(176 days)
Straumann® Modular Cassette is used in healthcare facilities to organize, enclose, sterilize, transport and store Straumann instruments between surgical uses. Straumann® Modular Cassette is not intended to maintain sterility on its own, but is intended to be used in conjunction with a legally marketed, validated sterilization double pouch to maintain the sterility of the enclosed devices.
The Straumann® Modular Cassette has been validated for the following maximum loads:
- Module A 400g .
- . BCC Maximum permissible stack BCC 611g
The A module is intended to be sterilized individually, without stacking with other modules.
The B and C module are intended to be sterilized individually, or by stacking the B module on top of C module bases. The maximum permissible stack for sterilization is one B module on top of two C module bases.
The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments.
Only use the following sterilization parameters:
- Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time .
Straumann Modular Cassette consists of three modules: A, B and C module.
The A module could be inserted with multiple removable instrument trays and grommet trays. The B module could be inserted with one removable workflow tray for the specific implant line. The trays consist of further subcomponents, strips and holders that are made out of silicone rubber and are intended to hold the instruments in place during the surgical procedure as well as during the sterilization process. The C module has fixed silicone supports for instrument storage.
To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System meant to be stored in the Straumann Modular Cassette are used for bed preparation, placement, maintenance and explantation of the implants from the 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.
This document describes the Straumann Modular Cassette, a device used to organize, sterilize, transport, and store dental instruments. The device is intended for use in conjunction with a legally marketed, validated sterilization double pouch.
However, the provided text does not contain acceptance criteria or a detailed study description with performance metrics. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Straumann BLX Surgical Cassette) through a comparison of technological characteristics and a general statement about non-clinical testing.
Here's a breakdown of what is available and what is missing from the provided text against your requested information:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. While there are "validated loads" and "sterilization parameters," these are operational specifications rather than acceptance criteria with corresponding performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not explicitly provided. The document mentions "limits of reuse testing (100 reprocessing cycles)" but does not specify the number of cassettes tested or other details about the test set. There's no information about data provenance.
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. The testing described is non-clinical performance testing (cleaning, sterilization, biocompatibility), which typically does not involve human expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the testing described does not involve human adjudication for ground truth.
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 is not applicable as the device is a physical medical device (sterilization cassette), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical testing mentioned:
- Sterilization validation: The ground truth for sterility is typically established through recognized microbiological methods, such as the absence of viable microorganisms after exposure to sterilization, aiming for a Sterility Assurance Level (SAL) of 10^-6 using the biological indicator (BI) overkill method.
- Cleaning validation: The ground truth for cleaning effectiveness is established by measuring residual soil (e.g., protein, hemoglobin, carbohydrates) on the device after cleaning, demonstrating levels below specified thresholds.
- Biocompatibility: The ground truth is established by standardized in-vitro tests (e.g., cytotoxicity) and often in-vivo tests, assessed against established biological response criteria defined in standards like ISO 10993.
8. The sample size for the training set:
This is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
This is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.
Summary of available information regarding performance:
The document states that "The test results demonstrate that the Modular Cassette is similar to the predicate device" and concludes that it is "as safe, as effective, and performs as well as the legally marketed predicate devices."
Validated Operational Specifications/Performance Claims (from the "Indications for Use" and "Technological Characteristics" sections):
| Parameter | Acceptance Criteria / Reported Performance | Study Proving Acceptance |
|---|---|---|
| Maximum Loads | Module A: 400g | "The Straumann® Modular Cassette has been validated for the following maximum loads" (implies in-house validation testing was conducted) |
| B and C Modules: Maximum permissible stack 611g (one B module on top of two C module bases). A module sterilized individually. | "The Straumann® Modular Cassette has been validated for the following maximum loads" (implies in-house validation testing was conducted) | |
| Sterilization Parameters | Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time | "The sterilization parameters have been validated to a sterility assurance level (SAL) of 10^-6 using the biological indicator (BI) overkill method. In addition to the SAL validation, dry times were validated using full cycle parameters and limits of reuse testing (100 reprocessing cycles) was validated by visual inspection." (Cleaning and Sterilization Validation section). The testing followed FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015." |
| Material Biocompatibility | No cytotoxic effect in in-vitro cytotoxicity test (similar to predicate) | "The biological assessment of the Modular Cassette was performed according to ISO 10993-1:2009 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and the biocompatibility evaluation flow chart according to the FDA Guidance document 'Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'... Results of conducted studies... show that it is biocompatible for its intended use." |
| Reusable Cycles | Validated for 100 reprocessing cycles (visual inspection) | "limits of reuse testing (100 reprocessing cycles) was validated by visual inspection." (Cleaning and Sterilization Validation section) |
Missing Specifics: The document lacks detailed study reports including raw data, exact sample sizes for each test mentioned (e.g., how many cassettes were subjected to 100 cycles, how many sterilization cycles were performed for validation, lot numbers, etc.), statistical analysis, and specific quantitative results beyond the pass/fail statements. It refers to these as non-clinical tests that "demonstrate" equivalence but does not provide the specifics of the actual acceptance criteria or the numerical results achieved against those criteria.
§ 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).