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The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.

The Endo Tabletop is designed to drive dental endodontic instruments for a rotating treatment of root canals. Therefore, the Endo Tabletop provides different kinds of movement:

1. Continuous rotary motions (adjustable speed, torque and direction depending on the file used)
2. Reciprocating motions (speed, torque, direction, and angles depending on the file used)
   This functionality is provided by a Brushless Direct Current (BLDC) motor having speed and torque controls. The motor speed control is driven by a dedicated controller using pulse width modulation (PWM) of the excitation voltage and the motor torque control is performed by controlling and limiting the maximum current flow. The contra-angle transmits the motor movement in speed and direction to the endodontic file.
   The user can set the device by a graphical user interface on a 7" touch Thin-Film Transistor (TFT) display. The handpiece can be started/ stopped with a finger switch and foot control.
   All models can also be used for root canal length determination using the integrated apex locator functionality. This apex locator functionality is provided by evaluating the electical impedance between to the file clamp, placed into the dental root canal and the lip clip placed on the patient. The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray.
   The proposed apex locator function has two modes standalone mode. In standalone mode, the apex determination works with the lip and the endodontic file, which is connected to a file clamp. In combined mode, the apex determination works with the lip clip and the endodontic file which is connected to the contra-angle.

This is a 510(k) summary for a dental handpiece with an apex locator. The document does not contain the specific acceptance criteria and detailed study results in the format requested.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance with specific numerical values for metrics like accuracy, precision, or other quantitative measures typically found in performance studies. Instead, it lists various standards and guidance documents that the device's testing complied with. For example, it states:

• "All testing to the applicable elements of the standard passed." (referring to ISO 14457:2017)
• "Results confirm that the design inputs, function, and performance specifications for the proposed device are met."
• "performance data support the conclusion that the proposed device performs as well as the predicate device EndoPilot2 (K202906)."

This implies that the device met the requirements outlined in these standards, but the specific performance data against those requirements is not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any of the performance tests (e.g., how many devices were tested for endurance, how many measurements were taken for the apex locator accuracy). It also does not mention the data provenance in terms of country of origin or whether studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document. The testing described focuses on mechanical, electrical, software, and biocompatibility performance of the device and does not involve human interpretation or classification of medical images/data.

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

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document.

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 section is not applicable. The device described is a dental handpiece and electronic apex locator, which are physical tools, not AI-driven diagnostic software that would typically be involved in MRMC studies to assess human reader improvement. The document explicitly states, "There are no clinical tests submitted, referenced or relied on in the 510(k) for a determination of substantial equivalence."

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

The device is not an algorithm, so the concept of standalone algorithm performance does not directly apply. However, the performance of the apex locator functionality (e.g., its accuracy in determining file tip position) would be considered part of its standalone performance. The document states:

• "The apex location is the same, at ≤ 0.5 mm." This refers to the accuracy of the apex locator functionality compared to the predicate device.
• "File performance (speed/torque) is determined by the system consisting of contra-angle and motor together."
• Various non-clinical tests were conducted to confirm the performance, including those conforming to ISO 14457:2017.

While specific numerical results beyond "≤ 0.5 mm" for apex location are not provided in this summary, the mentioned tests represent the standalone performance evaluation of the device's functions.

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

For the apex locator, the "ground truth" would likely be established through a reference method, such as direct measurement on extracted teeth validated by X-ray or micro-CT, or comparison to a clinically accepted gold standard. The document mentions: "The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray." However, it does not explicitly state how the "≤ 0.5 mm" accuracy was determined or what the ground truth method was for the performance testing.

For other aspects like mechanical, electrical, and biocompatibility testing, the "ground truth" is defined by the requirements of the relevant international standards (e.g., ISO 14457:2017, IEC 60601 series, ISO 10993 series).

8. The sample size for the training set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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A dental contra-angle handpiece that attaching a vertical reciprocating dental strips intended to be used in interproximal reduction of teeth; And it is part of orthodontic treatment of finishing interdental and subgingival area, finishing cavity edges, removing the dentin of teeth adjacent, removing subgingival plague and tripping. The device incorporates a small micro motor normally driven by compressed air; This is a reusable device.

The OK handpiece is a reciprocating contra-angle handpiece that is used in connection with an air motor. The rotational force of the air motor is transmitted to the handpiece head through the shaft of the handpiece body, and the rotational force of the shaft is converted into vertical reciprocating motion in the head. The OK handpiece is a reprocessing medical device. Users must steam sterilize before each use, and clean thoroughly after use. The OK handpiece does not have water/air spray and light supply. Therefore, the air motor connection of the handpiece is designed to comply with the coupling size of TYPE 1 of ISO 3964. For the strip connecting to the OK handpiece, you must use Orthok-Strips and OK Proxofile of Jaintek Co., Ltd.

The provided text (K221814) describes the 510(k) premarket notification for the "OK Handpiece," a dental contra-angle handpiece. This device is classified as a Class I medical device (21 CFR 872.4200) and is cleared based on substantial equivalence to predicate devices, not requiring extensive clinical trials typically associated with novel or higher-risk devices.

Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on non-clinical performance testing and compliance with relevant standards, rather than complex clinical studies involving human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the OK Handpiece (K221814)

This device, a dental handpiece, demonstrates substantial equivalence through non-clinical bench testing and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on a Non-Clinical Device)

Given that this is a Class I dental handpiece, the "study" is primarily a series of non-clinical bench tests and adherence to recognized international standards. The device is not software-based or image-analyzing AI, so many of the requested items related to AI/MRMC studies are not applicable.

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical data for a handpiece. Performance was verified on the device itself against standard requirements. For physical testing (e.g., bur extraction force, durability), usually a representative sample of manufactured devices would be tested to demonstrate consistency with design specifications. The document implies that "the proposed device" met the specifications, suggesting testing was performed on actual devices.
• Data Provenance: The tests were non-clinical bench tests conducted to "verify that the proposed device met all design specifications" and demonstrated compliance with ISO standards. There is no mention of country of origin for test data, as it's performed to international standards. It's an engineering validation, not data from patients.

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

• Not applicable as this is a physical device undergoing non-clinical testing against engineering and material standards. "Ground truth" is established by the specifications of the standards themselves (e.g., ISO 3964 requires a specific coupling dimension, ISO 10993 outlines biocompatibility criteria). Expertise would lie with engineers and biocompatibility specialists performing and interpreting the tests, ensuring compliance with the specified standards.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is measured objectively against quantitative and qualitative criteria defined by the standards (e.g., a dimension either meets ISO 3964 or it doesn't; a material either passes cytotoxicity or it doesn't). There is no "adjudication" in the sense of expert consensus on an interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging devices, especially those involving AI, where human readers interpret medical images. The OK Handpiece is a mechanical dental tool, not an imaging or diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No, a standalone algorithm performance study was not done. This device does not incorporate any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on engineering specifications and compliance with established international consensus standards (e.g., ISO for mechanical properties, ISO for biocompatibility, ISO/ANSI/AAMI for sterilization). For example, the "ground truth" for motor coupling is adherence to the dimensions specified in ISO 3964.

8. The Sample Size for the Training Set:

• Not applicable. This device is a mechanical medical instrument. It does not utilize machine learning or AI, and therefore has no "training set."

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.

The Midwest Rhino XE and Air Motor M are low speed air motors. The motors are reusable and can be sterilized in an autoclave. Air Motor M includes an external spray port whereas the Midwest Rhino XE does not have the external sprayport.

This document is a 510(k) premarket notification for the Dentsply Sirona Midwest Rhino XE and Air Motor M dental handpieces. As such, it focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove them.

The information provided confirms that no clinical performance data from human studies was included to support substantial equivalence. The substantial equivalence is based on:

• Identical Indications for Use with the predicate device (LS-100, K792302).
• Same fundamental technology and intended uses as the predicate and a reference device (W&H Air-Powered Handpieces and Handpiece Attachments (Air Motor AM-25 E RM), K162926).
• Non-clinical performance testing to verify conformity with various ISO standards and FDA guidance documents.

Therefore, many of the requested sections related to acceptance criteria and a primary study are not applicable to this 510(k) submission. However, I can extract the relevant information regarding the performance comparison and the non-clinical testing conducted to support substantial equivalence.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, "acceptance criteria" in the context of a primary study proving efficacy are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstration of meeting relevant standards and having comparable technical specifications to predicates. The "reported device performance" are the specifications of the proposed devices.

Note: The document primarily highlights differences and how they are addressed (e.g., conformity testing to ISO 14457). The "Acceptance Criteria" for proposed devices are framed as demonstrating substantial equivalence to the predicate, often meaning being within a cleared range or addressing differences through standard conformity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to non-clinical performance testing. The document states "Testing to verify the performance requirements of the proposed devices... was conducted." It specifies the standards to which this testing conformed but not the sample size, data provenance, or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as no human clinical studies were performed, and thus no expert-established ground truth for a test set was necessary for this type of 510(k) submission.

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

This is not applicable as no human clinical studies were performed.

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. This device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

This is not applicable, as the device is a physical dental handpiece and not an algorithm.

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

For the non-clinical performance data, the "ground truth" can be considered the established requirements and parameters defined by the various ISO standards and FDA guidance documents listed (e.g., ISO 14457 for dentistry handpieces and motors, ISO 17665-1 for moist heat sterilization, ANSI/AAMI ST79 for steam sterilization, AAMI TIR 30 and ISO 15883-5 for cleaning validation, ISO 10993-1 and ISO 7405 for biocompatibility). The devices' performance was "verified" against these technical and safety standards.

8. The sample size for the training set

This is not applicable as no algorithm or AI component is involved requiring a training set.

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

This is not applicable as no algorithm or AI component is involved.

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