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510(k) Data Aggregation
(223 days)
Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.
When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.
The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:
- Temperature: 270°F/132°C
- Exposure time: 4 minutes.
- Drying time: 20 minutes.
- The cassettes are not to be stacked during sterilization.
KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.
Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.
Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.
The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.
The provided text describes the "Microdent Sterilization Cassette" and its performance data. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Cycle Validation | Sterility assurance level (SAL) of ≤ 10⁻⁶ | Pass |
| Drying Validation | No visible moisture | Pass |
| Cleaning (Manual Pre-Cleaning and Automated Cleaning) | No visible soil. Protein: < 6.4 µg/cm² Hemoglobin: < 2.2 µg/cm² | Pass |
| Reprocessing of Trays (cleaning and sterilization) | No signs of flush rust, rust, corrosion, deformation or damage | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. It mentions that "KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively." This suggests that at least two representative models were likely tested for some validations.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are referred to as "non-clinical test data" and performed by Implant Microdent System S.L.U. (a Spanish company), implying prospective, bench testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these non-clinical tests is based on established scientific methodology and quantitative measurements (e.g., SAL ≤ 10⁻⁶, µg/cm² for protein/hemoglobin, visual inspection for moisture/damage), rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as the tests are non-clinical and rely on objective measurements against defined standards, not human interpretation that would require 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
Not applicable. This is a non-clinical device (sterilization cassette), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The ground truth for these tests is based on:
- Established scientific standards and regulatory guidelines: e.g., ISO 17665-2:2009, ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI ST77:2013 for sterilization; AAMI TIR30:2011 for cleaning.
- Objective measurements and visual inspection: e.g., sterility assurance level, protein/hemoglobin levels, absence of visible moisture or damage.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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