(34 days)
Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.
STERILE SUREFLEX® FILES AND INSTRUMENTS are precision instruments cut from a nickel titanium shaft for increased flexibility over stainless steel instruments. They conform better to the curved surface of most root canals. They reduce the chance of apical transportation and breakage from binding in the canal. They feature non-slip plastic handles for a firmer grip, as well as ISO color coding for easy identification.
After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments. No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation.
The device package is a compartmentalized container with six (6) individually separated cells. The package includes a heat-sealed non-tearing perforated thermal adhesive strip. This strip allows for a single cell to be opened per file as required by the dentist, while all other file cells remain sealed and sterile.
This document is a 510(k) summary for DENTSPLY's STERILE SUREFLEX® FILES AND INSTRUMENTS. It primarily focuses on demonstrating substantial equivalence to a previously marketed non-sterile version of the same product, rather than providing the kind of detailed performance study typically associated with AI/software-as-a-medical-device (SaMD) clearances. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable as the submission is not about an AI/ML device or a device requiring complex performance validation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Identity to Predicate Device (Composition, Manufacturing Process, Sterilization Process) | "identical to the Presterilized SureFlex® files and instruments now marketed" (K951607) |
| Sterility (Proof of effective sterilization) | "subjected to sterilization by gamma irradiation from a Cobalt 60 source." Validation method: "AAMI Method 1." |
| Mechanical Properties after Sterilization (Torsion, Shear Stress, Plastic Handle Behavior) | "presented the same resistance in torsion and shear stress as non-sterilized instruments." |
| "No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation." | |
| Intended Use | "Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity." |
| Packaging Integrity | "compartmentalized container with six (6) individually separated cells." |
| "heat-sealed non-tearing perforated thermal adhesive strip." (Allows single cell opening while others remain sterile) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the way a clinical trial for software would. The "test" involved comparing the properties of sterilized versus non-sterilized instruments. The number of instruments tested for torsion, shear stress, and handle behavior is not specified.
- Data Provenance: The study was conducted by DENTSPLY, likely internal testing. The country of origin of the data is not specified but is implicitly associated with DENTSPLY's manufacturing and testing facilities (York, PA, USA). It is a prospective evaluation of the new, sterilized devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for a physical medical device (dental files), not an AI/ML-based diagnostic or imaging device requiring expert ground truth for classification. The "ground truth" for mechanical properties would be measured values, and for sterility, it would be the results of standard sterility tests.
4. Adjudication Method for the Test Set
- Not applicable. There was no human interpretation or adjudication in the sense of a diagnostic classification. The measurements were objective (e.g., resistance in torsion, presence/absence of microbial growth post-sterilization).
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 not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- Objective Measurements/Standards:
- Sterility: Adherence to "AAMI Method 1" for sterilization validation. This method typically involves biological indicators and direct testing for microbial growth.
- Mechanical Integrity: Measured resistance in torsion and shear stress, and visual/physical assessment of plastic handle behavior (color, mechanical properties). The "ground truth" is that these values should be "the same" as the non-sterilized predicate device.
- Composition/Manufacturing: Direct comparison to the predicate device to confirm identical nature.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
§ 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.