Search Results

Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:

• X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm)
• X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).
  The Oral Surgery Contra handpieces are a prescription-only device.

This document describes a 510(k) premarket notification for the "Oral Surgery Contra" device. It is a submission for substantial equivalence based on comparisons to predicate and reference devices, and no clinical studies were conducted that prove device meets acceptance criteria.

Here's an analysis based on the provided text:

No clinical studies were performed. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Oral Surgery Contra." Therefore, there is no information in the provided text regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria through clinical data.

The "Summary of Performance Testing" section mentions "verification/validation testing to internal functional specifications" and conformance to various ISO standards (AAMI/ANSI/ISO 17665-1:2006 for sterilization, ISO 14457:2012 for handpieces and motors, and AAMI/ANSI/ISO 10993-1: 2018 for biocompatibility). These are bench tests and evaluations, not clinical studies involving patients or expert review of clinical images/data.

Therefore, since no clinical study was performed, the following requested information cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not applicable for clinical performance.
2. Sample sized used for the test set and the data provenance: Not applicable as there was no test set from a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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. This device is a mechanical 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 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.

In summary, this document describes a regulatory submission relying on substantial equivalence to predicate devices and bench testing, rather than novel clinical performance studies.

Ask a specific question about this device