Packaging Products Co., Ltd. from China). The tests are retrospective in the sense that they were performed on manufactured devices to demonstrate compliance.

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

Not applicable. This device is a sterilization packaging material, and its performance is evaluated against engineering, material, microbiological, and chemical standards, not by human interpretation of medical images or diagnoses. Ground truth is established by the specified test methods and criteria within the aforementioned standards.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical testing. The outcomes of the tests are objective measurements and observations (e.g., color change, absence of microbial growth, resistance to pressure, absence of leaks, material integrity).

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

No. This is a Class II medical device (sterilization wrap) and the validation is based on non-clinical performance standards. MRMC studies are typically for diagnostic imaging devices where human reader performance is a key metric.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not directly applicable. The device itself is not an algorithm. Its performance is inherent in its physical and chemical properties when subjected to sterilization processes. The "standalone" performance here refers to the device's ability to meet its functional requirements (e.g., maintain sterility, indicate sterilization) independent of human variability in the use of the device, assuming proper handling and sterilization procedures are followed. The non-clinical tests validate these inherent properties.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is based on established scientific and engineering standards and validation protocols. This includes:

• Physical measurements (e.g., pressure resistance, seal integrity).
• Microbiological challenge testing (e.g., absence of growth).
• Chemical reactions (e.g., specific color change of indicators).
• Biocompatibility assessments (e.g., cytotoxicity, irritation).
• Material science evaluations (e.g., material degradation, aging).

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for this device comes from its design and manufacturing process, optimized to meet the performance standards.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.

The recommended (and validated) sterilization cycle parameters are;

· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.

· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.

Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.

After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.

The provided text describes the acceptance criteria and performance data for a medical device called "PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)". However, it does not contain the level of detail requested for AI/ML device studies (e.g., number of experts, adjudication methods, training/test set sample sizes, ground truth provenance for training set). This is because the document is a 510(k) premarket notification for a sterilization pouch, which is a physical medical device, not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance are not applicable.

Here's the information that can be extracted from the document, presented in a format that aligns with the request where possible:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document is for a physical medical device (sterilization pouch), not an AI/ML device. Therefore, a "test set" in the context of an AI/ML algorithm is not applicable. The performance data is based on various standard tests for sterilization packaging and indicators. The provenance mentioned is PMS Tıp Teknolojileri Sanayi ve Ticaret Limited Şirketi, located in Mersin, Turkey. The testing would have been conducted as part of the device's development and validation, which is prospective in nature, but specific sample sizes for each test are not detailed in this summary document.

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)

This question is not applicable to a physical medical device like a sterilization pouch, as "ground truth" established by experts in the context of AI/ML algorithms does not apply here. Performance is evaluated against established physical, chemical, and microbiological standards.

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

This question is not applicable to a physical medical device. Performance is evaluated against objective, measurable criteria and standards, not expert adjudication of complex interpretations.

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

This question is not applicable to a physical medical device. MRMC studies are relevant for imaging or diagnostic AI where human readers interact with the AI.

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

This question is not applicable to a physical medical device. There is no AI algorithm involved. The device operates independently of human interpretation in terms of its core function (sterilization and indication).

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

For this physical device, the "ground truth" used for testing would be based on:

• Physical/Chemical Standards: Adherence to material specifications, seal strength, and indicator color change criteria as defined by international standards (e.g., ISO 11140-1, ISO 11607-1).
• Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10^-6, typically confirmed through biological indicator tests and sterility testing after exposure to validated sterilization cycles.
• Performance Standards: Ability to maintain sterility for the stated shelf life (30 days in this case).

8. The sample size for the training set

This question is not applicable, as this is not an AI/ML device that requires a training set.

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

This question is not applicable, as this is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterlity of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.

The Sterilucent Self-Seal Sterilization Pouch is a self sealing pouch used to enclose another medical device that is to be sterilized by a healthcare provider. It is available in sizes to suit the healthcare provider. Devices are inserted into the pouch, sealed, and then sterilized in the Sterilucent low temperature vaporized hydrogen peroxide (VHP) process. After completion of the sterilization process, the pouch maintains sterility of the enclosed medical devices until the seal is opened.

The pouches are constructed of a Tyvek backing with a clear, laminated polyethylene terephthalate (PET)/low density polyethylene (LDPE) film material front. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment.

The provided text describes the Sterilucent Self-Seal Sterilization Pouch and its non-clinical performance data. Here's an analysis of the requested information based on the text:

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

The document doesn't explicitly list acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes the outcome of studies, stating that "all acceptance criteria were met."

However, we can infer criteria and performance from the "Summary of Non-Clinical Performance Data" section:

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

The document does not explicitly state the sample size used for the test set or the number of pouches used for each test.
The data provenance is from non-clinical studies, which typically means laboratory testing rather than human patient data. The country of origin of the data is not specified.

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

This information is not provided in the document. Given that the studies are non-clinical, it's unlikely that "experts" in the sense of clinical specialists were used to establish ground truth. Ground truth for sterilization efficacy and microbial barrier properties would typically be established by established microbiological testing standards and results.

4. Adjudication method for the test set

This information is not provided as it's not applicable to non-clinical laboratory tests as described. Adjudication methods like "2+1" are typically used for interpreting human-read data (e.g., medical images).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools with human readers, which is not the nature of this device (a sterilization pouch).

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

This question is not applicable to the Sterilucent Self-Seal Sterilization Pouch. This device is a physical product (a pouch) used in a sterilization process, not an algorithm or AI system. Its performance is evaluated through its physical and biological properties.

7. The type of ground truth used

The ground truth used for the non-clinical studies was based on:

• Biological Indication (BI) overkill method and half-cycle validation: For sterilization efficacy (determining a 12 log reduction and SAL of 10-6).
• Real-time event-related shelf life studies: For sterility maintenance over time.
• Whole package microbial challenge testing: Exposing pouches to a specified concentration of Bacillus atrophaeus CFU to assess microbial barrier properties.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of validating a medical device like a sterilization pouch, as it's not an AI or machine learning model. Its performance is evaluated through physical and biological testing.

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

This information is not applicable/not provided for the same reasons as #8.

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Ask a specific question about this device

The Granton® Medical 121-135°C Self-Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be steam sterilized at 121-135°C by a healthcare provider, following the ANSI/AAMI ST-46 sterilization recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

The proposed Granton® Medical 121-135°C Self-Seal Sterilization Pouches (121-135°C Sterilization Pouches) are essentially identical in design and materials to Granton Medical's Self Seal Sterilization Pouch (Self Seal Sterilization Pouch) described in K023025. Like the predicate Self Seal Sterilization Pouch, the 121-135°C Sterilization Pouches are single use bags with an adhesive strip on the open end for sealing the bag prior to sterilization. The six pouch sizes available for the proposed 121-135°C Sterilization Pouches are identical to those of the predicate Self Seal Sterilization Pouch. The proposed 121-135°C Sterilization Pouches are manufactured with a throughput process indicator applied to the paper surface of the pouch using a flexographic printing method.

The provided text describes a 510(k) summary for Granton® Medical 121-135°C Self-Seal Sterilization Pouches. However, it does not contain the detailed performance testing results, acceptance criteria, or study specifics typically found in a full study report.

The document states: "Data was provided that demonstrates that the proposed 121-135°C Sterilization Pouches can be used for sterilization of the enclosed medical device in cycles with temperatures up to 135°C. Package integrity testing was also performed to confirm that the seal strength and seal integrity of the proposed 121-135°C Sterilization Pouches are not affected by steam sterilization at 135°C."

Based on the provided text, I can infer the general nature of the performance testing but cannot extract specific numeric acceptance criteria or detailed study parameters.

Here's what can be inferred and what cannot, based on the input:

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

• Acceptance Criteria (Inferred):
  • Functionality with higher temperature sterilization: The pouches must withstand and function correctly during steam sterilization cycles up to 135°C.
  • Package integrity: Seal strength and seal integrity must be maintained after steam sterilization at 135°C.
  • Process indicator functionality: The throughput process indicator must correctly distinguish between processed and unprocessed units after sterilization at 135°C.
• Reported Device Performance (Inferred): The document states "Data was provided that demonstrates that the proposed 121-135°C Sterilization Pouches can be used for sterilization... Package integrity testing was also performed to confirm that the seal strength and seal integrity... are not affected..." This implies the device met the unstated acceptance criteria for these aspects. However, no specific performance metrics (e.g., actual seal strength values, visual change of indicator) are reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified, but the manufacturer is Granton® Medical Ltd. in Sheffield, England, suggesting the studies likely originated from or were sponsored by this UK-based company. The submission is to the US FDA.
• Retrospective or Prospective: Not specified.

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/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., medical imaging devices), not for a sterilization pouch. The "ground truth" here would be objective measurements of physical properties and indicator changes.

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

• Not applicable/Not specified. This typically refers to resolving discrepancies among human readers, which is not relevant for this device.

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, not an AI-powered diagnostic tool.

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

• Not applicable. This device does not involve an algorithm. The performance testing described relates to the physical and chemical properties of the pouch.

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

• Inferred: The "ground truth" would be established through objective laboratory testing and measurements. This includes:
  • Verified high-temperature steam sterilization conditions (e.g., using calibrated autoclaves and temperature probes).
  • Standardized methods for measuring seal strength and integrity (e.g., peel tests, burst tests).
  • Visual or instrumental assessment of the process indicator color change under verified sterilization conditions.

8. The sample size for the training set

• Not applicable. This device does not employ machine learning or AI, so there is no training set in this context.

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

• Not applicable. (See point 8).

Summary of available information regarding the study:

• Purpose of Study: To demonstrate that the Granton® Medical 121-135°C Self-Seal Sterilization Pouches can be used for steam sterilization cycles up to 135°C and that their package integrity is maintained at this temperature. It also implies functionality of the new throughput process indicator at this temperature.
• Tests Performed:
  • Sterilization efficacy demonstration at temperatures up to 135°C.
  • Package integrity testing (seal strength and seal integrity) after steam sterilization at 135°C.
• Outcome: The data provided "demonstrates" and "confirms" that the pouches meet the intended performance for these new conditions.

To get the specific numeric acceptance criteria and detailed study parameters, one would typically need access to the full 510(k) submission document, which often includes the testing protocols and results in more detail than the summarized version readily available.

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Winner® Self Seal Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling.

The provided text describes a 510(k) submission for the Winner® Self Seal Sterilization Pouch, focusing on demonstrating substantial equivalence to predicate devices. It outlines the intended use, device description, and studies conducted to support the claim. However, the document does not contain the specific details required to complete your request in the format of a typical AI/ML medical device performance study.

Here's an analysis based on the available information:

This is NOT an AI/ML device. The submission is for a physical medical product (sterilization pouch), not a software algorithm or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance studies (e.g., sample size for training set, number of experts for ground truth establishment, MRMC studies, standalone algorithm performance, AI vs. human improvement) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes material and performance characteristics that were tested to establish substantial equivalence. These act as "acceptance criteria" for the physical properties of the pouch.

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

• Sample Size: The document does not specify the exact number of pouches or samples tested for each characteristic. It only states that testing was performed on "non-sterile, steam sterilized and ethylene oxide sterilized finished devices."
• Data Provenance: The testing was presumably conducted by the manufacturer, Winner Industries Co., LTD, based in Shenzhen, China, or by a contracted lab. The document does not explicitly state the country of origin of the data beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of the Winner® Self Seal Sterilization Pouch for this 510(k) submission.

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

This concept is not directly applicable to a physical product's material and performance testing. The "ground truth" here is established by standardized testing methods and material specifications. For example, "seal strength" has a defined measurement and acceptance range, not an expert opinion.

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

Not applicable. The testing involves objective measurements against established standards, not interpretation or adjudication by experts.

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, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

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

The "ground truth" is based on standardized engineering and material science specifications and performance test methods relevant to sterilization packaging. For instance:

• ASTM standards for material properties (e.g., tensile strength, elongation).
• ISO or AAMI standards for package integrity (e.g., seal strength, burst testing).
• Biological indicator results demonstrating sterilization efficacy.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device.

Conclusion:

The provided document describes a regulatory submission for a physical medical device (sterilization pouch) and details the physical and performance characteristics that were tested to demonstrate substantial equivalence to predicate devices. It clearly demonstrates the device meets the necessary "acceptance criteria" by showing conformity to recognized material standards and successful performance in various tests related to its intended use (sterilization and maintenance of sterility). However, the requested information format is largely geared towards AI/ML device studies, which do not apply to this product.

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The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.

Self Seal Sterilization Pouch

This is a 510(k) clearance letter for a medical device called "Self Seal Sterilization Pouch". This document is an administrative letter from the FDA and unfortunately, it does not contain the specific information you are requesting about acceptance criteria and device performance studies.

The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. However, it does not provide details about the performance criteria, study design, or results typically found in full submissions or scientific publications.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or its data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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