(90 days)
FX15 / FX15m / FX25 / FX25m
FX Contra 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.
FX57 / FX57m
FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.
The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m).
The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m.
The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave).
The provided text describes a 510(k) summary for the Nakanishi Inc. FX Contra dental handpieces. However, it does not include detailed acceptance criteria or a specific study proving the device meets those clinical performance acceptance criteria in the format requested. The document focuses on regulatory compliance, non-clinical performance testing (bench testing, sterilization, cleaning, biocompatibility), and a comparison to a predicate device to establish substantial equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is explicitly not present:
1. A table of acceptance criteria and the reported device performance
- Not present in the document. The document states that "The product's conformance with applicable international and internal standards was verified in the course of bench testing" and "Tests were performed on the subject device including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent." However, specific numerical acceptance criteria (e.g., minimum torque, maximum vibration) and the corresponding measured performance values are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not present in the document. The document mentions "bench testing" and "verification/validation testing to internal functional specifications," but it does not specify sample sizes for these tests or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not present. This type of information is typically relevant for studies involving human interpretation or clinical endpoints. Since this document describes non-clinical performance testing for a dental handpiece, there's no mention of experts establishing a "ground truth" for a test set in the conventional sense of diagnostic or AI-driven medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. Similar to point 3, this is relevant for studies involving human readers and interpretations, which are not described here.
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
- No, this was not done. The document explicitly states: "Clinical Testing: Clinical testing was not required as non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the FX Contra handpieces." Therefore, no MRMC study or AI assistance evaluation was performed as per this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a dental handpiece, not an algorithm or AI-driven system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not present in a clinical sense. For the non-clinical tests mentioned (sterilization, performance to ISO standards, cleaning, biocompatibility), the "ground truth" would be the specifications and requirements defined by the respective standards. However, actual data points or methods for confirming these are not detailed.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Summary of available information related to performance testing:
The device is the FX Contra dental handpiece.
The document indicates that the device's substantial equivalence largely relies on non-clinical performance testing and a comparison to a predicate device (SciCan GmbH SANAO Dental Handpieces, K132356).
Performance Testing Mentioned:
- Sterilization Validation: Conformance to AAMI/ANSI/ISO 17665-1:2006 "Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."
- Performance (General): Conformance to ISO 14457:2017 "Dentistry - Handpieces and Motors." (Specific parameters or acceptance criteria from this standard are not detailed, nor are the measured results).
- Cleaning Validation: Compliance with "Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff."
- Biocompatibility Testing: Selected in accordance with AAMI/ANSI/ISO 10993-1: 2018 and FDA Guidance Use on International Standard ISO 10993. This included:
- Cytotoxicity per ISO10993-5
- Sensitization per ISO10993-10
- Irritation per ISO10993-10
- Acute Systemic Toxicity per ISO 10993-11
- Pyrogenicity per ISO 10993-11
Conclusion from the document:
NAKANISHI INC. considers the FX Contra handpieces to be substantially equivalent to the predicate device based on similarities in primary intended use, principles of operation, functional design, and established medical use, supported by the non-clinical testing. Clinical testing was deemed not required.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.