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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.

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.

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:

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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The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading.

The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.

The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.

The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.

PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.

BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4. In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region. BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts.

The healing posts are sterile packaged Titanium Grade 5 dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage).

The abutments are prefabricated prosthetic components made of Titanium Grade 5 directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user. They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments. The abutments are marketed with the compatible prosthesis and a technician screw.

The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools. The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.

The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set. The Easy-Con system is used to retain full supported dentures in the mandible or maxilla on two to four implants.

The provided document is a 510(k) Premarket Notification for the BEGO Semados® RS/RSX Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain the kind of information requested in your prompt (e.g., acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details). The "performance data" section (Section 11) refers to non-clinical testing of the physical implant system, such as biocompatibility, mechanical properties (fatigue, corrosion), and sterilization, typical for traditional medical devices. Section 12 explicitly states that "no human clinical testing was required."

This submission is about demonstrating that a new dental implant system is as safe and effective as existing, legally marketed implant systems, based on similar technology, materials, and non-clinical performance characteristics. It is not an AI/ML device submission.

Thus, I cannot extract the requested information as it is not present in the provided text.

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The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

BEGO Semados® S-Line with TiPure"155 Surface is a dental implant system that can be placed subgingivally in both the upper and lower jaw using a one- or two-stage surgical procedure.

The provided text does not contain any information about acceptance criteria, device performance, specific studies with sample sizes, or expert adjudication for the BEGO Semados® S-Line.

The document is a 510(k) premarket notification summary, which primarily establishes substantial equivalence to a legally marketed predicate device (XIVE Dental Implant System® K032158) rather than detailing performance studies with specific metrics.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory approval based on equivalence and indications for use.

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