(56 days)
The ODONTOSURGE 2 is intended for use in cutting (removing) soft tissue and controlling bleeding in the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
The ODONTOSURGE 2 is a high frequency electrosurgery unit that is comprised of the following three principal components: control box, hand piece and cord, and six different electrodes contained in a separate case. The ODONTOSURGE 2 is compact and easily portable. The ODONTOSURGE 2 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the ODONTOSURGE 2.
The provided text does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical measures like sensitivity, specificity, or accuracy.
Instead, the document is a 510(k) summary for a medical device (ODONTOSURGE 2) seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as a legally marketed predicate device. It does not typically involve a clinical trial with acceptance criteria for performance metrics in the same way a de novo or PMA submission might.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. This document is a 510(k) showing substantial equivalence, not a performance study with pre-defined criteria. | Not specified. The document concludes the device is "substantially equivalent" to predicate devices based on intended use, general design, materials, and performance, but no quantitative performance metrics are provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No test set or clinical study demonstrating performance metrics using a sample size is described. The comparison is based on device characteristics.
- Data Provenance: Not applicable. The document describes the device and its comparison to a predicate, not data from a test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. No ground truth establishment by experts is described as this is a 510(k) submission for substantial equivalence, not a clinical validation study.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study or any study involving human readers with or without AI assistance. The ODONTOSURGE 2 is an electrosurgery unit and does not appear to involve AI or diagnostic interpretation.
6. Standalone Performance Study (Algorithm Only):
- No. The ODONTOSURGE 2 is a hardware electrosurgery unit, and the document explicitly states, "There is no software utilized in the operation of the ODONTOSURGE 2." Therefore, an algorithm-only standalone performance study is not relevant or applicable.
7. Type of Ground Truth Used:
- Not applicable. No ground truth is established or used in this 510(k) submission.
8. Sample Size for the Training Set:
- Not applicable. There is no software or algorithm that would require a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set mentioned in the document.
Summary of Device Rationale for Marketing (from the document):
The rationale for marketing the ODONTOSURGE 2 is based on its substantial equivalence to the predicate device, the ArthroCare Dental Electrosurgery System (K962445), and other devices on the market prior to May 28, 1976. The key comparative points are:
- Intended Use: The same as the predicate device (cutting and coagulating soft tissue in the oral cavity for various dental procedures).
- Sterilization Method: The same.
- Mode of Operation: The same.
- General Design, Materials of Fabrication, and Performance: Concluded to be the same.
- Difference: The only noted difference is the frequency of operation, which PERIOgiene believes offers convenience and safety advantages. However, this difference does not invalidate the conclusion of substantial equivalence for regulatory purposes here.
The FDA's decision to clear the device (K981390) confirms their agreement that it is substantially equivalent to a legally marketed predicate, meaning it is as safe and effective as existing devices, based on a comparison of device characteristics rather than a new performance study with explicit acceptance criteria.
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.