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Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementation of post and screws; Final cementation of ceramic, composite or metal restorations on implant abutments; Cementation of abutments made of Lava™ zirconium oxide ceramic.

Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.

Here's a breakdown of the acceptance criteria and the study details for the Unicem HM device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device, Unicem HM, was compared to its predicate device, Unicem Aplicap, across several performance metrics. The acceptance criteria were established by relevant ISO and DIN standards.

Table 1: Acceptance Criteria and Reported Device Performance for Unicem HM

Summary of Device Performance against Acceptance Criteria:

Based on the table above, Unicem HM met all the specified limits for film thickness, working time, setting time, radiopacity, flexural strength (both dark and light cured), and compressive strength (both dark and light cured). For surface hardness, which had no specified numerical limit ("n.a."), the values are provided for comparison. The study concluded that Unicem HM is "safe and effective as as the predicate devices."

Study Details

The provided document describes a bench testing study comparing Unicem HM to a predicate device, Unicem Aplicap, and other predicate devices (Panavia F 2.0, Maxcem 2) were also referenced for substantial equivalence. This is not a clinical study involving human patients.

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

   • The document does not explicitly state the sample sizes (number of specimens tested) for each performance metric. It provides mean values and standard deviations (± values), which implies multiple samples were tested for each metric to calculate these statistics.
   • Data Provenance: The company submitting the 510(k) is 3M ESPE AG, based in Germany. Therefore, the data likely originated from Germany. The study is retrospective in the sense that the data appears to be from laboratory tests conducted to demonstrate compliance with standards for the premarket notification.

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

   • This question is not applicable (N/A) to this type of study. Ground truth, in the context of expert consensus, refers to clinical assessments or interpretations. As this is a bench testing study evaluating material properties against established standards, it does not involve expert readers establishing ground truth. The "ground truth" here is objective physical and chemical properties measured according to standardized methods.

3. Adjudication method for the test set:

   • N/A. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in clinical studies or image interpretation. This study involves objective measurements of material properties, not human interpretation, so no adjudication method was used.

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. This is not an MRMC study. It is a bench testing study for a dental cement, not a diagnostic device involving human readers or AI assistance.

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

   • No. This is not an algorithm or AI device. It is a material science study.

6. The type of ground truth used:

   • The "ground truth" in this context is based on established international standards (ISO and DIN) for dental materials. The device's performance was measured against these objective standards. Additionally, the performance of the predicate device serves as a benchmark for comparison to demonstrate substantial equivalence.

7. The sample size for the training set:

   • N/A. This is a material testing study, not a machine learning study, so there is no concept of a "training set."

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

   • N/A. As there is no training set for this type of study, this question is not applicable.

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Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic

Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.

The provided text is a 510(k) summary for a dental cement (Unicem Aplicap/Maxicap). It focuses on establishing substantial equivalence to predicate devices and expanding indications for use, primarily through comparison of performance data and biocompatibility testing. The document does not contain information on clinical studies that would involve acceptance criteria, test sets, ground truth establishment, or human reader performance as typically seen with AI/CADe devices.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria or a direct performance table as would be found for an AI/CADe device. It generally states that "the comparison for performance data and indications for use shows that Unicem Aplicap™ /Maxicap™ is substantially equivalent to its predicate devices."

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

Not applicable. The submission is for a dental cement, not an AI/CADe device that uses a "test set" of clinical data in this manner. The "performance data" mentioned likely refers to physical and chemical properties of the cement, not clinical image data.

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)

Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on medical images) is not relevant to this dental cement submission.

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

Not applicable.

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

Not applicable.

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

Not applicable.

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

Not applicable in the context of clinical image interpretation. For dental cements, "ground truth" would likely refer to established physical and chemical properties and their compliance with relevant international standards, which are not detailed here beyond a general statement of "biocompatibility testing."

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and therefore does not have a "training set" in the machine learning sense.

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

Not applicable.

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Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips.

Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. §872.3275[b]) because it is a device composed of various materials other than zinc oxideeugenol. Unicem is intended to affix dental :.cvices such as crowns and bridges. Unicem currently is available in two single dose delivery systems called Unicem Aplicap™ and Unicem Maxicap™. The existing and 510(k) cleared device Unicem is modified as follows: A multi-dose handmix version of Unicem, called Unicem HM, will be added to the single dose delivery systems. Unicem HM is considered as a modification to its predicate device Unicem. Unicem HM consists of a base and catalyst base and will be available in 3M ESPE's multi-dose device Clicker™. The intended use of Unicem HM is the same as cleared for Unicem, and the slight differences in chemical composition have been assessed for any effects regarding biocompatibility. The physical and chemical properties of Unicem HM were compared to those of Unicem. Furthermore, the physical-chemical property to release fluoride ions is added to the product description of Unicem. For this purpose, the fluoride release rates of Unicem have been measured following the guidance document: "Dental Cements - Premarket Notification" issued by CDRH on August 18, 1998, section 6.0.

The provided text is a 510(k) summary for a dental cement called Unicem. This document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance using the requested metrics.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Type of Device: Unicem is a dental cement, a physical material used to affix dental devices. It is not an AI/ML-driven diagnostic or image analysis device, which are the types of devices typically associated with "acceptance criteria," "reported device performance" in terms of accuracy/sensitivity/specificity, "sample sizes for test sets," "expert ground truth," "adjudication methods," "MRMC studies," or "standalone performance."
• Regulatory Focus: The 510(k) summary primarily focuses on demonstrating "substantial equivalence" of a modified version (Unicem HM, a multi-dose handmix version) to a previously cleared predicate device (Unicem). This involves comparing chemical composition, physical properties, and intended use, rather than clinical performance metrics in the way you've described for AI/ML devices.
• "Study" Mentioned: The only "study" mentioned is the measurement of fluoride release rates for Unicem, following a guidance document. This is a chemical/physical properties test, not a clinical trial or performance study against a ground truth in the context of an AI/ML device.

Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain that type of information for this kind of device.

If the request was for an AI/ML-driven diagnostic medical device, the information provided in such a 510(k) summary or associated study reports would typically include these details. However, for a dental cement, the "performance" is assessed through material properties and biocompatibility, not through diagnostic accuracy metrics or human reader studies.

The closest one could get to "acceptance criteria" and "reported device performance" from this document would be related to the physical and chemical properties compared with the predicate. For example, if the predicate device had specific benchmark values for flexural strength, bond strength, or setting time, the new device would need to meet those, and the study would show the measured values. However, these specific benchmarks are not detailed in this summary.

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Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips

Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275[b]) because it is a device composed of various materials other than zinc oxide-eugenol. Unicem is intended to affix dental devices such as crowns and bridges. Unicem self adhesive luting cement due to its newly developed chemistry combines the advantages of glass ionomer luting cements with esthetic properties of composite luting cements.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification summary for a dental cement called Unicem, indicating its substantial equivalence to predicate devices. The document mainly covers:

• Submitter Information: Company details, contact person.
• Device Name: Proprietary, classification, and common names.
• Predicate Devices: A list of existing devices used for comparison.
• Description for Premarket Notification: Details about Unicem, its composition, and its intended use (affixing dental devices). It mentions toxicology testing for biocompatibility and comparison with predicate devices for effectiveness, focusing on physical and mechanical properties.
• FDA Correspondence: A letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence.
• Indications for Use: The specified uses for the Unicem device.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance based on the provided text. The document states that the device was compared to predicate devices for effectiveness based on physical and mechanical properties, and biocompatibility testing was carried out, but it does not detail specific acceptance criteria or the study methodology, sample sizes, ground truth, or expert involvement as requested.

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