Search Results

Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.

Coloring Liquid is water based, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures

The provided documentation is a 510(k) summary for a medical device called "Coloring Liquid." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human subjects or complex algorithms.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding sample sizes, expert ground truth, adjudication methods, multi-reader studies, and training sets are not applicable to this type of submission. This document describes a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document reports and compares safety testing results, which can be interpreted as demonstrating that the device meets acceptance criteria for biocompatibility.

Study Proving Device Meets Acceptance Criteria:

The document states: "Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."

This indicates that internal bench tests and specific biocompatibility tests, following ISO 10993 standards, were conducted to demonstrate the safety of the device. The results of these biocompatibility tests are summarized in Table 5.2. The conclusion drawn is that the subject device's performance in these safety tests is comparable to the predicate device, thus meeting the implied safety acceptance criteria for this type of product.

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

• Not Applicable. This submission is for a material (coloring liquid) and focuses on biocompatibility and physicochemical properties, not a diagnostic or AI-powered imaging device that would require a "test set" of patient data in the typical sense. Biocompatibility tests are usually conducted on material samples in controlled laboratory settings (e.g., cell cultures, animal models as per ISO standards). The document does not specify the number of samples or specific animal models used, but refers to ISO standards.

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

• Not Applicable. Ground truth, in the context of device performance, typically refers to a definitive diagnosis or outcome for diagnostic/prognostic devices. For a coloring liquid, "ground truth" would relate to the chemical composition, color properties, and biocompatibility, which are verified through objective scientific methods and established ISO standards, not expert consensus in a clinical reading scenario.

4. Adjudication Method for the Test Set:

• Not Applicable. As there is no "test set" in the context of clinical interpretation, no adjudication method is relevant. Biocompatibility test results are typically interpreted by qualified laboratory personnel following established protocols.

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. The device is a "Coloring Liquid" for dental zirconia, not an AI-assisted diagnostic tool.

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

• Not Applicable. The device is a chemical product, not an algorithm.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Biocompatibility Assays. For this device, the "ground truth" for proving safety and effectiveness (as understood in this context) comes from the results of standardized laboratory tests (e.g., cytotoxicity assays, irritation tests, sensitization tests, systemic toxicity tests, genotoxicity assays) conducted according to recognized international standards (ISO 10993 series). These tests provide objective data on the biological responses to the material.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device

X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals

"X-cera Pre-shaded Zirconia Blanks" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2+ Y2O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.

"X-cera Pre-shaded Zirconia Blanks" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.

"X-cera Pre-shaded Zirconia Blanks" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty nine different colors. The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3).

The provided text describes a 510(k) premarket notification for "X-cera Pre-shaded Zirconia Blanks," a dental device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (physical and chemical properties) and biocompatibility testing. It does not describe an AI/ML-driven medical device, nor does it involve a study with human readers, ground truth derived from expert consensus/pathology, or the typical metrics (sensitivity, specificity, AUC) associated with such devices.

Therefore, many of the requested details for an AI/ML device (e.g., sample size for training/test sets, expert qualifications, HRMC studies, standalone performance with AI, effect size of human improvement with AI) are not applicable to this submission.

Here's a breakdown of the information that is applicable, based on the provided text, and an explanation of why other points are not.

Acceptance Criteria and Device Performance (based on provided text):

The acceptance criteria are generally "met specifications" and "met all relevant requirements in the test standard" (ISO 6872 for performance, ISO 10993 for biocompatibility). The performance is presented as a comparison to the predicate device, not in terms of specific numerical thresholds for each test, but rather that the results were "very similar" or "comparable."

Information NOT Applicable/Available for this Device Type (AI/ML Context):

Most of the questions relate to studies for AI/ML devices, which are not relevant here. The "device" in this context is a physical material (zirconia blanks) used for dental restorations, not a software algorithm.

Here's why and what's explicitly not available or applicable:

2. Sample sizes used for the test set and the data provenance: This refers to the number of cases or patients in a clinical image dataset for AI evaluation. For a physical material, "test set" would refer to the number of material samples tested. The document states "Bench testing was performed per ISO 6872:2015 and internal procedures." It does not specify the number of individual blanks or samples tested for each property (e.g., flexural strength). There is no "data provenance" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is entirely irrelevant. "Ground truth" for this device's performance is established by physical and chemical laboratory tests (e.g., measuring flexural strength, chemical composition, performing biocompatibility assays), not human expert interpretation of medical images.
4. Adjudication method for the test set: Not applicable. There is no human interpretation or "adjudication" of findings.
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 does not involve human readers interacting with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized laboratory measurements and chemical analysis as defined by ISO standards (ISO 6872 for performance, ISO 10993 for biocompatibility).
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary regarding the provided document's context:

The FDA 510(k) clearance process for a physical dental material like zirconia blanks focuses on demonstrating safety and effectiveness by showing that the material performs as intended (e.g., strength, durability) and is biocompatible, and that it is substantially equivalent to a legally marketed predicate device. This is done through well-established bench testing (physical property measurements) and biocompatibility studies, not through clinical studies involving patient data, expert readers, or AI performance metrics.

Ask a specific question about this device