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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):

For DeltaFil Conditioner vs. Predicate 3M Espe Ketac Conditioner (K872984):

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.

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LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically. Specifically: Crown restorations: For restoration of the anatomical form in order to provide durable protection for the remaining tooth; In order to restore chewing function; For esthetic corrections. Bridge restorations: In order to restore chewing function; For esthetic corrections.

LuxaCrown is a bis-acrylic resin-based self-curing composite for the fabrication of semipermanent crowns and bridges. LuxaCrown is available in a range of shades to ensure an aesthetically-pleasing restoration. LuxaCrown is a non-sterile device intended for use by licensed dental professionals. Because LuxaCrown is intended for the fabrication of semi-permanent dental restorations, it may remain in the oral cavity for more than 30 days. LuxaCrown is supplied in dual-barreled syringes for use with the DMG Automix selfmixing dispenser and Automix Tips, which were previously cleared in K101710 (DMG LuxaTemp Ultra), K013674 (DMG LuxaTemp) and K924830 (DMG LuxaTemp Automix).

The provided text describes a 510(k) premarket notification for a dental material called LuxaCrown, a self-curing composite for fabricating semi-permanent crowns and bridges. The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical specifications, biocompatibility, and physical properties.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets those criteria in the format requested. The "Discussion of Non-Clinical Tests" section mentions various tests performed (ISO 10447, internal DMG methods, biocompatibility testing) and states that "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." This indicates that there are internal specifications and ISO limits, but the document does not list them as "acceptance criteria" in a table or provide detailed study results that meticulously "prove" the device meets them with specific performance metrics beyond a general statement of compliance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

The document states: "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." However, it does not provide the specific numerical acceptance criteria nor detailed reported performance data in a tabular format. It only lists the types of tests conducted.

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

• Sample Size for Test Set: Not specified for any of the tests mentioned (flexural strength, water sorption, water solubility, working time, setting time, compressive strength, biocompatibility, shelf life).
• Data Provenance: The tests were performed by DMG Chemisch-Pharmazeutische Fabrik GmbH, which is a German company (Hamburg, Germany). It's implied these are laboratory tests, not clinical studies with human data, so "retrospective or prospective" is not fully applicable in the conventional sense for patient data.

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 question is not applicable. The tests are for physical and chemical properties of a material, not for diagnostic accuracy or human interpretation requiring expert consensus.

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

Not applicable, as there's no human interpretation or ground truth establishment in this context.

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 is a material science and biocompatibility assessment, not a study involving human readers or AI assistance.

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

Not applicable. This is a material science assessment.

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

For the physical and chemical tests, the "ground truth" is established by the specified standards (ISO 10447, ISO 10993-3, -5, -10, ASTM F1980) and the manufacturer's internal product specifications. For biocompatibility, it's compliance with established biological safety requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device.

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

Not applicable. This is not a machine learning or AI-based device.

Summary Table (with available information):

In conclusion, while the document confirms that testing was done and met specified requirements, it does not provide the granular detail needed to fill out all aspects of the requested table, particularly the specific numerical acceptance criteria and the detailed reported performance data.

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