(246 days)
The MTS System (Multiple Tray Sterilization System) 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. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks.
The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.
The MTS System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. Single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider.
Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load.
The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of a minimum of 4 minutes and a dry cycle of a minimum of 10 minutes. Sterility is maintained for up to 30 days.
The provided document is a 510(k) premarket notification letter from the FDA regarding the MTS225 and MTS300 Multiple Tray Sterilization Systems. It outlines the device's indications for use, a comparison with a predicate device, and a summary of nonclinical testing.
However, the document does not describe an AI medical device or a study that assesses a human-AI team's performance. The device in question is a physical sterilization system, and the "study" mentioned refers to nonclinical testing (sterilization efficacy verification studies) of this physical device. Therefore, many of the requested elements for an AI medical device study (such as expert reads, MRMC studies, training/test set ground truth for AI, etc.) are not applicable to this document.
I will provide the information that is available from the document, acknowledging that most of the requested criteria for an AI device are not present.
Acceptance Criteria and Reported Device Performance
The document describes the performance parameters and validation against specific standards for the MTS225 and MTS300 Multiple Tray Sterilization Systems. While not "acceptance criteria" in the sense of a statistical threshold for an AI model, these are the performance goals and validated capabilities of the sterilization system.
| Characteristic | Acceptance Criteria (Implied/Validated) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (SAL) | Achieve a 10⁻⁶ SAL (Sterility Assurance Level) | Achieved a 10⁻⁶ SAL when sterilizing rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm, as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. |
| Minimum Dry Time | Meet or exceed a minimum dry time of 10 minutes (for the subject device, compared to the predicate's 30 minutes). | Demonstrated the ability to meet or exceed the shorter minimum dry time of 10 minutes. |
| Sterility Maintenance Duration | Maintain sterility for up to 30 days. | Maintained sterility for 30 days following rigorous outdoor transportation and storage outside the sterilization facility. |
| Compatible Lumen Dimensions (Smallest/Longest) | Able to sterilize instruments with lumens down to 0.7mm inner diameter and 500mm length, or 1.0mm inner diameter and 850mm length. (Predicate was 3.8mm inner diameter, 370mm length). | The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Devices should not be used with instruments smaller than 0.7mm (ID) and longer than 500mm (length) or smaller than 1.0mm (ID) and longer than 850mm (length). |
| Sterilization Parameters (Prevacuum Steam Sterilizers) | Prevacuum cycle of 270°F and exposure time of 4 minutes. | Validated for use with prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. |
| Load Capacity | No more than 3 trays per shelf or 25 lbs. per tray. Maximum 75 lbs per shelf (3x25lbs). MTS300 Cabinet: up to 300 lbs per load. MTS225 Cabinet: up to 225 lbs per load. | The system specifications state these load capacities. Testing would confirm that sterilization efficacy is maintained at these maximum loads. |
| Volume-to-Vent Ratio (MTS225) | Smaller Volume-to-Vent ratio compared to the MTS300 System, while maintaining efficacy. | MTS225 System has a Volume-to-Vent ratio of 94.725 (MTS300 is 129.131). The document states that the system "demonstrated the ability to... achieve a 10-6 SAL" with this ratio. |
| Regulatory Equivalence | As safe, as effective, and perform as well as or better than the legally marketed predicate device (MTS300 Multiple Tray Sterilization System K152014). | Nonclinical tests demonstrated that the MTS225 and MTS300 Multiple Tray Sterilization Systems are as safe, as effective, and perform as well as or better than the legally marketed predicate device, the MTS300 Multiple Tray Sterilization System (K152014). |
Regarding the study proving the device meets acceptance criteria:
The document refers to "Nonclinical data" and "Sterilization efficacy verification studies".
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Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size for the "test set" in terms of number of runs or specific items tested.
- Data Provenance: The studies were performed to ensure the systems meet intended use and were conducted "in accordance with the requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization." The location or specific retrospective/prospective nature of the data collection is not detailed, but it is implied to be laboratory testing for device validation.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as the device is a physical sterilizer, not an AI or diagnostic device that requires expert interpretation of data for ground truth establishment. The ground truth for sterilization efficacy is typically established through microbiological methods (e.g., spore tests) and physical/chemical indicators, referencing established standards like SAL (Sterility Assurance Level).
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Adjudication Method for the Test Set:
- Not applicable. This applies to human reading or AI interpretation studies, not physical device performance validation.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a study design for evaluating the impact of AI on human readers (e.g., radiologists, pathologists). The subject device is a physical sterilization system.
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Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical device, not a software algorithm.
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Type of Ground Truth Used:
- The ground truth for sterilization efficacy is established through scientific and regulatory standards, primarily microbiological testing (e.g., achieving a 10⁻⁶ SAL, which implies a one in a million chance of a non-sterile item). This is confirmed by challenging the system with difficult-to-sterilize instruments and ensuring spore elimination. Additionally, physical parameters (temperature, pressure, time) and chemical indicators are used to monitor the sterilization process.
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Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI model that requires a "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no AI training set.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device 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.(b)
Classification. Class II (performance standards).