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EXPERTsurg: This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations).
INTRA LUX S600 LED: The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and classified as a type B application part.
SURGmatic S201 L / C; SURGmatic S201 XL / XC; SURGmatic S11 L / C: The medical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction procedures, implantology, osteotomia, root resection and oral, jaw and facial surgery.

The MASTERsurg / EXPERTsurg is a dental surgical system out of:

• EXPERTsurg (surgical control unit)
• INTRA LUX S600 LED (surgical motor)
• SURGmatic S201 L / C (handpieces)
• SURGmatic S201 XL / XC (handpieces)
• SURGmatic S11 L / C (handpieces)
  The MASTERsurg / EXPERTsurg is a system out of a surgical control unit (EXPERTsurg), a surgical motor (INTRA LUX S600 LED) and different handpieces (SURGmatic).
  The surgical control unit (EXPERTsurg) consists of a surgical controller, a motor cable, an instruments tray, a holder and a tube set. The surgical motor (INTRA LUX S600 LED) consists of the motor, a stopper for maintenance purposes and exchange O-rings for the motor coupling.
  As a functional principle the software-based surgical controls the speed and torque of a dental micro motor. The unit is equipped with a pump for the use with external irrigation tubing allowing irrigation of the working area. The surgical control unit is operated through the buttons on the tabletop console or via foot control. The surgical control unit is intended to be used with the INTRA LUX S600 LED motor. Straight or contra-angle handpieces with a handpiece connection according to ISO 3964 can be equipped. The instrument tray allows the dentist to deposit the SURGmatic handpieces in a safe position. The holder is intended to be used for general storage. The tube set is needed to deliver the external irrigation from the bottle (not part of this 510(k)) to the SURGmatic handpieces. A power cord provides electric power to the unit. The EXPERTsurg will be delivered with software on the surgical control unit. The EXPERTsurg follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings.
  Each of the different handpieces (SURGmatic) consists of the handpiece, a spray clip (only SURGmatic S201 L / C and SURGmatic S201 XL / XC), a jet needle for cleaning purposes and a tube for the external spray.
  The SURGmatic handpieces are electrical driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system (L version). The devices can be sterilized by the steam autoclave method. Through the INTRA LUX S600 LED motor connected to the surgical control unit, the SURGmatic handpieces equipped with a handpiece connection according to ISO 3964 receives the energy, the cooling water and air for treatment and the light for illumination the operation area (L version). Surgical burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797 can be used with the SURGmatic handpieces. The SURGmatic handpieces use external spray allowing external irrigation to the working area. The mechanism of action for the SURGmatic handpieces is as follows. The dental straight and contra-angle handpieces are electrical-driven handpieces which will be supplied with energy, air and light through the dental micro motor of the surgical control unit. Dental burs (not part of this 510(k)) according to ISO 1797 could be inserted into the chuck system of the handpieces. Based on the speed adjusted in the surgical control unit the handpiece bur rotates up to 40,000 rpm. The SURGmatic handpieces interacts with the patient through a rotating bur with the patient teeth according to the intended use.

The provided document is a 510(k) premarket notification for a dental surgical system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against acceptance criteria in the context of a new, quantifiable medical AI device evaluation. Therefore, much of the requested information (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, specific ground truth types, etc.) is not applicable or available in this type of submission.

The document describes non-clinical testing performed to show conformance to standards and software validation, but it does not present a study designed to establish device performance against predefined acceptance criteria in the way one would for a diagnostic or AI-driven system.

However, I can extract information related to the device's characteristics and the non-clinical tests performed.

Here's a summary of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the sense of quantifiable metrics for diagnostic accuracy or clinical outcomes. Instead, it demonstrates compliance with international standards and describes functional principles and technical characteristics that are deemed substantially equivalent to predicate devices.

The "performance" is implicitly demonstrated through conformance to established standards and validation of software functionality, rather than through meeting specific numerical thresholds for a novel diagnostic claim.

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

• Sample Size for Test Set: Not applicable. The submission describes non-clinical engineering and bench testing (electrical safety, EMC, biocompatibility, software validation), not a clinical study with a "test set" of patients or data in the typical sense of evaluating diagnostic performance.
• Data Provenance: The tests described are engineering and laboratory tests, not clinical data from patients. Therefore, information like "country of origin of data" and "retrospective or prospective" is not relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of "ground truth" or expert review in the context of establishing performance for a diagnostic or AI system. The "ground truth" for non-clinical tests would be the specifications and requirements of the relevant international standards.

4. Adjudication method for the test set

Not applicable, as there is no human review of a "test set" to establish 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

Not applicable. This is not an AI-driven or diagnostic device that involves human readers interpreting cases.

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

Not applicable. This is a dental surgical system, not an algorithm or AI device. The software validation confirms the functional performance of the device's control unit, not an independent algorithm's diagnostic accuracy.

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

Not applicable. For non-clinical tests, "ground truth" would be the defined specifications and parameters of the standards (e.g., a certain voltage, current, or biocompatibility threshold).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a training set.

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

Not applicable. There is no training set.

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