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510(k) Data Aggregation
(100 days)
this device is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work
Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.
The provided text is a 510(k) summary for a dental impression material (PEAK NS033CF, PEAK NS017CF). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic medical device.
Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document because the premarket notification for this type of device does not typically require such detailed clinical study information.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with international standards for dental impression materials and biocompatibility. The "reported device performance" section primarily states that the new device meets these standards, rather than providing specific numerical performance metrics.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 10993-5 (Cytotoxicity) | Compliant (Biocompatible) |
| ISO 10993-10 (Skin Irritation, Sensitization) | Compliant (Biocompatible) |
| ISO 4823:2015 (Dentistry - Elastomeric Impression Materials) | Compliant (Technological characteristics including setting time, consistency, elastic recovery, strain-in-compression are similar to predicate and meet standard). |
2. Sample Size for the Test Set and Data Provenance
Not provided in the document. The document states that performance and biocompatibility tests were carried out, but it does not specify the sample sizes or the provenance of the data (e.g., country of origin, retrospective/prospective nature). These tests would typically be laboratory-based rather than involving human subjects for effectiveness testing in the way a diagnostic AI would.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided in the document. For a dental impression material, "ground truth" would relate to its physical and chemical properties and biocompatibility as measured in laboratory settings against established standards, not interpretation by human experts in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical diagnostic studies where multiple readers interpret cases and their consensus defines ground truth. This is not relevant for the type of testing described for an impression material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not done. An MRMC study is relevant for diagnostic devices that assist human readers (e.g., AI for radiology). This device is a dental impression material, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Not applicable/Not done. This concept applies to AI algorithms. The device in question is a physical material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by international standards (ISO 4823:2015 for physical properties and ISO 10993-5, ISO 10993-10 for biocompatibility). This involves objective measurements and tests according to the methodologies defined by these standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
Not applicable/Not provided in the document. The concept of a "training set" applies to machine learning algorithms. This device is a physical product, not an AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document. As stated above, this device does not involve a training set for an AI algorithm.
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(79 days)
NS033C is to be used as a light body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- · Silicon dental impressions
- Crown/bridge work
- Inlays, Onlays
NS017C/NS017T is to be used as a heavy body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- Inlays, Onlays
MSP is to be used as a putty body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- Inlays. Onlays
MSBC is to be used as a bite type for:
- Making accurate occlusal registrations
- · Standards bite registrations in the end bite position.
- · Key material for needle point registration.
- Production of small model segments
MSRC is to be used as a regular body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, Onlays
MSCC is to be used as a regular body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- · Reline impressions
- Crown/bridge work
- Inlays. Onlays
PEAK is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon.
PEAK offers one light body type: NS033C.
PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance.
PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly.
This document describes the Neosil Co., Ltd. PEAK dental impression material and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore, the requested information regarding acceptance criteria and study details for such a device is not present.
However, based on the provided text for the PEAK dental impression material, I can extract the acceptance criteria and performance data for this traditional medical device.
1. A table of acceptance criteria and the reported device performance:
The document compares the PEAK device to a predicate device (BONASIL A+ by DMP, Limited) based on physical properties, which serve as the acceptance criteria.
| Acceptance Criteria (Predicate) | Reported Device Performance (PEAK) |
|---|---|
| ISO 4823 Specifications | Meets ISO 4823 specifications |
| Biocompatibility conforming to ISO 10993-1 | Biocompatible conforming to ISO 10993-1 |
| Physical Properties | |
| 1) Bonasil A+ Light (Type 3): | 1) NS033C (Type 3): |
| - Working time: about 120sec | - Working time: more than 40sec |
| - Elastic recovery rate: more than 96.5% | - Elastic recovery rate: more than 96.5% |
| - Linear Dimensional change: less than 1.5% | - Linear Dimensional change: less than 1.5% |
| 2) Bonasil A+ Heavy (Type 1): | 2) NS017C/NS017T (Type 1): |
| - Working time: about 120sec | - Working time: more than 40sec |
| - Elastic recovery rate: more than 96.5% | - Elastic recovery rate: more than 96.5% |
| - Linear Dimensional change: less than 1.5% | - Linear Dimensional change: less than 1.5% |
| 3) Bonasil A+ Putty (Type 0): | 3) MSP (Type 0): |
| - Elastic recovery rate: more than 96.5% | - Elastic recovery rate: more than 96.5% |
| - Linear Dimensional change: less than 1.5% | - Linear Dimensional change: less than 1.5% |
| 4) Bonasil A+Bonabite (Type 2): | 4) MSBC (Type 1): (Note: Classification Type differs for bite material, but other criteria are comparable.) |
| - Working time: about 30sec | - Working time: more than 30sec |
| - Linear Dimensional change: less than 1.5% | - Linear Dimensional change: less than 1.5% |
| - Hardness: more than 20HD | (No direct comparable hardness criterion listed for MSBC, but it is a bite type material.) The document states "Classification according to the standards (ISO 4823) : Type 1" for MSBC, while Bonabite is Type 2. This difference in classification type is noted. |
| 5) MSRC (Type 2): | |
| (No direct predicate comparison for MSRC) | - Mixing time: more than 30sec |
| - Elastic recovery rate: more than 96.5% | |
| - Linear Dimensional change: less than 1.5% | |
| 6) MSCC (Type 2): | |
| (No direct predicate comparison for MSCC) | - Mixing time: more than 30sec |
| - Elastic recovery rate: more than 96.5% | |
| - Linear Dimensional change: less than 1.5% |
Note: For the MSRC and MSCC types, direct predicate comparisons for their specific physical properties are not listed in the table, but the conclusion states "All the test results support substantial equivalence to the predicate devices." indicating their performance met relevant criteria.
The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests.
The requested information regarding AI/ML device studies is not applicable to this document. The document describes a traditional dental impression material, not an AI/ML powered device. Therefore, the following points cannot be answered:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
Details available from the document regarding the study:
- Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing.
- Tests Performed:
- ISO 4823 (Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test)
- ISO 10993-5 (Cytotoxicity Test)
- ISO 10993-10 (Skin Sensitization Test, Oral Mucous Irritation Test)
- ISO 10993-11 (Acute Systemic Toxicity Test)
- Other bench testing (Shelf life, Visual Inspection, Weight and Component Color Check)
- Conclusion: The manufacturer concluded that the PEAK device is substantially equivalent to the predicate devices based on these testing results.
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