(193 days)
The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
The provided text is a 510(k) summary for the DMETEC SmarThor Ultrasonic Surgery device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria, performance metrics, and detailed study design as might be done for a novel device or AI/software.
Therefore, the following information is extracted or inferred based on the nature of a 510(k) submission for this type of device (an ultrasonic bone-cutting instrument).
Here's a breakdown of the information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (EMS Piezon Master Surgery). The performance is reported by comparing the specifications of the SmarThor to the predicate device.
| Characteristic / Acceptance Criteria (Implied) | DMETEC (SmarThor) Reported Performance | EMS (Piezon Master Surgery) Predicate Performance |
|---|---|---|
| Indication for Use | The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. | The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry. |
| Supply Voltage | 24V DC | 100-240 V AC |
| Power Consumption (max) | 50W max | 105VA |
| Maximum Output Power with Load | 50W | 25W |
| Frequency Range Available | 24-32 kHz | 24-32 kHz |
| Transformer Input | 100-240 VAC, 50-60Hz | 100/220 VAC/50-60Hz |
| Transformer Output | 24V DC/ 2.7A | 24V AC/ 1.25A |
| Main Components | 1 Unit Body, 1 Hand-piece, 1 Tip | 1 Unit Body, 1 Hand-piece, 5 Tips |
| Tip Material (contact with patient) | Stainless steel | Stainless steel |
| Biocompatibility | Meets ISO 10993-5:2009 (Grade 0 cytotoxicity, 0% sensitization, no oral mucosa irritation/mortality) | (Implied predicate meets standards) |
| Electrical Safety | Meets IEC 60601-1:1988 + A1:1991 + A2:1995 | (Implied predicate meets standards) |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1-2: 2007 | (Implied predicate meets standards) |
| Software Validation | Software validation report shows substantial equivalence and proper performance. | (Implied predicate has validated software) |
| Device Life | 5 years | (Not explicitly stated for predicate in summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. No specific "test set" of cases or patients was used for evaluating performance in the way an AI/software study would. The evaluation is based on non-clinical bench testing and comparison of specifications to a predicate device, as well as biocompatibility testing on biological samples.
- Data Provenance:
- Non-clinical tests (biocompatibility, electrical safety, EMC, software validation): These tests would have been performed by DMETEC CO., LTD. in Korea (country of origin). These are "prospective" tests conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This 510(k) does not involve expert-established ground truths for performance evaluation in the way a diagnostic AI would. The "ground truth" for compliance with standards (e.g., biocompatibility) is defined by the standard itself, and the comparison to the predicate relies on published specifications and post-market experience.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical "test set" requiring adjudication by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This device is a physical instrument, and its 510(k) submission relies on demonstrating substantial equivalence through technical specifications, non-clinical bench testing, and comparison with a predicate device, not through a comparative effectiveness study involving human readers and interpretations.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (ultrasonic surgery instrument), not an AI algorithm. Its performance is inherent in its physical and electrical characteristics.
7. The Type of Ground Truth Used
- For non-clinical tests (biocompatibility, electrical safety, EMC): The ground truth is established by the requirements and methodologies defined in the cited international standards (e.g., ISO 10993-5:2009, IEC 60601-1, IEC 60601-1-2).
- For comparison to the predicate: The ground truth is the published technical specifications and intended use of the legally marketed predicate device (EMS Piezon Master Surgery), as well as its established safety and effectiveness through "post-market experience."
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.