(703 days)
The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.
This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.
The provided text describes a 510(k) premarket notification for a medical device called "The Trust," which measures the stability of dental implants. To answer your request about acceptance criteria and the study proving the device meets them, I need to focus on the "Performance Data" section and the "Comparison Technological Characteristics with the Predicate Devices" table, as these are the most relevant parts.
Here's a breakdown based on the information provided and common expectations for such submissions:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a separate table with specific pass/fail values. Instead, the document relies on demonstrating "similar performance" to a predicate device and meeting "established specifications." The key performance characteristic mentioned is the "Error of measurement value."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (The Trust) |
|---|---|
| Error of measurement value: ≤ ±3 ISV (Implied, matching predicate) | ±3 ISV |
| Angle deviation alarm functionality | Alarm sounds when out of angle of use (Setting angle 0~90°) |
| Tapping Strength | Under 3N |
| Tapping Times | 7 times |
| Tapping Duration per time | 0.3 sec / 1 time |
| Biological Safety (Biocompatibility) | Non-toxic, non-sensitizing to biological bone and tissues (Met ISO 10993 standards) |
| Compliance with Electrical/Mechanical Standards | Meets IEC 60601-1 |
| Usability (Auto Power off) | 120sec (±10%) |
| Continuous operation mode | Continuous Operation |
| Display functionality | Power ON display, Operation display, Start Charging display, ISV scale display (1~99), Operating Error display, Charging error display |
| Commands/Functionality | Power ON, Measurement, Power OFF |
Study Information:
Based on the provided text, the study proving the device meets the acceptance criteria is primarily an equivalence test to the predicate device (AnyCheck IMT-100), rather than an independent clinical study with human subjects.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison tests. It mentions "performance comparison tests with already licensed products" (refer to "002 Equivalence test to AnyCheck"). This often implies bench testing or testing on phantom models, rather than a large clinical test set with patient data.
- Data Provenance: Not specified. Given it's a Korean manufacturer, it's likely the testing was conducted in South Korea. The type of study (retrospective or prospective) is not explicitly stated, but equivalence testing of this nature for dental handpieces typically involves prospective bench-top testing.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. For this type of device and performance testing, ground truth would likely be established by controlled experimental setups and direct measurement by engineers/technicians, rather than expert review of images or clinical outcomes.
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Adjudication Method for the Test Set:
- Not applicable/Not specified. As the "ground truth" is likely derived from calibrated measurements in a controlled environment, there wouldn't typically be a need for expert adjudication in the way it's used for AI diagnostic studies.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is typically performed for AI-driven diagnostic devices where human readers interpret medical images. This device measures implant stability mechanically. There is no indication of such a study being conducted or required.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.
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Standalone (Algorithm Only) Performance:
- Yes, implicitly. The "Performance Data" section refers to tests to ensure the device met "established specifications" and "consistent performance for the intended use." This strongly suggests bench testing or in vitro (non-human) testing of the device's measurement capabilities, which would be considered standalone performance. The "±3 ISV" error of measurement is a standalone performance metric.
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Type of Ground Truth Used:
- Likely bench-top measurements / calibrated experimental setup. The device measures a physical property (time between abutment and striking rod, quantified as ISV). The "ground truth" for evaluating its accuracy would come from highly controlled conditions where the "true" stability or a reference value is known (e.g., using standardized implant models with predefined stability levels or comparing to a gold standard measurement technique). It is not pathology, expert consensus, or outcomes data.
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Sample Size for the Training Set:
- Not applicable/Not specified. This device is described as a mechanical measurement device using an acceleration sensor, not an AI/machine learning device that requires a "training set" in the conventional sense. The "principle to measure the contact time according to the acceleration change... by using the acceleration sensor mounted on the Attack Pole" suggests a direct physical measurement.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there's no indication of a "training set" for an AI algorithm.
Summary of Device Performance Test and Conclusion:
The performance evaluation for "The Trust" appears to have focused on demonstrating its technical accuracy and equivalence to a legally marketed predicate device (AnyCheck IMT-100). The key performance metric highlighted is the "Error of measurement value" of ±3 ISV, which matches that of the predicate. The submission argues that similarities in operational principles and biological safety, despite minor design differences (e.g., how the calibrator is integrated, magnetic vs. screw connection for the attack pole), do not raise new questions of safety or effectiveness. Biocompatibility testing was also conducted according to ISO 10993 standards and found the materials to be non-toxic and non-sensitizing.
§ 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.