(49 days)
The Deep Blue® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.
The Deep Blue® consists of a detachable handpiece that contains the LED (light emitting diode) light source, microprocessor control system, a light guide that directs light to the treatment area on the patient, and a connector for connection of the device to a power source. Two versions of the device will be marketed in the U.S., the Doris I and Doris II. The Doris I and Doris II configurations differ in the power source. The Doris I configuration is powered by a connection to a commercially available EMS Electro Medical Systems ultrasonic scaler. The Doris II configuration is powered by an electrical connection to a dental operative unit. The function of the connected ultrasonic scaler or the dental operative unit is limited to providing power to the handpiece.
The provided text is a 510(k) summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA Deep Blue® dental curing light. While it describes the device, its intended use, and substantial equivalence to predicate devices, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
- Acceptance Criteria Table: The document mentions "Performance testing has been conducted that confirms that the Deep Blue" is able to cure resin within the specified timeframe without causing thermal damage to the tissue." However, it does not provide a specific table of acceptance criteria (e.g., light intensity thresholds, curing depths, temperature limits) or the reported performance against those criteria in a quantitative manner.
- Study Details: The document states that "Performance testing has been conducted," but it does not describe the study itself. Therefore, it lacks information on:
- Sample size for the test set.
- Data provenance (country, retrospective/prospective).
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
Based only on the provided text, I cannot complete the table or answer the detailed questions you've posed. The document confirms that performance testing occurred and demonstrated the device's ability to cure resin without thermal damage, which served as a basis for substantial equivalence, but it does not elaborate on the specifics of that testing or the defined acceptance criteria.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.