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The Stat-Mat® Minor multipurpose surgical instrument tray is used for loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses.

The Stat-Mat® Minor is designed using plastic and metal materials that can be reused with prevacuum or gravity displacement steam sterilization methods. The Stat-Mat® Minor should be used only with FDA-cleared and legally marketed sterilization wraps that have been cleared for the sterilization cycles listed below. The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123]. The base containing organized surgical instrumentation can be placed directly on the back table or onto a Mayo Tray. Instruments with lumens were not tested in the Stat-Mat® Minor validation process and are therefore not recommended for use with the Stat-Mat® Minor.

Sterilization cycle parameters:

| Cycle Type | Temperature | Sterilization
Time | Pre-Vac Pulses | Dry Time |
|------------|---------------|-----------------------|----------------|------------|
| Gravity | 250°F (121°C) | 30 minutes | none | 30 minutes |
| Pre-vacuum | 270°F (132°C) | 4 minutes | 4 | 30 minutes |

Device Description

The Stat-Mat® Minor is a multipurpose surgical instrument tray that consists of three primary components: a base, cover, and instrument roll. The base and cover are composed of Radel plastic. which meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with standard steam sterilization methods. The instrument roll is composed of aluminum and is used to keep ringed instruments open during sterilization. The Stat-Mat® does not contact the patient.

AI/ML Overview

The provided text describes a medical device called the Stat-Mat® Minor, a sterilization tray, and details the nonclinical testing performed to validate its sterilization effectiveness. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on the aspects related to AI, ground truth establishment for AI, MRMC comparative effectiveness studies, or standalone algorithm performance.

Here's the information related to the device and its validation as per the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Stat-Mat® Minor are defined by its ability to achieve sterility assurance under specific steam sterilization cycles, as demonstrated by the inactivation of Geobacillus stearothermophilus spores. The reported performance confirms that these criteria were met.

Acceptance Criterion (Sterilization Effectiveness)	Reported Device Performance
Gravity Displacement Cycle: Sterilization at 121°C for 15 minutes (half-cycle)	The Stat-Mat® Minor was successfully sterilized in a gravity displacement cycle at 121°C for a 15-minute half-cycle. This condition was considered adequate to achieve a sterility assurance level (SAL) of 10⁻⁶ at twice the stated exposure time (i.e., 30 minutes).
Pre-vacuum Cycle: Sterilization at 132°C for 2 minutes (half-cycle)	The Stat-Mat® Minor was successfully sterilized in a pre-vacuum cycle at 132°C for a 2-minute half-cycle. This condition was considered adequate to achieve a sterility assurance level (SAL) of 10⁻⁶ at twice the stated exposure time (i.e., 4 minutes).
Compatibility with specified sterilization wraps and cycles	The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123] for both gravity displacement and pre-vacuum steam sterilization methods, adhering to the specified temperature and time parameters.
Successful sterilization for consecutive and separate half-cycles	The Stat-Mat® Minor was successfully sterilized for three consecutive and separate sterilization half cycles.
Verification of thermocouples and satisfactory controls	The thermocouples passed the verification calibration, and all positive and negative controls were satisfactory.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The text states, "10 Geobacillus stearothermophilus spore strips and thermocouples were placed in the test articles." It also mentions "The test articles were double-wrapped." The number of "test articles" (Stat-Mat® Minor units) used is not explicitly stated, but it implies a sufficient number were tested to accommodate 10 spore strips and thermocouples.
- Data Provenance: The study was conducted by MacPherson Medical Inc., presumably in the USA. The study design appears to be prospective in nature, as it involves active testing of the device for sterilization efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study involves a physical device and sterilization efficacy, which is determined by microbiological and physical measurements, not interpretation by human experts. The "ground truth" is objective (sterility or lack thereof).
Adjudication method for the test set:
- Not applicable as the determination of sterility is based on scientific methods (presence/absence of microbial growth, temperature readings), not subjective expert judgment requiring adjudication.
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 typically used for diagnostic devices involving human interpretation (e.g., radiology images) to assess the impact of AI on reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument tray, not an AI algorithm.
The type of ground truth used:
- The ground truth used was microbiological efficacy and physical parameter measurement:
  - Microbiological: The inactivation of Geobacillus stearothermophilus spore strips to demonstrate a sterility assurance level (SAL) of 10⁻⁶. This is assessed by culturing the spore strips after sterilization to determine if any viable spores remain.
  - Physical: Thermocouples were used to verify that the required temperatures were reached and maintained within the test articles during the sterilization cycles. This ensures the physical conditions for sterilization were met.
The sample size for the training set:
- Not applicable. This is a nonclinical validation study for a physical device, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device validation.

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