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510(k) Data Aggregation
(60 days)
PUTTY SOFT is to be used as preliminary materials for:
-Two-step Putty-wash impression technique
-One-step Putty-wash impression technique
HEAVY BODY materials for:
-One-step impression technique (simultaneous technique) using single or dual viscosities
-Two-step impression technique using dual viscosities
-Functional impression
MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
-Functional impressions
-Fabricating crown and bridgework or inlays
-Fabricating full or partial dentures
-Reline impressions
-Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
-Transferring root posts when fabricating posts and cores indirectly
LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
EXTRA LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
BITE REGISTRATION is used for impression as below.
-Taking occlusal surfaces
-Confirming occlusal surfaces
-Recording after putting the articulator
The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil. It is used by dentists to obtain anatomical data of the patient's mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions and/or check their effectiveness. They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy and resistance to permanent deformation, cured by addition reaction.
The IMICRYL family of silicone impression materials consists of six different viscosities (putty soft, heavy body, medium/monophase/regular body, light body, extra light body, bite registration) for various application systems. Putty Soft consists of 1:1 250 and 1:1 300 mL jars, other consistencies 1:1 50 mL syringes. Although the consistency and composition of medium, monophase and regular body products, which have type 2 consistency, are exactly the same, they are offered for sale under three different names.
The provided text describes the acceptance criteria and performance of the IMICRYL Impression Materials device, specifically focusing on its physical properties and comparison to a predicate device. However, it does not describe an AI/ML-based medical device. Therefore, I cannot extract information related to ground truth establishment, expert adjudication, MRMC studies, or training/test set sizes for AI/ML models.
Based on the information provided, here's an attempt to answer your questions with the available data, clarifying where information is missing due to the nature of the device:
Device Type: Dental Impression Material (not an AI/ML device)
Study Purpose: To demonstrate substantial equivalence to a legally marketed predicate device (HySil Impression Materials, K170736) for FDA 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the ISO 4823:2021 standard requirements and the comparison to the predicate device's performance. The "Remark" column in the provided table indicates where the new device's performance is considered "Same" or comparable, even if the exact numerical acceptance criteria aren't explicitly stated as pass/fail thresholds. The reported device performance is directly given in the "New Device" columns.
| Characteristic | Acceptance Criteria (Implied by ISO 4823:2021 & Predicate) | IMICRYL Impression Materials Performance (New Device) | Predicate Device Performance (HySil Impression Materials) | Remark/Comparison |
|---|---|---|---|---|
| PULY SOFT | ||||
| Type | Type 0 | Type 0 | Type 0 | Same |
| Consistency | Comparable to predicate (e.g., within a certain deviation) | 28.40 mm | 31.27 mm | |
| Working Time | Adequate for clinical use (e.g., >90 sec) | 90 sec | - | |
| Mixing Time | Consistent with predicate (e.g., ~30-38 sec) | 30 sec | 38 sec | |
| Detail Reproduction | Pass (e.g., ≤50μm) | 50μm | Pass | Consistent |
| Compatibility with gypsum | Pass (e.g., ≤50μm) | 50μm | Pass | Consistent |
| Linear Dimensional change | Minimize change (e.g., ≤0.031%) | 0.01% | 0.031% | Better/Similar |
| Elastic Recovery | High (e.g., ≥99.00%) | 99.00% | 99.8% | Similar |
| Strain-in-Compression | Low for stiffness (e.g., ~1.6%) | 1.6% | 1.6% | Same |
| HEAVY BODY | ||||
| Type | Type 1 | Type 1 | Type 1 | Same |
| Consistency | Comparable to predicate | 30.18 mm | 28.47 mm | |
| Working Time | Adequate for clinical use (e.g., >90 sec) | 90 sec | 2.022 min | |
| Mixing Time | Consistent with predicate | Auto (30 sec) | Pass | Consistent |
| Detail Reproduction | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Compatibility with gypsum | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Linear Dimensional change | Minimize change (e.g., ≤0.02%) | 0.01% | 0.02% | Better/Similar |
| Elastic Recovery | High (e.g., ≥98.80%) | 99.60% | 98.80% | Similar/Better |
| Strain-in-Compression | Similar to predicate (e.g., ~2.30%) | 2.30% | 2.30% | Same |
| MEDIUM/MONOPHASE/REGULAR BODY | ||||
| Type | Type 2 | Type 2 | Type 2 | Same |
| Consistency | Comparable to predicate | 34.35 mm | 35.65 mm | |
| Working Time | Adequate for clinical use (e.g., >90 sec) | 90 sec | 2.612 min | |
| Mixing Time | Consistent with predicate | Auto (30 sec) | Pass | Consistent |
| Detail Reproduction | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Compatibility with gypsum | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Linear Dimensional change | Minimize change (e.g., ≤0.02%) | 0.02% | 0.02% | Same |
| Elastic Recovery | High (e.g., ≥98.60%) | 99.99% | 98.60% | Similar/Better |
| Strain-in-Compression | Similar to predicate (e.g., ~3.00%) | 3.68% | 3.00% | |
| LIGHT BODY | ||||
| Type | Type 3 | Type 3 | Type 3 | Same |
| Consistency | Comparable to predicate | 36.67 mm | 45.60 mm | |
| Working Time | Adequate for clinical use (e.g., >90 sec) | 90 sec | 2.850 min | |
| Mixing Time | Consistent with predicate | Auto (30 sec) | Pass | Consistent |
| Detail Reproduction | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Compatibility with gypsum | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Linear Dimensional change | Minimize change (e.g., ≤0.03%) | 0.02% | 0.03% | Better/Similar |
| Elastic Recovery | High (e.g., ≥98.70%) | 99.99% | 98.70% | Similar/Better |
| Strain-in-Compression | Similar to predicate (e.g., ~2.30%) | 3.38% | 2.30% | |
| EXTRA LIGHT BODY | ||||
| Type | Type 3 | Type 3 | Type 3 | Same |
| Consistency | Comparable to predicate | 43.42 mm | 44.61 mm | |
| Working Time | Adequate for clinical use (e.g., >90 sec) | 90 sec | 3.6 min | |
| Mixing Time | Consistent with predicate | Auto (30 sec) | Pass | Consistent |
| Detail Reproduction | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Compatibility with gypsum | Pass (e.g., ≤20μm) | 20μm | Pass | Consistent |
| Linear Dimensional change | Minimize change (e.g., ≤0.027%) | 0.02% | 0.027% | Better/Similar |
| Elastic Recovery | High (e.g., ≥99.5%) | 99.99% | 99.5% | Similar/Better |
| Strain-in-Compression | Similar to predicate (e.g., ~2.6%) | 3.18% | 2.6% | |
| BITE REGISTRATION | ||||
| Type | Type B | Type B | Type B | Same |
| Mixing Time | Consistent with predicate | 30 sec | Pass | Consistent |
| Working Time | Consistent with predicate | 90 sec | Pass | Consistent |
| Time in Mouth (minimum) | Adequate for clinical use (e.g., ~1.5 min) | 3 min | 1 min. 30 sec. | Longer/Similar |
| Linear Dimensional change | Minimize change (e.g., ≤-0.16%) | 0.02% | -0.16% | Better/Similar |
| Compression set | Low (e.g., ≤0.06mm) | 0.06mm | Pass | Consistent |
| Hardness | Comparable to predicate (e.g., 50-55 HD) | 50 HD, 55 HD | 50 HD, 55 HD | Similar |
Note: "Pass" as a predicate device performance often implies that it met the ISO standard for that parameter. Some specific numerical benchmarks for "acceptance criteria" are derived from the predicate's performance or implied by the ISO standard.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document refers to "in-vitro bench tests." The specific sample sizes for each physical test (e.g., how many samples were tested for consistency, dimensional change, etc.) are not specified in this summary document.
- Data Provenance: The tests were conducted by the manufacturer, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S., which is based in Turkey. These are laboratory bench tests, not patient data. The nature is prospective in the sense that the tests were performed specifically for this 510(k) submission on manufactured material samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not an AI/ML device, so there is no "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for the physical properties is established through standardized laboratory bench testing methods defined in ISO 4823:2021. The results are objective measurements (e.g., mm, %, sec, μm), not subjective interpretations requiring expert review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device involving human interpretation review. Bench tests are objective measurements based on specified protocols.
5. Is 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 is a material testing for a dental impression material, not an AI/ML device designed to assist human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective physical measurements conducted in a laboratory setting according to the ISO 4823:2021 standard (Dentistry-Elastomeric impression and bite registration materials). The measurements include consistency, working/mixing time, detail reproduction, dimensional change, elastic recovery, strain-in-compression, and hardness.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for physical material properties.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, no "ground truth for a training set" was established. The "ground truth" (physical properties) is determined by direct laboratory measurement.
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