(33 days)
Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.
FlexoFile® files and instruments are manufactured for DENTSPLY Caulk by DENTSPLY Maillefer®. They are pre-1976 medical devices and are exempt from premarket notification. However, this 510(k) submission is necessary because DENTSPLY Caulk plans to market these devices as Sterile and to revise the labeling to reflect this change. There are no changes to the composition, manufacturing process, or sterilization process. STERILE FLEXOFILE® FILES AND INSTRUMENTS are precision instruments twisted from a single shaft of stainless steel for maximum fracture resistance. They feature preinserted silicone stops for convenience and safety. 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 stenlization, 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.
The provided 510(k) summary for "STERILE FLEXOFILE® FILES AND INSTRUMENTS" describes a submission for a legally marketed predicate device (K943584) to be marketed as "Sterile". The submission argues for substantial equivalence primarily based on the fact that there are no changes to the composition, manufacturing process, or sterilization process of the device itself, besides the validation of sterilization.
Therefore, the study focuses on validating the sterilization process and demonstrating that the sterilization does not negatively impact the device's original performance characteristics (which are assumed to be safe and effective based on the predicate).
Here's an analysis of the acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance and Confirmation |
|---|---|---|
| Sterility | Device must be sterile. | "Subjected to sterilization by gamma irradiation from a Cobalt 60 source. The validation method used was AAMI Method 1." This indicates that the sterilization process was validated per recognized standards, implying that sterility was achieved. |
| Mechanical Performance | Sterilized instruments must maintain their original mechanical properties (e.g., torsion and shear stress resistance). | "After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments." This directly meets the criterion. |
| Physical Appearance | Sterilization should not significantly alter the color or mechanical behavior of plastic components. | "No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation." This directly meets the criterion. |
| Packaging Integrity | Packaging must maintain sterility and allow for aseptic single-use access. | "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 describes the packaging design intended to meet the criterion. |
| Clinical Equivalence | The "new" sterile device must be clinically equivalent to the predicate device. | "We believe that the fact that the new device is identical to the predicate device, along with the sterilization data presented, supports the safety and effectiveness of STERILE FLEXOFILE® FILES AND INSTRUMENTS for the intended uses." The core argument is based on identity to the predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the mechanical and physical tests (torsion, shear stress, color, mechanical behavior of handles). It only states "these files and instruments," implying a representative sample was tested.
- Data Provenance: The data appears to be internal testing conducted by the manufacturer (DENTSPLY Caulk) or on their behalf ("manufactured for DENTSPLY Caulk by DENTSPLY Maillefer®"). The country of origin for the testing is not specified, but the submission originated from York, PA, USA. The data is prospective in the sense that the tests were performed to validate the sterilization process for the current 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not applicable. This submission concerns a physical dental instrument and its sterilization, not clinical interpretation of images or symptoms requiring expert consensus. The "ground truth" for mechanical properties and sterility is established through standardized testing methodologies (e.g., AAMI Method 1 for sterilization, and standard mechanical testing protocols for torsion and shear stress).
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or expert medical review to establish a consensus ground truth. For the mechanical and sterility tests described, the outcome is objective (e.g., pass/fail for sterility, quantitative measurements for torsion/shear that are compared statistically).
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
- MRMC Study: No. This is not an AI/software device or an imaging device requiring human reader interpretation. It is a physical dental instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithm or software. It is a physical dental instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth:
- Sterility: Achieved according to AAMI Method 1 validation, a recognized standard for gamma irradiation sterilization.
- Mechanical Performance: Established via direct quantitative measurement of torsion and shear stress, compared against the validated performance of the non-sterilized predicate device.
- Physical Appearance (Color/Mechanical Behavior of Handles): Established via visual inspection and/or mechanical testing against the non-sterilized predicate device.
- Clinical Efficacy/Safety: The "ground truth" for these aspects is essentially derived from the legally marketed predicate device (K943584), assuming its established safety and effectiveness. The current submission's argument is that since the device is chemically and physically identical (except for being made sterile), its performance will be identical.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. The "device" in this context refers to the physical FlexoFile® instruments.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.