(245 days)
DeltaFil (in capsule) is used for geriative filling procedures. The procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.
DeltaFil Conditioner:
- Treatment of the smear layer
- Conditioning of the cavity
DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form (DeltaFil in capsule), and a compatible tooth conditioner (DeltaFil Conditioner). DeltaFil Conditioner and DeltaFil (in capsule) are used together for the creation of permanent or temporary dental restorations as described in the device labelling. DeltaFil is available in Vita shades A1, A2, A3, A3.5, and A4.
DeltaFil (in capsule) is a two-part powder/liguid glass polyalkenoate restorative cement as defined in ISO 9917-1:2006 Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements. The powder and liquid components are supplied in the correct mixing ratio in disposable "Applicap" capsules for use with the DMG Applicap Dispenser. DeltaFil Conditioner is a 10% aqueous polyacrylic acid solution, which is applied to the prepared tooth surface prior to placement of the mixed DeltaFil (in capsule) material. DeltaFil Conditioner improves the adhesive bond between the tooth tissue and the restorative cement material by treating the smear layer and conditioning the prepared cavity.
This is a 510(k) premarket notification for a dental device, not an AI/ML device, so the usual criteria for AI/ML acceptance and studies are not applicable. The document discusses performance criteria for a dental cement and conditioner.
Here's an analysis based on the provided text, focusing on the nearest equivalents to your requested categories for a non-AI/ML medical device:
The device under review is DeltaFil (in capsule), a radiopaque glass ionomer restorative material, and DeltaFil Conditioner, a 10% aqueous polyacrylic acid solution. Both are used in dental filling procedures.
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table against two predicate devices (GC Fuji IX GP for DeltaFil and 3M Espe Ketac Conditioner for DeltaFil Conditioner), which implicitly sets the acceptance criteria by demonstrating "substantial equivalence." The acceptance criteria are essentially defined by meeting or being similar to the performance characteristics of the legally marketed predicate devices, and in some cases, meeting ISO standards.
Acceptance Criteria and Reported Device Performance (Derived from Comparison Tables):
For DeltaFil (in capsule) vs. Predicate GC Fuji IX GP (K961448):
| Attribute | Acceptance Criteria (Predicate/ISO Standard) | Reported Device Performance (DMG DeltaFil) | Result |
|---|---|---|---|
| Common Name | Restorative Dental Cement and Tooth Conditioner | Restorative Dental Cement and Tooth Conditioner | Same |
| Classification Name | Dental Cement | Dental Cement | Same |
| Device Class | II | II | Same |
| Regulation | 21 CFR 872.3275 | 21 CFR 872.3275 | Same |
| Regulation Name | Dental Cement | Dental Cement | Same |
| Product Code | EMA | EMA | Same |
| Indications for Use | Similar to Predicate (geriatric/pediatric fillings, Class I, II, III, V deciduous teeth, long-term restorative in non-load bearing Class I & II lesions, restorative/sandwich material for heavy stress in Class I & II, core build-up) | Same as Predicate | Same |
| Use Environment | Dental office/clinic | Dental office/clinic | Same |
| Material Composition | Radiopaque glass ionomer cement supplied in capsules | Radiopaque glass ionomer cement supplied in capsules | Same |
| Principle of Operation | Two-part powder-liquid glass ionomer polyalkenoate restorative dental cement as defined in ISO 9917-1:2007 | Same, with Conditioner applied to condition tooth surface | Same |
| Supplied in Mixing Capsules? | Yes | Yes | Same |
| Capsule Dispenser Available? | Yes | Yes | Same |
| Powder:Liquid Ratio | 0.40:0.11 (Predicate) | 4.96:1 | Similar (different numerical ratio but functionally equivalent for purpose) |
| Mixing Time (sec) | 10 | 10 | Same |
| Working Time (min.) at 23°C (inclusive of mixing time) | 120 | 120 | Same |
| Net Setting Time (max.) at 37°C (exclusive of mixing time) | 140 (Predicate) | 240 | Similar (within acceptable range) |
| Compressive Strength (MPa) (after 24 hrs) | $\ge$ 100 MPa (ISO 9917-1 requirement) / 220 (Predicate) | $\ge$ 180 | Similar; both meet ISO 9917-1 requirement |
| Radiopacity | 2 mm Al (ISO 9917-1 requirement) / 3.7 mm (Predicate) | 200 %Al | Similar; both meet ISO 9917-1 requirement fund. |
| Acid Erosion (mm) | $\le$ 0.17 mm (ISO 9917-1 requirement) / 0.21 (Predicate) | $\le$ 0.1 | Similar; DeltaFil meets ISO 9917-1 requirement |
| Shear Bond Strength on Dentin (MPa) (after 24 hrs) | 5.1 ± 2.1 (Predicate with Conditioner) | 4.9 ± 1.3 (with Conditioner) | Similar (for samples prepared with compatible Conditioner) |
| Shear Bond Strength on Enamel (MPa) (after 24 hrs) | 11.8 ± 7.7 (Predicate with Conditioner) | 13.6 ± 2.4 (with Conditioner) | Similar (for samples prepared with compatible Conditioner) |
| Acid Soluble Lead Content (ppm) | $\le$ 100 ppm (ISO 9917-1 requirement) / unknown (Predicate) | $\le$ 100 | Similar; DMG material meets ISO 9917-1 requirement |
| Opacity C0,70 (%) | 0.35 – 0.9 % (ISO 9917-1 requirement) / unknown (Predicate) | 0.35 – 0.9 | Similar; DMG material meets ISO 9917-1 requirement |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
| Single Use / Reusable | Single Use | Single Use | Same |
| Sterilization / Reprocessing | Non-sterile device; no reprocessing requirements | Non-sterile device; no reprocessing requirements | Same |
| Software | Device does not contain software | Device does not contain software | Same |
| Electrical Safety & EMC | Not applicable | Not applicable | Same |
For DeltaFil Conditioner vs. Predicate 3M Espe Ketac Conditioner (K872984):
| Attribute | Acceptance Criteria (Predicate/Implied) | Reported Device Performance (DeltaFil Conditioner) | Result |
|---|---|---|---|
| Common Name | Tooth Conditioner | Tooth Conditioner | Same |
| Classification Name | Dental Cement | Dental Cement | Same |
| Device Class | II | II | Same |
| Regulation | 21 CFR 872.3275 | 21 CFR 872.3275 | Same |
| Regulation Name | Dental Cement | Dental Cement | Same |
| Product Code | EMA | EMA | Same |
| Indications for Use | Similar to Predicate (Dentin pretreatment prior to filling with glass ionomer cement) | Treatment of the smear layer, Conditioning of the cavity | Same |
| Use Environment | Dental office/clinic | Dental office/clinic | Same |
| Material Composition | 20 - 30% aqueous polyacrylic acid, blue colorant (Predicate) | 10% aqueous polyacrylic acid, Blue colorant | Similar (different concentration but functionally similar) |
| Principle of Operation | Improves adhesive bond between tooth tissue and restorative cement by treating smear layer and conditioning cavity | Same | Same |
| Technological Characteristics | Mild PAA acid solution applied to prepared tooth surface removes smear layer, improving direct contact for restorative material. | Same, with evidence shown through increased bond strength for DeltaFil | Same |
| Shear Bond Strength on Dentin (with Conditioner) | 5.1 ± 2.1 (Predicate) | 4.9 ± 1.3 | Similar |
| Shear Bond Strength on Dentin (without Conditioner) | 6.5 ± 1.5 (Predicate) | 4.4 ± 3.7 | Similar |
| Shear Bond Strength on Enamel (with Conditioner) | 11.8 ± 7.7 (Predicate) | 13.6 ± 2.4 | Similar |
| Shear Bond Strength on Enamel (without Conditioner) | 10.6 ± 4.5 (Predicate) | 13.6 ± 6.5 | Similar |
| Biocompatibility | ISO 10993 | ISO 10993 (with reference to K192273 for methylene blue pigment) | Same (with justification for colorant) |
| Single Use / Reusable | Single Use | Single Use | Same |
| Sterilization / Reprocessing | Non-sterile device; no reprocessing requirements | Non-sterile device; no reprocessing requirements | Same |
| Software | Device does not contain software | Device does not contain software | Same |
| Electrical Safety & EMC | Not applicable | Not applicable | Same |
2. Sample size used for the test set and the data provenance
The document states "Performance data demonstrated that DeltaFil (in capsule) and DeltaFil Conditioner meet all predetermined acceptance criteria contained in the product specification and are suitable for their intended use." It also mentions "Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation."
However, specific sample sizes for each physical test (e.g., compressive strength, radiopacity, shear bond strength, acid erosion) are not detailed in this summary. The provenance of the data is not explicitly stated beyond being studies conducted to support the substantial equivalence claim for the subject device. It is generally understood that such testing is conducted by the manufacturer (DMG Chemisch-Pharmazeutische Fabrik GmbH, Germany). The studies are likely prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is not an AI/ML device, and therefore no "experts" are adjudicating image interpretations or similar for ground truth. The "ground truth" for the performance tests comes from objective physical and chemical measurements (e.g., MPa for strength, mm for erosion, %Al for radiopacity) against established ISO standards and comparisons to predicate device data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no human adjudication of results in the way it would be for an AI/ML diagnostic device interpreting images. Physical and chemical tests typically involve standardized protocols and measurements.
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 dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The performance evaluation is inherently for the materials themselves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the DeltaFil and DeltaFil Conditioner, the "ground truth" is established through:
- International Standards: Primarily ISO 9917-1:2007 (Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements) for physical and chemical properties like compressive strength, radiopacity, acid erosion, and acid soluble lead content.
- Predicate Device Data: Performance characteristics of legally marketed devices (GC Fuji IX GP and 3M Espe Ketac Conditioner) serve as a benchmark for comparison.
- Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set. The regulatory path is based on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards through physical and biocompatibility testing.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.