(4 days)
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness.
The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated.
The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated.
The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray.
Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.
Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
Lascod Impression Materials are addition-curing polyvinylsiloxane silicones. They exhibit excellent accuracy, maximum thixotropy, and hydrophilicity. Additional elastomeric properties include, fast in the mouth setting time, high resistance to tear, dimensional accuracy, and resistance to permanent deformation. The Lascod impression material product line boasts multiple different variants: hard and soft putty; heavy, regular, light and superlight body – all putties and bodies, are available both as normal and fast set; mono and bite. Putties are provided in 300 or 150 ml plastic jars. The body and the bite product lines, are usually offered in the standard (1: 1) 50 ml dual barrel cartridges. The Mono product line is provided in two forms; a standard (1: 1) 50 ml dual cartridge, and a (5: 1) 380 ml, large dual cartridge.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is Lascod Impression Materials. The study proving its compliance refers to performance testing and biocompatibility testing against established standards.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 4823:2015 & ISO 10993) | Reported Device Performance (Lascod Impression Materials) |
|---|---|
| Consistency | Pass |
| Working time | Pass |
| Mixing time | Pass |
| Detail Reproduction | Pass |
| Compatibility with Gypsum | Pass |
| Linear Dimensional Change | Pass |
| Elastic Recovery | Pass |
| Strain in Compression | Pass |
| Shore A Hardness | Pass |
| Shelf Life | 3 Years |
| Cytotoxicity | Pass |
| Irritation | Pass |
| Sensitization | Pass |
Study Details:
The provided document describes a 510(k) Premarket Notification for Lascod Impression Materials, asserting its substantial equivalence to a predicate device (HySil Impression Materials, K170736). The "study" mentioned refers to the performance and biocompatibility testing conducted to demonstrate this equivalence.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the performance tests (e.g., how many samples were tested for consistency, detail reproduction, etc.).
- The data provenance is not explicitly stated as "country of origin of the data" or "retrospective/prospective." However, the tests were conducted to comply with international standards (ISO 4823:2015 and ISO 10993), implying a controlled laboratory setting. Given that Lascod Spa is based in Florence, Italy, it's reasonable to infer that the testing was either conducted in Italy or by accredited labs adhering to international standards. The testing described is prospective in nature, as it's for premarket notification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device. The "ground truth" for impression materials is not typically established by human expert consensus but rather by objective physical and chemical measurements against industry-defined standards (ISO 4823:2015). The "acceptance criteria" are the physical and chemical thresholds defined by the ISO standard.
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Adjudication method for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes. For material performance testing, the "adjudication" is inherent in the measurement process itself, where tests are performed according to a defined standard protocol, and results are objectively measured and compared against specified limits. There is no mention of human adjudication in this context.
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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 is not applicable. An MRMC study is relevant for AI or diagnostic imaging devices where human readers interpret data. This submission is for an impression material, a physical dental device, and does not involve AI or human readers interpreting its output in a diagnostic capacity.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is a physical impression material and not an algorithm or AI system.
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The type of ground truth used:
- The "ground truth" here is defined by international standards and specifications:
- ISO 4823:2015 "Dentistry Elastomeric Impression Materials": This standard defines the acceptable ranges and pass/fail criteria for physical properties like consistency, working time, detail reproduction, dimensional change, elastic recovery, strain in compression, and Shore A Hardness.
- ISO 10993 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": This standard defines the methods and criteria for biocompatibility testing, which includes cytotoxicity, irritation, and sensitization.
- The "ground truth" here is defined by international standards and specifications:
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The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning or AI model that requires a "training set."
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of device. The "ground truth" for the device's performance is established by the specifications and test methods outlined in the aforementioned ISO standards, which represent a consensus of expert knowledge in dental materials science.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).