Search Results

X65L / X65 / M65

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.

FX65 / FX65m / EX-5B

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.

This document describes the 510(k) summary for the "General Cutting Straight" dental handpiece. It details its intended use, technological characteristics, and comparison to a predicate device. However, this document does not contain information about a study proving the device meets specific performance acceptance criteria beyond general statements that it met applicable tests from ISO 14457:2017.

The device in question, "General Cutting Straight," is a dental handpiece, which is a mechanical device. The clearance is based on substantial equivalence to a predicate device, not on clinical performance data from an AI or imaging-based diagnostic system. Therefore, the specific questions related to AI/imaging device performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, ground truth establishment) are not applicable to this submission type.

Here’s a breakdown of why many of your specific requests cannot be fulfilled from the provided document:

• Type of Device: This is a Class I basic mechanical dental instrument (a handpiece), not an AI/imaging diagnostic device. Substantial equivalence for such devices typically relies heavily on non-clinical performance testing (e.g., safety, mechanical function, biocompatibility) and comparison of specifications to a legally marketed predicate, rather than human-in-the-loop clinical efficacy studies with ground truth derived from expert consensus on images.
• Regulatory Pathway: This is a 510(k) submission for a Class I device. Clinical data is often not required for Class I devices, especially when substantial equivalence can be demonstrated through non-clinical means. The document explicitly states: "Clinical testing was not required as the differences from the predicate device are minor and non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the General Cutting Straight."

Given the nature of the device and the provided document, here's what can be extracted and why other questions are not applicable:

Acceptance Criteria and Device Performance (as far as provided for this mechanical device type):

The document states that NAKANISHI INC. conducted performance testing in accordance with ISO 14457:2017 "Dentistry - Handpieces and motors" and that "All acceptance criteria for the applicable tests were met."

However, the specific quantitative acceptance criteria and the numerical results of the "reported device performance" are not detailed in this summary. The summary only provides qualitative confirmation of compliance with the standard.

Answers to Specific Questions in the Context of this Mechanical Device 510(k):

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

   • As shown above, the document states general compliance with ISO standards (ISO 14457:2017 for performance, ISO 10993-1:2018 for biocompatibility, ISO 17665-1:2006 for reprocessing). Specific quantitative acceptance criteria or numerical performance data are not provided in this 510(k) summary. The "acceptance criteria" listed are the qualitative statements of meeting the standards.

2. Sample sizes used for the test set and the data provenance:

   • Not Applicable. This is a mechanical device, not an AI/imaging diagnostic device that uses "test sets" of patient data in the way you are implying for AI algorithm validation. Performance testing was likely conducted on a sample of manufactured devices, but the size and specifics are not provided in this summary. Data provenance (country of origin of data, retrospective/prospective) is not relevant for this type of mechanical device testing.

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

   • Not Applicable. Ground truth in the context of expert review of images is not relevant for a mechanical dental handpiece. The "ground truth" for this device is its mechanical functionality, safety (biocompatibility), and ability to be reprocessed, which are assessed through engineering and laboratory tests, not human image interpretation.

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

   • Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in imaging studies. This is not applicable to the performance testing of a mechanical dental handpiece.

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 is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies are designed for evaluating diagnostic AI systems in conjunction with human readers.

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

   • Not Applicable. This is a mechanical device; there is no "algorithm" to be evaluated in a standalone manner.

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

   • For this mechanical device, "ground truth" pertains to its engineering specifications, material properties, and functionality under test conditions. This is established through laboratory testing against predefined engineering and biocompatibility standards, not through expert consensus on clinical images or pathology findings.

8. The sample size for the training set:

   • Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning or AI.

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

   • Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not pertinent.

In summary, the provided document is a 510(k) clearance letter and summary for a basic mechanical dental handpiece. It confirms compliance with relevant mechanical and biocompatibility standards but does not detail the specific quantitative results of the performance tests or involve the types of studies (e.g., clinical imaging trials, AI algorithm validation) that would address most of your specific questions.

Ask a specific question about this device