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An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.

The provided document is a 510(k) summary for a medical device called "Elastic Impression Material." It details the comparison with a predicate device and includes information on testing performed.

Here's an analysis to extract the requested information:

1. A table of acceptance criteria and the reported device performance

The document references ISO 4823:2021 for device effectiveness. Without the full standard or more specific details from the submission, the exact acceptance criteria for each parameter as defined by ISO 4823 cannot be fully detailed here. However, the document states: "The product submitted for inspection adopts Type 0 type product. which is based on the requirements of the ISO4823 standard, which divides this product into 0, 1, 2 and 3 type products, and the difference between these 4 types is mainly in the difference of 'consistency' index, and its chemical properties and biological evaluation requirements are consistent, and the Type 0 silicone rubber with the largest consistency is fully representative."

This implies that the device was evaluated against the requirements for a "Type 0" elastic impression material as per ISO 4823. The performance is reported as meeting these requirements, which leads to the conclusion of substantial equivalence.

For Biocompatibility, the device was tested according to ISO 10993 standards. The acceptance criteria for these would be specific to each test (e.g., absence of irritation, cytotoxicity, sensitization). The reported performance is that the device "has been verified in accordance with the above FDA recognized standards."

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

The document does not explicitly state the sample sizes used for the non-clinical tests (ISO 4823 or ISO 10993). It only mentions that the device "was tested." The data provenance is not specified beyond the fact that the tests were conducted for Beijing OKVD Biological Technology Ltd. in China. Given these are physical/chemical and biocompatibility tests, they are typically conducted in a laboratory setting, not on patient data. No clinical tests were performed, so concepts like retrospective/prospective clinical data do not apply.

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)

This question is not applicable. The evaluations performed are non-clinical (device effectiveness and biocompatibility) and rely on objective measurements against ISO standards. There is no "ground truth" established by experts in the context of clinical interpretation for this type of device.

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

This question is not applicable as there is no clinical data or expert review process described for the test set.

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 MRMC comparative effectiveness study was done. This device is an impression material, not an AI software or a device that requires human interpretation of outputs.

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

This question is not applicable. The device is a physical impression material, not an algorithm.

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

For device effectiveness (ISO 4823) and biocompatibility (ISO 10993): The "ground truth" is established by the specified requirements and test methodologies within the internationally recognized ISO standards themselves. These standards prescribe objective measurements and criteria, rather than subjective expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

The provided document describes the substantial equivalence determination for the "DentMix VPS Impression Material" (K223892) by comparing it to a predicate device, "Elements™" (K151150). The acceptance criteria are based on meeting or exceeding the performance of the predicate device across various physical properties, typically measured against recognized standards like ISO 4823-2015.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

A direct table of "acceptance criteria" is not explicitly stated as distinct from the predicate device's performance. Instead, the study aims to show that the subject device performs at least as well as the predicate device. Therefore, the predicate device's performance serves as the de facto acceptance benchmark.

Note on "Acceptance Criteria": For each of these properties, the acceptance criterion implicitly is that the DentMix VPS Impression Material is functionally equivalent to or performs within an acceptable range compared to the predicate device, often guided by the ISO 4823-2015 standard. "PASS" explicitly indicates meeting a standard. For numerical values, the goal is typically to be similar or better.

Study Details for DentMix VPS Impression Material

The document outlines a comparison study to demonstrate substantial equivalence, primarily focusing on physical properties.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the numerical "sample size" for each test point (e.g., number of specimens tested for consistency, working time, etc.). However, the values reported for "Linear Dimensional Change," "Elastic Recovery," and "Strain-In-Compression" include standard deviations (e.g., "0.14% (0.01)"), which implies that multiple measurements were taken to calculate an average and variability.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It presents the results as part of a 510(k) submission by IPB Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of detail (number and qualifications of experts) is typically associated with clinical studies or studies where human interpretation or consensus is required (e.g., image analysis). For material property testing as performed here, the "ground truth" is established by direct measurement of physical properties according to standardized test methods (e.g., those described in ISO 4823-2015). Experts in material science or dentistry might design and oversee these tests, but their "consensus" is not the ground truth in the same way it would be for diagnosing a medical image.

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

   • Adjudication methods (e.g., 2+1) are relevant for studies involving human interpretation and potential disagreement (e.g., reading medical images). For physical property testing of dental impression materials, direct measurements are taken, and typically, there is no "adjudication" in this sense. Quality control and adherence to standard protocols ensure reliability.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for evaluating a dental impression material, as it's a diagnostic tool comparison for medical imaging interpretation, not a material property evaluation.

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

   • This question is also not applicable. The device is a physical dental impression material, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the material itself.

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

   • The "ground truth" for the performance evaluation in this context is the results of standardized physical property tests as defined by recognized standards (specifically ISO 4823-2015). This is a direct measurement of material characteristics against objective criteria, not based on human consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • This concept is not applicable. The evaluation is a direct comparison of physical material properties against a predicate, not a machine learning model that requires a "training set."

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

   • Not applicable, as there is no training set for this type of device evaluation.

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Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

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The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.

The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.

The Dental Impression Material is very easy to mix and has good dimensional stability which helps to make precise impression taking.

The information provided describes the acceptance criteria and performance of the Dental Impression Material by Chemoment Materials Co.,ltd, as detailed in the 510(k) summary K221668.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each performance test. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device." These tests were conducted according to ISO standards (ISO 10993-05, ISO 10993-10, and ISO 4823:2021). The data provenance is not explicitly mentioned but is implied to be from laboratory testing performed by or for Chemoment Materials Co.,ltd as part of their regulatory submission. The tests are non-clinical, meaning they don't involve human subjects, and are therefore not classified as retrospective or prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device's performance was evaluated against established engineering and material science standards (ISO standards), not against a ground truth established by medical experts for diagnostic purposes.

4. Adjudication method for the test set

This information is not applicable as the tests are objective measurements against established standards, not subjective assessments requiring expert adjudication.

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 such study was conducted. This device is a material (dental impression material), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is defined by the objective pass/fail criteria set forth in the international standards ISO 4823:2021, and the biocompatibility standards ISO 10993-05:2009 and ISO 10993-10:2010. These standards provide specific measurable parameters for acceptable performance for dental impression materials.

8. The sample size for the training set

This is not applicable. The product is a material, not a machine learning algorithm that requires a training set.

9. 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.

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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.

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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The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.

The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.

The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.

1. Table of Acceptance Criteria and Reported Device Performance:

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VPS Impression Material(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;

K203824:VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as atwo-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.

The provided text is a 510(k) summary for a dental impression material (VPS Impression Material) and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.

The document describes the submission of a conventional medical device (dental impression material) and references standard performance testing (physical properties according to ISO 4823:2015) and biocompatibility testing (ISO 10993-5 and ISO 10993-10) to support its substantial equivalence to a predicate device. These tests are not related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor do they involve ground truth established by experts or multi-reader studies.

Therefore, I am unable to fulfill the request as it pertains to AI/ML device characteristics.

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HySil Heavy Plus is to be used as heavy-bodied materials for:

• One-step impression technique (simultaneous technique) using single or dual viscosities -
• Two-step impression technique using dual viscosities -
• Functional impressions -

HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:

• Taking impressions over fixed/removable restorations and implants -(i.e., transferring impressi on 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

HySil Light Plus 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 -

HySil Heavy Plus Auto is to be used as heavy-bodied materials for:

• One-step impression technique (simultaneous technique) using single or dual viscosities -
• Two-step impression technique using dual viscosities -
• Functional impressions -

HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.

I am sorry, but the provided text does not contain information about a study proving a device meets acceptance criteria related to artificial intelligence (AI) performance in medical image analysis. The document is an FDA 510(k) premarket notification for "HySil Plus Impression Materials," which are dental impression materials.

The document discusses:

• The device's name, regulation number, classification, and product code.
• Indications for use for different viscosities of the impression materials.
• Comparison to predicate devices, focusing on material composition, standards conformed to (ISO 4823), working time, shelf-life, and principle of operation.
• Non-clinical performance testing, including biocompatibility (ISO 10993-1, 5, 10, 11), sterilization validation (not applicable as non-sterile), shelf-life determination, and mechanical properties (ISO 4823).
• A statement that "No clinical studies are submitted."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI-powered device meets them, as this document is about a dental impression material and does not involve AI or medical image analysis.

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Used for all crown, bridge, and orthodontic impression techniques.

The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon. Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.

Based on the provided text, the document is a 510(k) summary for a dental "Impression Material" and does not describe an AI/ML-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, human-in-the-loop performance, etc.) are not applicable to this submission.

The document discusses the substantial equivalence of the "Impression Material" to a predicate device based on non-clinical tests and material properties.

Here's an analysis of the provided information, noting where the requested criteria are not applicable:

1. A table of acceptance criteria and the reported device performance

The relevant information is in "Table 2 Performance parameter" on page 5.

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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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