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RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).

RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.

The provided document describes a 510(k) premarket notification for the REDENT NOVA's RDT3 Handpiece Head. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. However, it does not include information about a clinical study involving human or even simulated patients, nor does it involve AI, expert consensus for ground truth, or statistical measures like sensitivity, specificity, or AUC typically associated with device performance in diagnostic or prognostic applications.

The acceptance criteria and "study" described are engineering and material performance tests.

Here is the information based on the provided text, recognizing the limitations of its scope regarding "acceptance criteria" in a clinical sense:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test with pass/fail values. Instead, it states that tests were carried out in accordance with ISO 7785-2 and an in-house test, and for all of them, the device "functioned as intended" and "results observed were as expected." This implies that the RDT3 met the implied performance standards of the ISO standard and the internal test.

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

The document does not specify exact sample sizes for the performance tests (e.g., how many handpieces were tested for chuck friction grip or corrosion). The tests are described as in vitro engineering and material tests, not tests on clinical data. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not applicable to these types of tests.

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

Not applicable. The ground truth for these engineering tests would be derived from the objective measurements and standards set forth in ISO 7785-2, not from expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 device is a dental handpiece head, a mechanical device. The submission does not involve AI or human readers, and therefore no MRMC study was conducted.

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

Not applicable. This device is a mechanical handpiece head, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on the standards and methodologies outlined in ISO 7785-2 and presumably a documented internal specification for the in-house Sodium Hypochlorite Exposure test.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning model, so there is no training set in the typical sense.

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

Not applicable, as there is no training set.

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The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.

The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment.

The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel.

The VATEA is an electronically operated device, powered by a rechargeable battery.

Here's a summary of the acceptance criteria and the study details for the VATEA Endodontic Irrigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical trial involving human subjects or a large collection of case data. The "test set" here refers to the number of units or conditions tested during the performance validation.

• Sample Size for performance validation: Not explicitly stated as a number of devices, but implies testing of the device's flow rate mechanism and battery under specified conditions.
• Data Provenance: The studies were performed by the company (ReDent Nova Ltd.) as "performance validation." The location is Israel, as this is the sponsor's country of origin. The studies are prospective in the sense that they are specifically designed to test the VATEA device's performance.

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

Not applicable. The performance validation involved objective measurements of flow rate and battery life, not interpretation by experts.

4. Adjudication Method for the Test Set

Not applicable. The data appears to be quantitative measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance validation represents a standalone study of the device's functionality. The device (VATEA) itself was tested for its performance characteristics (flow rate, battery life). There is no "algorithm" in the sense of AI being evaluated here; rather, it is electro-mechanical performance.

7. The Type of Ground Truth Used

The ground truth used was based on:

• Objective measurement: For flow rate, the "actual irrigant flow rate" was measured against the "displayed flow rate." For battery life, it was based on continuous operation at maximum output.
• Engineering and safety standards: Compliance with IEC 60601-1 and IEC 60601-1-2 implies that the device was tested against established international safety and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set.

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The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.

The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.

The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.

The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.

The provided 510(k) summary for the REDENT NOVA's SAF (Self Adjusting File) does not contain the detailed information requested regarding specific acceptance criteria, a quantitative study proving the device meets those criteria, or details about ground truth establishment, sample sizes for test and training sets, or expert involvement.

The summary states: "Performance tests were carried out to evaluate the properties of the SAF. In all instances the SAF functioned as intended and results observed were as expected." However, it does not provide the specifics of these tests.

Therefore, many of the requested fields cannot be filled. Based on the provided text, here is what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Note: The document broadly states the device "functioned as intended" and "results observed were as expected." This is a general statement and lacks quantitative or specific performance metrics that would typically define acceptance criteria for a medical device.

Study Information

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

   • Not provided. The document only mentions "Performance tests were carried out," but no details about the sample size or type of study (in vitro, in vivo, etc.) are given.

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

   • Not applicable / Not provided. The summary does not describe a study involving "ground truth" established by experts in the context of diagnostic or interpretive performance. The performance tests mentioned appear to be mechanical or functional evaluations of the device itself.

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

   • Not applicable / Not provided. No information on adjudication is present as this type of study was not described.

4. 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:

   • No. This device is an endodontic file, a mechanical tool, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to interpretation would not be applicable.

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

   • Not applicable. This is a mechanical device, not an algorithm.

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

   • Not applicable / Not provided. The document describes performance tests for a mechanical device. The "ground truth" would likely be defined by engineering specifications or established dental standards for root canal preparation, but the specifics are not detailed.

7. The sample size for the training set:

   • Not applicable. This device is a mechanical tool and does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. This device is a mechanical tool and does not involve a "training set" or "ground truth for a training set" in the context of machine learning.

Summary of what is known:

The REDENT NOVA's SAF (Self Adjusting File) is a mechanically operated endodontic file for cleaning and shaping root canals. Performance tests were conducted, and the manufacturer reported that the device "functioned as intended" and "results observed were as expected." The device was found substantially equivalent to predicate devices (Quantec Series 2000, ProFile Series 29, and ProTaper) based on similar intended use, indications, technological characteristics, principles of operation, and these performance data.

Key Missing Information:

The document lacks any specific, quantifiable acceptance criteria. It also does not provide details about the methodology, sample sizes, specific measurements, or results of the "performance tests" that were conducted. Without these details, a comprehensive description of how the device demonstrably meets quantitative acceptance criteria cannot be provided.

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