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PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

Device Description

The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.

All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.

The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.

AI/ML Overview

This document is a 510(k) Premarket Notification from Zirkonzahn srl to the FDA for their dental polymer blanks (discs) named ABRO 1, RESITON GINGIVA, PRIME, and THERAPON TRANSPA. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (UNION DENTAL S.A.'s IDODENTINE blanks) rather than proving the device meets specific performance acceptance criteria through a clinical study involving human patients or complex AI models.

Therefore, many of the requested criteria for describing a study proving the device meets acceptance criteria are not applicable to this type of regulatory submission for a medical device that is a material for dental restorations.

Here's a breakdown based on the provided document:

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

The document refers to performance testing according to ISO 10477:2018 and states that "All tested samples meet the requirements of the standard and show similar values as the predicate device."

The comparison table on page 5 provides specific physical property values for both the new devices and the predicate, with acceptance being meeting standard requirements and showing similarity.

Criterion Type	Acceptance Criteria (Implied by reference to ISO standards)	Reported Device Performance (New Devices: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA)	Comparison to Predicate (IDODENTINE blanks)
Biocompatibility	Established in consideration of ISO 10993-1:2010 Part 1	Established	Same
Physical Properties	According to ISO 10477:2018 (meeting requirements)	According to ISO 10477:2018	Same (Predicate was ISO 10477:2004)
Flexural Strength	≥ 105 MPa (for new devices, as stated performance)	≥ 105 MPa	Similar (Predicate: 83-94 MPa)
Water Absorption	≤ 24 µg/mm³ (for new devices, as stated performance)	≤ 24 µg/mm³	Similar (Predicate: 22.3-25.8 µg/mm³)
Water Solubility	≤ 0.3 µg/mm³ (for new devices, as stated performance)	≤ 0.3 µg/mm³	Similar (Predicate: 0.7-0.9 µg/mm³)
Residual Monomer Content	Resiton Gingiva: 0.71 wt%, Therapon Transpa: < 5.0 wt%	Resiton Gingiva: 0.71 wt%, Therapon Transpa: < 5.0 wt%	Similar (Predicate: 1.4 %)
Shelf Life	10 years (specified for new devices)	10 years	Different (Predicate: None specified)

Note: The acceptance criteria for the new devices are primarily demonstrated by meeting the stated performance values or falling within ranges defined by the referenced ISO standards, and by showing equivalence or superiority to the predicate device's performance where applicable. The document explicitly states: "All tested samples meet the requirements of the standard and show similar values as the predicate device." and "most results indicate that the Zirkonzahn devices performed in a slight better way than the predicates. These differences are considered non-significant. All devices meet the requirements of the standards."

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes used for the non-clinical tests (e.g., how many specimens were tested for flexural strength, water absorption, etc.). It generally states "All tested samples."
Data Provenance: The tests were carried out by Zirkonzahn srl, which is an Italian company (Via An der Ahr 7 Gais, ITALY 39030). The data would be prospective, as it's generated 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 the "ground truth" for material properties is established through adherence to standardized laboratory testing protocols (e.g., ISO 10477) using calibrated equipment, not through expert consensus or interpretation of complex data by human experts for a diagnostic output.

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

This question is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for laboratory testing of material properties.

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:

This question is not applicable. This is a submission for dental polymer blanks, not an AI-assisted diagnostic device.

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

This question is not applicable. This is a submission for dental polymer blanks, not an AI algorithm.

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

The "ground truth" for this device is based on standardized laboratory test results for physical and chemical properties (e.g., ISO 10477 for physical properties, ISO 10993-1 for biocompatibility). These standards define the methods and criteria for evaluating the material.

8. The sample size for the training set:

This question is not applicable. This type of device (dental polymer blanks) does not involve a "training set" in the context of machine learning or deep learning.

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

This question is not applicable for the same reason as point 8.

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