(89 days)
The Easy X-Trac System is to be used to extract single and double rooted teeth as an implemented pre-implantological method by professionals only. The Easy X-Trac is only to be used for extraction of single and double rooted teeth by I he Lasy X-Trac is only. The system may be used to extract broken-down teeth with ucular professionals only . Its extract vertically or horizontally fractured teeth.
The Easy X-Trac System is a tooth extraction system that is used to extract single- and double-rooted teeth. Use of this system may minimize bone loss, reduce damage to soft tissue and preserve the alveolous prior to immediate or delayed implant placement more than with regular extraction instruments such as extraction forceps and root elevators. The Easy X-Trac System uses a complete vertical lifting motion without rotary- or tliting movements to lift a tooth out of the socket. By using this technique the user might have a greater chance of preserving the socket and preventing damage to hard soft tissues such as lamella and buccal and labial plates.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Easy X-Trac System:
Summary of Device and Approval:
The Easy X-Trac System is a tooth extraction system designed to extract single and double-rooted teeth. Its intended use is by professionals for pre-implantological methods. The device was cleared through a 510(k) premarket notification process by the FDA in 2006, claiming substantial equivalence to the Meisinger Benex.
Acceptance Criteria and Study Information:
Based on the provided 510(k) summary, formal acceptance criteria and a detailed study report demonstrating the device's performance against those criteria are not explicitly present.
The 510(k) clearance process for devices like the Easy X-Trac System, especially those classified as Class I and seeking substantial equivalence to existing predicate devices, often relies on a comparison of fundamental technological characteristics and intended use, rather than extensive clinical performance studies with predefined acceptance criteria.
Let's break down why and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in the 510(k) summary. For this type of device and 510(k) submission, functional equivalence to a predicate device, and the ability to achieve the intended use given its design and operational principles, typically serves as the primary "acceptance." | "The Easy X-Trac System uses a complete vertical lifting motion without rotary- or tilting movements to lift a tooth out of the socket. By using this technique, the user might have a greater chance of preserving the socket and preventing damage to hard soft tissues such as lamella and buccal and labial plates." This describes the mechanism of action and potential benefits but is not a quantified performance measure against a specified criterion. |
| Safety: Implicitly, the device must be safe for its intended use. | No specific safety study results are detailed. Safety is generally addressed through risk analysis and comparison to the predicate device's safety profile. |
| Effectiveness: Implicitly, the device must be effective for its intended use of extracting teeth. | The claim is that it "may minimize bone loss, reduce damage to soft tissue and preserve the alveolus prior to immediate or delayed implant placement more than with regular extraction instruments such as extraction forceps and root elevators." This is a comparative claim, but no study data is presented to quantify this "more than." |
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. Given the nature of a 510(k) for a basic dental instrument, it's highly probable that any supporting data involved bench testing, literature review, and possibly limited simulated or cadaveric use, rather than a formal clinical "test set" in the sense of a clinical trial. There's no mention of country of origin or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
For this type of device, "ground truth" would likely be established through engineering analysis, materials testing, and expert opinion (e.g., dental professionals' evaluation of the design and technique), rather than a formal consensus process on individual cases.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. This commonly refers to clinical trial adjudication, which is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, there is no indication that an MRMC comparative effectiveness study was conducted. This type of study is more common for diagnostic imaging devices where different readers interpret cases. The Easy X-Trac System is a surgical instrument.
- Effect size of improvement with AI vs. without AI assistance: Not applicable, as this device does not incorporate AI.
6. Standalone (Algorithm Only) Performance:
- Standalone Performance: Not applicable, as this device is a mechanical instrument and does not involve an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: For a device of this nature, the "ground truth" is intrinsically tied to its mechanical function and the principles of dental extraction. It would rely on:
- Engineering principles and design specifications: Ensuring the components meet strength, durability, and biocompatibility requirements.
- Expert opinion/clinical consensus: Dental professionals' agreement that the proposed extraction technique and device design are sound and capable of achieving the stated benefits (e.g., "minimizing bone loss").
- Comparison to predicate device: The predicate device itself serves as a "ground truth" for accepted clinical practice and safety/effectiveness standards.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable, as there is no training set for an algorithm.
Conclusion Regarding the Study:
The provided 510(k) summary for the Easy X-Trac System (K060691) does not detail a specific clinical study with explicit acceptance criteria or quantified performance data. The FDA cleared this device based on its substantial equivalence to a predicate device (Meisinger Benex) and the description of its technological characteristics and intended use. The language used, such as "may minimize bone loss" and "might have a greater chance," indicates potential benefits derived from its operational principle (vertical lifting motion) rather than statistically proven outcomes from a controlled study presented in this summary.
For Class I devices following the 510(k) pathway, especially those with clear predicate devices, the "study" often consists of demonstrating that the new device does not raise new questions of safety or effectiveness when compared to the legally marketed predicates, primarily through design comparisons, material compatibility, and functional equivalence.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.