(145 days)
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
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Attributes | |
| Holds instrumentation during cleaning, use, and sterilization cycle | Indicated for holding medical device instrumentation in place throughout entire instrument use, cleaning, and sterilization cycle. (Stated in "Indications for use" and "General Technical Characteristics") |
| Compatibility with Pulsing High Vacuum (pre-vac) steam sterilization at 132°C for 4-minute minimum with 15-minute drying time | Suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132°C for a 4-minute minimum with a 15-minute drying time. (Stated in "Indications for use" and "General Technical Characteristics") |
| Reusability | Intended to be reused: Yes. |
| Design Attributes | |
| Various sizes available | 10.375" x 21.75" x 2.5" to 10.375" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case. |
| Methods for holding instruments in place | Utilizes various methods of holding instruments in place: Yes. |
| May incorporate latch system | May incorporate latch system to hold lid in place: Yes. |
| Material Attributes | |
| Made of Aluminum, stainless steel, plastic | Yes. |
| Performance Standard Compliance | |
| Tested in accordance with AAMI TIR No. 12-1994 | Tested in accordance to AAMI TIR No. 12-1994: Yes. |
| Validation study performed with half cycles to challenge sterilization method | Validation study performed with half cycles to challenge sterilization method used: Yes. |
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.
§ 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).