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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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STEP-I PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the smface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.

STEP-1 PumEtch is a tooth preparation formulation combining a 37% phosphoric acid etch and pumice, a polishing agent, into one gel liquid solution. The product is used to prepare natural tooth surfaces for the application of sealants or direct bond appliances.

This describes the acceptance criteria and study proving the device meets them, based on the provided text:

The document is a 510(k) summary for a dental product called STEP-1 PumEtch, which is a prophylaxis and phosphoric acid etchant. The primary method for proving substantial equivalence to predicate devices is through comparative performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies these are the acceptance criteria by stating that the comparative performance testing "demonstrated there is no statistically significant difference between the subject and predicate devices" for these metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the Shear Bond Strength (SBS) and pH comparative performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The study focuses on direct physical and chemical property comparisons (SBS, pH) rather than expert-based ground truth.

4. Adjudication Method for the Test Set

This is not applicable and not provided. The study design involves direct measurement and comparison of physical/chemical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The device is a dental etchant, not an AI or imaging device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. A standalone algorithm study was not done. The device is a physical/chemical product, not an algorithm.

7. Type of Ground Truth Used

The ground truth or reference for evaluation in this context is the performance of legally marketed predicate devices in terms of Shear Bond Strength and pH. The study aims to show that the new device performs equivalently to these established benchmarks.

8. Sample Size for the Training Set

This is not applicable and not provided. The device is a physical/chemical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable and not provided for the same reasons as above.

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