FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique)
Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique)
Pressing of ceramic margins (metal-ceramic)
Pressing of gingiva components (metal-ceramic)
Processing on the most popular dental alloys in the CTE range of 13.8 14.5 10-6/K
(25 500°C) (Cu

Device Description

IPS Style comprises both materials for the conventional veneering technique and the press technique.

. IPS Style Ceram: is available as Opaquer 870 in 42 Shades, Opaquer 960 in 42 shades, Margin Powder in 11 Shades, Dentin porcelain in 32 Shades, deep Dentin porcelain in 16 Shades, Incisal Porcelain in 10 Shades, Transparent Porcelain 7 Shades, Mamelon in 3 shades, Occlusal Dentin 2 Shades, Incisal Edge 1 Shade, Opal Effect in 6 Shades, Special Incisal 2 Shades, Inter Incisal 1 Shades, Cerv. Transparent 4 Shades, Add on Ceramic 4 Shades, Bleach Ceramic in 14 Shades, Gingiva Porcelain in 11 Shades and 4 Liquids.
IPS Style Ceram One: is available in 16 Shades and Shades Guides .
. IPS Style Press: Press Ingots LT is available in 8 Shades, Press Ingot HT in 8 Shades and Press Ingot Gingiva in 1 Shade.
. IPS Style Liquids including Build-up and Opaquer which burn out after firing.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding dental ceramic materials (IPS Style Ceram, IPS Style Ceram One, and IPS Style Press). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device as would be found in a clinical trial report or a performance study for a novel device.

Therefore, the requested information cannot be fully extracted from the provided text for the following reasons:

Nature of the Document: A 510(k) summary primarily demonstrates that a new device is "substantially equivalent" to a predicate device already on the market. This often involves comparing chemical compositions, physical properties, indications for use, and working principles, as well as showing compliance with relevant international standards. It does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or an MRMC study comparing AI performance against human readers.
Device Type: The devices described are dental ceramic materials (porcelain powders and press ingots) used for fabricating dental restorations. These are materials, not diagnostic AI devices or devices that produce a clinical "read" that would typically be evaluated with metrics like sensitivity, specificity, or reader performance improvement.
Focus on Equivalence: The document explicitly states, "The comparison shows that IPS Style Ceram and IPS Style Ceram One are substantially equivalent to the predicate device" and "IPS Style Press is substantially equivalent to the predicate device." The "acceptance criteria" here are essentially meeting the standards of the predicate and relevant ISO standards for physical and biocompatibility properties.

However, I can extract information related to the physical properties and biocompatibility assessments, which serve as foundational "acceptance criteria" for this type of material device within the context of a 510(k) submission.

Analysis of the Provided Text for "Acceptance Criteria"

Based on the information provided, the "acceptance criteria" for these dental ceramic materials are primarily focused on:

Biocompatibility: The device must not cause adverse biological reactions.
Physical Properties: The device must meet the requirements of relevant ISO standards for dental ceramics, especially regarding flexural strength and metal-ceramic bond strength.
Chemical Composition: The key ingredients should be silica-based dental glass ceramic with similar elements to the predicate.
Indications for Use & Working Principle: The device should have similar intended uses and working principles to its predicate devices.

Extracted Information:

1. Table of "Acceptance Criteria" and Reported Device "Performance" (Based on Material Characteristics and Standards)

Acceptance Criteria Category	Specific Criteria/Standard	Predicate Devices (K121359 & K071848) Performance	IPS Style (New Device) Performance
Biocompatibility	ISO 10993-1:2009 standards	"not expected to cause any adverse mucosal reactions."	Assessed for cytotoxicity (no cytotoxic potential), genotoxicity (non-mutagenic), sensitization, acute & subchronic systemic toxicity, implantation, and radioactivity. "fully assessed and is equivalent to IPS 99."
Physical Properties	ISO 6872	"meets the requirements."	"meets the requirements."
Physical Properties	ISO 9693 (Debonding/crack initiation strength)	"meets the requirements."	"meets the requirements."
Physical Properties	Flexural Strength	Met requirements of product-specific standard.	"new value fulfils the requirements of the product-specific standard. The test results for flexural strength are significantly above the specification and similar to those of the predicate device IPS InLine PoM."
Physical Properties	Metal-Ceramic Bond	Met requirements of product-specific standard.	"fulfill the requirements for metal-ceramic bond given in the product-specific standard."
Chemical Composition	Key ingredients	Silica-based dental glass ceramic.	"Silica-based dental glass ceramic including the chemical elements: aluminum, lithium, zirconium, yttrium, potassium, phosphorous, magnesium, cerium, boron, calcium, sodium, titanium., strontium, fluoride, zinc, lanthanum."
CTE Range	IPS Style Ceram	13.8-15.0 x 10^-6/K (25-500°C)	13.8 – 15.2 x 10^-6/K (25 – 500°C)
CTE Range	IPS Style Press	13.8 - 14.5 x 10^-6/K (25-500°C)	13.8 – 14.5 x 10^-6/K (25 – 500°C)

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

Not explicitly stated for physical property tests. The document mentions that "The product has been tested to ISO 6872" and "ISO 9693" and "The test results for flexural strength are significantly above the specification." However, the exact sample sizes (number of specimens tested) for these mechanical tests are not provided in this summary.
Data Provenance: Not specified, but generally, such tests are conducted in-house by the manufacturer (Ivoclar Vivadent Ag, Liechtenstein) or by accredited testing laboratories on behalf of the manufacturer. The date prepared is May 16, 2016.

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)

Not applicable/Not stated. This type of information is relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic or treatment devices. For material science properties and biocompatibility, "ground truth" is established through standardized laboratory tests and analytical methods, not expert consensus on interpretations.

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

Not applicable. See point 3.

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

No. An MRMC study is not relevant for this type of material device. This is typically used for AI-powered diagnostic imaging or medical decision support systems involving human readers/interpreters.

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

No. This device is a material, not an algorithm.

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

For biocompatibility: Laboratory test results following ISO 10993-1, including cytotoxicity and genotoxicity assessments.
For physical properties: Measurements obtained through standardized laboratory testing methods conforming to ISO 6872 and ISO 9693. This generates objective, quantitative data.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.