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The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.

Containers should not be stacked when used within cthylene oxide sterilizers

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

• Container bottoms (both perforated and non-perforated versions)
• Container baskets,
• Container lids (perforated only), and .
• u Container color-coding "labels."

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. The container is intended for use with non-porous materials such as stainless steel surgical instruments. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

| Acceptance Criteria / Performance Standard | Miltex System Reported Performance | Predicate Device Performance
(for comparison but not direct acceptance) |
| :----------------------------------------- | :-------------------------------------------------------------------------- | :------------------------------------------------------------------------------------------- |
| Conformance to appropriate AAMI standards | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization | Yes, conforms to AAMI ST 33- Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for ETO Sterilization and Steam Sterilization in Health Care Facilities |
| Ethylene Oxide Sterile Efficacy Testing | Yes | Yes |
| Aeration Time and EO Residuals | 8-hours/ below maximum acceptable levels | 12-hours/ below maximum acceptable levels |
| Sterility Maintenance (Duration) | 30-day real time w/ weekly handling events | 90-day real time w/ weekly handling events. 30-day real time w/ daily handling events. |
| Load Capacity (Small container) | Up to 16-lbs. | Up to 22-lbs. |
| Load Capacity (Medium container) | Up to 20-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Load Capacity (Large container) | Up to 25-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Inoculated Lumens (Dimensions) | Yes--3-mm I.D. x 200-mm, metal | Yes-- 2.2-mm I.D. x 457-mm, metal |
| Inoculated Stainless Steel Medical Devices Location | Yes (hinge area of medical pliers and knurled instruments) | Yes (blades) |

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "Validation Testing" which usually implies a pre-defined sample size for each test. However, the exact number of containers or tests performed is not detailed.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, as it involves "Validation Testing" and "real-time" sterility maintenance, implying active testing of the Miltex system.

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. The studies described are performance tests of the device itself (e.g., sterile efficacy, sterility maintenance, load capacity), not studies requiring human expert assessment or ground truth establishment in the way it would be for, say, an AI-powered diagnostic device. The "ground truth" for these tests would typically be established by validated laboratory methods for sterilization effectiveness and sterility.

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

• This information is not applicable to the type of studies described. Adjudication methods are typically used in studies involving human interpretation or subjective assessment (e.g., medical image reading) where multiple experts might disagree. The performance tests for a sterilization container are objective and measured against pre-defined physical and biological parameters.

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 is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. The Miltex Rigid Sterilization Container System is a physical medical device, not an AI or software-as-a-medical-device (SaMD).

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

• This is not applicable. As stated above, this is a physical medical device, not an algorithm. The "standalone" performance refers to the device's ability to sterilize and maintain sterility based on its design and materials, which is what the validation testing evaluates.

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

• The ground truth for the performance tests would be established through laboratory testing and microbiological methods. For example:
  • Ethylene Oxide Sterile Efficacy Testing: Ground truth would be the complete kill (sterilization) of specified resistant microorganisms (e.g., Bacillus atrophaeus spores) inoculated onto test articles within the container, followed by incubation and verification of no growth.
  • Aeration Time and EO Residuals: Ground truth would be the measurement of residual EO levels below acceptable safety thresholds using standardized analytical chemistry techniques.
  • Sterility Maintenance: Ground truth would be the absence of microbial ingress after specified handling events and storage times, verified by microbiological culture methods.
  • Load Capacity: Ground truth would be the ability of the container to hold the specified weight without structural failure or compromise to its function.

8. The sample size for the training set:

• This is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The development of the device would involve engineering design, prototyping, and iterative testing, but not a data-driven training process in the AI sense.

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

• This is not applicable for the same reason as point 8.

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The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

• Container bottoms (both perforated and non-perforated versions)
• Container baskets,
• Container lids (perforated only), and
• Container color-coding "labels."
  The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

The provided text describes a 510(k) premarket notification for the Miltex Rigid Sterilization Container System. It does not describe an AI or algorithm-based device, but rather a medical device designed for sterilizing other medical instruments. Therefore, many of the requested details, such as those related to AI performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes, are not applicable to this document.

However, I can extract information related to the device's performance against relevant standards and the nature of the study conducted, which is a validation study demonstrating the device's sterilization capabilities.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Miltex Rigid Sterilization Container System are based on conformance to AAMI standards and successful validation testing for steam sterilization.

(These are fundamental design and functional requirements inherent to the product category, and the "Yes" confirms they are met for the Miltex system). |

Study Information (as applicable for a non-AI medical device):

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

   • The document does not explicitly state a sample size in terms of number of containers or tests in a statistical sense for the validation. Rather, it describes the conditions and types of loads tested.
   • The "test set" in this context refers to the conditions and materials used during the validation testing: "inoculated lumens" (3-mm I.D. x 400-mm, metal, and 3-mm I.D. x 200-mm, metal) and "inoculated stainless steel medical devices."
   • Data provenance: Not specified, but likely laboratory-based (in-vitro) testing conducted by the manufacturer or a contracted lab to demonstrate efficacy for regulatory submission. It is prospective in the sense that the testing was performed specifically to validate the device's performance prior to market approval.

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

   • This concept is not applicable to this type of device validation. Ground truth for sterilization efficacy is established through scientific methods like spore-kill assays and sterility testing, not expert consensus interpretation. The "ground truth" here is the absence of viable microorganisms after the sterilization cycle.

3. Adjudication method for the test set:

   • Not applicable. Sterilization efficacy is typically determined by objective biological and physical indicators (e.g., biological indicators showing no growth, chemical indicators showing proper sterilant exposure, physical parameters like temperature and pressure).

4. 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 study is for a physical medical device (sterilization container), not an AI algorithm.

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

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used:

   • The ground truth for adequate sterilization is based on microbiological sterility (absence of viable microorganisms) for the inoculated test pieces (lumens and stainless steel devices), confirmed by appropriate biological indicators and sterility testing methods. This aligns with scientific and regulatory standards (like AAMI) for sterilization efficacy.

7. The sample size for the training set:

   • Not applicable. This is not an AI or algorithm-based device that requires a training set. The "training" here would refer to the developmental process of the container design and manufacturing.

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

   • Not applicable.

In summary, the provided document details the conformance and validation testing of a physical medical device (sterilization container) against established performance standards and functional requirements. It does not pertain to software, AI, or diagnostic algorithms, and therefore, many of the requested categories related to such technologies are not relevant.

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