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BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are intended to store and organize the BEGO Semados® surgical instruments, insertion tools, drill stops and prosthetic instruments during both steam sterilization in an autoclave and implant/ prosthetic treatments.

BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are not intended on its own to maintain sterility; it is intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch.

Device Description

BEGO SEMADOS® Tr 58350 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.

BEGO SEMADOS® Tr 58350 is supplied without BEGO Semados® surgical instruments and insertion tools.

BEGO SEMADOS® RS/RSX-LINE TRAY PLUS is supplied as a kit with BEGO SEMADOS® Tr 58350 and BEGO Semados® surgical instruments and insertion tools.

BEGO Semados® Tr 58349 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.

BEGO Semados® Tr 58349 is supplied without BEGO Semados® surgical instruments and insertion tools.

BEGO Semados® Tr 58348 is supplied as a kit with BEGO Semados® Tr 58349 and BEGO Semados® surgical instruments and insertion tools.

BEGO Semados® DSTr 58356 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the drill stops. The tray container is printed to indicate the position of the drill stops within the tray for reprocessing and implant treatments.

BEGO Semados® DSTr 58356 is supplied without drill stops.

DRILL STOP TRAY PLUS (RS/RSX-Line) is supplied as a kit with BEGO Semados® DSTr 58356 and drill stops.

BEGO SEMADOS® PKTr 58357 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the BEGO Semados® insertion tools and prosthetic instruments. The tray container is printed to indicate the position of the above mentioned instruments within the tray for reprocessing and implant/prosthetic treatments.

BEGO SEMADOS® PKTr 58357 is supplied without BEGO Semados® insertion tools and prosthetic instruments.

PROSTHETIC KIT is supplied as a kit with BEGO SEMADOS® PKTr 58357 and BEGO Semados® insertion tools and prosthetic instruments.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (BEGO Semados® Trays), which outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This type of document is not an academic study or research paper that involves AI algorithms or complex statistical analysis with human readers. Therefore, several of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test/Methodology	Purpose	Acceptance Criteria	Reported Device Performance
AAMI TIR30:2011 (Automated Cleaning - Protein)	Verify cleaning instructions are efficacious for removing gross amounts of soil to a residual protein level	Residual protein level of 6.4 µg protein/cm²	The manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a residual protein level of 6.4 µg protein/cm².
AAMI TIR30:2011 (Automated Cleaning - TOC)	Verify cleaning instructions are efficacious for removing gross amounts of soil to a total organic carbon content	Total organic carbon (TOC) content of 3.1 µg of C/cm²	The manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a total organic carbon (TOC) content of 3.1 µg of C/cm².
ISO 10993-5:2009 (Cell Growth Analysis)	Verify the device does not have a cytotoxic potential	Inhibition of cell growth (ICG) of more than 30% is considered as cytotoxic effect (i.e., less than or equal to 30% inhibition is acceptable)	The cytotoxicity testing concluded that test devices met the requirements of the test and are not considered to have a cytotoxic potential.
ISO 17665-1:2006-08, ISO TS 17665-2:2009-01, ANSI/AAMI ST77:2013 (Sterilization validation)	Verify the device and cycle parameters achieve a Sterility Assurance Level (SAL)	SAL of 10⁻⁶	The tested devices achieved a SAL of 10⁻⁶ after processing in pre-vacuum steam sterilization cycle at 132°C for 4 minutes.
AAMI TIR12:2010 (Drying Time testing)	Verify the device is properly dried using the specified cycle parameters	"Properly dried" (specific quantitative criteria for "properly dried" are not explicitly stated in the provided text, but it implies complete dryness with no visible moisture)	The BEGO Semados® Trays are considered properly dried following processing in pre-vacuum steam sterilization cycle at 132°C for 4 minutes, and drying time of 20 minutes. (Note: Comparison table mentions 20-30 minutes for Drying time)

2. Sample size used for the test set and the data provenance:

The document describes non-clinical laboratory testing, not a clinical study with patient data. Therefore, the concept of a "test set" in the context of patient data, data provenance (country of origin, retrospective/prospective), and related terms are not applicable. The "test set" for these evaluations would be the physical devices and associated laboratory samples (e.g., inoculated materials for sterilization, cultured cells for cytotoxicity). The sample sizes for each specific test (e.g., number of devices tested for cleaning, number of biological indicators for sterilization) are not explicitly detailed in this summary, but implied to be sufficient for standard validation protocols of these benchmarks. The testing was conducted by BEGO Implant Systems GmbH & Co. KG, located in Bremen, Germany.

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 as the ground truth for these non-clinical tests is established by standardized laboratory methods and scientific principles, not by expert human graders or consensus on medical images/diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as there is no human adjudication for these types of non-clinical, objective laboratory tests.

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. The device is a sterilization tray, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical device (sterilization tray), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests described:

Cleaning Validation (Protein & TOC): Ground truth is established by quantitative laboratory measurements of residual protein and total organic carbon using standardized assays.
Cytotoxicity: Ground truth is established by cell culture assays measuring cell viability and proliferation, comparing effects of device extracts to controls.
Sterilization Validation: Ground truth is established by biological indicators (BIs) that contain a known population of resistant microorganisms, and physical/chemical indicators, demonstrating the kill of all microorganisms to a specified probability (SAL).
Drying Time Testing: Ground truth is established by visual inspection and/or quantitative measurement of residual moisture following sterilization cycles according to industry standards.

8. The sample size for the training set:

This is not applicable as the text describes non-clinical laboratory validation for a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

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