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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.

Regarding the study proving the device meets acceptance criteria:

The document refers to "Nonclinical data" and "Sterilization efficacy verification studies".

1. 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.

2. 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).

3. Adjudication Method for the Test Set:

   • Not applicable. This applies to human reading or AI interpretation studies, not physical device performance validation.

4. 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.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This is a physical device, not a software algorithm.

6. 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.

7. Sample Size for the Training Set:

   • Not applicable. This is a physical device, not an AI model that requires a "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, no AI training set.

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The MTS300 System is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterlization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks.

The MTS300 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 MTS300 System was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm.

Use only uncovered, perforated or wire mesh general delivery trays within the MTS300 System.

The MTS300 Multiple Tray Sterilization System (also referred to as the MTS300 System) includes 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 TM tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. The MTS System is intended to sterilize a maximum weight of 300 pounds of devices and instruments for a single patient surgery. The loaded cabinet is deployed from the adjustable transfer cart and processed in a pre-vacuum steam sterilizer and then dried for 30 minutes. Sterility is maintained for up to 30 days.

Here's a breakdown of the acceptance criteria and study information for the MTS300 Multiple Tray Sterilization System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often references studies done to meet existing standards or guidance documents rather than detailing a single, comprehensive study testing a device against specific, novel acceptance criteria. The information below reflects what is extractable from this type of document.

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 specific "sample size" of items tested for the sterilization efficacy studies (e.g., number of sterilization cycles, number of biological indicators). It refers to "sterilization efficacy verification studies" performed.

• Data Provenance: The studies were performed in accordance with ANSI/AAMI ST77:2013 and the recommendations of the Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Healthcare Facilities, Draft Guidance for Industry and FDA, March 7, 2002. This implies that the testing methodologies would follow standard industry practices and regulatory guidance, likely conducted in a controlled laboratory or healthcare setting. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's for a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer or a contract research organization.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods (e.g., culturing biological indicators to confirm sterility), not usually by expert consensus in the typical sense of reading medical images.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human readers (e.g., radiologists) in diagnostic studies, not for the technical performance testing of a sterilization system. The verification studies follow established protocols where results (e.g., growth/no growth of biological indicators) are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The MTS300 is a sterilization system, not an imaging or diagnostic device involving human interpretation in that manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "sterilization efficacy verification studies" and "engineering analysis" are standalone performance evaluations of the device itself (the "algorithm" in this context refers to the device's functional performance). There isn't an "AI algorithm" involved in the way typically discussed in diagnostic imaging. The device is intended to perform its function without constant human intervention during the sterilization cycle. The "usability study" involves human interaction but evaluates the system's ease of use and ability to meet human needs, not human diagnostic performance.

7. The Type of Ground Truth Used

For sterilization efficacy, the ground truth is primarily based on microbiological testing (e.g., culturing biological indicators to confirm the absence of viable microorganisms after the sterilization process). For stability and usability, the ground truth would be based on engineering analysis (meeting design specifications) and potentially user feedback/observation in the usability study demonstrating successful and safe operation.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI in a way that requires a "training set." Its performance is based on physical and chemical principles and validated through engineered design and testing.

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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