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Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.

Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved. The contents of the kit are 1 Endo-Express® Handpiece, 1 Lubricant bottle, 1 nozzle attachment.

The provided document is a 510(k) summary for the Endo-Express® Handpiece, stating its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a dedicated study with the specific components you requested (such as sample sizes, expert qualifications, and MRMC studies).

Here's a breakdown of why this information isn't present in the provided text:

• Nature of the Document: This is a premarket notification (510(k)) seeking clearance based on substantial equivalence. For Class I and many Class II devices, clinical trials with formal acceptance criteria, statistical analyses, and ground truth establishment are often not required if substantial equivalence to a legally marketed predicate device can be demonstrated through performance testing, comparison of technological characteristics, and intended use.
• "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" (Section 7): This explicitly states that specific non-clinical tests were not performed in a way that would require detailed reporting of acceptance criteria and results in this summary. It implies that the demonstration of substantial equivalence relied on other factors, primarily comparison of intended use and technological characteristics to the predicate.
• "Discussion of Clinical Tests Performed: Not Applicable" (Section 8): This confirms that no clinical studies were performed for the purpose of this 510(k) submission. Therefore, there would be no data on sample sizes, expert-established ground truth, MRMC studies, or standalone algorithm performance.

Based on the provided document, the following information is available for your request:

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

(Note: The document implies the "acceptance" is based on the device having similar characteristics and intended use to the predicate. There are no numerical performance metrics or thresholds explicitly defined as acceptance criteria for this specific submission.)

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

• Sample Size for Test Set: Not applicable. No test set for performance comparison was described as part of a new study in this submission.
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth establishment by experts for a test set was described in this submission.

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:

• Not applicable. No MRMC study was performed or described. This device is a mechanical dental handpiece, not an AI-assisted diagnostic tool.

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

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

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

• 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.

Summary of the study that proves the device meets the acceptance criteria:

The document states, "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" and "Discussion of Clinical Tests Performed: Not Applicable."

Instead of a specific performance study, the substantial equivalence was demonstrated by:

• Comparison of Intended Use: The Endo-Express® Handpiece has the same intended use as the predicate device (TEP E4R).
• Comparison of Technological Characteristics: The device has similar technological characteristics to the predicate, with the main differences being cosmetic appearance and maximum allowable motor speed. The key functional characteristics (latch type, file type, motor connection, reduction ratio) are identical to the predicate.

The "study" proving the device meets the implicit acceptance criteria (i.e., being substantially equivalent to a legally marketed predicate) is primarily a direct comparison of specifications and intended use outlined in Section 6, rather than a clinical or detailed non-clinical performance study with explicit acceptance criteria and results.

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