(123 days)
The Tuttnauer Mini Container and Standard Case Cassettes are general dental/medical instrument cassettes intended to hold instruments and accessories in place during the sterilization cycle. The devices are indicated for use in both gravity and pre-vacuum steam sterilization.
The Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are sterilization cassettes that are designed to allow steam to pass through the device to ensure effective sterilization. The Mini Container and Standard Case Cassettes are small to medium-sized trays with silicone mats that are useful in the organization, containment and transport of medical and dental instruments. An array of Mini Container sizes are available to accommodate various instrument sizes. The Mini Container also offers an integrated instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette, based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Primary Function: Allow effective sterilization of instruments within the cassette. | "Tuttnauer cassettes allow effective steam sterilization of instruments contained within them during normal autoclave operation." |
| Sterilization Efficacy (Gravity Steam): Achieve successful sterilization in gravity steam cycles. | "Three half-cycle tests were performed on each cassette for [gravity] steam sterilization. Successful sterilization was accomplished with all cassettes in each test." |
| Sterilization Efficacy (Prevacuum Steam): Achieve successful sterilization in prevacuum steam cycles. | "Three half-cycle tests were performed on each cassette for [prevacuum] steam sterilization. Successful sterilization was accomplished with all cassettes in each test." |
| Compatibility with Sterilization Types: Perform effectively in steam sterilization cycles. | "The devices are indicated for use in steam sterilization." (Implies effective in both gravity and prevacuum steam given the testing). |
| Instrument Containment: Hold instruments and accessories in place during the sterilization cycle. | "The Tuttnauer Mini Container and Standard Case Cassettes are designed to hold instruments and accessories in place during the sterilization cycle." (This is part of the intended use and implicitly met by the design). "An array of Mini Container sizes are available to aboundsted instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter." |
| Material Durability/Compatibility: Manufactured from a chemical-resistant thermoplastic compatible with all forms of sterilization. | "Tuttnauer cassettes are manufactured from a chemical resistant thermoplastic that has been tested by its manufacturer for capability with all forms of sterilization." (Specific test results not provided, but the manufacturer's claim is presented.) |
| Substantial Equivalence: Demonstrate substantial equivalence to predicate devices regarding intended use, reusability, sterilization methods (gravity/vacuum steam), available sizes, instrument holding methods, and latch systems. | The comparison table indicates "Yes" for all listed criteria for Tuttnauer Cassettes, matching the predicate devices where applicable (e.g., Intended Use, Reusable, Sterilization by Gravity Steam, Sterilization by Vacuum Steam, Various size cassettes available, Various methods for holding instruments, Latch system to hold lid in place). |
| Compliance with AAMI TIR 12-1994: Be tested to AAMI TIR 12-1994. | "Tested to AAMI TIR 12-1994: Yes" (for Tuttnauer Cassettes). |
| Half-Cycle Validation: Undergo half-cycle validation to challenge sterilization. | "Half-cycle validation to challenge sterilization: Yes" (for Tuttnauer Cassettes). Actual test results indicated "Successful sterilization was accomplished with all cassettes in each test" for both gravity and prevacuum steam. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: For the efficacy portion of the non-clinical testing, three half-cycle tests were performed on each cassette for each method of sterilization (gravity and prevacuum steam). This implies at least 6 tests per cassette type (3 for gravity, 3 for prevacuum), and likely 12 tests in total since both "Mini Container" and "Standard Case" cassettes were tested. The number of physical cassettes tested isn't explicitly stated beyond "each cassette."
- Data Provenance: The document does not specify the country of origin of the data. The study was conducted by Tuttnauer, a U.S. company. The study is prospective as it describes specific validation studies performed by the manufacturer for the purpose of this submission.
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. The type of testing performed (half-cycle sterilization validation) typically involves laboratory-based methods and the use of biological or chemical indicators to assess sterility, rather than expert human interpretation of results in the traditional sense of medical imaging or diagnostic devices. Someone performed the tests and evaluated the indicators for "successful sterilization," but their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the study describes physical performance testing (sterilization efficacy) rather than human interpretation of data requiring adjudication. The assessment of "successful sterilization" would be based on objective indicators rather than subjective expert consensus.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument cassette, not an AI-powered diagnostic or assistive tool, so such a study would be irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (a sterilization cassette), not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant or described.
7. The Type of Ground Truth Used
The ground truth used for the sterilization efficacy tests was likely based on:
- Biological Indicators (BIs): These contain highly resistant bacterial spores; their inactivation after a sterilization cycle confirms sterility.
- Chemical Indicators (CIs): These change color or form upon exposure to specific sterilization parameters (e.g., steam, temperature, time).
- Physical Monitoring: Readings from sterilizer gauges or printouts (temperature, pressure, time).
The combination of these, particularly the BIs, would establish the "successful sterilization" ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve machine learning or AI, 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, this question is not relevant.
§ 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).