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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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The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.

The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal. The tips are composed of stainless steel with a layer of fine diamond particles.

This document is a 510(k) summary for the Sybron Dental Specialties, Inc. Ultrasonic Tips with Diamond Coating. This type of regulatory submissiondoes not include detailed performance studies or acceptance criteria tables like those found for software or AI/ML devices.

The content focuses on demonstrating "substantial equivalence" to a predicate device, which means the new device is as safe and effective as a legally marketed device. This is typically achieved by showing similar intended use, technological characteristics, and performance characteristics (though often not quantified in the same way as for advanced software).

Therefore, I cannot provide the requested information because it is not present in the provided text. Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states the device "functions in a manner similar to and is intended for the same use" as a predicate device, which is the basis for substantial equivalence, not specific performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of performance metrics for an AI/ML device is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no mention of a ground truth establishment by experts for performance evaluation.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (ultrasonic tips), not a software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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