(14 days)
The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
The PlasmaCure BXe is a device used for the polymerization of dental materials using blue light. It consists of a base unit and a cord connected hand piece. The molded plastic control unit (base unit) contains a power inlet receptacle for a detachable mains power cord, fuse holder and fuses, power supply & controller printed circuit board (control circuitry for lamp and cooling fan functions). The cord connected hand piece contains a printed circuit board, lamp reflector module assembly, optical filter assembly, fibertip insert and fiber optic tip that generates blue light energy having the wavelength range of approximately 385-495 nm. An external trigger switch (hand piece) activates the curing lamp. The emitted intensity and exposure time level depends on which type of eeleCoolTip™ is inserted in the hand piece and which key was last activated on the keypad of the base unit. The hand piece also has a removable and rotatable light shield that will protect the user when in operation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PlasmaCure BXe device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K033795) is a 510(k) summary for a dental curing light. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for a new type of medical device. The "acceptance criteria" here are implicitly tied to the performance of existing, legally marketed predicate devices.
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit) | Reported Device Performance (PlasmaCure BXe) |
|---|---|---|
| Effectiveness | Polymerization of dental restorative materials and tooth whitening (similar to predicate devices and other plasma arc lights). | "The PlasmaCure BXe performed similar to other plasma arc lights, & polymerized faster than the halogen, laser, & LED lights evaluated at that time." |
| Safety - Electrical | Compliance with electrical safety standards (UL 2601-1, IEC 60601-1, CAN/CSA-C22.2, IEC 60601-1-4). | "Safety: Pending Approval of UL 2601-1 including IEC 60601-1. CAN/CSA-C22.2 and evaluation to IEC 60601-1-4." |
| Safety - EMC/EMI | Compliance with electromagnetic compatibility/interference standards (EN50081-1, FCC 15, EN55011 Class B). | "Immunity testing to EN50081-1 as well as Radiated and Conducted emissions testing to FCC 15 and EN55011 Class B limits to 1 GHz." |
| Biocompatibility | Meeting biocompatibility requirements. | "Bench testing was performed, which included biocompatibility... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements." |
| Sterilization | Meeting sterilization requirements. | "Bench testing was performed, which included... sterilization... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements." |
| Packaging | Meeting packaging requirements. | "Bench testing was performed, which included... packaging... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements." |
| Functionality | Performing its intended function similar to predicate devices. | "Bench testing was performed, which included... functionality to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements." |
| Environmental & Dynamic Testing | Withstanding environmental and dynamic stresses (temperature, humidity, shock). | "Environmental & Dynamic Testing including temperature, humidity, Mil-Std-810-E Method 514.4 category 1 and shock testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of clinical studies. The testing described is primarily bench testing of the device itself (biocompatibility, sterilization, packaging, functionality, environmental, electrical safety, EMC). For the effectiveness claim ("polymerized faster than..."), it mentions "Independent Testing Facility test results for equivalence (nonclinical performance data)," but the specific number of tests or samples (e.g., how many dental materials were tested, how many times) is not provided.
- Data Provenance: The data comes from bench testing conducted by eele Laboratories and an unnamed "Independent Testing Facility." There is no mention of human clinical data, retrospective, or prospective studies involving patients. The focus is on the device's technical specifications and performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device's performance is based on established engineering standards, material science principles (e.g., polymerization rates of dental resins), and comparisons to the technical specifications of predicate devices, not on expert clinical interpretation of medical images or patient outcomes.
- Qualifications of Experts: Not applicable in the traditional sense of clinical experts. The "expertise" involved would be in engineering, materials science, and regulatory compliance.
4. Adjudication Method for the Test Set
- Not applicable. As described above, the "test set" involves laboratory and bench testing against established performance metrics and engineering standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images with and without AI assistance to measure diagnostic accuracy. The PlasmaCure BXe is a medical device (dental curing light), not an AI diagnostic tool.
- Effect size of human readers with vs. without AI: Not applicable for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable, but in a different context. The "standalone performance" of the PlasmaCure BXe refers to its ability to cure dental materials and provide illumination for tooth whitening as a device, independent of direct human judgment being assessed. The bench testing performed demonstrates the device's functional performance in a "standalone" capacity, apart from human interaction influencing the curing process itself (though a human operates the device). There is no "algorithm" in the sense of AI being evaluated here.
7. The Type of Ground Truth Used
- The ground truth for this device is based on objective measurements of physical properties and compliance with engineering and safety standards.
- Effectiveness: Measured polymerization rates of dental materials (e.g., hardness, depth of cure) and light intensity/wavelength for tooth whitening, compared to industry benchmarks and predicate devices.
- Safety: Compliance with electrical safety, EMC, and biocompatibility standards.
- Functionality: Verification that the device operates as designed (e.g., light output, control features).
8. The Sample Size for the Training Set
- Not applicable. The PlasmaCure BXe is a physical device (dental curing light), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, engineering, and manufacturing processes rely on established principles, specifications, and quality control, not on data training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for a training set.
§ 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.