(124 days)
General dental / medical instrument cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning and sterilization cycle. These cassettes are suitable for Gravity Steam, Pulsing High Vacuum steam and EO sterilization. Instruments may be cleaned by chemical sterilant.
A cassette system and accessories designed to hold various dental and medical instrument to be cleaned and sterilized. The design is a metal, aluminum and stainless steel container which has various methods of holding the instruments in place. Available in various sizes ranging which have a typical size of 1.5" x 3.5" x 1" to 8" x 15.5" x 2.5".
Here's a breakdown of the acceptance criteria and study information for the C/T Med-Systems Cassette System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on demonstrating equivalence to predicate devices and compliance with relevant AAMI (Association for the Advancement of Medical Instrumentation) standards and specifications for sterilization, cleaning, and material compatibility.
| Acceptance Criteria (Performance Standards / Specifications) | Reported Device Performance (C/T Med-System Cassette System) |
|---|---|
| AAMI TIR No. 12-1994 compliance | Yes (Independently tested according to AAMI TIR No. 12-1994) |
| Validation study performed with half-cycles to challenge sterilization method used | Yes |
| AAMI ST 33 -1992 requirements | |
| 3.4-3.5 Instructions provided for different cleaning methods of cassette | Yes |
| 3.6-4.2 Instructions for inspections | Yes |
| 6.2.2 Sterilization manufacturer documentation available | Yes |
| 6.2.3 Drying time in labeling | Yes |
| 6.2.4 EO residual removal in labeling | Yes |
| 6.3 User (basic) responsibilities listed in labeling | Yes |
| 7.3.1 Routine inspection in labeling | Yes |
| Materials: Aluminum and stainless steel | Yes (Device design uses metal, aluminum, and stainless steel) |
| Intended Use: Holding dental and medical instruments and accessories in place throughout entire instrument use, cleaning and sterilization cycle | Yes (Stated as intended use) |
| Intended to be reused | Yes |
| Sterilization by Gravity Steam, Pulsing High Vacuum Steam and Ethylene Oxide (EO) | Yes (Tested for Pulsing High Vacuum and Gravity Steam and Ethylene Oxide (EO)) |
| Design: Various sizes offered ranging typically from 1.5" x 3.5" x 1" to 8" x 15.5" x 2.5" | Yes (Stated as typical sizes) |
| Utilizes various methods of holding instruments in place | Yes |
| May incorporate latch system to hold | (Implied through "various methods of holding instruments") |
| Ultrasonic cleaning compatibility | Tested for ultrasonic cleaning by Indiana University |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical "sample size" for the performance testing in terms of number of cassettes or specific sterilization cycles beyond stating that the system "was independently tested."
- Data Provenance: The testing was "independently tested" according to AAMI TIR No. 12-1994 and "tested for ultrasonic cleaning by Indiana University." This suggests external, objective testing. The document does not specify the country of origin of the data beyond "Indiana University" for ultrasonic cleaning. It is a prospective study, as the device was subjected to specific performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document for the performance testing of the sterilization cassettes. The assessment is against established industry standards (AAMI TIR No. 12-1994, AAMI ST 33 -1992) rather than expert consensus on individual outcomes.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of expert review for clinical outcomes. The performance testing appears to be based on objective measurements against scientific standards and methods outlined in AAMI documents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical interpretation where human readers are involved. This document describes a medical device for sterilization, not diagnostic interpretation.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The document states: "The C/T Med-System Cassette system was independently tested according to AAMI TIR No. 12-1994 for its performance under three (3) sterilization methods - Pulsing High Vacuum and Gravity steam and Ethylene Oxide (EO). It was also tested for ultrasonic cleaning by Indiana University." This refers to the algorithm/device (cassette system) performing in isolation to meet the established performance standards.
7. The Type of Ground Truth Used
The ground truth used for this device's performance assessment is established industry standards and scientific methods for sterilization efficacy and material compatibility, specifically:
- AAMI TIR No. 12-1994 (Technical Information Report for designing a sterilization process)
- AAMI ST 33 -1992 (Guidelines for the safe and effective use of steam sterilization)
- Standardized tests for ultrasonic cleaning.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is not an AI or machine learning device. The document describes performance testing for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).