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The DentalJect™ is intended for topical application to intact mucous membrane (oral cavity). The DentalJect™ is used to target a minimally sized cooling area for lessening pain associated with injections.

The DentalJect™ is a prescription device which attaches to a standard dental syringe and dispenses a non-medicated, non-flammable vapocoolant blend as a topical anesthetic for intact oral mucosa.
Pressurized dispensing container, which includes the vapocoolant, canister and valve; Syringe barrel attachment Dental Connector; and DentalJect™ accessory nozzle (actuator).

This FDA approval letter for the DentalJect device (K243654) does not contain sufficient information to fully complete all sections of your request regarding acceptance criteria and the study proving the device meets those criteria. The letter emphasizes non-clinical testing and substantial equivalence rather than detailed clinical performance studies with specific statistical acceptance criteria for efficacy.

However, based on the provided text, I can extract the following information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document describes several non-clinical tests but does not explicitly state quantitative acceptance criteria for device performance with numerical targets and reported results in the same way a clinical trial might for sensitivity/specificity. Instead, it states that tests were performed "to ensure the subject device, DentalJect™, met predefined requirements pertaining to fit, form and safe function" and that "All of the results successfully met the test criteria."

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

The document does not explicitly state the sample sizes for the "test sets" or the data provenance (e.g., country of origin, retrospective/prospective) for any of its non-clinical tests. It implies that "user groups" were involved in usability testing and that standard bench tests were conducted.

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

Not applicable. The reported studies are non-clinical (bench testing, biocompatibility, usability), not clinical trials requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring adjudication in the provided text.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical Testing: Not Applicable."

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

Not applicable. The DentalJect is a physical device (vapocoolant dispenser), not an algorithm or AI software for which standalone performance would be relevant.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was based on established industry standards and regulatory test criteria (e.g., ISO 10993 series for biocompatibility, CFR for flammability, predefined specifications for fit/form). There is no mention of pathology, outcomes data, or expert consensus as would be used in a diagnostic clinical study.

8. The Sample Size for the Training Set:

Not applicable. As a physical device rather than an AI/ML algorithm, there is no "training set" in the context of machine learning.

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

Not applicable, for the same reason as point 8.

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The Elements Obturation Unit is intended to be used in Dentistry to:

1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
2. For tissue cauterization and coagulation, and
3. To backfill and downpack gutta percha during Endodontic root canal treatment.
4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.

The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.

The provided text is a 510(k) Summary for the "Elements Obturation Unit," a dental device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory submission for premarket notification, focusing on demonstrating that the device is "substantially equivalent" to already legally marketed devices. This regulatory pathway typically relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than requiring formal clinical trials or new performance studies to demonstrate safety and effectiveness from scratch.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.

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For use during condensation of gutta percha in tooth root canals. May also be used as a pulp r of use during ochaoned. Of Samal stimulus through molten gutta percha.

Thermique Thermal Condenser

The provided text is a 510(k) premarket notification approval letter for the "Thermique Thermal Condenser." This document focuses on establishing substantial equivalence to a predicate device and does not contain information about the device's specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a clinical study report.

Therefore, I cannot provide the requested information from the given input.

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The Elements Diagnostic Unit is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The device is a battery-operated, endodontic diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

The provided text does not contain information about specific acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or detailed study methodologies. The document is a 510(k) summary for the "Elements Diagnostic Unit," primarily focusing on establishing substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The text describes the device's intended use and functionality, and states that it is substantially equivalent to a previously marketed device. There is no information about how this equivalence was demonstrated through specific performance testing or clinical studies with detailed acceptance criteria.

Information NOT Found in the Document:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

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Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the device "Pharmaethyl Local Pulp and Vitality Testing Agent" and its Indications for Use statement. However, it does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device, and does not include the technical study report that would contain the requested information.

Therefore, I cannot provide the requested table and study details based on the input text.

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• 1. COOLING HEAT SENSITIVE ORTHODONTIC WIRES
• 2. TOPICAL ANESTHETIC
• 3. PULP TEST THE VITALITY OF TEETH

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named "Chillit." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for further inquiries.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document simply does not contain that type of information.

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The intended use of the endodontic analyzer is to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The Endo Analyzer, Model 8005, Modified is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The device is a battery-operated, endodontic analyzer which is designed to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth) and to locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit is battery operated using six (6) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a pulp tester or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

This 510(k) summary (K990225) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) summary for a modified endodontic analyzer device (Endo Analyzer, Model 8005, Modified). It primarily focuses on demonstrating substantial equivalence to a predicate device based on similar function and intended use.

Here's what the document does include and what it lacks in relation to your request:

Information Present:

• Device Name: Endo Analyzer, Model 8005, Modified
• Intended Use: To test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.
• Predicate Device: Analytic Endodontics, Endo Analyzer, Model 8005
• Submission Date: January 1999

Missing Information (Crucial for your request):

The document does not contain any details about acceptance criteria, performance studies, or clinical data. This type of information is typically found in the full 510(k) submission, not necessarily in the summary provided to the FDA for public reference. Therefore, I cannot construct the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement.

To obtain the requested information, you would need to access the complete 510(k) submission for K990225, which would include performance data, clinical testing protocols, and results.

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The Endo Analyzer, Model 8005, is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The device is a battery-operated, endodontic analyzer which is designed to test the vitality of a tooth and to locate the apical foramen of a root canal during root canal treatment. The unit is battery operated using three (3) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a vitality scanner or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The handpiece and cord assembly, including the vitality scanner tips and lip clip used with the device, are autoclavable.

The provided text is a 510(k) summary for a medical device called the "Endo Analyzer, Model 8005", which is an endodontic analyzer designed to test tooth vitality and locate the apical foramen. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.

The document primarily focuses on:

• Device Description and Intended Use: Explaining what the device is, how it works, and its purpose.
• Substantial Equivalence: Comparing the device to other legally marketed devices (Analytic Technology Corporation's Apex Finder A.F.A. and Vitality Scanner) to demonstrate that it functions similarly and has the same intended use.
• Regulatory Information: A letter from the FDA confirming the device's 510(k) clearance based on substantial equivalence to predicate devices, and outlining general regulatory requirements.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.

The document is a regulatory submission for 510(k) clearance, which typically relies on demonstrating substantial equivalence to existing devices rather than presenting new clinical study data with defined acceptance criteria for a novel performance claim. If a performance study was conducted, its details would be in a separate section or document not included here.

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The System B HeatSource, Model 1005, is intended to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus and for tissue cauterization and coagulation.

The device is a battery-operated dental instrument heater which is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation, respectively. The battery is fully rechargeable through the use of the plug-in charge adapter. The temperature is regulated by a feedback control system which automatically maintains a preset temperature for consistent results. The handpiece and cord assembly are completely removable. Both the handpiece and cord assembly and the dental instruments used with the device are autoclavable.

It seems there might be a misunderstanding or a lack of relevant information in the provided text. The documents describe a "System B HeatSource" dental instrument heater and its intended uses, as well as a claim of substantial equivalence to an existing device.

However, the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the specific details requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details).

The text is a 510(k) summary and an Indications for Use statement, which primarily focus on:

• Device Name and Submitter Information: Identifying the product and the company.
• Device Description: What the device is and how it works (a battery-operated dental instrument heater for thermal stimulus testing and tissue cauterization).
• Intended Use: The clinical applications of the device.
• Substantial Equivalence Claim: Stating that it is similar to another legally marketed device (Analytic Technology Corporation, Touch N' Heat).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

To answer your request, I would need a different type of document, such as:

• Performance testing reports: Detailing specific tests, their methodologies, acceptance criteria, and results.
• Clinical trial summaries: If applicable, describing patient populations, outcome measures, and statistical analyses.
• Verification and Validation (V&V) documentation: Outlining the V&V activities conducted for the device.

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The intended use of the device is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus.

The device, which is battery-operated (Model 5001 and 5004) or powered by a wall adapter (Model 5002), is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus. The battery operated models are fully rechargeable through the use of the plug-in charge adapter. The Hot Pulp Test Tip is heated to the desired temperature. A medium, such as a ball of softened gutta percha, is used to transfer the heat from the Hot Pulp Test Tip to the tooth. The gutta percha ball is dipped into talcum powder or Vaseline to prevent it from sticking to the tooth. The Hot Pulp Test Tip is placed in firm contact with the tooth, ensuring that a good contact is established. The patient's response to the heat is evaluated by the clinician to determine whether the pulp is healthy or inflamed.

The provided text describes a "Touch n' Heat" dental instrument heater and its intended use as a thermal pulp tester. However, it does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, ground truth, expert qualifications, adjudication methods), or any comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them because the necessary information is absent from the input.

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