(218 days)
The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals.
The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.
The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.
Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.
The provided document describes the acceptance criteria and the performance testing for the Straumann® Surgical Cassettes, which are used to organize, sterilize, and transport surgical instruments.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Type of Testing | Purpose (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation (AAMI TIR 30:2011) | Evaluate and validate the manual cleaning of the subject devices: | |
| • No visible soil | ||
| • Amount of protein per sample 70% | Pass |
2. Sample size used for the test set and the data provenance:
- The document states: "The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worst-case instruments to be contained."
- It also mentions "Test samples must withstand 100 cycles of use". This indicates that at least one "worst-case" sample was subjected to repeated testing for the life cycle validation.
- Specific numerical sample sizes for each test (e.g., number of cassettes for cleaning validation, or number of sterilization runs) are not provided in the excerpt.
- Data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" for these performance tests is based on established scientific and regulatory standards (e.g., ISO, AAMI standards) and objective measurements of sterilization, cleaning efficacy, and material biocompatibility, rather than expert consensus on interpretive tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the evaluation of device performance in these tests is based on objective measurements against defined criteria, not on subjective interpretations 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:
- This information is not applicable. The device is not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (sterilization cassette).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing is based on objective measurements against established scientific and regulatory standards. For example:
- Cleaning efficacy: Measured levels of protein and hemoglobin, and visual inspection for soil, compared against quantitative thresholds.
- Sterilization: Sterility Assurance Level (SAL) of ≤10⁻⁶ using biological indicators, which is a quantitative measure of microbial inactivation.
- Biocompatibility: Cell viability percentage (>70%) compared against a quantitative threshold in cytotoxicity testing.
- Life cycle: Functional integrity after a specified number of cycles, assessed objectively.
8. The sample size for the training set:
- This information is not applicable as the device is not an AI algorithm that requires a training set. The performance testing validates the physical characteristics and reprocessing effectiveness of the cassettes.
9. How the ground truth for the training set was established:
- This information is not applicable as the device is not an AI algorithm.
§ 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).