(86 days)
The Straumann BLX Cassette is used in healthcare facilities to organize, cleaning, sterilize, transport, and store medical devices between surgical uses. The BLX Cassette is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated sterilization wrap.
The BLX Surgical Cassette is a container composed of three main components: a lid, a cassette base and a tray, all made of polyphenylsulfone (Radel R5000). The base and the tray have silicone rubber grommets to hold the instruments. The base and tray are printed to indicate the surgical workflow and the position of the instruments within the cassette.
This is a 510(k) summary for a medical device (Straumann BLX Surgical Cassette), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of an AI algorithm's performance.
Therefore, many of the requested sections about AI algorithm performance, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or cannot be extracted from this document. The document describes non-clinical testing for the cassette's cleaning, sterilization, and biocompatibility.
I will fill in the applicable information based on the provided text, and mark sections as "N/A" (Not Applicable) when the information pertains to AI algorithm studies which are not relevant to this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Focus) | Reported Device Performance (Summary) |
|---|---|
| Cleaning Validation: | Demonstrated effectiveness of recommended manual and automated cleaning processes. |
| Sterilization Validation: | Achieved a Sterility Assurance Level (SAL) of ≥10⁻⁶ using the biological indicator (BI) overkill method. Dry times were validated. |
| Biocompatibility: | Biocompatible for its intended use, based on in vitro cytotoxicity and chemical characterization studies. |
2. Sample size used for the test set and the data provenance
N/A. This document describes non-clinical laboratory testing of a physical medical device (a surgical cassette) for its cleaning, sterilization, and biocompatibility, not an AI algorithm. Therefore, "test set" and "data provenance" (in the context of AI data) are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in the context of expert consensus for AI interpretation is not relevant here. The ground truth for the cleaning was determined by assays measuring residual soil, sterilization by BI overkill method for SAL, and biocompatibility by standard in-vitro and chemical characterization. These are standard laboratory methods, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
N/A. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth in AI studies. This document discusses laboratory testing, not human judgment for a test set.
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
N/A. MRMC studies are used to evaluate diagnostic performance of AI or human readers, which is not relevant for this device (a surgical cassette).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This document pertains to a physical medical device, not a standalone AI algorithm.
7. The type of ground truth used
The ground truth or validation methods used were:
- Cleaning: Efficacy evaluated through laboratory methods demonstrating the removal of simulated soil on the device.
- Sterilization: Sterility Assurance Level (SAL) of ≥10⁻⁶ was validated using the biological indicator (BI) overkill method according to ANSI/AAMI/ISO 17665-1. Dry times were validated according to AAMI TIR12:2010.
- Biocompatibility: Evaluated based on ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1) and FDA guidance, including in vitro cytotoxicity according to ISO 10993-12 and ISO 10993-5, and chemical characterization according to ISO 10993-12 and 10993-18.
8. The sample size for the training set
N/A. There is no AI algorithm training set for this medical device.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no AI algorithm training set.
§ 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).