Search Results

A device intended for use surgical procedure 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMETEC Ultrasonic Surgery Machine:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master Surgery) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by showing that the DMETEC device is "similar in functions and efficiency" and has "similar specification and performance" to the predicate.

Here's a table comparing the DMETEC device's reported performance against the predicate, which serves as the de facto "acceptance criteria" through substantial equivalence:

Note: The differences, particularly in supply voltage and output power, are acknowledged, but the submission argues for substantial equivalence based on the overall functional similarity and safety.

Study Information

The document does not describe a classic clinical study with an explicit test set and detailed performance metrics as one might expect for novel technology. Instead, it relies on demonstrating substantial equivalence through non-clinical testing and comparison to post-market experience of the predicate device.

1. Sample size used for the test set and the data provenance:

   • No specific sample size for a clinical "test set" is mentioned in the context of device performance evaluation.
   • Data provenance: The document mentions "post market experience" of the predicate device. This suggests retrospective data from the market performance of the EMS Piezon Master Surgery. No specific country of origin is mentioned for this "post market experience."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no mention of a defined "test set" requiring expert ground truth establishment for clinical performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as no clinical test set requiring adjudication is described.

4. 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 device is a surgical instrument, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers" improving with/without AI are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical surgical instrument, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for substantial equivalence appears to be derived from documented performance and safety records of the predicate device (EMS Piezon Master Surgery), as well as compliance with recognized standards (IEC 60601-1, ISO 10993). For biocompatibility, lab tests (in vitro cytotoxicity, skin sensitization, oral mucosa irritation) served as the basis for assessing safety.

7. The sample size for the training set:

   • Not applicable. As this isn't an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, for the same reason as above.

Summary of Non-Clinical Tests Conducted:

• Biocompatibility Tests:
  • In vitro cytotoxicity test (ISO 10993-5 criteria: evaluated as Grade 0, no cell lysis or toxicity).
  • Skin sensitization test (scores were zero, 0% sensitization rates at 24 hours).
  • Oral mucosa irritation test (no mortality, no body weight changes, no differences between saline and test group).
• Electric Safety and Electromagnetic Compatibility:
  • Tested according to EN 60601-1 and IEC 60601-1-2. Device met the requirements.
• Software Validation:
  • A software validation report indicated the device "performs as it should" and is substantially equivalent.

Overall Conclusion of Studies:

The manufacturer concludes that the DMETEC Ultrasonic Surgery Machine (Surgy Star, AIC Surgery) is substantially equivalent to the predicate device based on:

• Similar intended use.
• Similar specifications and performance, despite some numerical differences (e.g., output power).
• Successful completion of non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, software validation) demonstrating safety.
• Comparison to the post-market experience of the predicate device to infer similar functions and efficiency.

Ask a specific question about this device