(56 days)
- Polymerization of light-cured dental materials
- Polymerization of restorative composite materials
LCxx00 Compacta lamp is a polymerization lamp which provides light primarily in the range between 400 - 515 nm and is capable of curing light-cured dental materials. It is a component intended for integration in a standard dental unit and the light source is supplied with power from the unit. Compressed air for cooling of the handpiece is also provided from the unit.
The LCxx00 Compacta lamp is supplied with a 25 Watt, 40W, 60W or 80W halogen bulb. The visible light from the bulb is filtered to provide a wavelength between 400 and 515 nm which is directed to a light guide with an 8mm diameter. Light in this wavelength range is able to cure light composit material used for dental fillings.
The output from the LCxx00 Compacta through the autoclayable, detachable light guide is approximately 530 mW/cm² , 750 mW/cm² , 1080 mW/cm², 1440 mW/cm2 respectively, in total. Within the range of 400 - 515 nm the lamp has an output of approx. 390 mWlcm², 590 mW/cm2 , 825 mW/cm2 , 1180 mW/cm2 respectively. These measurements are carried out according to requirements in ISO/DIS 10650.2.
This light cures the restorative composite materials to a depth of about 5.5 mm, 5.7 mm, 6.0 mm, 6.7 mm respectively in 40 seconds. The composite is cured 100 % to a depth of 2.4 mm, 2.5 mm, 2.7mm and 3.1 mm respectively.
The halogen bulb is built into a handpiece which is ergonomically shaped so that it is comfortable and easy to use for a dentist. The housing of the handpiece is made of thermoplastic material. Excessive heat is cooled by air from the dental unit and if the cooling air should fail, a built in thermal fuse and a thermal switch will disconnect the electrical connection.
The LCxx00 Compacta is supplied with power and with air from the dental unit via a cable. This cable has a connector so that it is detachable from the handpiece.
The handpiece contains a bayonet-like connector which enables the front section to be detached from the rear section so that the halogen bulb and the light filter can be exchanged by the user.
The provided text describes a 510(k) submission for the Lysta LCxx00 Compacta polymerization light-curing device, which is substantially equivalent to a previously cleared device. The "study" referenced in the prompt would be the performance data presented to demonstrate this substantial equivalence.
Here's an analysis of the provided information against your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Lysta LCxx00 Compacta are implicitly defined by comparing its performance to that of the predicate device, the Lysta LC2500 C/BA (K991138), and compliance with ISO/DIS 10650.2.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (LCxx00 Compacta) |
|---|---|---|
| Light Output (Total) | Equivalent to predicate device (LC2500 C/BA) for the LC2500 Compacta model. Compliance with ISO/DIS 10650.2. | LC2500 Compacta: approx. 530 mW/cm² |
| LC4000 Compacta: approx. 750 mW/cm² | ||
| LC6000 Compacta: approx. 1080 mW/cm² | ||
| LC8000 Compacta: approx. 1440 mW/cm² | ||
| (All measurements according to ISO/DIS 10650.2) | ||
| Light Output (400-515 nm range) | Equivalent to predicate device (LC2500 C/BA) for the LC2500 Compacta model. Compliance with ISO/DIS 10650.2. | LC2500 Compacta: approx. 390 mW/cm² |
| LC4000 Compacta: approx. 590 mW/cm² | ||
| LC6000 Compacta: approx. 825 mW/cm² | ||
| LC8000 Compacta: approx. 1180 mW/cm² | ||
| (All measurements according to ISO/DIS 10650.2) | ||
| Curing Depth (Partial, 40s exposure) | Equivalent to predicate device (LC2500 C/BA) for the LC2500 Compacta model. | LC2500 Compacta: about 5.5 mm |
| LC4000 Compacta: about 5.7 mm | ||
| LC6000 Compacta: about 6.0 mm | ||
| LC8000 Compacta: about 6.7 mm | ||
| Curing Depth (100%, 40s exposure) | Equivalent to predicate device (LC2500 C/BA) for the LC2500 Compacta model. The predicate's 100% curing depth is implicitly at least 2.4mm. | LC2500 Compacta: 2.4 mm |
| LC4000 Compacta: 2.5 mm | ||
| LC6000 Compacta: 2.7 mm | ||
| LC8000 Compacta: 3.1 mm | ||
| Wavelength Range | Effective for curing light-cured dental materials (typically 400-515 nm for common dental composites). | Primarily in the range between 400 - 515 nm |
| Integration | Suitable for integration into a standard dental unit; power/air supplied from the unit. | Component intended for integration in a standard dental unit; light source/compressed air supplied from the unit. |
| Safety Features | Should include mechanisms to prevent overheating or electrical hazards. | Built-in thermal fuse and a thermal switch to disconnect electrical connection if cooling air fails. |
| Maintenance/Usability | User-exchangeable bulb/filter, detachable handpiece and light guide. | Handpiece ergonomically shaped; housing of thermoplastic material; detachable cable/connector; bayonet-like connector for detaching front section to exchange halogen bulb and light filter; autoclavable, detachable light guide. |
| Substantial Equivalence | Performance and technical characteristics are not relevant with regard to safety and effectiveness compared to the predicate device (Lysta LC2500 C/BA). | "The LCxx00 Compacta is, in relative technical terms, almost identical to the predicate device. Relative technical and physical differences are insignificant and are not relevant with regard to safety and effectiveness during use. The smallest of the four Compacta lamp versions (LC2500 Compacta) is identical to the predicate device as far as capacity is concerned." The presented performance metrics support this claim for the various models. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for any specific "test set" in terms of number of devices or number of composite samples tested for curing depth. It refers to general measurements and performance characteristics.
- Data Provenance: The data is presented by the manufacturer, Lysta A/S, based in Farum, Denmark. It appears to be prospective testing conducted by the manufacturer for the purpose of the 510(k) submission. The document doesn't specify if it's retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. For a device like this, the "ground truth" for performance would typically be established through objective physical measurements (like light output, depth of cure) using calibrated instruments, not through expert consensus or interpretation.
4. Adjudication Method for the Test Set
- An adjudication method is not applicable and therefore not mentioned. The performance data is derived from direct measurements, not from subjective assessments requiring adjudication.
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
- This question is not applicable to the device described. The Lysta LCxx00 Compacta is a polymerization light-curing device, not an AI-powered diagnostic or assistive tool for human readers/experts. Therefore, no MRMC study or AI-related effectiveness data would be relevant or expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical light-curing unit, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance is established through objective physical measurements (e.g., spectral analysis for wavelength, power meters for light output, physical depth measurements for curing capabilities) and adherence to recognized standards (ISO/DIS 10650.2).
8. The sample size for the training set
- This question is not applicable. As a physical medical device (not an AI algorithm), there is no 'training set' in the context of machine learning. The device's design and engineering are based on principles of physics and materials, not data training.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons stated above (not an AI algorithm).
§ 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.