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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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