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Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.

The W&H Assistina TWIN MB-302 is an electrically and pneumatically driven maintenance device with the following functions:

• Rinsing the spray channels with cleaning solution (water basis) and drying with compressed air.
• Lubricating the rotational internal gear parts. The oil is spread and a constant lubrication film is set up.

The provided text describes the W&H Assistina TWIN MB-302, a device for cleaning and lubricating dental and surgical handpieces. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth), and training set information is not available in the provided text.

The closest information provided related to performance or testing is under the "Performance Testing" section (page 6), which lists various tests performed to demonstrate safety and effectiveness:

• Electrical Safety Tests according to IEC 61010-1
• Electromagnetic Compatibility Test according to IEC 61326-1
• Software validation according to IEC 62304:2006
• Biological Assessment and Cytotoxicity Testing of the liquids according to EN ISO 10993
• Risk Analysis according to ISO 14971
• Testing of cleaning performance according to ISO 15883
• Validation of wipe disinfection according to the IFU
• Bench Tests like Lifetime tests (Activation of start button, moving/removing of sliding door, Lifecycle test)

However, specific acceptance criteria values and the reported performance against these criteria are not detailed. The text only states that the results "demonstrate substantial equivalence" and that the biological assessment "meets the requirements," without specifying what those requirements are or the numerical results achieved. It also explicitly states "Clinical Testing: Not applicable," indicating that no clinical studies were performed.

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XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous mode during an endodontic procedure.

The XSmart iQ is a cordless motor hand-piece having a power stage (motor hand-piece, gears and power supplier), a console based on an Apple iPad Mini® and a communication system (Bluetooth). The motor parameters can be transferred, stored and displayed via a dedicated iPad Mini® application (Endo iQ app), connected to the cordless motor hand-piece through a Bluetooth communication protocol.

Device components (including accessories):

• Motor hand-piece support and case ●
• Motor hand-piece
• Contra angle
• Spray nozzle (used for lubrication)
• iPad Mini® Protective case (Rubber Plugs and Protective case opener) ●
• AC adapter ●
• Getting started guide
• iPad Mini® with Endo iQ iOS App (not part of the kit) ●

The provided document is a 510(k) premarket notification for the Dentsply Sirona XSmart iQ, a cordless motor hand-piece for endodontic procedures. It details the device's characteristics and compares it to a predicate device, the e3 Torque Control Motor (K103653). The document primarily focuses on demonstrating substantial equivalence through non-clinical performance data and risk analysis.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a single table labeled "Acceptance Criteria." Instead, it lists various tests performed and their successful outcomes. The "acceptance criteria" are implied by the statement "Test results indicated that the XSmart iQ complies with the applicable Standard" or "XSmart iQ passed the test" for each study.

Here's a consolidated table based on the non-clinical performance data:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size:
  • For "Expected Life" testing, the sample size was n=15 for the first pass and n=5 for the second pass for the micro motor and contra angle.
  • For "Micro-Motor Performance" and "Button Test", the specific sample size isn't explicitly stated, but the Button Test mentions visual inspection after various push cycles, implying testing on some sample units.
  • For "Contra Angle Tests" and "Effectiveness of Contra Angle Test", specific numbers of instruments or units are mentioned (e.g., two prototype instruments for ultimate moment), but a general sample size for these tests is not provided beyond the contra angle specific tests.
  • For other tests like Biocompatibility, EMC/Electrical Safety, Marking Tests, Docking Station Disinfection, Packaging Resistance, Usability, and Bluetooth tests, a specific sample size is not explicitly stated in the document. However, performing such tests implies they were done on a representative number of devices.
• Data Provenance: The document does not specify the country of origin of the data. All studies are non-clinical bench testing, meaning they were performed in a lab setting rather than on human subjects. They are inherently prospective in nature, as they were conducted specifically to evaluate the XSmart iQ device's performance against predefined standards and criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This category is not applicable to the provided document. The studies described are non-clinical bench tests and do not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense. The "ground truth" for these tests is defined by objective engineering and safety standards (e.g., ISO, IEC, EN standards) and the physical properties of the device and its accessories.

4. Adjudication Method for the Test Set:

Not applicable. As the studies are non-clinical bench tests evaluated against objective standards, there is no need for an adjudication method involving multiple human readers or experts. The results are based on measurement and observation against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Not applicable." The studies are non-clinical bench tests comparing the device's technical specifications and performance to a predicate device and relevant standards.

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

The device described, the XSmart iQ, is a physical dental hand-piece with integrated software (Endo iQ app on an iPad Mini). It is not an "algorithm only" device. The performance tests evaluate the device as a whole, including its mechanical, electrical, and software components, in its intended operational context. Therefore, a "standalone algorithm only" performance test, as might be done for AI-driven diagnostic software, is not relevant and was not performed.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is based on:

• Established International Standards: Such as ISO 10993, IEC 60601, EN 60601, ISO 14457, ISO 21530. Compliance with these standards is the primary "ground truth."
• Defined Performance Parameters: Explicit mechanical or electrical limits (e.g., "withstood load until 16 milli-Newton meters," "efficiency levels measured (90%–95%) are significantly over the 80% required," "backlash fluctuated within the stipulated tolerance of ±6°").
• Absence of Adverse Events: (e.g., "no impact or motor defects observed," "no degradation of the cells," "no ingress of oil could be observed," "no device failure occurred," "no visual cracks").

There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data used to establish ground truth for the evaluations presented.

8. The Sample Size for the Training Set:

This question is not applicable. The XSmart iQ is a hardware device with associated software, not a machine learning or AI model that requires a "training set" in the conventional sense. The "software validation" mentioned refers to standard software engineering verification and validation, not training of a learned model.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this type of medical device's evaluation.

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