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photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.

The Satelec Mini L.E.D. product is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide).

This Satelec Mini L.E.D. Polymerization Light-Curing Device 510(k) submission (K032465) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in the provided 510(k) summary. The submission primarily relies on comparing the device's characteristics and intended use to already cleared devices.

Here's an attempt to answer the questions based on the provided text, indicating where information is not present:

1. A table of acceptance criteria and the reported device performance

The 510(k) summary does not present a formal table of acceptance criteria with corresponding device performance metrics in the way a clinical study or performance verification test would. Instead, the "performance" is implicitly demonstrated through the device's specifications and comparison to predicate devices, particularly regarding its ability to achieve sufficient power density within the stated wavelength band for polymerization.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The submission does not describe a clinical or performance test set. The submission relies on technical specifications and comparison to predicate devices rather than new performance data from a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no described test set or ground truth established by experts within the context of a performance study in the 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described test set or adjudication process in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a dental polymerization light-curing device. This type of study is more relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A "standalone" performance study in the context of an algorithm or AI is not applicable here. This device is a physical light-curing tool. Its performance is inherent to its physical properties (wavelength, power density) and its ability to cure dental materials, not an "algorithm only" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically defined for diagnostic or AI-driven devices is not directly applicable here. The "truth" for this device's function is its physical specifications (power density, wavelength output) and its ability to effectively polymerize various dental materials. This is assessed through physical measurements and material science principles, not expert consensus or pathology on a clinical dataset. The implicit "ground truth" for showing effectiveness is the established ability of the predicate devices to cure materials effectively.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device. The device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not provided and is not applicable to this type of device. There is no training set mentioned in the context of this 510(k) submission.

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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.

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.

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