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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:

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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."

8. 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.

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Kromopan type 1 and 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Kromopan type 1, Kromopan type 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions.

The provided text describes dental impression materials (alginates) and their compliance with established standards, not an AI/ML powered medical device. Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics, sample sizes for test and training sets, expert qualifications, and AI-specific study details, is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices through chemical composition, intended use, and adherence to ISO standards and internal performance criteria for traditional material properties.

However, I can extract and present the relevant information regarding the performance and acceptance criteria for these dental alginate materials based on the provided text, and explain why other requested details are not present.

Acceptance Criteria and Device Performance (for Dental Alginates)

Since this is not an AI/ML device, performance is measured against established material standards and internal specifications, rather than clinical metrics like sensitivity or specificity.

Why other requested details are not applicable or provided in this document:

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

   • This document describes the properties of dental impression materials. Performance is evaluated against published international standards (ISO) and the manufacturer's own internal standards for material properties (e.g., mixing time, dimensional stability, elastic recovery). These tests are typically conducted in a laboratory setting on samples of the material, not on a "test set" of patient data or clinical images. Therefore, concepts like data provenance (country, retrospective/prospective) and sample size in the context of clinical data are not relevant here. The ISO standards themselves define the number of specimens required for each test.

2. 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):

   • "Ground truth" in the context of material properties is established by objective measurements based on scientific principles and standardized testing procedures (e.g., using calipers for dimensional stability, rheometers for setting time). It does not involve expert clinical interpretation in the way AI/ML models are evaluated.

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

   • Not applicable for material testing.

4. 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 is not an AI-powered device, nor does it involve "human readers" or "cases" in the diagnostic sense.

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

   • Not applicable. This is a physical dental material, not an algorithm.

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

   • The "ground truth" for material properties is derived from physical and chemical measurements following highly standardized laboratory protocols (e.g., dimensional accuracy measured against a known standard, mechanical properties measured using calibrated instruments).

7. The sample size for the training set:

   • Not applicable. This is a manufactured product, not a statistical model that requires a training set. The "training" for such a product involves R&D and manufacturing process validation.

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, the provided document is a 510(k) summary for traditional dental impression materials, focusing on demonstrating substantial equivalence to predicate devices and compliance with established material standards. It does not pertain to AI/ML powered devices, and thus the requested AI/ML specific information is not present.

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