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Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.

Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Carr Sterilization Cases, Trays, and Cassettes:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a "table of acceptance criteria." The criteria are inferred from the "Indications for Use" and the "General Technical Characteristics" section which outlines the device's design, materials, and performance expectations. The reported device performance is essentially a restatement or confirmation that the device meets these inferred criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The Carr Metal Products Sterilization Cases, Trays, and Cassettes were independently tested according to AAMI TIR No. 12-1994 for their performance with the Pulsing High Vacuum (prevacuum) Steam sterilization method."

• Sample Size: The document does not specify the sample size (e.g., number of cases, trays, cassettes or sterilization cycles) used for the performance testing.
• Data Provenance: The testing was conducted "independently." The country of origin of the data is not explicitly stated, but given the FDA submission, it's highly likely to be U.S.-based or conducted according to U.S. standards. The study appears to be prospective in nature, as it describes performance testing conducted specifically for the device's clearance.

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

This information is not provided in the document. The testing was described as "independently tested," implying a qualified testing facility, but details on expert involvement or their qualifications are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (sterilization cases), adjudication in the context of expert review for image interpretation or diagnosis is not applicable. The testing would likely involve objective measurements (e.g., sterility indicators, temperature/pressure monitoring) rather than subjective human assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening tools where reader performance is a key metric. This device is a medical device accessory (sterilization case) and does not involve AI or human "readers" in that context.

6. 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 passive physical product, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective measurements and adherence to recognized performance standards for sterilization efficacy. Specifically:

• AAMI TIR No. 12-1994: This technical information report provides guidelines for designing and testing reusable medical device sterilization processing. Compliance with this standard implies that the device successfully maintained sterility, allowed steam penetration, and protected instruments during sterilization.
• Validation Study with Half Cycles: This indicates a robust sterilization validation process designed to confirm the effectiveness of the sterilization method even under stressed conditions. The "ground truth" would be the biological and physical indicators confirming sterility after these half-cycle challenges.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

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Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.

A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of containers tested). It mentions that "The Carr Container system was independently tested."
• Data Provenance: Retrospective, as the testing was completed prior to the 510(k) submission. The country of origin of the data is not specified, but the applicant (Carr Metal Products, Inc.) is based in Indianapolis, IN, USA, and the FDA review is for the USA market.

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

The document states, "The Carr Container system was independently tested according to AAMI ST 33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its performance." This implies that the validation of the device's sterility and performance was conducted by a testing facility or experts in sterilization standards. However, the exact number and qualifications of these experts are not specified in the provided text.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Performance was assessed against established industry standards (AAMI, ANSI) and the criteria within those standards. It's likely that a "pass/fail" determination was made based on meeting these pre-defined criteria, rather than a subjective adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a sterilization container, not an AI-assisted diagnostic tool for which such a study would be relevant.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was performed. The testing described focuses solely on the performance of the Carr Container system itself, independent of human interaction beyond normal use for loading/unloading and sterilization processes. The results ("Passed all criteria") reflect the device's intrinsic capabilities.

7. The type of ground truth used

The ground truth was established by compliance with recognized industry performance standards/specifications for sterilization containers, specifically:

• AAMI ST 33-R-11/95
• ANSI / AAMI ST 41-1992
• ST 24-1992 (likely ST24-1992, as listed elsewhere in the document)
• Validation studies demonstrating sterility of contents after sterilization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilization container), not an AI algorithm requiring data for machine learning.

9. How the Ground Truth for the Training Set was Established

As explained in point 8, a training set is not relevant for this type of device.

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