(41 days)
Polymerization of light-cured dental materials, Polymerization of restorative composite materials, and, Polymerization of bonding and sealing materials.
The ACTA OEM Module is a sub-assembly of the ACTA Polymerization Light Curing Device which received 510(k) clearance for the polymerization of light-cured dental materials, the polymerization of restorative composite materials, and the polymerization of bonding and sealing materials (K961735) on July 31, 1996. The ACTA OEM Module maintains all the same functions and main components of the ACTA: it is a stand-alone sub-assembly manufactured by SATELEC with all the same components and materials used in the manufacture of the original ACTA product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735).
The ACTA OEM Module is a multi-purpose high intensity curing light generator kit to be marketed as a modular sub-assembly ("Original Equipment Manufacturer" - OEM) The ACTA OEM Module, similar to its predicate to manufacturers of dental units. device ACTA (K961735) operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials.
The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range. The radiation from the halogen bulb (44 watt) is selectively reflected, focused, and filtered to reduce the ultraviolet, infrared radiation and unneeded visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.
An ergonomic handpiece is supplied with ACTA OEM Module Kit and is designed for ease of use, comfort and convenience. The handpiece casing is made of thermoplastic allov. The handpiece houses the low voltage halogen lamp, and a lamp cooling fan. The kit also includes a disconnectable silicone cord, and a box which consists of one (1) deflector of a 0.3 in, one (1) optic fiber of ø 0.3 in , four (4) protection caps. one (1) 44 W bulb, and one (1) instruction booklet. The Kit includes a connection diagram and PC board as well.
The provided document describes a 510(k) premarket notification for a medical device, the ACTA OEM Module, a polymerization light-curing device. The document primarily focuses on establishing substantial equivalence to a predicate device (ACTA, K961735) rather than conducting a separate study to prove the device meets specific acceptance criteria based on direct performance measurements.
Therefore, for many of the requested categories, the information is not directly available in this 510(k) summary.
Here's an breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or a performance table. The core argument for acceptance is substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Criterion: Substantial Equivalence to Predicate Device (ACTA K961735) | |
| Same intended use | "The intended use...are identical to those of its predicate device, the ACTA (K961735)." |
| Same technical performance | "The technical characteristics of the ACTA are almost identical to those of the predicate, ACTA." "Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the ACTA OEM Module relative to its predicate." |
| Same clinical indications | "The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735)." |
| Production of visible blue light in 400-520 nm waveband for polymerization | "operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials." |
| Curing of all dental restoratives activated by light in that wavelength range | "The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range." |
| Built-in filter system to block non-essential emitted radiation outside 400-520 nm | "A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range." |
2. Sample sized used for the test set and the data provenance
Not applicable. There was no specific "test set" of patient data or clinical samples used to evaluate the ACTA OEM Module's performance against predefined acceptance criteria. The evaluation was based on a comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No expert review of a "test set" to establish ground truth was conducted for this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No test set adjudication method was used.
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 a light-curing device, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument, not an algorithm. Its "standalone" performance is inherent in its operation as a light-curing device, which is considered equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No direct "ground truth" was established for the ACTA OEM Module's performance in a study. The "truth" for its safety and effectiveness is inferred from its substantial equivalence to the previously cleared predicate device.
8. The sample size for the training set
Not applicable. As a medical device that cures dental materials, there is no "training set" in the context of an algorithm or AI model for this product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.