(276 days)
The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).
The Compex HD uses a heating device to elevate the temperature of dental composite material contained in a compule (PLT) to allow it to flow and be easily extruded. It utilizes a plastic housing in the shape of a traditional dispensing qun. The housing contains a heater element(s) and/or an electrically conductive plastic compule that itself acts as a heater when a current is applied. A control circuit board assembly and rechargeable lithium lon battery are used to apply power to the heater. A separate wall plug-in USB power supply is used to charge the battery. The unit will not function with the USB power supply connected to the unit.
The provided text describes the Compex HD device, a composite warmer for dental materials, and compares it to a predicate device, the Calset. It focuses on non-clinical performance data to demonstrate substantial equivalence, rather than a detailed AI algorithm performance study. Therefore, some of the requested information, particularly related to AI-specific metrics like human reader improvement with AI assistance, MRMC studies, or training set details, is not applicable to this device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Heats dental composite materials to approximately 155°F (68°C). | The Compex HD heats the composite to an approximate temperature of 155°F (68°C). |
| Dispenses dental composite materials from a compule or PLT. | The Compex HD is designed to warm and dispense dental composite materials contained in a compule or PLT. |
| Compliance with general safety and essential performance standards. | Successfully passed ANSI/AAMI/IEC 60601-1 (general requirements for basic safety and essential performance) and ANSI/AAMI/IEC 60601-1-2 (electromagnetic disturbances). |
| Compliance with specific temperature accuracy for composite warming. | Both the Compex HD and the predicate Calset heat the composite to a temperature of approximately 155°F (68°C). |
| Material flow improvement after heating. | The heated composite exhibits improved flow and is dispensed more easily. |
| Elimination of additional temperature settings for anesthetic carpules/whitening bleach. | The Compex HD is not designed to warm anesthetic solutions or whitening bleach and does not have the 98°F (37°C) or 130°F (54°C) temperature settings found in the predicate. The physical design is incompatible with these materials. |
| Ease and safety of dispensing. | The process of dispensing composite is similar to the predicate, requiring fewer steps and less time with the Compex HD. The unit is considered as safe and effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to a "test set" in the context of comparing the Compex HD and Calset devices.
- Sample Size: The number of compules/PLTs tested is not explicitly stated. It mentions "testing was performed on both devices using thermocouples inserted into composite filled compules."
- Data Provenance: The tests were conducted internally by the manufacturer, AdDent, Inc. The data is retrospective, as it's part of the 510(k) submission. No country of origin for the data is specified beyond the company's location in Danbury, Connecticut, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a warming and dispensing tool, not an AI diagnostic or decision support system that requires expert interpretation for ground truth. The performance evaluation relies on physical measurements (temperature, flow, safety standards compliance) rather than expert consensus on diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not Applicable. As the performance evaluation involves objective physical measurements and adherence to engineering standards, there is no need for an adjudication method typically used for subjective diagnostic interpretations.
5. 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 not an AI-powered system, and no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device does not involve an algorithm for standalone performance evaluation in the context of AI. Its performance is evaluated mechanically and thermally.
7. The Type of Ground Truth Used
- The "ground truth" for the performance evaluation primarily consists of:
- Direct Physical Measurements: Thermocouple readings to verify the composite temperature reached 155°F (68°C).
- Engineering Standards Compliance: Successful adherence to international safety and EMC standards (ANSI/AAMI/IEC 60601-1 and ANSI/AAMI/IEC 60601-1-2).
- Qualitative Assessment: Observation of improved flow of heated composite and ease of dispensing.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/machine learning device, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for it.
§ 872.6100 Anesthetic warmer.
(a)
Identification. An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.