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Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.

The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

The document provided is a 510(k) premarket notification for "Disposable Barrier Sleeves and Covers" (K160232) by DENTSPLY International. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information requested regarding acceptance criteria and studies proving a device meets them for a complex AI/ML device is largely not applicable in this context.

However, I can extract the relevant information from the provided document as it pertains to the substantial equivalence determination for this non-AI medical device.

Here's a breakdown based on the provided document and the nature of a 510(k) submission for a non-AI device:

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

The acceptance criteria are generally established by recognized standards for medical device materials and performance. The document defines the "Proposed Device" as "Disposable Barrier Sleeves and Covers" and compares its performance against a "Predicate Device," "TIDIShield™ Curing Light Sleeve (K132953)".

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 explicitly state the sample sizes for the mechanical and performance tests. It refers to "samples" being tested. For biocompatibility, it states "the proposed devices, Disposable Barrier Sleeves and Covers" underwent testing.
The data provenance is not specified beyond "testing conducted to support substantial equivalence." It's common for such bench testing to be conducted in-house by the manufacturer or by contract labs. There is no indication of country of origin or whether it was retrospective or prospective, as these are typically not relevant for a 510(k) submission for this type of device.

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. For a physical barrier device like this, ground truth is established by standardized material and performance testing against recognized industry standards (e.g., ASTM, ISO). There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in clinical studies, typically for diagnostic devices. This device is a physical barrier, and its performance is evaluated by objective laboratory tests, not by expert adjudication of subjective assessments.

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 entirely not applicable.
* This device is a disposable physical barrier, not an AI/ML-powered diagnostic device.
* No human "readers" are involved.
* No "cases" are being interpreted.
* No AI assistance is provided or claimed.
* No MRMC study was conducted or is relevant for this device.

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

This is entirely not applicable.
* This device is a physical product, not an algorithm.
* There is no "human-in-the-loop" concept for this device's function.

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

The "ground truth" for this device's performance is based on the objective outcomes of standardized laboratory tests as defined by international standards (e.g., ISO, ASTM). For example:

• Biocompatibility: Demonstrated non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993 series.
• Performance (Barrier): Demonstrated resistance to synthetic blood and viral penetration as per ASTM F1670/F1670M and ASTM F1671/F1671M.
• Mechanical Properties: Measured tensile strength, puncture resistance, and tear resistance as per ASTM D882, F1342/F1342M, and D1004.

These are quantitative measurements against defined criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This is not applicable, as there is no training set for this type of device.

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1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured):
   • 1.1 Direct, light cured composite and compomer restorations
   • 1.2 Indirect restorations; light cured, resin cemented veneers
   • 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers
   • 1.4 Composite, ceramic and amalgam repairs
   • 1.5 Cavity varnish for use with fresh amalgam

• 2. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure):
  • 2.1 Direct, dual cure or self-cure composite restorations and core build-ups
  • 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers
  • 2.3 Dual cured and self-cured resin cemented endodontic post cementation
• 3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst:
  • 3.1 Adhesive bonding of direct amalgam restoration
• 4. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing):
  • 4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement
  • 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage.

When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin.

*Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).

The provided text includes information about the DENTSPLY International Inc. device, Prime&Bond Elect® Universal Dental Adhesive. However, it does not describe specific acceptance criteria in the form of numerical thresholds for device performance, nor does it detail a standalone study proving the device meets acceptance criteria.

Instead, the document states that the proposed device (Prime&Bond Elect® Universal Dental Adhesive) has an identical design and formulation to a predicate device (XENO® Adhesive with Activator, K051463), meaning the biocompatibility and performance data of the predicate device support the proposed device. A table of "Physical Properties Tested" is provided, and for each property, the result is simply "Meets specification," without providing the actual specifications or measured values.

Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study details, ground truth type and establishment for training, and specific acceptance criteria with numerical performance) cannot be extracted from this document, as a typical clinical study with such details was not conducted or reported for this 510(k) submission.

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

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

Note: The document states "all of the test results have met the specifications" but does not provide the specific numerical specifications or the measured results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. The document relies on the predicate device's data.

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)
Not applicable. No multi-reader, ground truth establishment study is described. The performance claim is based on equivalence to a predicate device and physical property testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
No, a MRMC comparative effectiveness study was not done. The device is a dental adhesive, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Physical property testing was done for the standalone device. The results are summarized generically as "Meets specification" without providing numerical values or sample sizes. The biocompatibility and primary performance claims are based on the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical properties listed, the "ground truth" would be established by standardized material testing procedures and their associated specifications. No details on these specific standards or how the specifications were derived are provided in this document. For the overall performance, the "ground truth" is the performance of the legally marketed predicate device (K051463), whose data was used as a basis for substantial equivalence.

8. The sample size for the training set
Not applicable. There's no machine learning algorithm described.

9. How the ground truth for the training set was established
Not applicable.

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• A root end filling material
• For the repair of repair of root canals as an apical plug during apexification
• For repair of root perforations during root canal therapy or as a consequence of internal resorption
• As a pulp capping material
• Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations

ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided text is a 510(k) premarket notification for a dental device, ProRoot MTA White/Gray (Pediatric Pulpotomy). It focuses on establishing substantial equivalence to previously cleared predicate devices and adding a new indication for use: "Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations."

It's important to note that this document is not a standalone study report with explicit acceptance criteria and detailed performance metrics as one might find for a diagnostic or imaging AI/software device. Instead, it's a regulatory submission demonstrating the safety and effectiveness of expanding the indications for an existing material based on clinical literature. Therefore, the information requested will be interpreted within this context.

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense (e.g., "sensitivity must be >90%"). Instead, the acceptance criterion for the new indication is demonstrating safety and effectiveness for pulpotomy in pediatric patients, supported by existing clinical literature.

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

• Sample Size (Test Set): The filing mentions "completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth)." This represents the total number of patients and teeth across the summarized clinical literature.
• Data Provenance: The data originates from "independently reviewed medical literature" and "relevant clinical data available in independently reviewed medical literature." One specific reference is provided: Srinivasan, V, et al "Mineral trioxide aggregate in paediatric dentistry" International Journal of Paediatric Dentistry, 19:34-47, 2009. The studies are retrospective as they are existing published literature. The country of origin of the data is not specified but is presumably international given the nature of scientific literature.

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

The document does not specify the exact number of experts involved in establishing the ground truth for the collected literature. It refers to studies conducted by "dental professionals." The provided reference is to an "International Journal of Paediatric Dentistry," suggesting the experts involved would be pediatric dentists or dental professionals specializing in pediatric dentistry. Their specific years of experience are not detailed.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (like 2+1, 3+1, none) for the clinical literature review or for establishing ground truth within those studies. The assessment relies on the conclusions and methods presented in the published scientific literature.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/software device designed to assist human readers. It is a dental material used directly in treatment.

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

N/A. This is a dental material, not an algorithm or software. Its performance is evaluated based on its clinical outcomes after application by a dental professional.

7. The type of ground truth used

The ground truth used in the referenced clinical literature would be clinical outcomes data relevant to pulpotomy procedures, such as:

• Clinical success (e.g., absence of pain, swelling, mobility)
• Radiographic success (e.g., absence of periapical or furcal radiolucency, normal root development)
• Histological findings (if biopsies were taken, though less common for outcome assessment in pulpotomy for regulatory purposes).
• Retention rates of the teeth.

8. The sample size for the training set

N/A. This device does not use an "algorithm" in the traditional sense that requires a training set for machine learning. The clinical experience and data from the 171 pediatric patients (408 teeth) constitute the evidence base, not a training set for an algorithm.

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

N/A. As above, there is no training set for an algorithm. The ground truth for the clinical studies (evidence base) was established through standard clinical and radiographic follow-up protocols within the individual studies published in the medical literature.

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RAYPEX® 6 is a microprocessor controlled device used for locating the apex.

RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex. The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal. RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device. Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories. For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the RAYPEX® 6 apex locator:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in terms of accuracy metrics (e.g., percentage deviation from true apex within a specific range). Instead, the acceptance criterion for RAYPEX® 6 is based on demonstrating substantial equivalence to its predicate device, the BINGO PRO apex locator (K111474). This means the performance of RAYPEX® 6 must be "equivalent to" or "clinically acceptable" compared to the predicate.

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

• Sample Size: The document does not specify the exact number of "extracted teeth" used for the ex-vivo test. It only states that the test was performed "on extracted teeth."
• Data Provenance: The study was conducted "ex-vivo" (meaning outside a living organism, likely in a laboratory setting using extracted human or animal teeth). The country of origin for the data is not specified. It is a retrospective or prospective study from the perspective of how the test set was collected. Given that it's an ex-vivo test on extracted teeth, it would be considered prospective in the sense that the test was specifically designed and executed for this regulatory submission.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the extracted teeth. The "ground truth" for an apex locator study typically involves physically measuring the true apex after the teeth have been prepared or sectioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (such as 2+1, 3+1, or none) for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. This study focuses on the standalone performance of the device compared to a predicate device, not on how human readers improve with AI assistance.

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

Yes, a standalone study was performed. The "ex-vivo test was performed on extracted teeth" directly evaluating the RAYPEX® 6 apex locator's measurements and comparing them to those of the BINGO PRO apex locator. This assesses the device's ability to locate the apex on its own, without direct real-time human intervention influencing its measurement output.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a physical measurement of the true apex on extracted teeth. While not explicitly stated, ex-vivo apex locator studies typically rely on histological or direct microscopic measurement of the true anatomical apex after the tooth has been prepared or sectioned.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. Apex locators like RAYPEX® 6 are typically engineered based on physical principles (impedance measurement at different frequencies) and do not usually involve machine learning models that require a "training set" in the conventional sense (i.e., for supervised learning). The "microprocessor controlled device" refers to its operational logic, not necessarily an AI algorithm trained on data.

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

Not applicable, as no training set (in the context of machine learning) is described for this device.

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NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.

NUPRO® Sensodyne® is a premium prophylaxis paste containing NovaMin®, a calcium sodium phosphosilicate. The dye-free formulations are available in fluoride and non-fluoride formulations, with two different grits to gently remove dental plaque and stains. The Polish Grit is ideal for prophy procedures requiring minimal tooth abrasion. The Stain Removal Grit is suitable for most cleaning procedures where a high level of polish is desired for stain removal.

The provided text describes the NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a quantitative manner or present a table of acceptance criteria versus reported device performance against those specific criteria.

Instead, the submission focuses on demonstrating the device's safety and efficacy, particularly regarding its ability to reduce tooth hypersensitivity, to support an expanded indication for use.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for cleaning, polishing, or sensitivity reduction. The study aims to demonstrate efficacy and safety, rather than meeting predefined numerical thresholds for device performance.

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

• Sample Size: 151 participants
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as a "single site" study. Given the submission is to the US FDA, it's highly probable the study was conducted in the US, but this is not explicitly confirmed.
  • Retrospective or Prospective: Prospective ("A single site, double-blind, randomized, three arm parallel group study to determine the efficacy...")

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

The text refers to "the examiner" for observing pathological conditions, but does not specify the number or qualifications of experts involved in establishing a formal "ground truth" for tooth hypersensitivity or other clinical outcomes beyond the study design itself. The judgment of hypersensitivity was based on qualifying responses to stimuli (tactile and air blast) from participants, which are direct patient responses, not expert consensus on an independent truth.

4. Adjudication Method for the Test Set

Not applicable. The study was a "double-blind, randomized, three arm parallel group study." The assessment of hypersensitivity was based on direct responses from participants to stimuli, and observations for adverse events by an "examiner." There is no mention of an adjudication panel or method for conflicting interpretations of objective data.

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 medical product (prophylaxis paste), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is a medical product (prophylaxis paste) primarily intended for manual application by a dental professional, not an algorithm.

7. The Type of Ground Truth Used

For sensitivity reduction, the "ground truth" was based on patient-reported responses to standardized stimuli (tactile and air blast) at baseline and follow-up, which were qualified by specific criteria. For safety, it was based on direct clinical observation by an examiner for pathological conditions and adverse events.

8. The Sample Size for the Training Set

Not applicable. This device is a prophylaxis paste, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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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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