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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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The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.

The e3 Torque Control Motor is an electric motor-driven handpiece intended for the endodontic industry. It works in both reciprocating mode and continuous rotation. This motor is provided with pre-programmed settings for the most popular nickel titanium rotary file systems sold by DENTSPLY. The dentist is also able to program 15 settings of their choice for speed and torque control. The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate the motor. A power supply is also connected to the control unit to allow the dealer to charge the battery. The motor is connected to the control unit and a 6:1 contra angle. Files attach to the contra angle.

This submission K103653 for the e3 Torque Control Motor is a 510(k) premarket notification claiming substantial equivalence to a predicate device, the X-Smart™ Easy (K092614). It does not contain a study that demonstrates the device meets specific performance acceptance criteria in the way a clinical trial or a detailed scientific study would for a novel medical device.

Instead, the submission focuses on demonstrating substantial equivalence through:

1. Technological Characteristics Comparison: Highlighting similarities and minor differences between the subject device and the predicate device.
2. Compliance with Recognized Standards: Showing that the device meets safety and performance standards (e.g., Biocompatibility, EMC, Electrical Safety, Software Validation).

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, in the context of performance metrics like accuracy, sensitivity, or specificity, is not applicable to this type of submission. There are no performance acceptance criteria defined in terms of quantifiable device output that would typically be fulfilled by a comparative effectiveness study or a standalone algorithm performance study.

Here's a breakdown of what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense of a performance study. The "acceptance criteria" here are compliance with recognized standards and the "performance" is demonstrated by meeting these standards and showing comparable technological characteristics to a legally marketed predicate device.

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

Not applicable. This submission did not involve a "test set" of patient data or samples for performance evaluation in the way a diagnostic or AI-driven device would. The testing was primarily against engineering and safety standards.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. Ground truth, in the context of clinical or diagnostic performance, was not established for this device as it's an electromechanical tool rather than an interpretive one.

4. Adjudication Method

Not applicable. No adjudication was performed as there was no assessment of diagnostic output or subjective interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers or interpreters are involved (e.g., radiologists interpreting images). The e3 Torque Control Motor is an electromechanical handpiece for dentists.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. There is no "algorithm" in the sense of an AI or diagnostic algorithm whose standalone performance needs to be evaluated. The device has software for control, but its performance is assessed through compliance with standards like EN 62304 for software validation, not through clinical output metrics.

7. Type of Ground Truth Used

Not applicable. The "ground truth" here is compliance with established engineering, safety, and biocompatibility standards, rather than clinical outcomes or pathology reports.

8. Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or algorithms that learn from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

In summary: The K103653 submission for the e3 Torque Control Motor demonstrates substantial equivalence by comparing its technological characteristics to a predicate device and by showing compliance with relevant international and national standards for safety, biocompatibility, electromagnetic compatibility, electrical safety, and software validation. It does not involve performance studies in the way an AI/ML or diagnostic device would, and therefore, many of the requested points are not relevant to this submission.

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